does 10 mcg of vagifem need progesterone
 

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Drugs associated with Hypoestrogenism

The following drugs and medications are in some way related to, or used in the treatment of Hypoestrogenism. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.


Drug List: Activella Alora Cenestin Climara Clinagen-La-40 Combipatch-Patch-Bi-Weekly Delestrogen Dep-Gynogen Depo-Estradiol Enjuvia Estrace Estrace-Cream Estraderm-Patch Estradiol-Patch Estragyn-La-5 Estratab Estring-Local Gynodiol Gynogen-La-20 Menaval-20 Menest Mimvey Ogen Ogen-0-625 Ogen-1-25 Ogen-2-5 Ortho-Est Premarin Premarin-Injection Vagifem-Local Vivelle-Patch Vivelle-Dot
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Vagifem


Pronunciation: ES-tra-DYE-ol
Generic Name: Estradiol
Brand Name: Vagifem

Vagifem should not be used to prevent heart disease, heart attacks, strokes, or dementia. Estrogens have been shown to increase the risk of heart disease (including heart attack), stroke, dementia, serious blood clots (eg, in the lungs or legs), cancer of the uterus, and breast cancer in some women. Tell your doctor right away if you have unusual vaginal bleeding while you use Vagifem. Talk with your doctor if you have questions about the benefits and risks of using Vagifem.

Vagifem should be used for the shortest possible time at the lowest effective dose to minimize the risk of these side effects. Talk with your doctor regularly about your need to use Vagifem.


Vagifem is used for:

Treating itching, burning, and dryness in or around the vaginal area in women past menopause.

Vagifem is a vaginal estrogen tablet. It works by increasing the amount of estrogen in the body in certain women who do not produce enough on their own.

Do NOT use Vagifem if: you are allergic to any ingredient in Vagifem you are pregnant or suspect you may be pregnant, have recently given birth or are breast-feeding you have unexplained, abnormal vaginal bleeding; known or suspected cancer of the breast or uterus; or estrogen-dependent tumors you have a history of breast cancer, blood clots (eg, deep vein thrombosis, pulmonary embolism), or liver problems you have had a heart attack or stroke within the last year

Contact your doctor or health care provider right away if any of these apply to you.

Before using Vagifem:

Some medical conditions may interact with Vagifem. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you or a family member has a history of lumps in the breast, an abnormal mammogram, or breast cancer if you have yellowing of the whites of the eyes or skin during pregnancy or with past estrogen use, or high blood pressure during pregnancy (toxemia) if you have uterine problems (eg, uterine fibroids/endometriosis) or vaginal conditions (eg, abnormal vaginal bleeding, recurring vaginal infections, prolapse, stenosis) if you have abnormal calcium levels in the blood, asthma, cancer, a certain blood disorder (porphyria), cholesterol or lipid problems, depression, diabetes, excessive weight gain, gallbladder disease, heart disease or other heart problems, high blood pressure, kidney or liver problems, low thyroid hormone levels, lupus, migraine headaches, pancreas disease, seizures (eg, epilepsy), vision problems, or yellowing of the skin or eyes if you smoke, will be having surgery, or will be on bed rest

Some MEDICINES MAY INTERACT with Vagifem. Tell your health care provider if you are taking any other medicines, especially any of the following:

Clarithromycin, erythromycin, itraconazole, ketoconazole, or ritonavir because they may increase the risk of Vagifem's side effects Barbiturates (eg, phenobarbital), carbamazepine, hydantoins (eg, phenytoin), rifampin, or St. John's wort because they may decrease Vagifem's effectiveness Blood thinners (eg, warfarin), corticosteroids (eg, prednisone), succinylcholine, or tacrine because their actions and the risk of their side effects may be increased by Vagifem

This may not be a complete list of all interactions that may occur. Ask your health care provider if Vagifem may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Vagifem:

Use Vagifem as directed by your doctor. Check the label on the medicine for exact dosing instructions.

An extra patient leaflet is available with Vagifem. Talk to your pharmacist if you have questions about this information. To use, tear off a single applicator, separate the plastic wrap, and remove the applicator from the plastic wrap. Select the position for vaginal insertion that is most comfortable for you (lying on the bed, squatting, or standing with one leg on a stool). Use the finger of one hand to press the applicator plunger. Use the other hand to gently and comfortably guide the applicator into the vagina. If the tablet falls out of the applicator before inserting the filled applicator, use a new applicator with a fresh tablet. Insert the tablet as far into the vagina as it can comfortably go without force. After inserting the filled applicator, gently press the plunger until you hear a click and the plunger is fully depressed. This will eject the tablet inside your vagina. The tablet will dissolve slowly over several hours. After depressing the plunger, gently remove the applicator and throw it away. Do not reuse the applicator. You may insert the tablet-filled applicator any time of day. You should use the applicator at the same time each day. Grapefruit and grapefruit juice may increase the risk of Vagifem's side effects. Talk to your doctor before including grapefruit or grapefruit juice in your diet while you are taking Vagifem. If you miss a dose of Vagifem, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Vagifem.

Important safety information: Vagifem may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Vagifem with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. Limit alcoholic beverages while you are using Vagifem. Vagifem may cause dark skin patches on your face (melasma). Exposure to the sun may make these patches darker and you may need to avoid prolonged sun exposure and sunlamps. Consult your doctor regarding the use of sunscreens and protective clothing. Vagifem may increase the risk of blood clots. The risk may be greater if you smoke (especially in women older than 35 years of age). Contact your doctor if vaginal bleeding of unknown cause occurs. This could be a sign of a serious condition requiring immediate medical attention. Contact your doctor if vaginal discomfort occurs or if you suspect you have developed an infection while taking Vagifem. Follow your doctor's instructions for examining your breasts, and report any lumps immediately. If you wear contact lenses and you develop problems with them, contact your doctor. If you will be having surgery or will be confined to a chair or bed for a long period of time (eg, a long plane flight), notify your doctor beforehand. Special precautions may need to be taken in these circumstances while you are taking Vagifem. Vagifem may increase the risk of breast and endometrial cancer. Your doctor may prescribe another hormone (progestin) to decrease this risk. Your doctor should reevaluate you every 3 to 6 months to determine whether you need to continue taking Vagifem. Diabetes patients - Vagifem may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine. Vagifem may interfere with certain lab tests. Be sure your doctor and lab personnel know you are using Vagifem. Lab tests, including hormone levels, physical exams, and blood pressure, may be performed while you use Vagifem. These tests may be used to monitor your condition or check for side effects. You should have breast and pelvic exams and a Pap test at least once a year. You should also have periodic mammograms as determined by your doctor. Be sure to keep all doctor and lab appointments. Use Vagifem with caution in the ELDERLY; they may be more sensitive to its effects, including an increased risk of heart problems, stroke, breast or uterine cancer, and certain mental problems (eg, dementia). Vagifem should not be used in CHILDREN; safety and effectiveness in children have not been confirmed. PREGNANCY and BREAST-FEEDING: Do not use Vagifem if you are pregnant. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. Vagifem is found in breast milk. Do not breast-feed while taking Vagifem. Possible side effects of Vagifem:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Breast pain or tenderness; diarrhea; hair loss; headache; mild nausea or vomiting; spotting or breakthrough bleeding; stomach cramps or bloating.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); back pain; breast discharge or lump in the breast; calf or leg pain or swelling; chest pain; coughing up blood; dark urine; dizziness; fainting; fever; memory problems; mental or mood changes (eg, depression); muscle pain; one-sided weakness; painful or difficult urination; persistent or severe breast pain or tenderness; persistent or severe headache, nausea, or vomiting; severe or persistent stomach pain or swelling; slurred speech; sudden shortness of breath; sunburn-like rash; swelling of the hands, legs, or feet; unusual vaginal bleeding, discharge, itching, or odor; unusual weight changes; vision changes; vomiting; weakness or numbness of an arm or leg; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include excessive vaginal bleeding; severe nausea; vomiting.

Proper storage of Vagifem:

Store Vagifem at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Vagifem out of the reach of children and away from pets.

General information: If you have any questions about Vagifem, please talk with your doctor, pharmacist, or other health care provider. Vagifem is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Vagifem. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc.
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Progesterone Insert


Pronunciation: proe-JES-ter-one
Generic Name: Progesterone
Brand Name: Endometrin
Progesterone Insert is used for:

Supporting embryo implants and early pregnancy in certain women. It is also used as part of an assisted reproductive technology (ART) treatment program. It may also be used for other conditions as determined by your doctor.

Progesterone Insert is a hormone. It works by changing the lining of the uterus.

Do NOT use Progesterone Insert if: you are allergic to any ingredient in Progesterone Insert you have vaginal bleeding of an unknown cause, you have had a recent miscarriage, or the embryo is implanted outside the uterus (ectopic pregnancy) you know or suspect that you have breast cancer you have bleeding in the brain or severe blood vessel problems you have a history of bleeding or blood clotting problems (eg, blood clots in the legs, lungs, or eyes), heart attack, stroke, or liver disease you are using other vaginal products (eg, vaginal antifungal creams)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Progesterone Insert:

Some medical conditions may interact with Progesterone Insert. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have a history of heart or blood vessel problems, depression or other mental/mood problems, or cancer

Some MEDICINES MAY INTERACT with Progesterone Insert. Tell your health care provider if you are taking any other medicines, especially any of the following:

Carbamazepine or rifampin because they may decrease Progesterone Insert's effectiveness Other vaginal products (eg, vaginal antifungal creams) because they may alter Progesterone Insert's actions

This may not be a complete list of all interactions that may occur. Ask your health care provider if Progesterone Insert may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Progesterone Insert:

Use Progesterone Insert as directed by your doctor. Check the label on the medicine for exact dosing instructions.

An extra patient leaflet is available with Progesterone Insert. Talk to your pharmacist if you have questions about this information. Wash your hands before and after using Progesterone Insert. Unwrap the applicator and place one insert in the space provided at the end of the applicator. You may use Progesterone Insert while standing, sitting, or when lying on your back with your knees bent. Gently place the thin end of the applicator well into the vagina. Push the plunger to release the insert, then remove the applicator and throw it away in the trash. If you miss a dose of Progesterone Insert, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Progesterone Insert.

Important safety information: Progesterone Insert may cause drowsiness, dizziness, blurred vision, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Progesterone Insert with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. Do not use Progesterone Insert at the same time as other vaginal therapy without checking with your doctor. Progesterone Insert may cause harm if it is swallowed. If you may have taken it by mouth, contact your poison control center or emergency room right away. Progesterone Insert should not be used in CHILDREN; safety and effectiveness in children have not been confirmed. PREGNANCY and BREAST-FEEDING: Progesterone Insert is used to support early pregnancy. Progesterone Insert is found in breast milk. If you are or will be breast-feeding while you use Progesterone Insert, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Progesterone Insert:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Bloating; breast tenderness; constipation; cramping; drowsiness; fluid retention; headache; nausea; stomach pain; tiredness; vaginal burning or irritation; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (eg, rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal vaginal bleeding; calf or leg pain, swelling, or tenderness; change in emotions, mood, or behavior; chest pain; coughing up blood; fainting; one-sided weakness; pain in the groin; partial or complete loss of vision; stomach pain, swelling, or tenderness; sudden, severe headache, vomiting, dizziness, or fainting; sudden shortness of breath; swelling of hands, ankles, or feet; unusual vaginal itching, discharge, or odor; visual or speech disturbances; weakness or numbness in an arm or leg; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Progesterone side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Progesterone Insert:

Store Progesterone Insert at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat and light. Do not remove from the sealed foiled pouch until just before use. Keep Progesterone Insert out of the reach of children and away from pets.

General information: If you have any questions about Progesterone Insert, please talk with your doctor, pharmacist, or other health care provider. Progesterone Insert is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Progesterone Insert. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Progesterone resources Progesterone Side Effects (in more detail) Progesterone Use in Pregnancy & Breastfeeding Progesterone Drug Interactions Progesterone Support Group 15 Reviews for Progesterone - Add your own review/rating Compare Progesterone with other medications Amenorrhea Endometrial Hyperplasia, Prophylaxis Perimenopausal Symptoms Premature Labor Progesterone Insufficiency Seizures Uterine Bleeding
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Vagifem 25 ?g film-coated tablets


Vagifem 25 micrograms film-coated vaginal tablets

Estradiol hemihydrate

Read all of this leaflet carefully, before you start using this medicine. Keep this leaflet. You may need to read it again. If you have any questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet please tell your doctor or pharmacist. In this leaflet: 1. What Vagifem is and what it is used for 2. Before you use Vagifem 3. How to use Vagifem 4. Possible side effects 5. How to store Vagifem 6. Further information What Vagifem Is And What It Is Used For

Vagifem contains estradiol

Estradiol is a female sex hormone It belongs to a group of hormones called oestrogens It is exactly the same as the estradiol produced by the ovaries of women.

Vagifem belongs to a group of medicines called Hormone Replacement Therapy (HRT).

It is intended for post-menopausal women and is used to relieve menopausal symptoms in the vagina such as dryness or irritation. In medical terms this is known as ‘vaginal atrophy’. It is caused by a drop in the levels of oestrogen in your body. This happens naturally around the menopause.

Vagifem works by replacing the oestrogen which is normally produced in the ovaries of women.

It is inserted into your vagina, so the hormone is released where it is needed.

The experience of treating women older than 65 years is limited.

Before You Use Vagifem Medical check-ups

Before you start using Vagifem, your doctor will tell you about the risks and benefits of the treatment (see also Section 4). Before you start using Vagifem and regularly during treatment, your doctor will check whether Vagifem is the right treatment for you. Once you’ve started on HRT, your doctor will tell you how often to go for regular check-ups. At these check-ups, your doctor may discuss with you the benefits and risks of continuing to take HRT.

If you have a close relative (e.g. mother, sister, maternal or paternal grandmother), who has suffered from any serious illness such as blood clots or breast cancer, you might be at a higher risk for serious illness. Always tell your doctor about any close relative(s) suffering from serious illness.

As well as regular check-ups with your doctor, you should:

Regularly examine your breasts for any changes, such as dimpling or sinking of the skin, changes in the nipple, or any lumps you can see or feel. Tell your doctor if you notice any changes. Go for regular breast screening (mammography) and cervical smear tests. Do not use Vagifem if: You are allergic (hypersensitive) to estradiol or any of the other ingredients of Vagifem (listed in Section 6 below) You have or have ever had, or think you might have breast cancer You have or have had a hormone dependent tumour (e.g. cancer of the lining of the womb) You have unusual vaginal bleeding which you have not told your doctor about You have thickening of the lining of the womb (endometrial hyperplasia) and you are not being treated for it You have or previously have had a blood clot inside the blood vessels of the legs or lungs (deep vein thrombosis or pulmonary embolism) You have porphyria. This is a rare disease which affects the production of some of your blood pigments. You have active or recent arterial thromboembolic disease (e.g. angina, myocardial infarction) You have acute liver disease or history of liver disease as long as liver function tests have failed to return to normal

Do not use Vagifem if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before using this medicine.

Take special care with Vagifem

Check with your doctor before using Vagifem if you have or have ever had any of the illnesses in the list below. He or she may want to follow you more closely.

Asthma Epilepsy Diabetes Gallstones High blood pressure Migraines or severe headaches Liver problems such as ‘liver adenoma’ (a benign tumour) Endometrial hyperplasia (thickening of the lining of your womb) Otosclerosis. This is when you lose your hearing over a period of time Systemic lupus erythematosus (a disease affecting the skin, joints and kidneys) Blood clots or risk factors for blood clots (see Section 4 ‘Other side effects of systemic HRT’) Leiomyoma (benign tumours of the womb) or endometriosis (growth of the womb lining outside the womb)

If any of the above applies to you, or if you are not sure, talk to your doctor or pharmacist before using Vagifem.

Using other medicines

Please tell your doctor or pharmacist if you are using or have recently used any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding Do not use Vagifem if you think you might be pregnant, or if you are breast-feeding If you get pregnant while you are using Vagifem, stop using it and see a doctor straight away. Driving and using machines

No known effect.

How To Use Vagifem

Always use Vagifem exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Using this medicine You can start using Vagifem on any day which is best for you Insert the vaginal tablet into your vagina with the applicator.

The ’USER INSTRUCTIONS’ at the end of the leaflet tell you how to do this. Read the instructions carefully before using Vagifem.

How much to use Use one vaginal tablet each day for the first 2 weeks Then use one vaginal tablet twice a week. Leave 3 or 4 days between each dose. If you use more Vagifem than you should If you have used more Vagifem than you should, talk to a doctor or pharmacist. An overdose of oestrogen could make you feel sick or vomit. If you forget to use Vagifem If you forget a dose, use the medicine as soon as you remember. Do not use a double dose to make up for a forgotten dose.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

General information about treating symptoms of the menopause When using medicines for any menopausal symptoms, use the lowest dose that works. Also, use the medicine for as short a time as you need to.

Only continue treatment if the benefit is more than the risk.

Talk to your doctor about this.

Possible Side Effects

Like all medicines, Vagifem can cause side effects, although not everybody gets them.

Stop using Vagifem and see a doctor straight away if you notice any of the following side effects: A migraine-type headache you have not had before Yellow colouring of your skin or eyes (jaundice) or other liver problems A big increase in blood pressure Blood clots called ‘deep vein thrombosis’ (see also ‘Other side effects of systemic HRT’) If you develop any of the illnesses listed in Section 2, ’Do not use Vagifem You become pregnant Tell your doctor or pharmacist if any of the following side effects get serious or last longer than a few days:

Common (may affect more than 1 in 100 women)

Headache Passing wind (flatulence) Feeling sick (nausea) or being sick (vomiting) Indigestion Stomach pain, discomfort or distension Swelling of arms or legs (oedema) Vaginal bleeding, discharge or discomfort An infection of the genitals caused by a fungus or inflamed vagina Breast oedema or breast enlargement, breast pain or breast tenderness.

Very rare (may affect less than 1 in 10000 women)

Breast cancer Cancer of the lining of the womb (endometrial cancer) Thickening of the lining of your womb (endometrial hyperplasia) Blood clots called ‘deep vein thrombosis’ Other side effects of systemic HRT are: Allergic reaction (hypersensitivity) Diarrhoea Weight increase Fluid retention Being unable to sleep (insomnia) Feeling depressed Worsening of existing migraine Rash, including itchy, lumpy rash called ‘hives or urticaria’ Itching of the genitals Vaginal pain, irritation of the vagina, painful spasm of the vagina (vaginismus) or vaginal ulcers Increase in blood oestrogen (shown in blood test) Drug ineffective. Important information on the side effects of HRT

Vagifem is used for local treatment in the vagina and contains only a small amount of estradiol. This means that the chances of getting the diseases described below are less likely than with HRT products used for systemic treatment (treatment that affects the body as a whole).

As well as benefits, HRT has some risks which you need to consider when you’re deciding whether to take it, or whether to carry on taking it.

Effects on your heart or circulation

Heart disease

HRT is not recommended for women who have heart disease, or have had heart disease recently. If you have ever had heart disease, talk to your doctor to see if you should be taking HRT. HRT will not help to prevent heart disease.

Studies with one type of HRT (containing conjugated oestrogen plus the progestogen MPA) have shown that women may be slightly more likely to get heart disease during the first year of taking the medication. For other types of HRT, the risk is likely to be similar, although this is not yet certain.

If you get:

a pain in your chest that spreads to your arm or neck See a doctor as soon as possible and do not take any more HRT until your doctor says you can. This pain could be a sign of heart disease.

Stroke

Recent research suggests that systemic HRT slightly increases the risk of having a stroke. Other things that can increase the risk of stroke include:

getting older high blood pressure smoking drinking too much alcohol an irregular heartbeat

If you are worried about any of these things, or if you have had a stroke in the past, talk to your doctor to see if you should take HRT.

Compare

Looking at women in their 50s who are not taking HRT - on average, over a 5-year period, 3 in 1000 would be expected to have a stroke.

For women in their 50s who are taking HRT, the figure would be 4 in 1000.

Looking at women in their 60s who are not taking HRT - on average, over a 5-year period, 11 in 1000 would be expected to have a stroke.

For women in their 60s who are taking HRT, the figure would be 15 in 1000.

If you get:

unexplained migraine-type headaches, with or without disturbed vision See a doctor as soon as possible and do not take any more HRT until your doctor says you can. These headaches may be an early warning sign of a stroke.

Blood clots

Systemic HRT may increase the risk of blood clots in the veins (also called deep vein thrombosis, or DVT), especially during the first year of taking it.

These blood clots are not always serious, but if one travels to the lungs, it can cause chest pain, breathlessness, collapse or even death. This condition is called pulmonary embolism, or PE. DVT and PE are examples of a condition called venous thromboembolism, or VTE.

You are more likely to get a blood clot:

if you are seriously overweight if you have had a blood clot before if any of your close family have had blood clots if you have had one or more miscarriages if you have any blood clotting problem that needs treatment with a medicine such as warfarin if you’re off your feet for a long time because of major surgery, injury or illness if you have a rare condition called SLE

If any of these things apply to you, talk to your doctor to see if you should take HRT.

Compare

Looking at women in their 50s who are not taking HRT - on average, over a 5-year period, 3 in 1000 would be expected to get a blood clot.

For women in their 50s who are taking HRT, the figure would be 7 in 1000.

Looking at women in their 60s who are not taking HRT - on average, over a 5-year period, 8 in 1000 would be expected to get a blood clot.

For women in their 60s who are taking HRT, the figure would be 17 in 1000.

If you get:

painful swelling in your leg sudden chest pain difficulty breathing See a doctor as soon as possible and do not take any more HRT until your doctor says you can. These may be signs of a blood clot.

If you’re going to have surgery, make sure your doctor knows about it. You may need to stop taking HRT about 4 to 6 weeks before the operation, to reduce the risk of a blood clot. Your doctor will tell you when you can start taking HRT again.

Effects on your risk of developing cancer

Breast cancer

Women who have breast cancer, or have had breast cancer in the past, should not take HRT

Taking HRT slightly increases the risk of breast cancer; so does having a later menopause. The risk for a post-menopausal woman taking oestrogen-only HRT for 5 years is about the same as for a woman of the same age who’s still having periods over that time and not taking HRT.

The extra risk of breast cancer goes up the longer you take it, but returns to normal within about 5 years after stopping HRT.

Your risk of breast cancer is also higher:

if you have a close relative (mother, sister or grandmother) who has had breast cancer if you are seriously overweight

Compare

Looking at women aged 50 who are not taking HRT - on average, 32 in 1000 will be diagnosed with breast cancer by the time they reach the age of 65.

For women who start taking oestrogen-only HRT at age 50 and take it for 5 years, the figure will be between 33 and 34 in 1000 (i.e. an extra 1-2 cases).

If they take oestrogen-only HRT for 10 years, the figure will be 37 in 1000 (i.e. an extra 5 cases).

If you notice

any changes in your breast, such as:

dimpling of the skin changes in the nipple any lumps you can see or feel Make an appointment to see your doctor as soon as possible.

Endometrial cancer (cancer of the lining of the womb)

Taking oestrogen-only HRT tablets orally for a long time can increase the risk of developing cancer of the lining of the womb (the endometrium). It is possible there may be a similar risk with oestrogen cream/rings/tablets used directly in the vagina for repeated treatments or over a long time.

If you get breakthrough bleeding or spotting, it’s usually nothing to worry about, but you should

Make an appointment to see your doctor. It could be a sign that your endometrium has become thicker.

Ovarian cancer

Ovarian cancer (cancer of the ovaries) is very rare, but it is serious. It can be difficult to diagnose, because there are often no obvious signs of the disease.

Some studies have indicated that taking oestrogen-only HRT for more than 5 years may increase the risk of ovarian cancer. It is not yet known whether other kinds of HRT increase the risk in the same way.

HOW TO STORE Vagifem

Keep out of the reach and sight of children.

Do not store above 25°C. Do not refrigerate. Keep the blisters in the outer carton in order to protect from light.

Do not use Vagifem after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further Information What Vagifem contains The active substance is estradiol 25 micrograms (as estradiol hemihydrate) Other ingredients are: hypromellose, lactose monohydrate, maize starch and magnesium stearate The film-coating contains: hypromellose and Macrogol 6000. What Vagifem looks like and content of the pack

Each Vagifem comes in an applicator which is used once only.

There are 15 applicators with vaginal tablets in each box.

Vagifem is engraved with NOVO 279.

Marketing Authorisation Holder Novo Nordisk A/S Novo Alle DK-2880 Bagsvaerd Denmark The registered office in the UK is: Novo Nordisk Limited Broadfield Park Crawley West Sussex RH11 9RT Tel:(01293) 613555

This leaflet was last approved in: 04/2010

Detailed information on this medicine is available on the web site of www.emc.medicines.org.uk

User Instructions How to use Vagifem 1. Tear off one single blister pack. Open the end as shown in the picture. 2. Insert the applicator carefully into the vagina.

Stop when you can feel some resistance.

3. To release the tablet, gently press the push button until you feel a click.

The tablet will stick to the wall of the vagina straight away.

It will not fall out if you stand up or walk.

4. Take out the applicator and throw it away

Vagifem is a trademark owned by Novo Nordisk Femcare AG, Switzerland.

© 2010

Novo Nordisk A/S

8-2790-01-033-1


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Progesterone Oil


Pronunciation: proe-JES-ter-one
Generic Name: Progesterone
Brand Name: Generic only. No brands available.
Progesterone Oil is used for:

Treating absent menstrual periods. It may also be used to treat abnormal uterine bleeding caused by hormone imbalance. It may also be used for other conditions as determined by your doctor.

Progesterone Oil is a progestin hormone. It works by restoring a normal balance progesterone. This helps to regulate the menstrual cycle and to stop abnormal uterine bleeding that occurs when the body does not make enough progesterone on its own.

Do NOT use Progesterone Oil if: you are allergic to progesterone, progesterone-like medicines, benzyl alcohol, or sesame seeds or oil you have a history of certain blood vessel problems; blood clots (eg, in the legs, lungs, eyes); bleeding in the brain or stroke; liver problems; cancer of the breast, ovary, uterus, cervix, or genitals; undiagnosed vaginal bleeding; or miscarriage you are pregnant

Contact your doctor or health care provider right away if any of these apply to you.

Before using Progesterone Oil:

Tell your health care provider if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have a history of cancer, an abnormal mammogram, fibrocystic breast disease, lumps in the breast, bleeding from your nipples if you have a history of kidney problems, high blood pressure, migraine headaches, asthma, heart problems, seizures, high blood sugar or diabetes, high cholesterol, or mental or mood problems (eg, depression) if you have a family history of breast cancer

Some MEDICINES MAY INTERACT with Progesterone Oil. Tell your health care provider if you are taking any of the following medicines.

Rifampin because it may decrease Progesterone Oil's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Progesterone Oil may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Progesterone Oil:

Use Progesterone Oil as directed by your doctor. Check the label on the medicine for exact dosing instructions.

An extra patient leaflet is available with Progesterone Oil. Talk to your pharmacist if you have questions about this information. Progesterone Oil is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Progesterone Oil at home, a health care provider will teach you how to use it. Be sure you understand how to use Progesterone Oil. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions. Do not use Progesterone Oil if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged. Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal. If you miss a dose of Progesterone Oil, contact your doctor as soon as possible.

Ask your health care provider any questions you may have about how to use Progesterone Oil.

Important safety information: Progesterone Oil may cause drowsiness, dizziness, lightheadedness, or vision changes. These effects may be worse if you take it with alcohol or certain medicines. Use Progesterone Oil with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. Progesterone Oil may cause dark skin patches on your face. Exposure to the sun may make these patches darker. If patches develop, use a sunscreen or protective clothing when exposed to the sun, sunlamps, or tanning booths. Progesterone Oil may cause a decrease in the amount of calcium in your bones. A decrease in bone calcium is of most concern if you have the following risk factors: adolescence, bone disease, anorexia nervosa (an eating disorder), a strong family history of osteoporosis, taking certain medicines (eg, for epilepsy or steroids), or drinking a lot of alcohol or smoking cigarettes often. When Progesterone Oil is stopped, the calcium in bones begins to come back. Your health care provider may recommend that you take calcium or vitamin D to help lower the amount of calcium lost from your bones. Diabetes patients - Progesterone Oil may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine. Progesterone Oil may interfere with certain lab tests, including urinary steroid levels, gonadotropin and other hormone levels, thyroid function, blood clotting tests, and blood cholesterol. Be sure your doctor and lab personnel know you are using Progesterone Oil. Lab tests, including breast exams, pap smears, pelvic exams, and blood calcium and bone density tests, may be performed while you use Progesterone Oil. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments. Progesterone Oil should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed. PREGNANCY and BREAST-FEEDING: Do not use Progesterone Oil if you are pregnant. If you think you may be pregnant, contact your doctor right away. Progesterone Oil is found in breast milk. If you are or will be breast-feeding while you use Progesterone Oil, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Progesterone Oil:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Acne; drowsiness; nausea; pain, redness, and swelling at injection site; trouble sleeping; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue); breast pain or tenderness; calf or leg pain or swelling; changes in menstrual flow, including breakthrough bleeding, spotting, or missed periods; chest pain; coughing up blood; fast or irregular heartbeat; fever; flushing; lumps in the breast; mental or mood changes (eg, anxiety, depression); seizures; severe dizziness or fainting; severe stomach pain; shortness of breath; slurred speech; sudden loss of coordination; sudden or severe headache or vomiting; swelling of fingers or ankles; unusual weight gain or loss; vision problems (eg, double vision, partial or complete loss of vision); weakness, numbness, or pain in the arms or legs; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Progesterone side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Progesterone Oil:

Store Progesterone Oil at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Progesterone Oil out of the reach of children and away from pets.

General information: If you have any questions about Progesterone Oil, please talk with your doctor, pharmacist, or other health care provider. Progesterone Oil is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Progesterone Oil. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Progesterone resources Progesterone Side Effects (in more detail) Progesterone Use in Pregnancy & Breastfeeding Progesterone Drug Interactions Progesterone Support Group 15 Reviews for Progesterone - Add your own review/rating Compare Progesterone with other medications Amenorrhea Endometrial Hyperplasia, Prophylaxis Perimenopausal Symptoms Premature Labor Progesterone Insufficiency Seizures Uterine Bleeding
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Progesterone


Pronunciation: pro-JES-ter-one
Generic Name: Progesterone
Brand Name: Prometrium

Progesterone when combined with estrogen should not be used to prevent heart disease, heart attacks, strokes, or dementia. Progestin hormones combined with estrogen may increase the risk of heart disease (including heart attack), stroke, dementia, serious blood clots (eg, in the lungs or legs), cancer of the uterus, and breast cancer in some women. Talk with your doctor if you have questions about the benefits and risks of using Progesterone.

Progesterone should be used for the shortest possible time at the lowest effective dose to minimize the risk of these side effects. Talk with your doctor regularly about your need to use Progesterone.


Progesterone is used for:

Protecting the lining of the uterus in certain women who are also taking estrogen. It is used to treat certain women who have do not have a menstrual period because of decreased progesterone in the body. It may also be used for other conditions as determined by your doctor.

Progesterone is a progestin hormone. It works by changing the lining of the uterus.

Do NOT use Progesterone if: you are allergic to any ingredient in Progesterone or to peanuts you have known or suspected breast cancer or a history of breast cancer you have abnormal vaginal bleeding of unknown cause you have active blood clots (eg, in the legs or lungs) or a history of blood clots, heart attack, or stroke you have a history of liver problems or liver disease you are pregnant or suspect that you may be pregnant

Contact your doctor or health care provider right away if any of these apply to you.

Before using Progesterone:

Some medical conditions may interact with Progesterone. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have a history of breast lumps, breast disease, or an abnormal mammogram or if a member of your family has had breast cancer if you have a vaginal infection or a history of uterus problems (eg, fibroids, endometriosis, abnormal vaginal bleeding, cancer) or you have had your uterus removed (hysterectomy) if you have heart or blood vessel problems, bleeding problems, high blood pressure, high cholesterol or lipid levels, diabetes, kidney problems, thyroid problems, asthma, migraine headaches, or lupus if you have a history of seizures, mental or mood problems (eg, depression), cancer, or tobacco use if a member of your family has had blood clots (eg, in the legs or lungs) if you are very overweight or have high calcium levels in your blood

Some MEDICINES MAY INTERACT with Progesterone. Tell your health care provider if you are taking any other medicines, especially any of the following:

Efavirenz or rifamycins (eg, rifampin) because they may decrease Progesterone's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Progesterone may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Progesterone:

Use Progesterone as directed by your doctor. Check the label on the medicine for exact dosing instructions.

An extra patient leaflet is available with Progesterone. Talk to your pharmacist if you have questions about this information. Take Progesterone by mouth at bedtime, unless your doctor tells you otherwise. It may be taken with or without food. If you have trouble swallowing Progesterone, take it with a glass of water while in the standing position. Tell your doctor if you continue to have trouble swallowing Progesterone. If you miss a dose of Progesterone, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Progesterone.

Important safety information: Progesterone may cause drowsiness, dizziness, blurred vision, or light-headedness. These effects may be worse if you take it with alcohol or certain medicines. Use Progesterone with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. This product has peanut oil in it. Do not take Progesterone if you are allergic to peanuts. Diabetes patients - Progesterone may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine. If you will be having surgery or will be confined to a chair or bed for a long period of time (eg, a long plane flight), notify your doctor at least 4 to 6 weeks beforehand. You may need to stop taking Progesterone or take other special precautions for a period of time. Progesterone may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Progesterone. Lab tests, including physical exams, cholesterol levels, and blood pressure, may be performed while you use Progesterone. You should have breast and pelvic exams, and a Pap test at least once a year. You should also have periodic mammograms as determined by your doctor. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments. Progesterone should not be used in CHILDREN; safety and effectiveness in children have not been confirmed. PREGNANCY and BREAST-FEEDING: Do not use Progesterone if you are pregnant unless your doctor tells you otherwise. If you think you may be pregnant, contact your doctor. Progesterone is found in breast milk. If you are or will be breast-feeding while you use Progesterone, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Progesterone:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Bloating; breast tenderness; diarrhea; dizziness; drowsiness; fluid retention; headache; irritability; mild hair loss; muscle pain; nausea; spotting or breakthrough bleeding; stomach pain or cramping; tiredness; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal vaginal bleeding; breast lumps or pain; bulging eyes; calf or leg pain, swelling, redness, or tenderness; coughing up blood; fainting; mental or mood changes (eg, depression, anxiety); migraine or severe headache; new or worsening memory problems; seizures; severe or persistent dizziness; severe or persistent stomach pain or tenderness; shortness of breath; swelling of the hands, ankles, or feet; symptoms of a heart attack (eg, chest, jaw, or arm pain; sudden, severe nausea or vomiting; unusual sweating or weakness); symptoms of a stroke (eg, confusion; slurred speech; one-sided weakness); symptoms of liver problems (eg, dark urine, pale stools, yellowing of the skin or eyes); trouble walking; unusual vaginal discharge/itching/odor; vision problems or changes (eg, double vision; sudden, partial, or full loss of vision).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Progesterone side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Progesterone:

Store Progesterone at 77 degrees F (25 degrees C) in a tight, light-resistant container. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Progesterone out of the reach of children and away from pets.

General information: If you have any questions about Progesterone, please talk with your doctor, pharmacist, or other health care provider. Progesterone is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Progesterone. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Progesterone resources Progesterone Side Effects (in more detail) Progesterone Dosage Progesterone Use in Pregnancy & Breastfeeding Progesterone Drug Interactions Progesterone Support Group 15 Reviews for Progesterone - Add your own review/rating Progesterone Professional Patient Advice (Wolters Kluwer) Progesterone Prescribing Information (FDA) Progesterone Monograph (AHFS DI) Progesterone Natural MedFacts for Professionals (Wolters Kluwer) progesterone Advanced Consumer (Micromedex) - Includes Dosage Information Crinone Advanced Consumer (Micromedex) - Includes Dosage Information Crinone Prescribing Information (FDA) Endometrin Prescribing Information (FDA) Endometrin Consumer Overview Prochieve Prescribing Information (FDA) Progestins Monograph (AHFS DI) Prometrium Prescribing Information (FDA) Compare Progesterone with other medications Amenorrhea Endometrial Hyperplasia, Prophylaxis Perimenopausal Symptoms Premature Labor Progesterone Insufficiency Seizures Uterine Bleeding
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Vagifem 10 micrograms vaginal tablets


1. Name Of The Medicinal Product

Vagifem 10 micrograms vaginal tablets.

2. Qualitative And Quantitative Composition

Each vaginal tablet contains:

Estradiol hemihydrate equivalent to estradiol 10 micrograms.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Vaginal tablet.

White, film-coated, biconvex tablet, engraved with NOVO 278 on one side. Diameter 6 mm.

4. Clinical Particulars 4.1 Therapeutic Indications

Treatment of vaginal atrophy due to oestrogen deficiency in postmenopausal women (see section 5.1).

The experience treating women older than 65 years is limited.

4.2 Posology And Method Of Administration

Vagifem is administered intravaginally using the applicator.

Initial dose: One vaginal tablet daily for two weeks.

Maintenance dose: One vaginal tablet twice a week.

Treatment may be started on any convenient day.

If a dose is forgotten, it should be taken as soon as the patient remembers. A double dose should be avoided.

For initiation and continuation of treatment of postmenopausal symptoms, the lowest effective dose for the shortest duration (see also section 4.4) should be used.

A switch to the higher dose product Vagifem 25 micrograms should be considered if the response after three months is insufficient for satisfactory symptom relief.

Vagifem may be used in women with or without an intact uterus.

During treatment, especially during the first two weeks of daily administration, minimal systemic absorption may occur but as plasma estradiol levels usually do not exceed normal postmenopausal levels the addition of a progestagen is not recommended.

Vaginal infections should be treated before start of the Vagifem therapy.

Administration:

1. Open the blister pack at the plunger end.

2. Insert the applicator in the vagina until resistance is met (8-10 cm).

3. Release the tablet by pressing the plunger.

4. Withdraw the applicator and discard.

4.3 Contraindications

• Known, past or suspected breast cancer

• Known, past or suspected oestrogen-dependent malignant tumours (e.g. endometrial cancer)

• Undiagnosed genital bleeding

• Untreated endometrial hyperplasia

• Previous idiopathic or current venous thromboembolism (deep venous thrombosis, pulmonary embolism)

• Active or recent arterial thromboembolic disease (e.g. angina, myocardial infarction)

• Acute liver disease, or a history of liver disease as long as liver function tests have failed to return to normal

• Known hypersensitivity to the active substances or to any of the excipients

• Porphyria.

4.4 Special Warnings And Precautions For Use

For the treatment of postmenopausal symptoms, HRT should only be initiated for symptoms that adversely affect quality of life. In all cases, a careful appraisal of the risks and benefits should be undertaken at least annually and HRT should only be continued as long as the benefit outweighs the risk.

Medical examination/follow-up

Before initiating or reinstituting hormone therapy, a complete personal and family medical history should be obtained. Physical (including pelvic and breast) examination should be guided by this and by the contraindications and warnings for use. During treatment, periodic check-ups are recommended of a frequency and nature adapted to the individual woman. Women should be advised what changes in their breasts should be reported to their doctor or nurse. Investigations including mammography should be carried out in accordance with currently accepted screening practices, modified to the clinical needs of the individual.

Conditions which need supervision

If any of the following conditions are present, have occurred previously, and/or have been aggravated during pregnancy or previous hormone treatment, the patient should be closely supervised. It should be taken into account that these conditions may recur or be aggravated during systemic oestrogen treatment, in particular:

• Leiomyoma (uterine fibroids) or endometriosis

• A history of, or risk factors for, thromboembolic disorders (see below)

• Risk factors for oestrogen dependent tumours, e.g. 1st degree heredity for breast cancer

• Hypertension

• Liver disorders (e.g. liver adenoma)

• Diabetes mellitus with or without vascular involvement

• Cholelithiasis

• Migraine or (severe) headache

• Systemic lupus erythematosus

• A history of endometrial hyperplasia (see below)

• Epilepsy

• Asthma

• Otosclerosis.

Due to the local administration of low dose estradiol in Vagifem, the recurrence or aggravation of the above mentioned conditions is less likely than with systemic oestrogen treatment.

Reasons for immediate withdrawal of therapy

Therapy should be discontinued in case a contra-indication is discovered and in the following situations:

• Jaundice or deterioration in liver function

• Significant increase in blood pressure

• New onset of migraine-type headache

• Pregnancy

Endometrial hyperplasia

Women with intact uterus with abnormal bleeding of unknown aetiology or women with an intact uterus who have previously been treated with unopposed oestrogens should be examined with special care in order to exclude hyperstimulation/malignancy of the endometrium before initiation of treatment with Vagifem.

The risk of endometrial cancer after treatment with oral unopposed oestrogens is dependent on both duration of treatment and on oestrogen dose. The dose of estradiol in Vagifem is very low and treatment is local. A minor degree of systemic absorption may occur in some patients, especially during the first two weeks of once daily administration (see section 5.2). No systemic effect is expected during the local oestrogen treatment with Vagifem, and the addition of a progestagen is not recommended.

As a general rule, oestrogen replacement therapy should not be prescribed for longer than one year without another physical, including gynaecological examination being performed.

If bleeding or spotting appears at any time on therapy, the reason should be investigated, which may include endometrial biopsy to exclude endometrial malignancy.

The woman should be advised to contact her doctor in case bleeding or spotting occurs during treatment with Vagifem.

Unopposed oestrogen stimulation may lead to premalignant or malignant transformation in the residual foci of endometriosis. Therefore caution is advised when using this product in women who have undergone hysterectomy because of endometriosis, especially if they are known to have residual endometriosis.

Vagifem is a locally acting low dose estradiol preparation and therefore the occurrence of the below mentioned conditions is less likely than with systemic oestrogen treatment.

Breast cancer

Systemic oestrogen or oestrogen-progestagen treatment may increase the risk of breast cancer. Relative risk of breast cancer with conjugated equine oestrogens or estradiol was greater when a progestagen was added, either sequentially or continuously, and regardless of type of progestagen. A large randomised clinical trial (WHI trial) showed no increase in breast cancer incidence in hysterectomised postmenopausal women treated with conjugated equine oestrogen alone.

Venous thromboembolism

Systemic HRT is associated with a higher relative risk of developing venous thromboembolism (VTE), i.e. deep vein thrombosis or pulmonary embolism.

In the oestrogen alone sub-study of WHI, the risk of VTE (DVT and pulmonary embolism (PE)) was reported to be increased for women receiving daily conjugated equine oestrogens (CEE) compared to placebo (30 versus 22 per 10,000 women-years). The occurrence of such an event is more likely in the first year of treatment than later.

Generally recognised risk factors for VTE include a personal history or family history, severe obesity (BMI>30 kg/m2) and systemic lupus erythematosus (SLE). The risk of VTE may be temporarily increased with prolonged immobilisation, major trauma or major surgery. Where prolonged immobilisation is liable to follow elective surgery, particularly abdominal or orthopaedic surgery to the lower limbs, consideration should be given to temporarily stopping HRT 4 to 6 weeks prior to surgery, if possible. Treatment should not be restarted until the woman is completely mobilised.

If VTE develops after initiating therapy, the drug should be discontinued. Patients should be told to contact their doctors immediately when they experience a potential thromboembolic symptom (e.g., painful swelling of a leg, sudden pain in the chest, dyspnea). Those women already on anticoagulant treatment require careful consideration of the benefit-risk of use of HRT.

Coronary artery disease (CAD)

There is no evidence from randomised controlled trials that oestrogens or combined oestrogen-progestagen protect against coronary artery disease.

Stroke

In the WHI estrogen alone sub-study, a statistically significant increased risk of stroke was reported in women receiving daily conjugated oestrogens (CE 0.625 mg) compared to placebo (45 versus 33 per 10,000 women-years). The increase in risk was demonstrated after the first year of treatment and persisted.

Ovarian cancer

Use of systemic oestrogen alone and oestrogen plus progestagen therapies for at least 5-10 years has been associated with a slightly increased risk of ovarian cancer in some epidemiological studies.

Other conditions

Oestrogens may cause fluid retention, and therefore patients with cardiac or renal dysfunction should be carefully observed during the first weeks of treatment.

There is no conclusive evidence for improvement of cognitive function. There is some evidence from the WHI trial of increased risk of probable dementia in women who start using continuous combined CEE and MPA after the age of 65. It is unknown whether the findings apply to younger post-menopausal women or other HRT products.

Intravaginal applicator may cause minor local trauma, especially in women with serious vaginal atrophy.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Due to a local administration of the very low dose of estradiol in Vagifem, systemic interactions of clinical relevance are not expected.

4.6 Pregnancy And Lactation

Vagifem is not indicated during pregnancy. If pregnancy occurs during medication with Vagifem, treatment should be withdrawn immediately. The results of most epidemiological studies to date relevant to inadvertent foetal exposure to oestrogens indicate no teratogenic or foetotoxic effect.

Lactation

Vagifem is not indicated during lactation.

4.7 Effects On Ability To Drive And Use Machines

No effects known.

4.8 Undesirable Effects

Adverse events from clinical trials:

More than 673 patients have been treated with Vagifem 10 micrograms in clinical trials, including over 497 patients treated up to 52 weeks.

Oestrogen–related adverse events such as breast pain, peripheral oedema and postmenopausal bleedings have been reported at very low rates, similar to placebo, with Vagifem 10 micrograms, but if they occur, they are most likely present only at the beginning of the treatment. The adverse events observed with a higher frequency in patients treated with Vagifem 10 micrograms as compared to placebo and which are possibly related to treatment are presented below.

System organ class

Common

Uncommon

Rare

Infections and infestations

 

Vulvovaginal mycotic infection

 

Nervous system disorders

Headache

   

Gastrointestinal disorders

Abdominal pain

Nausea

 

Reproductive system and breast disorders

Vaginal haemorrhage, vaginal discharge or vaginal discomfort

   

Skin and subcutaneous tissue disorders

 

Rash

 

Investigations

 

Weight increased

 

Vascular disorders

 

Hot flush

Hypertension

 

Post-marketing experience:

In addition to the above mentioned adverse drug reactions, those presented below have been spontaneously reported for patients being treated with Vagifem 25 micrograms, and are considered possibly related to treatment. The reporting rate of these spontaneous adverse reactions is very rare (<1/10,000 patient years).

• Neoplasms benign and malignant (incl. cysts and polyps): breast cancer, endometrial cancer

• Immune system disorders: generalized hypersensitivity reactions (e.g. anaphylactic reaction/shock)

• Metabolism and nutrition disorders: fluid retention

• Psychiatric disorders: insomnia

• Nervous system disorders: migraine aggravated

• Vascular disorders: deep venous thrombosis

• Gastrointestinal disorders: diarrhoea

• Skin and subcutaneous tissue disorders: urticaria, rash erythematous, rash pruritic, genital pruritus

• Reproductive system and breast disorders: endometrial hyperplasia, vaginal irritation, vaginal pain, vaginismus, vaginal ulceration

• General disorders and administration site conditions: drug ineffective

• Investigations: weight increased, blood oestrogen increased.

Other adverse reactions have been reported in association with systemic oestrogen treatment:

• Myocardial infarction, congestive heart disease

• Stroke

• Gall bladder disease

• Skin and subcutaneous disorders: chloasma, erythema multiforme, erythema nodosum, vascular purpura

• Increase in size of fibroids

• Epilepsy

• Libido disorder

• Deterioration of asthma

• Probable dementia (see section 4.4).

4.9 Overdose

Vagifem is intended for intravaginal use and the dose of estradiol is very low. Overdose is therefore unlikely, but if it occurs, treatment is symptomatic.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Natural and semisynthetic oestrogens, plain

ATC code: G03CA03

The active ingredient, synthetic 17?-estradiol, is chemically and biologically identical to endogenous human estradiol.

Endogenous 17?-estradiol induces and maintains the primary and secondary female sexual characteristics. The biological effect of 17?-estradiol is carried out through a number of specific oestrogen receptors. The steroid receptor complex is bound to the cells DNA and induces synthesis of specific proteins.

Maturation of the vaginal epithelium is dependant upon oestrogens. Oestrogens increase the number of superficial and intermediate cells and decrease the number of basal cells in vaginal smear.

Oestrogens maintain vaginal pH around normal range (4.5) which enhances normal bacterial flora.

A 12-month double-blind, randomized, parallel group, placebo-controlled multicenter study was conducted to evaluate the efficacy and safety of Vagifem 10 micrograms in the treatment of postmenopausal vaginal atrophy symptoms.

After 12 weeks of treatment with Vagifem 10 micrograms the change from baseline, in comparison with placebo treatment, demonstrated significant improvements in the three primary endpoints: Vaginal Maturation Index and Value, normalization of Vaginal pH and relief of the moderate/severe urogenital symptoms considered most bothersome by the subjects.

Endometrial safety of Vagifem 10 micrograms was evaluated in the above mentioned trial and a second, open-label, multicenter trial. In total, 386 women underwent endometrial biopsy at the beginning and at the end of 52 weeks treatment. Incidence rate of hyperplasia and/or carcinoma was 0.52% (95% CI 0.06%, 1.86%), indicating no increased risk.

5.2 Pharmacokinetic Properties

Absorption

Oestrogens are well absorbed through the skin, mucous membranes, and the gastrointestinal tract. After vaginal administration, estradiol is absorbed circumventing first-pass metabolism.

A 12 weeks single-centre randomised, open label, multiple dose, parallel-group trial was conducted to evaluate the extent of systemic absorption of estradiol from the Vagifem 10 micrograms tablet. Subjects were randomized 1:1 to receive either 10 micrograms or 25 micrograms Vagifem. Plasma levels of estradiol (E2), oestrone (E1) and oestrone sulphate (E1S) were determined. AUC(0-24) for plasma E2 levels increased almost proportionally after the administration of 10 micrograms and 25 micrograms Vagifem. The AUC(0-24) indicated higher systemic estradiol levels for the 10 micrograms E2 tablet as compared to baseline on treatment days 1, 14 and 83, being statistically significant at days 1 and 14 (Table 1). However, average plasma E2 concentrations (Cave (0-24)) at all evaluated days remained within the normal postmenopausal range in all subjects. The data from days 82 and 83 as compared to baseline indicate that there is no cumulative effect during twice weekly maintenance therapy.

Table 1 Values of PK parameters from plasma Estradiol (E2) concentrations:

 

Vagifem 10 micrograms

   

AUC(0-24)

pg.h/mL

(geom. mean)

Cave(0-24)

pg/mL

(geom. mean)

Day -1

75.65

3.15

Day 1

225.35

9.39

Day 14

157.47

6.56

Day 82

44.95

1.87

Day 83

111.41

4.64

The levels of oestrone and oestrone sulphate after 12 weeks of Vagifem 10 micrograms administration did not exceed baseline levels, i.e., no accumulation of oestrone or oestrone sulphate was observed.

Distribution

The distribution of exogenous oestrogens is similar to that of endogenous oestrogens. Oestrogens are widely distributed in the body and are generally found in higher concentrations in the sex hormone target organs. Oestrogens circulate in the blood largely bound to sex hormone binding globulin (SHBG) and albumin.

Biotransformation

Exogenous oestrogens are metabolized in the same manner as endogenous oestrogens. The metabolic transformations take place mainly in the liver. Estradiol is converted reversibly to oestrone, and both can be converted to oestriol, which is the major urinary metabolite. In postmenopausal women, a significant portion of the circulating oestrogens exist as sulphate conjugates, especially oestrone sulphate, which serves as a circulating reservoir for the formation of more active oestrogens.

Elimination

Estradiol, oestrone and oestriol are excreted in the urine along with glucuronide and sulfate conjugates.

Special patient groups

The extent of systemic absorption of estradiol during treatment with Vagifem 10 micrograms has been evaluated in postmenopausal women, aged 60-70 (mean age 65.4) only.

5.3 Preclinical Safety Data

17?-Estradiol is a well-known substance. Nonclinical studies provided no additional data of relevance to clinical safety beyond those already included in other sections of the SPC.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Tablet core:

Hypromellose

Lactose monohydrate

Maize starch

Magnesium stearate

Film-coating:

Hypromellose

Macrogol 6000

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

3 years.

6.4 Special Precautions For Storage

Do not refrigerate.

6.5 Nature And Contents Of Container

Each tablet is contained in a disposable single-use polyethylene/polypropylene applicator. The applicators are packed separately in PVC/aluminium foil blisters.

18 packs contain 3 blister cards of 6 applicators with inset tablets

24 packs contain 4 blister cards of 6 applicators with inset tablets

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

Any unused product or waste material should be disposed of in accordance with local requirements.

7. Marketing Authorisation Holder

Novo Nordisk A/S

Novo All?

DK-2880 Bagsv?rd

Denmark

The registered office in the UK is:-

Novo Nordisk Ltd

Broadfield Park

Brighton Road

Crawley

West Sussex

RH11 9AT

Tel: 01293 613555

8. Marketing Authorisation Number(S)

PL 04668/0237

9. Date Of First Authorisation/Renewal Of The Authorisation

Date of first authorisation: 17th February 2010

10. Date Of Revision Of The Text
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Utrogestan 100mg Capsules


1. Name Of The Medicinal Product

UTROGESTAN 100MG CAPSULES

2. Qualitative And Quantitative Composition

Each capsule contains 100 mg micronised progesterone (INN). For excipients, see 6.1.

3. Pharmaceutical Form

Capsules, soft

White

4. Clinical Particulars 4.1 Therapeutic Indications

Adjunctive use with estrogen in post-menopausal women with an intact uterus. (HRT)

4.2 Posology And Method Of Administration

Posology

In women receiving estrogen replacement therapy there is an increased risk of endometrial cancer which can be countered by progesterone administration. The recommended dose is 200 mg daily at bedtime, for twelve days in the last half of each therapeutic cycle (beginning on day 15 of the cycle and ending on day 26). Withdrawal bleeding may occur in the following week. Alternatively 100 mg can be given at bedtime from day 1 to day 25 of each therapeutic cycle, withdrawal bleeding being less with this treatment schedule.

Children: Not applicable.

Elderly: As for adults

Method of Administration: Oral. Utrogestan 100mg Capsules should not be taken with food

4.3 Contraindications

Known allergy or hypersensitivity to progesterone or to any of the excipients. The capsules contain arachis oil (peanut oil) and should never be used by patients allergic to peanuts. Severe hepatic dysfunction. Undiagnosed vaginal bleeding. Mammary or genital tract carcinoma. Thrombophlebitis. Thromboembolic disorders. Cerebral haemorrhage. Porphyria.

4.4 Special Warnings And Precautions For Use

Warnings:

Utrogestan 100mg Capsules are not a treatment for premature labour.

Prescription of progesterone beyond the first trimester of pregnancy may reveal gravidic cholestasis.

Utrogestan 100mg Capsules are not suitable for use as a contraceptive.

If unexplained, sudden or gradual, partial or complete loss of vision, proptosis or diplopia, papilloedema, retinal vascular lesions or migraine occur during therapy, the drug should be discontinued and appropriate diagnostic and therapeutic measures instituted.

Utrogestan 100mg Capsules are intended to be co-prescribed with an estrogen product as HRT. Epidemiological evidence suggests that the use of HRT is associated with an increased risk of developing deep vein thrombosis (DVT) or pulmonary embolism. The prescribing information for the co-prescribed estrogen product should be referred to for information about the risks of venous thromboembolism.

There is suggestive evidence of a small increased risk of breast cancer with estrogen replacement therapy. It is not known whether concurrent progesterone influences the risk of cancer in post-menopausal women taking hormone replacement therapy. The prescribing information for the co-prescribed estrogen product should be referred to for information about the risks of breast cancer.

Precautions

Prior to taking hormone replacement therapy (and at regular intervals thereafter) each woman should be assessed. A personal and family medical history should be taken and physical examination should be guided by this and by the contraindications and warnings for this product.

Utrogestan 100mg Capsules should not be taken with food and should be taken at bedtime. Concomitant food ingestion increases the bioavailability of Utrogestan 100mg Capsules.

Utrogestan 100mg Capsules should be used cautiously in patients with conditions that might be aggravated by fluid retention (e.g. hypertension, cardiac disease, renal disease, epilepsy, migraine, asthma); in patients with a history of depression, diabetes, mild to moderate hepatic dysfunction, migraine or photosensitivity and in breast-feeding mothers.

Clinical examination of the breasts and pelvic examination should be performed where clinically indicated rather than as a routine procedure. Women should be encouraged to participate in the national breast cancer screening programme (mammography) and the national cervical cancer screening programme (cervical cytology) as appropriate for their age. Breast awareness should also be encouraged and women advised to report any changes in their breasts to their doctor or nurse.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Utrogestan 100mg Capsules may interfere with the effects of bromocriptine and may raise the plasma concentration of ciclosporin. Utrogestan 100mg Capsules may affect the results of laboratory tests of hepatic and/or endocrine functions.

Metabolism of Utrogestan 100mg Capsules is accelerated by rifamycin an antibacterial agent.

The metabolism of progesterone by human liver microsomes was inhibited by ketoconazole (IC50 <0.1 ?M Ketoconazole is a known inhibitor of cytochrome P450 3A4. These data therefore suggest that ketoconazole may increase the bioavailability of progesterone. The clinical relevance of the in vitro findings is unknown.

4.6 Pregnancy And Lactation

Pregnancy

Utrogestan 100mg Capsules are not indicated during pregnancy. If pregnancy occurs during medication, Utrogestan 100mg Capsules should be withdrawn immediately.

Lactation

Detectable amounts of progesterone enter the breast milk. There is no indication for prescribing HRT during lactation.

4.7 Effects On Ability To Drive And Use Machines

Utrogestan 100mg Capsules may cause drowsiness and/or dizziness in a minority of patients; therefore caution is advised in drivers and users of machines. Taking the capsules at bedtime should reduce these effects during the day.

4.8 Undesirable Effects

Somnolence or transient dizziness may occur 1 to 3 hours after intake of the drug. Bedtime dosing and reduction of the dose may reduce these effects.

Shortening of the cycle or breakthrough bleeding may occur. If this occurs, the dose of Utrogestan 100mg Capsules can be reduced and taken at bedtime from day 1 to day 26 of each therapeutic cycle.

Acne, urticaria, rashes, fluid retention, weight changes, gastro-intestinal disturbances, changes in libido, breast discomfort, premenstrual symptoms, menstrual disturbances; also chloasma, depression, pyrexia, insomnia, alopecia, hirsutism; rarely jaundice.

Venous thromboembolism, i.e. deep leg or pelvic venous thrombosis and pulmonary embolism, is more frequent among hormone replacement therapy users than among non-users.

4.9 Overdose

Symptoms of overdosage may include somnolence, dizziness, euphoria or dysmenorrhoea. Treatment is observation and, if necessary, symptomatic and supportive measures should be provided.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Pharmacotherapeutic group (ATC code: G03D)

Progesterone is a natural progestogen, the main hormone of the corpus luteum and the placenta. It acts on the endometrium by converting the proliferating phase to the secretory phase. Utrogestan 100mg Capsules have all the properties of endogenous progesterone with induction of a full secretory endometrium and in particular gestagenic, antiestrogenic, slightly anti-androgenic and antialdosterone effects.

5.2 Pharmacokinetic Properties

Absorption

Micronised progesterone is absorbed by the digestive tract. Pharmacokinetic studies conducted in healthy volunteers have shown that after oral administration of 2 capsules (200mg), plasma progesterone levels increased to reach the Cmax of 13.8ng/ml +/- 2.9ng/ml in 2.2 +/- 1.4 hours. The elimination half-life observed was 16.8+/- 2.3 hours.

Although there were inter-individual variations, the individual pharmacokinetic characteristics were maintained over several months, indicating predictable responses to the drug.

Distribution

Progesterone is approximately 96%-99% bound to serum proteins, primarily to serum albumin (50%-54%) and transcortin (43%-48%).

Elimination

Urinary elimination is observed for 95% in the form of glycuroconjugated metabolites, mainly 3 ?, 5 ?–pregnanediol (pregnandiol).

Metabolism

Progesterone is metabolised primarily by the liver. The main plasma metabolites are 20 ? hydroxy- ? 4 ?- prenolone and 5 ?-dihydroprogesterone. Some progesterone metabolites are excreted in the bile and these may be deconjugated and further metabolised in the gut via reduction, dehydroxylation and epimerisation. The main plasma and urinary metabolites are similar to those found during the physiological secretion of the corpus luteum.

5.3 Preclinical Safety Data

Preclinical data revealed no special hazard for humans based on conventional studies of safety pharmacology and toxicity.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Arachis oil

Soya lecithin

Gelatin

Glycerol

Titanium dioxide

6.2 Incompatibilities

None.

6.3 Shelf Life

3 years.

6.4 Special Precautions For Storage

No special precautions for storage.

6.5 Nature And Contents Of Container

The product is supplied in PVC/Aluminium blisters contained in cartons.

Pack size: 30 capsules

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Laboratoires BESINS INTERNATIONAL

3, rue du Bourg l'Abb?

75003

Paris

France

8. Marketing Authorisation Number(S)

PL 16468/0001

9. Date Of First Authorisation/Renewal Of The Authorisation

10 January 2003

10. Date Of Revision Of The Text

Feburary 2006


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Prometrium


Pronunciation: pro-JES-ter-one
Generic Name: Progesterone
Brand Name: Prometrium

Prometrium when combined with estrogen should not be used to prevent heart disease, heart attacks, strokes, or dementia. Progestin hormones combined with estrogen may increase the risk of heart disease (including heart attack), stroke, dementia, serious blood clots (eg, in the lungs or legs), cancer of the uterus, and breast cancer in some women. Talk with your doctor if you have questions about the benefits and risks of using Prometrium.

Prometrium should be used for the shortest possible time at the lowest effective dose to minimize the risk of these side effects. Talk with your doctor regularly about your need to use Prometrium.


Prometrium is used for:

Protecting the lining of the uterus in certain women who are also taking estrogen. It is used to treat certain women who have do not have a menstrual period because of decreased progesterone in the body. It may also be used for other conditions as determined by your doctor.

Prometrium is a progestin hormone. It works by changing the lining of the uterus.

Do NOT use Prometrium if: you are allergic to any ingredient in Prometrium or to peanuts you have known or suspected breast cancer or a history of breast cancer you have abnormal vaginal bleeding of unknown cause you have active blood clots (eg, in the legs or lungs) or a history of blood clots, heart attack, or stroke you have a history of liver problems or liver disease you are pregnant or suspect that you may be pregnant

Contact your doctor or health care provider right away if any of these apply to you.

Before using Prometrium:

Some medical conditions may interact with Prometrium. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have a history of breast lumps, breast disease, or an abnormal mammogram or if a member of your family has had breast cancer if you have a vaginal infection or a history of uterus problems (eg, fibroids, endometriosis, abnormal vaginal bleeding, cancer) or you have had your uterus removed (hysterectomy) if you have heart or blood vessel problems, bleeding problems, high blood pressure, high cholesterol or lipid levels, diabetes, kidney problems, thyroid problems, asthma, migraine headaches, or lupus if you have a history of seizures, mental or mood problems (eg, depression), cancer, or tobacco use if a member of your family has had blood clots (eg, in the legs or lungs) if you are very overweight or have high calcium levels in your blood

Some MEDICINES MAY INTERACT with Prometrium. Tell your health care provider if you are taking any other medicines, especially any of the following:

Efavirenz or rifamycins (eg, rifampin) because they may decrease Prometrium's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Prometrium may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Prometrium:

Use Prometrium as directed by your doctor. Check the label on the medicine for exact dosing instructions.

An extra patient leaflet is available with Prometrium. Talk to your pharmacist if you have questions about this information. Take Prometrium by mouth at bedtime, unless your doctor tells you otherwise. It may be taken with or without food. If you have trouble swallowing Prometrium, take it with a glass of water while in the standing position. Tell your doctor if you continue to have trouble swallowing Prometrium. If you miss a dose of Prometrium, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Prometrium.

Important safety information: Prometrium may cause drowsiness, dizziness, blurred vision, or light-headedness. These effects may be worse if you take it with alcohol or certain medicines. Use Prometrium with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. This product has peanut oil in it. Do not take Prometrium if you are allergic to peanuts. Diabetes patients - Prometrium may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine. If you will be having surgery or will be confined to a chair or bed for a long period of time (eg, a long plane flight), notify your doctor at least 4 to 6 weeks beforehand. You may need to stop taking Prometrium or take other special precautions for a period of time. Prometrium may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Prometrium. Lab tests, including physical exams, cholesterol levels, and blood pressure, may be performed while you use Prometrium. You should have breast and pelvic exams, and a Pap test at least once a year. You should also have periodic mammograms as determined by your doctor. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments. Prometrium should not be used in CHILDREN; safety and effectiveness in children have not been confirmed. PREGNANCY and BREAST-FEEDING: Do not use Prometrium if you are pregnant unless your doctor tells you otherwise. If you think you may be pregnant, contact your doctor. Prometrium is found in breast milk. If you are or will be breast-feeding while you use Prometrium, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Prometrium:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Bloating; breast tenderness; diarrhea; dizziness; drowsiness; fluid retention; headache; irritability; mild hair loss; muscle pain; nausea; spotting or breakthrough bleeding; stomach pain or cramping; tiredness; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal vaginal bleeding; breast lumps or pain; bulging eyes; calf or leg pain, swelling, redness, or tenderness; coughing up blood; fainting; mental or mood changes (eg, depression, anxiety); migraine or severe headache; new or worsening memory problems; seizures; severe or persistent dizziness; severe or persistent stomach pain or tenderness; shortness of breath; swelling of the hands, ankles, or feet; symptoms of a heart attack (eg, chest, jaw, or arm pain; sudden, severe nausea or vomiting; unusual sweating or weakness); symptoms of a stroke (eg, confusion; slurred speech; one-sided weakness); symptoms of liver problems (eg, dark urine, pale stools, yellowing of the skin or eyes); trouble walking; unusual vaginal discharge/itching/odor; vision problems or changes (eg, double vision; sudden, partial, or full loss of vision).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Prometrium side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Prometrium:

Store Prometrium at 77 degrees F (25 degrees C) in a tight, light-resistant container. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Prometrium out of the reach of children and away from pets.

General information: If you have any questions about Prometrium, please talk with your doctor, pharmacist, or other health care provider. Prometrium is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Prometrium. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Prometrium resources Prometrium Side Effects (in more detail) Prometrium Dosage Prometrium Use in Pregnancy & Breastfeeding Drug Images Prometrium Drug Interactions Prometrium Support Group 12 Reviews for Prometrium - Add your own review/rating Prometrium Advanced Consumer (Micromedex) - Includes Dosage Information Prometrium Prescribing Information (FDA) Progesterone Prescribing Information (FDA) Progesterone Professional Patient Advice (Wolters Kluwer) Progesterone Natural MedFacts for Professionals (Wolters Kluwer) Progesterone Monograph (AHFS DI) progesterone Advanced Consumer (Micromedex) - Includes Dosage Information Crinone Prescribing Information (FDA) Endometrin Prescribing Information (FDA) Endometrin Consumer Overview Prochieve Prescribing Information (FDA) Progestins Monograph (AHFS DI) Compare Prometrium with other medications Amenorrhea Endometrial Hyperplasia, Prophylaxis Perimenopausal Symptoms Premature Labor Progesterone Insufficiency Seizures Uterine Bleeding
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Crinone Gel


Pronunciation: pro-JESS-ter-ohn
Generic Name: Progesterone
Brand Name: Crinone and Prochieve
Crinone Gel is used for:

Supplementing or replacing progesterone in infertile women with progesterone deficiency. It is also used in certain women who do not menstruate and have not responded to lower strengths of Crinone Gel. It may also be used for other conditions as determined by your doctor.

Crinone Gel is a hormone. It works by preparing the uterus (womb) for implantation of a fertilized egg and protecting the lining of the uterus. It is also needed for the maintenance of a healthy pregnancy.

Do NOT use Crinone Gel if: you are allergic to any ingredient in Crinone Gel you have cancer of the breast, ovary, lining of the uterus, cervix, or vagina; a history of blood clots or clotting problems; vaginal bleeding of unknown cause; or liver disease; or you have had a stroke, a recent miscarriage, or bleeding in the brain

Contact your doctor or health care provider right away if any of these apply to you.

Before using Crinone Gel:

Some medical conditions may interact with Crinone Gel. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have heart or blood vessel problems, bleeding problems, high blood pressure, high cholesterol or lipid levels, diabetes, kidney problems, asthma, migraine headaches, or lupus if you have a history of seizures, depression or other mental/mood problems, cancer, or tobacco use if you have a family history of blood clots if you are very overweight

Some MEDICINES MAY INTERACT with Crinone Gel. Tell your health care provider if you are taking any other medicines, especially any of the following:

Rifampin because it may decrease Crinone Gel's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Crinone Gel may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Crinone Gel:

Use Crinone Gel as directed by your doctor. Check the label on the medicine for exact dosing instructions.

An extra patient leaflet is available with Crinone Gel. Talk to your pharmacist if you have questions about this information. Review the patient insert for proper preparation and use of the vaginal applicator. If you miss a dose of Crinone Gel, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Crinone Gel.

Important safety information: Crinone Gel may cause drowsiness, dizziness, blurred vision, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Crinone Gel with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. Crinone Gel may cause dark skin patches on your face. Exposure to the sun may make these patches darker. If patches develop, use a sunscreen or protective clothing when exposed to the sun, sunlamps, or tanning booths. Do not use Crinone Gel at the same time as other vaginal therapy without checking with your doctor. If other vaginal therapy is to be used, administer it 6 or more hours before or after Crinone Gel, unless advised otherwise by your health care provider. Crinone Gel may cause harm if it is swallowed. If you may have taken it by mouth, contact your poison control center or emergency room right away. Diabetes patients - Crinone Gel may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine. Lab tests, including monthly breast self-exams, yearly breast exams, Pap smears, and pelvic exams, may be performed while you use Crinone Gel. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments. Crinone Gel should not be used in CHILDREN; safety and effectiveness in children have not been confirmed. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Crinone Gel while you are pregnant. Crinone Gel is found in breast milk. If you are or will be breast-feeding while you use Crinone Gel, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Crinone Gel:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Breast enlargement; breast pain; changes in sex drive; constipation; cramps; depression; diarrhea; difficult or painful sexual intercourse; drowsiness; fatigue; fluid retention/bloating; headache; increased appetite; joint pain; nausea; nervousness; pain around vaginal area; sleep disorder; urination at night; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal vaginal bleeding; breast lumps; calf/leg pain or tenderness; change in emotions, mood, or behavior; chest pain; coughing blood; dizziness; fainting; inflammation of the eye; numbness of arm or leg; one-sided weakness; pain in the groin; partial or complete loss of vision; seizure; stomach pain, swelling, or tenderness; sudden, severe headache, vomiting, dizziness, or fainting; sudden shortness of breath; swelling of hands, ankles, or feet; tremor; unusual vaginal discharge or odor; vaginal itching; visual or speech disturbances; weakness or numbness in an arm or leg; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Crinone side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Crinone Gel:

Store Crinone Gel at room temperature, below 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat and light. Keep Crinone Gel out of the reach of children and away from pets.

General information: If you have any questions about Crinone Gel, please talk with your doctor, pharmacist, or other health care provider. Crinone Gel is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Crinone Gel. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Crinone resources Crinone Side Effects (in more detail) Crinone Use in Pregnancy & Breastfeeding Crinone Drug Interactions Crinone Support Group 0 Reviews for Crinone - Add your own review/rating Compare Crinone with other medications Amenorrhea Endometrial Hyperplasia, Prophylaxis Perimenopausal Symptoms Premature Labor Progesterone Insufficiency Seizures Uterine Bleeding
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Endometrin



Dosage Form: vaginal tablet
FULL PRESCRIBING INFORMATION INDICATIONS AND USAGE

Endometrin is indicated to support embryo implantation and early pregnancy by supplementation of corpus luteal function as part of an Assisted Reproductive Technology (ART) treatment program for infertile women.

DOSAGE AND ADMINISTRATION General Dosing Information

The dose of Endometrin is 100 mg administered vaginally two or three times daily starting the day after oocyte retrieval and continuing for up to 10 weeks total duration. Efficacy in women 35 years of age and older has not been clearly established. The appropriate dose of Endometrin in this age group has not been determined.

Dosage Forms and Strengths

100 mg vaginal insert is a white to off-white oblong-shaped tablet debossed with “FPI” on one side and “100” on the other side.

Contraindications

Endometrin should not be used in individuals with any of the following conditions:

Previous allergic reactions to progesterone or any of the ingredients of Endometrin [see Description (11)] Known missed abortion or ectopic pregnancy Liver disease Known or suspected breast cancer Active arterial or venous thromboembolism or severe thrombophlebitis, or a history of these events Warnings and Precautions Cardiovascular or Cerebrovascular Disorders

The physician should be alert to earliest signs of myocardial infarction, cerebrovascular disorders, arterial or venous thromboembolism (venous thromboembolism or pulmonary embolism), thrombophlebitis, or retinal thrombosis. Endometrin should be discontinued if any of these are suspected.

Depression

Patients with a history of depression need to be closely observed. Consider discontinuation if symptoms worsen.

Use of Other Vaginal Products

Endometrin is not recommended for use with other vaginal products (such as antifungal products) as this may alter progesterone release and absorption from the vaginal insert [see Drug Interactions (7)].

Adverse Reactions Clinical Studies Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety data reflect exposure to Endometrin in 808 infertile women (74.9% White, 10.3% Hispanic, 5.4% Black, 5% Asian, and 4.6% Other) in a single Assisted Reproductive Technology 10 week clinical study conducted in the U.S. Endometrin was studied at doses of 100 mg twice daily and 100 mg three times daily. The adverse reactions that occurred at a rate greater than or equal to 2% in either Endometrin group are summarized in Table 1.

Table 1: Number and Frequency of Reported Adverse Reactions in Women Treated with Endometrin in an Assisted Reproductive Technology Study Body System Endometrin
100 mg twice
daily
(N=404) Endometrin
100 mg three
times daily
(N=404)   Preferred Term     Gastrointestinal Disorders   Abdominal pain 50 (12%) 50 (12%)   Nausea 32 (8%) 29 (7%)   Abdominal distension 18 (4%) 17 (4%)   Constipation 9 (2%) 14 (3%)   Vomiting 13 (3%) 9 (2%) General Disorders & Administration Site Conditions   Fatigue 7 (2%) 12 (3%) Infections and Infestations   Urinary tract infection 9 (2%) 4 (1%) Injury, Poisoning and Procedural Complications   Post-oocyte retrieval pain 115 (28%) 102 (25%) Nervous System Disorders   Headache 15 (4%) 13 (3%) Reproductive System and Breast Disorders   Ovarian hyperstimulation syndrome 30 (7%) 27 (7%)   Uterine spasm 15 (4%) 11 (3%)   Vaginal bleeding 13 (3%) 14 (3%)

Other less common reported adverse reactions included vaginal irritation, itching, burning, discomfort, urticaria, and peripheral edema.

Expected Adverse Reaction Profile Seen with Progesterone

Endometrin is also expected to have adverse reactions similar to other drugs containing progesterone that may include breast tenderness, bloating, mood swings, irritability, and drowsiness.

Drug Interactions

No formal drug-drug interaction studies have been conducted for Endometrin. Drugs known to induce the hepatic cytochrome-P450-3A4 system (such as rifampin, carbamazepine) may increase the elimination of progesterone. The effect of concomitant vaginal products on the exposure of progesterone from Endometrin has not been assessed. Endometrin is not recommended for use with other vaginal products (such as antifungal products) as this may alter progesterone release and absorption from the vaginal insert [see Warnings and Precautions(5.3)].

USE IN SPECIFIC POPULATIONS Pregnancy

Endometrin has been used to support embryo implantation and maintain clinical pregnancy in one clinical study. The livebirth outcomes of these pregnancies were as follows:

Among the 404 subjects treated with Endometrin twice daily, 143 subjects had livebirths consisting of 85 singletons, 56 twins, and 2 triplets. In this treatment group, 13 subjects had a spontaneous abortion, 1 subject had an ectopic pregnancy, and 7 subjects reported fetal birth defects (3.4% based on 203 livebirths). Among the 404 subjects treated with Endometrin three times daily, 155 subjects had livebirths consisting of 91 singletons, 60 twins, and 4 triplets. In this treatment group, 22 subjects had a spontaneous abortion, 4 subjects had an ectopic pregnancy, and 7 subjects reported fetal birth defects (3.1% based on 223 livebirths).

Birth defects reported in the Endometrin twice daily group included: one fetus with a cleft palate and intrauterine growth retardation, one fetus with spina bifida, three fetuses with congenital heart defects, one fetus with an umbilical hernia, and one fetus with an intestinal anomaly.

Birth defects reported in the Endometrin three times daily group included: one fetus with an esophageal fistula, one fetus with hypospadias and an underdeveloped right ear, one fetus with Down’s and an atrial septal defect, one fetus with congenital heart anomalies, one fetus with DiGeorge’s syndrome, one fetus with a hand deformity, and one fetus with cleft palate.

For additional information on the pharmacology of Endometrin and pregnancy outcome information [see Clinical Pharmacology (12) and Clinical Studies Sections (14)].

Nursing Mothers

Detectable amounts of progesterone have been identified in the milk of nursing mothers. The effect of this on the nursing infant has not been determined.

Pediatric Use

This drug is not intended for pediatric use and no clinical data have been collected in children. Therefore, the safety and effectiveness of Endometrin in pediatric patients have not been established.

Geriatric Use

No clinical data have been collected in patients over age 65.

Overdosage

Treatment of overdosage consists of discontinuation of Endometrin together with institution of appropriate symptomatic and supportive care.

Endometrin Description

Endometrin (progesterone) Vaginal Insert contains micronized progesterone. Endometrin is supplied with polyethylene vaginal applicators.

The active ingredient, progesterone, is present in 100 mg amount along with other excipients. The chemical name for progesterone is pregn-4-ene-3,20-dione. It has an empirical formula of C21H30O2 and a molecular weight of 314.5. Progesterone exists in two polymorphic forms. The form used in Endometrin, the alpha-form, has a melting point of 127-131°C.

The structural formula is:

C21H30O2

Each Endometrin Vaginal Insert delivers 100 mg of progesterone in a base containing lactose monohydrate, polyvinylpyrrolidone, adipic acid, sodium bicarbonate, sodium lauryl sulfate, magnesium stearate, pregelatinized starch, and colloidal silicone dioxide.

Endometrin - Clinical Pharmacology Mechanism of Action

Progesterone is a naturally occurring steroid that is secreted by the ovary, placenta, and adrenal gland. In the presence of adequate estrogen, progesterone transforms a proliferative endometrium into a secretory endometrium. Progesterone is necessary to increase endometrial receptivity for implantation of an embryo. Once an embryo is implanted, progesterone acts to maintain a pregnancy.

Pharmacokinetics

Absorption

Progesterone serum concentrations increased following the administration of the Endometrin Vaginal Insert in 12 healthy pre-menopausal females. On single dosing, the mean Cmax was 17.0 ng/mL in the Endometrin twice daily group and 19.8 ng/mL in the Endometrin three times daily group. On multiple dosing, steady-state concentrations were attained within approximately 1 day after initiation of treatment with Endometrin. Both Endometrin regimens provided average serum concentrations of progesterone exceeding 10 ng/mL on Day 5. The pharmacokinetic results are summarized in Table 2.

Table 2: Mean (±Standard Deviation) Serum Progesterone Pharmacokinetic Parameters Cmax Maximum progesterone serum concentration.
Tmax Time to maximum progesterone serum concentration.
Cavg Average progesterone serum concentration.
AUC0-24 Area under the drug concentration versus time curve from 0-24 hours post dose.
Cmin Minimum progesterone serum concentration. Pharmacokinetic
Parameter (unit) Endometrin
100 mg twice
daily (N=6) Endometrin
100 mg three times
daily (N=6)   Single Dosing Cmax (ng/mL) 17.0 ± 6.5 19.8 ± 7.2 Tmax (hr) 24.0 ± 0.0 17.3 ± 7.4 AUC0-24
(ng•hr/mL) 217 ± 113 284 ± 143 Day 5 of Multiple Dosing Cmax (ng/mL) 18.5 ± 5.5 24.1 ± 5.6 Tmax (hr) 18.0 ± 9.4 18.0 ± 9.4 Cmin (ng/mL) 8.9 ± 4.5 10.9 ± 6.7 Cavg (ng/ml) 14.0 ± 4.8 15.9 ± 4.3 AUC0-24
(ng•hr/mL) 327 ± 127 436 ± 106

Distribution

Progesterone is approximately 96% to 99% bound to serum proteins, primarily to serum albumin and corticosteroid binding globulin.

Metabolism

Progesterone is metabolized primarily by the liver largely to pregnanediols and pregnanolones. Pregnanediols and pregnanolones are conjugated in the liver to glucuronide and sulfate metabolites. Progesterone metabolites that are excreted in the bile may be deconjugated and may be further metabolized in the gut via reduction, dehydroxylation, and epimerization.

Excretion

Progesterone undergoes renal and biliary elimination. Following injection of labeled progesterone, 50-60% of the excretion of metabolites occurs via the kidney; approximately 10% occurs via the bile and feces. Overall recovery of the labeled material accounts for 70% of an administered dose. Only a small portion of unchanged progesterone is excreted in the bile.

Nonclinical Toxicology Carcinogenesis, Mutagenesis, Impairment Of Fertility

Nonclinical toxicity studies to determine the potential of Endometrin to cause carcinogenicity or mutagenicity have not been performed. The effect of Endometrin on fertility has not been evaluated in animals.

Clinical Studies Luteal Supplementation During Assisted Reproductive Treatment Study

A randomized, open-label, active-controlled study evaluated the efficacy of 10 weeks of treatment with two different daily dosing regimens of Endometrin (100 mg twice daily and 100 mg three times daily) for support of implantation and early pregnancy in infertile women participating in an Assisted Reproductive Technology treatment program. Efficacy was assessed on the endpoint of ongoing pregnancies, defined as the presence of at least one fetal heartbeat seen on ultrasound at 6 weeks post-embryo transfer. The study randomized to Endometrin 808 infertile women (74.9% White; 10.3% Hispanic, 5.4% Black, 5 % Asian, and 4.6% Other) between 19 and 42 years of age (mean age 33) who had a body mass index < 34 kg/m2 at screening.

The ongoing pregnancy rates for subjects treated with both dosing regimens of Endometrin were non-inferior (lower bounds of the 95% confidence interval of the difference between Endometrin and the active comparator excluded a difference greater than 10%) to the ongoing pregnancy rate for subjects treated with the active comparator. The results of this study are shown in Table 3.

Table 3: Ongoing Pregnancy Rates* in Patients Receiving Endometrin for Luteal Supplementation and Early Pregnancy While in an Assisted Reproductive Technology Treatment Program *Ongoing pregnancy defined as the presence of at least one fetal heartbeat seen on ultrasound at 6 weeks post-embryo transfer.   Endometrin
100 mg twice
daily Endometrin
100 mg three
times daily Number of subjects 404 404 Ongoing pregnancy: n (%) 156 (39%) 171 (42%) 95% Confidence Interval of
pregnancy rate [33.8,43.6] [37.5,47.3] Pregnancy rate percentage
difference between
Endometrin and comparator -3.6% 0.1% 95% Confidence Interval for
difference vs. comparator [-10.3, 3.2] [-6.7, 6.9]

Subjects participating in the study were stratified at randomization by age and ovarian reserve (as measured by serum FSH levels). The ongoing pregnancy rates for these subgroups are shown in Table 4.

Table 4: Ongoing Pregnancy Rates in Age- and Ovarian Reserve-Defined Subgroups Receiving Endometrin for Luteal Supplementation and Early Pregnancy While in an Assisted Reproductive Technology Treatment Program   Endometrin
100 mg twice
daily Endometrin
100 mg three
times daily Subjects age < 35 years (N) 247 247 Ongoing pregnancy: n (%) 111 (45%) 117 (47%) Pregnancy rate percentage difference between Endometrin and comparator 0.5% 2.9% 95% Confidence Interval for difference vs. comparator [-8.3, 9.3] [-5.9, 11.7] Subjects 35-42 years of age (N) 157 157 Ongoing pregnancy: n (%) 45 (28%) 54 (34%) Pregnancy rate percentage difference between Endometrin and comparator -10.1% -4.4% 95% Confidence Interval for difference vs. comparator [-20.3, 0.3] [-14.9, 6.3] Subjects with FSH < 10 IU/L (N) 350 347 Ongoing pregnancy: n (%) 140 (40%) 150 (43%) Pregnancy rate percentage difference between Endometrin and comparator -2.0% 1.2% 95% Confidence Interval for difference vs. comparator [-9.3, 5.3] [-6.1, 8.5] Subjects with FSH between 10 and 15 IU/L (N) 46 51 Ongoing pregnancy: n (%) 16 (35 %) 20 (39%) Pregnancy rate percentage difference between Endometrin and comparator -12.2% -7.7% 95% Confidence Interval for difference vs. comparator [-31.0, 7.7] [-26.6, 11.6]

In subjects under the age of 35 or with serum FSH levels less than 10 IU/L, results from both dosing regimens were non-inferior to the results from the comparator with respect to ongoing pregnancy rates. In women age 35 and older and in women with serum FSH levels between 10 and 15 IU/L, the results with respect to ongoing pregnancy rate for both dosing regimens of Endometrin did not reach the criteria for non-inferiority.

Subjects who became pregnant received study medication for a total of 10 weeks. Patients over 34 kg/m2 were not studied. The efficacy of Endometrin in this patient group is unknown.

How Supplied/Storage and Handling

Each Endometrin Vaginal Insert is a white to off-white oblong-shaped insert debossed with “FPI” on one side and “100” on the other side. Each Endometrin® (progesterone) Vaginal Insert, 100 mg, is packed individually in a sealed foil pouch. These pouches are available in cartons packed:

21 vaginal inserts with 21 disposable vaginal applicators (NDC 55566-6500-3)

Store at 25°C (77°F); excursions permitted between 15-30°C (59-86°F).

Patient Counseling Information

See FDA-Approved Patient Labeling (17.4)

Vaginal Bleeding

Inform patients of the importance of reporting irregular vaginal bleeding to their doctor as soon as possible.

Common Adverse Reactions with Progesterone

Inform patients of the possible side effects of progesterone therapy such as headaches, breast tenderness, bloating, mood swings, irritability, and drowsiness.

Coadministration of Vaginal Products

Inform patients that Endometrin is not recommended for use with other vaginal products.

FDA-Approved Patient Labeling

IMPORTANT:For Vaginal Use Only.

Read the patient information that comes with Endometrin before you start to use it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your medical condition or treatment. Your doctor may do a physical exam before prescribing Endometrin.

What is Endometrin?

Endometrin is a vaginal insert that contains the hormone progesterone. Endometrin is for women who need extra progesterone while undergoing treatment in an Assisted Reproductive Technology (ART) program.

Progesterone is one of the hormones essential for helping you to become and to stay pregnant. If you are undergoing ART treatment, your doctor may prescribe Endometrin to provide the progesterone your body needs.

Who should not use Endometrin?

Do not use Endometrin if you:

Are allergic to anything in Endometrin. See the end of this leaflet for a complete list of ingredients. Have unusual vaginal bleeding that has not been evaluated by a doctor. Currently have or have had liver problems. Have or have had blood clots in the legs, lungs, eyes, or elsewhere in your body.

Endometrin may not be right for you. Before starting Endometrin, tell your doctor about all your health problems.

Tell your doctor about all the medicines you take including prescription and nonprescription medicines, vaginal products, vitamins, herbal supplements. Some medicines may affect Endometrin.

Know what medicines you take. Keep a list of your medicines to show to the doctor and pharmacist.

How should I use Endometrin? Use Endometrin exactly as prescribed. The usual dose of Endometrin is one insert placed in your vagina 2 to 3 times a day for up to a total of 10 weeks, unless your healthcare provider advises otherwise. Place an Endometrin insert in your vagina with the disposable applicator provided.

Follow the steps below:

Unwrap the applicator. Put one insert in the space provided at the end of the applicator. The insert should fit snugly and not fall out. Place applicator with the insert into the vagina while you are standing, sitting, or when lying on your back with your knees bent. Gently place the thin end of the applicator well into the vagina. Push the plunger to release the insert. Remove the applicator and throw it away in the trash.

Other information for using Endometrin

If you forget a dose of Endometrin, take the dose as soon as you remember, but do not use more than your daily dose. Call your doctor if you use too much Endometrin. Do not use any other vaginal products when you are using Endometrin. What are the possible side effects of Endometrin?

Common side effects seen with ART and Endometrin included pelvic pain after surgery, abdominal pain, nausea, and swollen ovaries (ovarian hyperstimulation syndrome).

Other reported side effects included abdominal bloating, headache, urinary infections, uterine cramping, constipation, vomiting, tiredness, and vaginal bleeding.

Vaginal products with progesterone may also cause vaginal irritation, burning, and discharge.

Serious Risks of Progesterone

Progesterone can increase your chance of getting blood clots. Blood clots can be serious and lead to death.

Serious blood clots include those in the:

legs (thrombophlebitis) lungs (pulmonary embolus) eyes (blindness) heart (heart attack) brain (stroke)

Call your doctor or get medical help right away if you have:

persistent pain in the lower leg (calf) sudden shortness of breath coughing up blood sudden blindness, partial or complete severe chest pain sudden, severe headache, vomiting, dizziness, or fainting weakness in an arm or leg, or trouble speaking yellowing of the skin and/or white of the eyes indicating possible liver problem

Other risks of progesterone use include:

headache breast tenderness bloating or fluid retention mood swings and depression irritability drowsiness

Call your doctor immediately if you have abnormal vaginal bleeding

These are not all the side effects with Endometrin. Ask your doctor or pharmacist for more information.

How should I store Endometrin? Store Endometrin at room temperature, 25°C (77°F); excursions permitted between 15 to 30°C (59 to 86°F). Do not use Endometrin after the expiration date that is printed on the carton. Keep Endometrin and all medicines out of the reach of children. General information about Endometrin

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information Leaflet. Do not use Endometrin for a condition for which it was not prescribed. Do not give Endometrin to other women, even if they have the same condition as you do. It may harm them.

This leaflet summarizes the most important information about Endometrin. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Endometrin that was written for healthcare professionals. For more information call Ferring Pharmaceuticals at 1-800-822-8214.

What are the ingredients in Endometrin?

Active Ingredient: progesterone

Inactive Ingredients: lactose monohydrate, polyvinylpyrrolidone, adipic acid, sodium bicarbonate, sodium lauryl sulfate, magnesium stearate, pregelatinized starch, and colloidal silicone dioxide

Manufactured by:
Pharmaceutics International Inc., Hunt Valley, MD 21031

Manufactured for:
Ferring Pharmaceuticals Inc., Parsippany, NJ 07054

6323-02

PACKAGE LABEL - FOIL PACK LABEL

Endometrin®

(progesterone) Vaginal Insert 100 mg

Manufactured for:

Ferring Pharmaceuticals Inc.

Parsippany, NJ 07054

By: Pharmaceutics International Inc.

Hunt Valley, MD 21031

Store at 20°-25°C (68°-77°F);

exercurstions permitted between

15°-30°C (59°-86°F).

FOR VAGINAL USE ONLY

NDC 55566-6500-1

Rx only 6320-04

LOT XXXX.XXX

EXP XX/XX

PACKAGE LABEL - INNER CARTON

NDC 55566-6500-2

Endometrin®

(progesterone) Vaginal Insert 100 mg

Contents: 21 foil blisters, each containing

1 individually sealed 100 mg vaginal insert.

Endometrin®

(progresterone) Vaginal Insert 100 mg

Manufactured for: Ferring Pharmaceuticals Inc. Parsippany, NJ 07054

By: Pharmaceutics International Inc. Hunt Valley MD 21031

Patent Pending

6321-04

PACKAGE LABEL - OUTER CARTON

NDC 55566-6500-3

Endometrin®

(progesterone) Vaginal Insert 100 mg

Contents:

21 vaginal inserts with 21 disposable vaginal applicators

Each insert contains 100 mg progesterone, USP

FOR VAGINAL USE ONLY

Rx only

Endometrin®

6322-04


Endometrin 
progesterone  insert Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 55566-6500 Route of Administration VAGINAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength progesterone (progesterone) progesterone 100 mg Inactive Ingredients Ingredient Name Strength lactose monohydrate   povidone K29/32   adipic acid   sodium bicarbonate   sodium lauryl sulfate   magnesium stearate   starch, pregelatinized corn   colloidal silicon dioxide   Product Characteristics Color WHITE Score      Shape OVAL Size Flavor Imprint Code 100 Contains          Packaging # NDC Package Description Multilevel Packaging 1 55566-6500-3 1 CARTON In 1 CARTON contains a CARTON (55566-6500-2) 1 55566-6500-2 21 BLISTER PACK In 1 CARTON This package is contained within the CARTON (55566-6500-3) and contains a BLISTER PACK (55566-6500-1) 1 55566-6500-1 1 INSERT In 1 BLISTER PACK This package is contained within a CARTON (55566-6500-2) and a CARTON (55566-6500-3)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA022057 06/21/2007
Labeler - Ferring Pharmaceuticals Inc. (103722955) Establishment Name Address ID/FEI Operations Pharmaceutics International Inc. 878265586 manufacture Revised: 02/2008Ferring Pharmaceuticals Inc.
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First-Progesterone VGS


Generic Name: progestin (Oral route, Parenteral route, Vaginal route)

Commonly used brand name(s)

In the U.S.

Aygestin Camila Crinone Errin First-Progesterone VGS Jolivette Megace Megace ES Next Choice Ovrette Plan B Prochieve Prometrium

In Canada

Alti-Mpa Megace Os

Available Dosage Forms:

Tablet Suspension Capsule, Liquid Filled Gel/Jelly Cream Kit Suppository Uses For First-Progesterone VGS

Progestins are hormones. They are used by both men and women for different purposes.

Progestins are prescribed for several reasons:

To properly regulate the menstrual cycle and treat unusual stopping of the menstrual periods (amenorrhea). Progestins work by causing changes in the uterus. After the amount of progestins in the blood drops, the lining of the uterus begins to come off and vaginal bleeding occurs (menstrual period). Progestins help other hormones start and stop the menstrual cycle. . To help a pregnancy occur during egg donor or infertility procedures in women who do not produce enough progesterone. Also, progesterone is given to help maintain a pregnancy when not enough of it is made by the body. To prevent estrogen from thickening the lining of the uterus (endometrial hyperplasia) in women around menopause who are being treated with estrogen for ovarian hormone therapy (OHT). OHT is also called hormone replacement therapy (HRT) and estrogen replacement therapy (ERT). To treat pain that is related to endometriosis, a condition where the endometrial tissue which lines the uterus becomes displaced in other female organs. To treat a condition called endometriosis, to help prevent endometrial hyperplasia, or to treat unusual and heavy bleeding of the uterus (dysfunctional uterine bleeding) by starting or stopping the menstrual cycle. To help treat cancer of the breast, kidney, or uterus. Progestins help change the cancer cell's ability to react to other hormones and proteins that cause tumor growth. In this way, progestins can stop the growth of a tumor. To test the body's production of certain hormones such as estrogen. To treat loss of appetite and severe weight or muscle loss in patients with acquired immunodeficiency syndrome (AIDS) or cancer by causing certain proteins to be produced that cause increased appetite and weight gain.

Progestins may also be used for other conditions as determined by your doctor.

Depending on how much and which progestin you use or take, a progestin can have different effects. For instance, high doses of progesterone are necessary for some women to continue a pregnancy while other progestins in low doses can prevent a pregnancy from occurring. Other effects include causing weight gain, increasing body temperature, developing the milk-producing glands for breast-feeding, and relaxing the uterus to maintain a pregnancy.

Progestins can help other hormones work properly. Progestins may help to prevent anemia (low iron in blood), too much menstrual blood loss, and cancer of the uterus.

Progestins are available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, progestins are used in certain patients with the following medical conditions:

Carcinoma of the prostate Corpus luteum insufficiency Hot flashes Polycystic ovary syndrome Precocious puberty Before Using First-Progesterone VGS Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Although there is no specific information comparing use of progestins in children or teenagers with use in other age groups, this medicine is not expected to cause different side effects or problems in children or teenagers than it does in adults.

Geriatric

This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

Progesterone, a natural hormone that the body makes during pregnancy, has not caused problems. In fact, it is sometimes used in women to treat a certain type of infertility and to aid in egg donor or infertility procedures.

Other progestins have not been studied in pregnant women. Be sure to tell your doctor if you become pregnant while using any of the progestins. It is best to use some kind of birth control method while you are receiving progestins in high doses. High doses of progestins are not recommended for use during pregnancy since there have been some reports that they may cause birth defects in the genitals (sex organs) of a male fetus. Also, some of these progestins may cause male-like changes in a female fetus and female-like changes in a male fetus, but these problems usually can be reversed. Low doses of progestins, such as those doses used for contraception, have not caused major problems when used accidentally during pregnancy.

Breast Feeding

Although progestins pass into the breast milk, they have not been shown to cause problems in nursing babies. However, progestins may change the quality or amount (increase or decrease) of the mother's breast milk. It may be necessary for you to take another medicine or to stop breast-feeding during treatment. Be sure you have discussed the risks and benefits of the medicine with your doctor.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking any of these medicines, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using medicines in this class with any of the following medicines is not recommended. Your doctor may decide not to treat you with a medication in this class or change some of the other medicines you take.

Boceprevir Dofetilide

Using medicines in this class with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Felbamate Isotretinoin Theophylline Tizanidine Tranexamic Acid Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:

Asthma or Epilepsy (or history of) or Heart or circulation problems or Kidney disease (severe) or Migraine headaches—Progestins may cause fluid retention which may cause these conditions to become worse. Bleeding problems, undiagnosed, such as blood in the urine or changes in vaginal bleeding—May make diagnosis of these problems more difficult. Blood clots, or history of or Breast cancer, or history of or Deep vein thrombosis (blood clot in the leg), active or history of or Heart attack, active or history of or Liver disease, including jaundice, or history of or Pulmonary embolism (clot in the lung), active or history of or Stroke , active or history of or Venous thromboembolism (clot in the veins), or history of—Progestins should not be used in patients with these conditions. Breast disease (such as breast lumps or cysts), history of—May make this condition worse for diseases that do not react in a positive way to progestins. Diabetes mellitus—May cause an increase in your blood sugar and a change in the amount of medicine you take for diabetes; progestins in high doses are more likely to cause this problem. Memory loss (dementia)—May make this condition worse. Vision changes—This medicine may cause changes in vision; your medicine may need to be stopped if these conditions become worse. Proper Use of progestin

This section provides information on the proper use of a number of products that contain progestin. It may not be specific to First-Progesterone VGS. Please read with care.

To make the use of a progestin as safe and reliable as possible, you should understand how and when to take it and what effects may be expected. Progestins usually come with patient directions. Read them carefully before taking or using this medicine.

Take this medicine only as directed by your doctor. Do not take more of it and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects. Try to take the medicine at the same time each day to reduce the possibility of side effects and to allow it to work better.

Progestins are often given together with certain medicines. If you are using a combination of medicines, make sure that you take each one at the proper time and do not mix them. Ask your health care professional to help you plan a way to remember to take your medicines at the right times.

Dosing

The dose medicines in this class will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For medroxyprogesterone For oral dosage form (tablets): For controlling unusual and heavy bleeding of the uterus (dysfunctional uterine bleeding) or treating unusual stopping of menstrual periods (amenorrhea): Adults and teenagers—5 to 10 milligrams (mg) per day for five to ten days as directed by your doctor. For preparing the uterus for the menstrual period: Adults and teenagers—10 milligrams (mg) per day for five or ten days as directed by your doctor. For preventing estrogen from thickening the lining of the uterus (endometrial hyperplasia) when taking estrogen for ovarian hormone therapy in postmenopausal women: Adults—When taking estrogen each day on Days 1 through 25: Oral, 5 to 10 milligrams (mg) of medroxyprogesterone per day for ten to fourteen or more days each month as directed by your doctor. Or, your doctor may want you to take 2.5 or 5 mg per day without stopping. Your doctor will help decide the number of tablets that is best for you and when to take them. For intramuscular injection dosage form: For treating cancer of the kidneys or uterus: Adults and teenagers—At first, 400 to 1000 milligrams (mg) injected into a muscle as a single dose once a week. Then, your doctor may lower your dose to 400 mg or more once a month. For subcutaneous injection dosage form: For treating pain related to endometriosis: Adults and teenagers—104 milligrams (mg) injected under the skin of the anterior thigh or abdomen every three months (12 to 14 weeks) for not more than 2 years. For megestrol For oral dosage form (suspension): For treating loss of appetite (anorexia), muscles (cachexia), or weight caused by acquired immunodeficiency syndrome (AIDS): Adults and teenagers—800 milligrams (mg) a day for the first month. Then your doctor may want you to take 400 or 800 mg a day for three more months. For oral dosage form (tablets): For treating cancer of the breast: Adults and teenagers—160 milligrams (mg) a day as a single dose or in divided doses for two or more months. For treating cancer of the uterus: Adults and teenagers—40 to 320 milligrams (mg) a day for two or more months. For treating loss of appetite (anorexia), muscles (cachexia), or weight caused by cancer: Adults and teenagers—400 to 800 milligrams (mg) a day. For norethindrone For oral dosage form (tablets): For controlling unusual and heavy bleeding of the uterus (dysfunctional uterine bleeding) or treating unusual stopping of menstrual periods (amenorrhea): Adults and teenagers—2.5 to 10 milligrams (mg) a day from Day 5 through Day 25 (counting from the first day of the last menstrual cycle). Or, your doctor may want you to take the medicine only for five to ten days as directed. For treating endometriosis: Adults and teenagers—At first, 5 milligrams (mg) a day for two weeks. Then, your doctor may increase your dose slowly up to 15 mg a day for six to nine months. Let your doctor know if your menstrual period starts. Your doctor may want you to take more of the medicine or may want you to stop taking the medicine for a short period of time. For progesterone For oral dosage form (capsules): For preventing estrogen from thickening the lining of the uterus (endometrial hyperplasia) when taking estrogen for ovarian hormone therapy in postmenopausal women: Adults—200 milligrams (mg) per day at bedtime for 12 continuous days per 28-day cycle of estrogen treatment each month. For treating unusual stopping of menstrual periods (amenorrhea): Adults—400 milligrams (mg) per day at bedtime for ten days. For vaginal dosage form (gel): For treating unusual stopping of menstrual periods (amenorrhea): Adults and teenagers—45 milligrams (mg) (one applicatorful of 4% gel) once every other day for up to six doses. Dose may be increased to 90 mg (one applicatorful of 8% gel) once every other day for up to six doses if needed. For use with infertility procedures: Adults and teenagers—90 milligrams (mg) (one applicatorful of 8% gel) one or two times a day. If pregnancy occurs, treatment can continue for up to ten to twelve weeks. For injection dosage form: For controlling unusual and heavy bleeding of the uterus (dysfunctional uterine bleeding) or treating unusual stopping of menstrual periods (amenorrhea): Adults and teenagers—5 to 10 milligrams (mg) a day injected into a muscle for six to ten days. Or, your doctor may want you to receive 100 or 150 mg injected into a muscle as a single dose. Sometimes your doctor may want you first to take another hormone called estrogen. If your menstrual period starts, your doctor will want you to stop taking the medicine. For vaginal dosage form (suppositories): For maintaining a pregnancy (at ovulation and at the beginning of pregnancy): Adults and teenagers—25 mg to 100 milligrams (mg) (one suppository) inserted into the vagina one or two times a day beginning near the time of ovulation. Your doctor may want you to receive the medicine for up to eleven weeks. Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

For all progestins, except for progesterone capsules for postmenopausal women: If you miss a dose of this medicine, take the missed dose as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

For progesterone capsules for postmenopausal women: If you miss a dose of 200 mg of progesterone capsules at bedtime, take 100 mg in the morning then go back to your regular dosing schedule. If you take 300 mg of progesterone a day and you miss your morning and evening doses, you should not take the missed dose. Return to your regular dosing schedule.

Storage

Keep out of the reach of children.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using First-Progesterone VGS

It is very important that your doctor check your progress at regular visits. This will allow for your dosage to be adjusted and for any unwanted effects to be detected. These visits will usually be every 6 to 12 months, but some doctors require them more often.

The Prometrium® capsules contain peanut oil. If you have an allergy to peanuts, make sure your doctor knows this before you take this brand of progestin.

Progestins may cause some people to become dizzy. For oral or vaginal progesterone, dizziness or drowsiness may occur 1 to 4 hours after taking or using it. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert.

Unusual or unexpected vaginal bleeding of various amounts may occur between your regular menstrual periods during the first 3 months of use. This is sometimes called spotting when slight, or breakthrough menstrual bleeding when heavier. If this should occur, continue on your regular dosing schedule. Check with your doctor:

If unusual or unexpected vaginal bleeding continues for an unusually long time. If your menstrual period has not started within 45 days of your last period.

Missed menstrual periods may occur. If you suspect a pregnancy, you should stop taking this medicine immediately and call your doctor. Your doctor will let you know if you should continue taking the progestin.

If you are scheduled for any laboratory tests, tell your health care professional that you are taking a progestin. Progestins can change certain test results.

In some patients, tenderness, swelling, or bleeding of the gums may occur. Brushing and flossing your teeth carefully and regularly and massaging your gums may help prevent this. See your dentist regularly to have your teeth cleaned. Check with your medical doctor or dentist if you have any questions about how to take care of your teeth and gums, or if you notice any tenderness, swelling, or bleeding of your gums.

You will need to use a birth control method while taking progestins for noncontraceptive use if you are fertile and sexually active.

If you are using vaginal progesterone, avoid using other vaginal products for 6 hours before and for 6 hours after inserting the vaginal dose of progesterone.

Since it is possible that certain doses of progestins may cause temporary thinning of the bones by changing your hormone balance, it is important that your doctor know if you have an increased risk of osteoporosis. Some things that can increase your risk for having osteoporosis include cigarette smoking, abusing alcohol, taking or drinking large amounts of caffeine, and having a family history of osteoporosis or easily broken bones. Some medicines, such as glucocorticoids (cortisone-like medicines) or anticonvulsants (seizure medicine), can also cause thinning of the bones. However, it is thought that progestins can help protect against osteoporosis in postmenopausal women.

First-Progesterone VGS Side Effects

Along with their needed effects, progestins used in high doses sometimes cause some unwanted effects such as blood clots, heart attacks, and strokes, or problems of the liver and eyes. Although these effects are rare, some of them can be very serious and cause death. It is not clear if these problems are due to the progestin. They may be caused by the disease or condition for which progestins are being used.

The following side effects may be caused by blood clots. Although not all of these side effects may occur, if they do occur they need immediate medical attention.

Get emergency help immediately if any of the following side effects occur:

Rare Symptoms of blood clotting problems, usually severe or sudden, such as: headache or migraine loss of or change in speech, coordination, or vision numbness of or pain in chest, arm, or leg unexplained shortness of breath

Check with your doctor as soon as possible if any of the following side effects occur:

More common Changes in vaginal bleeding (increased amounts of menstrual bleeding occurring at regular monthly periods, lighter vaginal bleeding between menstrual periods, heavier vaginal bleeding between regular monthly periods, or stopping of menstrual periods) symptoms of blood sugar problems (dry mouth, frequent urination, loss of appetite, or unusual thirst) Less common Mental depression skin rash unexpected or increased flow of breast milk RareFor megestrol—During chronic treatment Backache dizziness filling or rounding out of the face irritability mental depression nausea or vomiting unusual decrease in sexual desire or ability in men unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common Abdominal pain or cramping bloating or swelling of ankles or feet blood pressure increase (mild) dizziness drowsiness (progesterone only) headache (mild) mood changes nervousness pain or irritation at place of injection site swelling of face, ankles, or feet unusual or rapid weight gain Less common Acne breast pain or tenderness brown spots on exposed skin, possibly long-lasting hot flashes loss or gain of body, facial, or scalp hair loss of sexual desire trouble in sleeping

Not all of the side effects listed above have been reported for each of these medicines, but they have been reported for at least one of them. All of the progestins are similar, so any of the above side effects may occur with any of these medicines.

After you stop using this medicine, your body may need time to adjust. The length of time this takes depends on the amount of medicine you were using and how long you used it. During this period of time check with your doctor if you notice the following side effect:

For megestrol Dizziness nausea or vomiting unusual tiredness or weakness Delayed return to fertility stopping of menstrual periods unusual menstrual bleeding (continuing)

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.


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estradiol and norethindrone


Generic Name: estradiol and norethindrone (ess tra DYE ole and nor ETH in drone)
Brand Names: Activella

What are estradiol and norethindrone?

Estradiol is a form of estrogen. Estrogen is a female sex hormone that is involved in the development and maintenance of the female reproductive system.

Norethindrone is a form of progesterone. Progesterone is a female hormone important for the regulation of ovulation and menstruation.

Together, estradiol and norethindrone are used to treat the symptoms of menopause such as feelings of warmth in the face, neck and chest, or sudden intense spells of heat and sweating ("hot flashes" or "hot flushes"); to treat vulvar and vaginal changes (itching, burning, dryness in or around the vagina, difficulty or burning with urination) caused by menopause; and to replace estrogen in conditions such as hypogonadism, removal of the ovaries, or primary ovarian failure that result in a lack of estrogen. Estradiol and norethindrone is also used to prevent thinning of the bones (osteoporosis).

Estradiol and norethindrone may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about estradiol and norethindrone?

Estradiol increases the risk of developing endometrial hyperplasia, a condition that may lead to cancer of the lining of the uterus. Using a progestin, such as norethindrone, with estradiol lowers the risk of developing this condition. Visit your doctor regularly and report any unusual vaginal bleeding right away.

Have yearly physical exams and examine your breasts for lumps on a monthly basis while taking estradiol and norethindrone.

What should I discuss with my healthcare provider before taking estradiol and norethindrone? Do not take estradiol and norethindrone without first talking to your doctor if you have

a circulation, bleeding, or blood-clotting disorder;

undiagnosed, abnormal vaginal bleeding;

any type of breast, uterine, or hormone-dependent cancer; or

liver disease.

Taking estradiol and norethindrone may be dangerous in some cases if you have any of the conditions listed above.

Before taking estradiol and norethindrone, tell your doctor if you have

high blood pressure, angina, or heart disease;

high levels of cholesterol or triglycerides in your blood;

kidney disease;

asthma;

epilepsy;

migraines;

depression;

diabetes;

gallbladder disease;

uterine fibroids; or

had a hysterectomy (uterus removed).

You may not be able to take estradiol and norethindrone, or you may need a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

Estradiol and norethindrone is in the FDA pregnancy category X. This means that estradiol and norethindrone is known to cause birth defects in an unborn baby. Do not take estradiol and norethindrone if you are pregnant or could become pregnant during treatment. Estradiol and norethindrone may decrease milk flow and have other effects on milk composition. Do not take estradiol and norethindrone without first talking to your doctor if you are breast-feeding a baby. How should I take estradiol and norethindrone?

Take estradiol and norethindrone exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a glass of water.

Try to take each dose at the same time every day.

Have yearly physical exams and examine your breasts for lumps on a monthly basis while taking estradiol and norethindrone.

Store ethinyl estradiol and norethindrone tablets at room temperature away from moisture, heat, and direct light.

See also: Estradiol and norethindrone dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the dose you missed and take only the next regularly scheduled dose. Do not take a double dose of this medication.

What happens if I overdose? Contact an emergency room or poison control center for advice if an overdose is suspected.

Symptoms of a estradiol and norethindrone overdose may include nausea, vomiting, and withdrawal bleeding may occur in females.

What should I avoid while using estradiol and norethindrone?

There are no restrictions on food, beverages, or activity while taking estradiol and norethindrone unless otherwise directed by your doctor.

Estradiol and norethindrone side effects If you experience any of the following serious side effects, stop taking estradiol and norethindrone and seek emergency medical attention or notify your doctor immediately:

an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);

shortness of breath or pain in the chest;

a painful, red, swollen leg;

abnormal vaginal bleeding;

pain, swelling, or tenderness in the abdomen;

severe headache or vomiting, dizziness, faintness or changes in vision or speech;

yellowing of the skin or eyes; or

a lump in a breast.

Other, less serious side effects may be more likely to occur. Continue to take estradiol and norethindrone and talk to your doctor if you experience

nausea and vomiting;

tenderness or enlargement of the breasts;

weakness;

swelling of the hands or feet;

spotty darkening of the skin, particularly on the face;

difficulty in wearing contact lenses;

vaginal irritation or discomfort; or

changes in menstrual cycle, painful menstruation, or break-through bleeding.

Estradiol increases the risk of developing endometrial hyperplasia, a condition that may lead to cancer of the lining of the uterus. Using a progestin, such as norethindrone, with estradiol lowers the risk of developing this condition. Visit your doctor regularly and report any unusual vaginal bleeding right away.

It is unclear to what extent estrogen and progesterone treatments may affect the risk of breast cancer.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

Estradiol and norethindrone Dosing Information

Usual Adult Dose for Atrophic Urethritis:

One (1 mg estradiol/0.5 mg norethindrone or 0.5 estradiol/ 0.1 mg norethindrone) tablet orally once a day.
-or-
One (0.05 mg-0.14 mg) patch applied twice weekly. If a greater progestin dose is desired, a single (0.05 mg-0.25 mg) patch may be applied twice weekly.
Alternatively, either patch may be applied as a continuation to an initial 14-day application of an estradiol-only transdermal patch within a 28-day cycle.
The patch should not be applied to, or near, the breasts. The application site should be smooth, clean, dry, fold-free, without damage or irritation, and be rotated with an interval of at least one week allowed to pass between applications to the same site.
If a patch dislodges, it may be reapplied to another area of the lower abdomen, or a new patch may be applied, in which case, the original treatment schedule resumes. However, only one patch should be worn at any given time during the three to four day dosing interval.

Usual Adult Dose for Atrophic Vaginitis:

One (1 mg estradiol/0.5 mg norethindrone or 0.5 estradiol/ 0.1 mg norethindrone) tablet orally once a day.
-or-
One (0.05 mg-0.14 mg) patch applied twice weekly. If a greater progestin dose is desired, a single (0.05 mg-0.25 mg) patch may be applied twice weekly.
Alternatively, either patch may be applied as a continuation to an initial 14-day application of an estradiol-only transdermal patch within a 28-day cycle.
The patch should not be applied to, or near, the breasts. The application site should be smooth, clean, dry, fold-free, without damage or irritation, and be rotated with an interval of at least one week allowed to pass between applications to the same site.
If a patch dislodges, it may be reapplied to another area of the lower abdomen, or a new patch may be applied, in which case, the original treatment schedule resumes. However, only one patch should be worn at any given time during the three to four day dosing interval.

Usual Adult Dose for Hypoestrogenism:

One (1 mg estradiol/0.5 mg norethindrone or 0.5 estradiol/ 0.1 mg norethindrone) tablet orally once a day.
-or-
One (0.05 mg-0.14 mg) patch applied twice weekly. If a greater progestin dose is desired, a single (0.05 mg-0.25 mg) patch may be applied twice weekly.
Alternatively, either patch may be applied as a continuation to an initial 14-day application of an estradiol-only transdermal patch within a 28-day cycle.
The patch should not be applied to, or near, the breasts. The application site should be smooth, clean, dry, fold-free, without damage or irritation, and be rotated with an interval of at least one week allowed to pass between applications to the same site.
If a patch dislodges, it may be reapplied to another area of the lower abdomen, or a new patch may be applied, in which case, the original treatment schedule resumes. However, only one patch should be worn at any given time during the three to four day dosing interval.

Usual Adult Dose for Postmenopausal Symptoms:

One (1 mg estradiol/0.5 mg norethindrone or 0.5 estradiol/ 0.1 mg norethindrone) tablet orally once a day.
-or-
One (0.05 mg-0.14 mg) patch applied twice weekly. If a greater progestin dose is desired, a single (0.05 mg-0.25 mg) patch may be applied twice weekly.
Alternatively, either patch may be applied as a continuation to an initial 14-day application of an estradiol-only transdermal patch within a 28-day cycle.
The patch should not be applied to, or near, the breasts. The application site should be smooth, clean, dry, fold-free, without damage or irritation, and be rotated with an interval of at least one week allowed to pass between applications to the same site.
If a patch dislodges, it may be reapplied to another area of the lower abdomen, or a new patch may be applied, in which case, the original treatment schedule resumes. However, only one patch should be worn at any given time during the three to four day dosing interval.

What other drugs will affect estradiol and norethindrone?

Before taking estradiol and norethindrone, tell your doctor if you are taking an anticoagulant (blood thinner) such as warfarin (Coumadin). You may not be able to take estradiol and norethindrone, or you may require a dosage adjustment or special monitoring during treatment.

Drugs other than those listed here may also interact with estradiol and norethindrone. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.

More estradiol and norethindrone resources Estradiol and norethindrone Dosage Estradiol and norethindrone Use in Pregnancy & Breastfeeding Estradiol and norethindrone Drug Interactions Estradiol and norethindrone Support Group 4 Reviews for Estradiol and norethindrone - Add your own review/rating Compare estradiol and norethindrone with other medications Atrophic Urethritis Atrophic Vaginitis Hypoestrogenism Postmenopausal Symptoms Where can I get more information? Your pharmacist has additional information about estradiol and norethindrone written for health professionals that you may read.
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progestin Oral, Parenteral, Vaginal


Commonly used brand name(s)

In the U.S.

Aygestin Camila Crinone Errin First-Progesterone VGS Jolivette Megace Megace ES Next Choice Ovrette Plan B Prochieve Prometrium

In Canada

Alti-Mpa Megace Os

Available Dosage Forms:

Tablet Suspension Capsule, Liquid Filled Gel/Jelly Cream Kit Suppository Uses For progestin

Progestins are hormones. They are used by both men and women for different purposes.

Progestins are prescribed for several reasons:

To properly regulate the menstrual cycle and treat unusual stopping of the menstrual periods (amenorrhea). Progestins work by causing changes in the uterus. After the amount of progestins in the blood drops, the lining of the uterus begins to come off and vaginal bleeding occurs (menstrual period). Progestins help other hormones start and stop the menstrual cycle. . To help a pregnancy occur during egg donor or infertility procedures in women who do not produce enough progesterone. Also, progesterone is given to help maintain a pregnancy when not enough of it is made by the body. To prevent estrogen from thickening the lining of the uterus (endometrial hyperplasia) in women around menopause who are being treated with estrogen for ovarian hormone therapy (OHT). OHT is also called hormone replacement therapy (HRT) and estrogen replacement therapy (ERT). To treat pain that is related to endometriosis, a condition where the endometrial tissue which lines the uterus becomes displaced in other female organs. To treat a condition called endometriosis, to help prevent endometrial hyperplasia, or to treat unusual and heavy bleeding of the uterus (dysfunctional uterine bleeding) by starting or stopping the menstrual cycle. To help treat cancer of the breast, kidney, or uterus. Progestins help change the cancer cell's ability to react to other hormones and proteins that cause tumor growth. In this way, progestins can stop the growth of a tumor. To test the body's production of certain hormones such as estrogen. To treat loss of appetite and severe weight or muscle loss in patients with acquired immunodeficiency syndrome (AIDS) or cancer by causing certain proteins to be produced that cause increased appetite and weight gain.

Progestins may also be used for other conditions as determined by your doctor.

Depending on how much and which progestin you use or take, a progestin can have different effects. For instance, high doses of progesterone are necessary for some women to continue a pregnancy while other progestins in low doses can prevent a pregnancy from occurring. Other effects include causing weight gain, increasing body temperature, developing the milk-producing glands for breast-feeding, and relaxing the uterus to maintain a pregnancy.

Progestins can help other hormones work properly. Progestins may help to prevent anemia (low iron in blood), too much menstrual blood loss, and cancer of the uterus.

Progestins are available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, progestins are used in certain patients with the following medical conditions:

Carcinoma of the prostate Corpus luteum insufficiency Hot flashes Polycystic ovary syndrome Precocious puberty Before Using progestin Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Although there is no specific information comparing use of progestins in children or teenagers with use in other age groups, progestin is not expected to cause different side effects or problems in children or teenagers than it does in adults.

Geriatric

progestin has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

Progesterone, a natural hormone that the body makes during pregnancy, has not caused problems. In fact, it is sometimes used in women to treat a certain type of infertility and to aid in egg donor or infertility procedures.

Other progestins have not been studied in pregnant women. Be sure to tell your doctor if you become pregnant while using any of the progestins. It is best to use some kind of birth control method while you are receiving progestins in high doses. High doses of progestins are not recommended for use during pregnancy since there have been some reports that they may cause birth defects in the genitals (sex organs) of a male fetus. Also, some of these progestins may cause male-like changes in a female fetus and female-like changes in a male fetus, but these problems usually can be reversed. Low doses of progestins, such as those doses used for contraception, have not caused major problems when used accidentally during pregnancy.

Breast Feeding

Although progestins pass into the breast milk, they have not been shown to cause problems in nursing babies. However, progestins may change the quality or amount (increase or decrease) of the mother's breast milk. It may be necessary for you to take another medicine or to stop breast-feeding during treatment. Be sure you have discussed the risks and benefits of the medicine with your doctor.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking any of these medicines, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using medicines in this class with any of the following medicines is not recommended. Your doctor may decide not to treat you with a medication in this class or change some of the other medicines you take.

Boceprevir Dofetilide

Using medicines in this class with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Felbamate Isotretinoin Theophylline Tizanidine Tranexamic Acid Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:

Asthma or Epilepsy (or history of) or Heart or circulation problems or Kidney disease (severe) or Migraine headaches—Progestins may cause fluid retention which may cause these conditions to become worse. Bleeding problems, undiagnosed, such as blood in the urine or changes in vaginal bleeding—May make diagnosis of these problems more difficult. Blood clots, or history of or Breast cancer, or history of or Deep vein thrombosis (blood clot in the leg), active or history of or Heart attack, active or history of or Liver disease, including jaundice, or history of or Pulmonary embolism (clot in the lung), active or history of or Stroke , active or history of or Venous thromboembolism (clot in the veins), or history of—Progestins should not be used in patients with these conditions. Breast disease (such as breast lumps or cysts), history of—May make this condition worse for diseases that do not react in a positive way to progestins. Diabetes mellitus—May cause an increase in your blood sugar and a change in the amount of medicine you take for diabetes; progestins in high doses are more likely to cause this problem. Memory loss (dementia)—May make this condition worse. Vision changes—progestin may cause changes in vision; your medicine may need to be stopped if these conditions become worse. Proper Use of progestin

To make the use of a progestin as safe and reliable as possible, you should understand how and when to take it and what effects may be expected. Progestins usually come with patient directions. Read them carefully before taking or using progestin.

Take progestin only as directed by your doctor. Do not take more of it and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects. Try to take the medicine at the same time each day to reduce the possibility of side effects and to allow it to work better.

Progestins are often given together with certain medicines. If you are using a combination of medicines, make sure that you take each one at the proper time and do not mix them. Ask your health care professional to help you plan a way to remember to take your medicines at the right times.

Dosing

The dose medicines in this class will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For medroxyprogesterone For oral dosage form (tablets): For controlling unusual and heavy bleeding of the uterus (dysfunctional uterine bleeding) or treating unusual stopping of menstrual periods (amenorrhea): Adults and teenagers—5 to 10 milligrams (mg) per day for five to ten days as directed by your doctor. For preparing the uterus for the menstrual period: Adults and teenagers—10 milligrams (mg) per day for five or ten days as directed by your doctor. For preventing estrogen from thickening the lining of the uterus (endometrial hyperplasia) when taking estrogen for ovarian hormone therapy in postmenopausal women: Adults—When taking estrogen each day on Days 1 through 25: Oral, 5 to 10 milligrams (mg) of medroxyprogesterone per day for ten to fourteen or more days each month as directed by your doctor. Or, your doctor may want you to take 2.5 or 5 mg per day without stopping. Your doctor will help decide the number of tablets that is best for you and when to take them. For intramuscular injection dosage form: For treating cancer of the kidneys or uterus: Adults and teenagers—At first, 400 to 1000 milligrams (mg) injected into a muscle as a single dose once a week. Then, your doctor may lower your dose to 400 mg or more once a month. For subcutaneous injection dosage form: For treating pain related to endometriosis: Adults and teenagers—104 milligrams (mg) injected under the skin of the anterior thigh or abdomen every three months (12 to 14 weeks) for not more than 2 years. For megestrol For oral dosage form (suspension): For treating loss of appetite (anorexia), muscles (cachexia), or weight caused by acquired immunodeficiency syndrome (AIDS): Adults and teenagers—800 milligrams (mg) a day for the first month. Then your doctor may want you to take 400 or 800 mg a day for three more months. For oral dosage form (tablets): For treating cancer of the breast: Adults and teenagers—160 milligrams (mg) a day as a single dose or in divided doses for two or more months. For treating cancer of the uterus: Adults and teenagers—40 to 320 milligrams (mg) a day for two or more months. For treating loss of appetite (anorexia), muscles (cachexia), or weight caused by cancer: Adults and teenagers—400 to 800 milligrams (mg) a day. For norethindrone For oral dosage form (tablets): For controlling unusual and heavy bleeding of the uterus (dysfunctional uterine bleeding) or treating unusual stopping of menstrual periods (amenorrhea): Adults and teenagers—2.5 to 10 milligrams (mg) a day from Day 5 through Day 25 (counting from the first day of the last menstrual cycle). Or, your doctor may want you to take the medicine only for five to ten days as directed. For treating endometriosis: Adults and teenagers—At first, 5 milligrams (mg) a day for two weeks. Then, your doctor may increase your dose slowly up to 15 mg a day for six to nine months. Let your doctor know if your menstrual period starts. Your doctor may want you to take more of the medicine or may want you to stop taking the medicine for a short period of time. For progesterone For oral dosage form (capsules): For preventing estrogen from thickening the lining of the uterus (endometrial hyperplasia) when taking estrogen for ovarian hormone therapy in postmenopausal women: Adults—200 milligrams (mg) per day at bedtime for 12 continuous days per 28-day cycle of estrogen treatment each month. For treating unusual stopping of menstrual periods (amenorrhea): Adults—400 milligrams (mg) per day at bedtime for ten days. For vaginal dosage form (gel): For treating unusual stopping of menstrual periods (amenorrhea): Adults and teenagers—45 milligrams (mg) (one applicatorful of 4% gel) once every other day for up to six doses. Dose may be increased to 90 mg (one applicatorful of 8% gel) once every other day for up to six doses if needed. For use with infertility procedures: Adults and teenagers—90 milligrams (mg) (one applicatorful of 8% gel) one or two times a day. If pregnancy occurs, treatment can continue for up to ten to twelve weeks. For injection dosage form: For controlling unusual and heavy bleeding of the uterus (dysfunctional uterine bleeding) or treating unusual stopping of menstrual periods (amenorrhea): Adults and teenagers—5 to 10 milligrams (mg) a day injected into a muscle for six to ten days. Or, your doctor may want you to receive 100 or 150 mg injected into a muscle as a single dose. Sometimes your doctor may want you first to take another hormone called estrogen. If your menstrual period starts, your doctor will want you to stop taking the medicine. For vaginal dosage form (suppositories): For maintaining a pregnancy (at ovulation and at the beginning of pregnancy): Adults and teenagers—25 mg to 100 milligrams (mg) (one suppository) inserted into the vagina one or two times a day beginning near the time of ovulation. Your doctor may want you to receive the medicine for up to eleven weeks. Missed Dose

If you miss a dose of progestin, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

For all progestins, except for progesterone capsules for postmenopausal women: If you miss a dose of progestin, take the missed dose as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

For progesterone capsules for postmenopausal women: If you miss a dose of 200 mg of progesterone capsules at bedtime, take 100 mg in the morning then go back to your regular dosing schedule. If you take 300 mg of progesterone a day and you miss your morning and evening doses, you should not take the missed dose. Return to your regular dosing schedule.

Storage

Keep out of the reach of children.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using progestin

It is very important that your doctor check your progress at regular visits. This will allow for your dosage to be adjusted and for any unwanted effects to be detected. These visits will usually be every 6 to 12 months, but some doctors require them more often.

The Prometrium® capsules contain peanut oil. If you have an allergy to peanuts, make sure your doctor knows this before you take this brand of progestin.

Progestins may cause some people to become dizzy. For oral or vaginal progesterone, dizziness or drowsiness may occur 1 to 4 hours after taking or using it. Make sure you know how you react to progestin before you drive, use machines, or do anything else that could be dangerous if you are not alert.

Unusual or unexpected vaginal bleeding of various amounts may occur between your regular menstrual periods during the first 3 months of use. This is sometimes called spotting when slight, or breakthrough menstrual bleeding when heavier. If this should occur, continue on your regular dosing schedule. Check with your doctor:

If unusual or unexpected vaginal bleeding continues for an unusually long time. If your menstrual period has not started within 45 days of your last period.

Missed menstrual periods may occur. If you suspect a pregnancy, you should stop taking progestin immediately and call your doctor. Your doctor will let you know if you should continue taking the progestin.

If you are scheduled for any laboratory tests, tell your health care professional that you are taking a progestin. Progestins can change certain test results.

In some patients, tenderness, swelling, or bleeding of the gums may occur. Brushing and flossing your teeth carefully and regularly and massaging your gums may help prevent this. See your dentist regularly to have your teeth cleaned. Check with your medical doctor or dentist if you have any questions about how to take care of your teeth and gums, or if you notice any tenderness, swelling, or bleeding of your gums.

You will need to use a birth control method while taking progestins for noncontraceptive use if you are fertile and sexually active.

If you are using vaginal progesterone, avoid using other vaginal products for 6 hours before and for 6 hours after inserting the vaginal dose of progesterone.

Since it is possible that certain doses of progestins may cause temporary thinning of the bones by changing your hormone balance, it is important that your doctor know if you have an increased risk of osteoporosis. Some things that can increase your risk for having osteoporosis include cigarette smoking, abusing alcohol, taking or drinking large amounts of caffeine, and having a family history of osteoporosis or easily broken bones. Some medicines, such as glucocorticoids (cortisone-like medicines) or anticonvulsants (seizure medicine), can also cause thinning of the bones. However, it is thought that progestins can help protect against osteoporosis in postmenopausal women.

progestin Side Effects

Along with their needed effects, progestins used in high doses sometimes cause some unwanted effects such as blood clots, heart attacks, and strokes, or problems of the liver and eyes. Although these effects are rare, some of them can be very serious and cause death. It is not clear if these problems are due to the progestin. They may be caused by the disease or condition for which progestins are being used.

The following side effects may be caused by blood clots. Although not all of these side effects may occur, if they do occur they need immediate medical attention.

Get emergency help immediately if any of the following side effects occur:

Rare Symptoms of blood clotting problems, usually severe or sudden, such as: headache or migraine loss of or change in speech, coordination, or vision numbness of or pain in chest, arm, or leg unexplained shortness of breath

Check with your doctor as soon as possible if any of the following side effects occur:

More common Changes in vaginal bleeding (increased amounts of menstrual bleeding occurring at regular monthly periods, lighter vaginal bleeding between menstrual periods, heavier vaginal bleeding between regular monthly periods, or stopping of menstrual periods) symptoms of blood sugar problems (dry mouth, frequent urination, loss of appetite, or unusual thirst) Less common Mental depression skin rash unexpected or increased flow of breast milk RareFor megestrol—During chronic treatment Backache dizziness filling or rounding out of the face irritability mental depression nausea or vomiting unusual decrease in sexual desire or ability in men unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common Abdominal pain or cramping bloating or swelling of ankles or feet blood pressure increase (mild) dizziness drowsiness (progesterone only) headache (mild) mood changes nervousness pain or irritation at place of injection site swelling of face, ankles, or feet unusual or rapid weight gain Less common Acne breast pain or tenderness brown spots on exposed skin, possibly long-lasting hot flashes loss or gain of body, facial, or scalp hair loss of sexual desire trouble in sleeping

Not all of the side effects listed above have been reported for each of these medicines, but they have been reported for at least one of them. All of the progestins are similar, so any of the above side effects may occur with any of these medicines.

After you stop using progestin, your body may need time to adjust. The length of time this takes depends on the amount of medicine you were using and how long you used it. During this period of time check with your doctor if you notice the following side effect:

For megestrol Dizziness nausea or vomiting unusual tiredness or weakness Delayed return to fertility stopping of menstrual periods unusual menstrual bleeding (continuing)

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.


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Megace ES


Generic Name: progestin (Oral route, Parenteral route, Vaginal route)

Commonly used brand name(s)

In the U.S.

Aygestin Camila Crinone Errin First-Progesterone VGS Jolivette Megace Megace ES Next Choice Ovrette Plan B Prochieve Prometrium

In Canada

Alti-Mpa Megace Os

Available Dosage Forms:

Tablet Suspension Capsule, Liquid Filled Gel/Jelly Cream Kit Suppository Uses For Megace ES

Progestins are hormones. They are used by both men and women for different purposes.

Progestins are prescribed for several reasons:

To properly regulate the menstrual cycle and treat unusual stopping of the menstrual periods (amenorrhea). Progestins work by causing changes in the uterus. After the amount of progestins in the blood drops, the lining of the uterus begins to come off and vaginal bleeding occurs (menstrual period). Progestins help other hormones start and stop the menstrual cycle. . To help a pregnancy occur during egg donor or infertility procedures in women who do not produce enough progesterone. Also, progesterone is given to help maintain a pregnancy when not enough of it is made by the body. To prevent estrogen from thickening the lining of the uterus (endometrial hyperplasia) in women around menopause who are being treated with estrogen for ovarian hormone therapy (OHT). OHT is also called hormone replacement therapy (HRT) and estrogen replacement therapy (ERT). To treat pain that is related to endometriosis, a condition where the endometrial tissue which lines the uterus becomes displaced in other female organs. To treat a condition called endometriosis, to help prevent endometrial hyperplasia, or to treat unusual and heavy bleeding of the uterus (dysfunctional uterine bleeding) by starting or stopping the menstrual cycle. To help treat cancer of the breast, kidney, or uterus. Progestins help change the cancer cell's ability to react to other hormones and proteins that cause tumor growth. In this way, progestins can stop the growth of a tumor. To test the body's production of certain hormones such as estrogen. To treat loss of appetite and severe weight or muscle loss in patients with acquired immunodeficiency syndrome (AIDS) or cancer by causing certain proteins to be produced that cause increased appetite and weight gain.

Progestins may also be used for other conditions as determined by your doctor.

Depending on how much and which progestin you use or take, a progestin can have different effects. For instance, high doses of progesterone are necessary for some women to continue a pregnancy while other progestins in low doses can prevent a pregnancy from occurring. Other effects include causing weight gain, increasing body temperature, developing the milk-producing glands for breast-feeding, and relaxing the uterus to maintain a pregnancy.

Progestins can help other hormones work properly. Progestins may help to prevent anemia (low iron in blood), too much menstrual blood loss, and cancer of the uterus.

Progestins are available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, progestins are used in certain patients with the following medical conditions:

Carcinoma of the prostate Corpus luteum insufficiency Hot flashes Polycystic ovary syndrome Precocious puberty Before Using Megace ES Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Although there is no specific information comparing use of progestins in children or teenagers with use in other age groups, this medicine is not expected to cause different side effects or problems in children or teenagers than it does in adults.

Geriatric

This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

Progesterone, a natural hormone that the body makes during pregnancy, has not caused problems. In fact, it is sometimes used in women to treat a certain type of infertility and to aid in egg donor or infertility procedures.

Other progestins have not been studied in pregnant women. Be sure to tell your doctor if you become pregnant while using any of the progestins. It is best to use some kind of birth control method while you are receiving progestins in high doses. High doses of progestins are not recommended for use during pregnancy since there have been some reports that they may cause birth defects in the genitals (sex organs) of a male fetus. Also, some of these progestins may cause male-like changes in a female fetus and female-like changes in a male fetus, but these problems usually can be reversed. Low doses of progestins, such as those doses used for contraception, have not caused major problems when used accidentally during pregnancy.

Breast Feeding

Although progestins pass into the breast milk, they have not been shown to cause problems in nursing babies. However, progestins may change the quality or amount (increase or decrease) of the mother's breast milk. It may be necessary for you to take another medicine or to stop breast-feeding during treatment. Be sure you have discussed the risks and benefits of the medicine with your doctor.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking any of these medicines, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using medicines in this class with any of the following medicines is not recommended. Your doctor may decide not to treat you with a medication in this class or change some of the other medicines you take.

Boceprevir Dofetilide

Using medicines in this class with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Felbamate Isotretinoin Theophylline Tizanidine Tranexamic Acid Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:

Asthma or Epilepsy (or history of) or Heart or circulation problems or Kidney disease (severe) or Migraine headaches—Progestins may cause fluid retention which may cause these conditions to become worse. Bleeding problems, undiagnosed, such as blood in the urine or changes in vaginal bleeding—May make diagnosis of these problems more difficult. Blood clots, or history of or Breast cancer, or history of or Deep vein thrombosis (blood clot in the leg), active or history of or Heart attack, active or history of or Liver disease, including jaundice, or history of or Pulmonary embolism (clot in the lung), active or history of or Stroke , active or history of or Venous thromboembolism (clot in the veins), or history of—Progestins should not be used in patients with these conditions. Breast disease (such as breast lumps or cysts), history of—May make this condition worse for diseases that do not react in a positive way to progestins. Diabetes mellitus—May cause an increase in your blood sugar and a change in the amount of medicine you take for diabetes; progestins in high doses are more likely to cause this problem. Memory loss (dementia)—May make this condition worse. Vision changes—This medicine may cause changes in vision; your medicine may need to be stopped if these conditions become worse. Proper Use of progestin

This section provides information on the proper use of a number of products that contain progestin. It may not be specific to Megace ES. Please read with care.

To make the use of a progestin as safe and reliable as possible, you should understand how and when to take it and what effects may be expected. Progestins usually come with patient directions. Read them carefully before taking or using this medicine.

Take this medicine only as directed by your doctor. Do not take more of it and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects. Try to take the medicine at the same time each day to reduce the possibility of side effects and to allow it to work better.

Progestins are often given together with certain medicines. If you are using a combination of medicines, make sure that you take each one at the proper time and do not mix them. Ask your health care professional to help you plan a way to remember to take your medicines at the right times.

Dosing

The dose medicines in this class will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For medroxyprogesterone For oral dosage form (tablets): For controlling unusual and heavy bleeding of the uterus (dysfunctional uterine bleeding) or treating unusual stopping of menstrual periods (amenorrhea): Adults and teenagers—5 to 10 milligrams (mg) per day for five to ten days as directed by your doctor. For preparing the uterus for the menstrual period: Adults and teenagers—10 milligrams (mg) per day for five or ten days as directed by your doctor. For preventing estrogen from thickening the lining of the uterus (endometrial hyperplasia) when taking estrogen for ovarian hormone therapy in postmenopausal women: Adults—When taking estrogen each day on Days 1 through 25: Oral, 5 to 10 milligrams (mg) of medroxyprogesterone per day for ten to fourteen or more days each month as directed by your doctor. Or, your doctor may want you to take 2.5 or 5 mg per day without stopping. Your doctor will help decide the number of tablets that is best for you and when to take them. For intramuscular injection dosage form: For treating cancer of the kidneys or uterus: Adults and teenagers—At first, 400 to 1000 milligrams (mg) injected into a muscle as a single dose once a week. Then, your doctor may lower your dose to 400 mg or more once a month. For subcutaneous injection dosage form: For treating pain related to endometriosis: Adults and teenagers—104 milligrams (mg) injected under the skin of the anterior thigh or abdomen every three months (12 to 14 weeks) for not more than 2 years. For megestrol For oral dosage form (suspension): For treating loss of appetite (anorexia), muscles (cachexia), or weight caused by acquired immunodeficiency syndrome (AIDS): Adults and teenagers—800 milligrams (mg) a day for the first month. Then your doctor may want you to take 400 or 800 mg a day for three more months. For oral dosage form (tablets): For treating cancer of the breast: Adults and teenagers—160 milligrams (mg) a day as a single dose or in divided doses for two or more months. For treating cancer of the uterus: Adults and teenagers—40 to 320 milligrams (mg) a day for two or more months. For treating loss of appetite (anorexia), muscles (cachexia), or weight caused by cancer: Adults and teenagers—400 to 800 milligrams (mg) a day. For norethindrone For oral dosage form (tablets): For controlling unusual and heavy bleeding of the uterus (dysfunctional uterine bleeding) or treating unusual stopping of menstrual periods (amenorrhea): Adults and teenagers—2.5 to 10 milligrams (mg) a day from Day 5 through Day 25 (counting from the first day of the last menstrual cycle). Or, your doctor may want you to take the medicine only for five to ten days as directed. For treating endometriosis: Adults and teenagers—At first, 5 milligrams (mg) a day for two weeks. Then, your doctor may increase your dose slowly up to 15 mg a day for six to nine months. Let your doctor know if your menstrual period starts. Your doctor may want you to take more of the medicine or may want you to stop taking the medicine for a short period of time. For progesterone For oral dosage form (capsules): For preventing estrogen from thickening the lining of the uterus (endometrial hyperplasia) when taking estrogen for ovarian hormone therapy in postmenopausal women: Adults—200 milligrams (mg) per day at bedtime for 12 continuous days per 28-day cycle of estrogen treatment each month. For treating unusual stopping of menstrual periods (amenorrhea): Adults—400 milligrams (mg) per day at bedtime for ten days. For vaginal dosage form (gel): For treating unusual stopping of menstrual periods (amenorrhea): Adults and teenagers—45 milligrams (mg) (one applicatorful of 4% gel) once every other day for up to six doses. Dose may be increased to 90 mg (one applicatorful of 8% gel) once every other day for up to six doses if needed. For use with infertility procedures: Adults and teenagers—90 milligrams (mg) (one applicatorful of 8% gel) one or two times a day. If pregnancy occurs, treatment can continue for up to ten to twelve weeks. For injection dosage form: For controlling unusual and heavy bleeding of the uterus (dysfunctional uterine bleeding) or treating unusual stopping of menstrual periods (amenorrhea): Adults and teenagers—5 to 10 milligrams (mg) a day injected into a muscle for six to ten days. Or, your doctor may want you to receive 100 or 150 mg injected into a muscle as a single dose. Sometimes your doctor may want you first to take another hormone called estrogen. If your menstrual period starts, your doctor will want you to stop taking the medicine. For vaginal dosage form (suppositories): For maintaining a pregnancy (at ovulation and at the beginning of pregnancy): Adults and teenagers—25 mg to 100 milligrams (mg) (one suppository) inserted into the vagina one or two times a day beginning near the time of ovulation. Your doctor may want you to receive the medicine for up to eleven weeks. Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

For all progestins, except for progesterone capsules for postmenopausal women: If you miss a dose of this medicine, take the missed dose as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

For progesterone capsules for postmenopausal women: If you miss a dose of 200 mg of progesterone capsules at bedtime, take 100 mg in the morning then go back to your regular dosing schedule. If you take 300 mg of progesterone a day and you miss your morning and evening doses, you should not take the missed dose. Return to your regular dosing schedule.

Storage

Keep out of the reach of children.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Megace ES

It is very important that your doctor check your progress at regular visits. This will allow for your dosage to be adjusted and for any unwanted effects to be detected. These visits will usually be every 6 to 12 months, but some doctors require them more often.

The Prometrium® capsules contain peanut oil. If you have an allergy to peanuts, make sure your doctor knows this before you take this brand of progestin.

Progestins may cause some people to become dizzy. For oral or vaginal progesterone, dizziness or drowsiness may occur 1 to 4 hours after taking or using it. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert.

Unusual or unexpected vaginal bleeding of various amounts may occur between your regular menstrual periods during the first 3 months of use. This is sometimes called spotting when slight, or breakthrough menstrual bleeding when heavier. If this should occur, continue on your regular dosing schedule. Check with your doctor:

If unusual or unexpected vaginal bleeding continues for an unusually long time. If your menstrual period has not started within 45 days of your last period.

Missed menstrual periods may occur. If you suspect a pregnancy, you should stop taking this medicine immediately and call your doctor. Your doctor will let you know if you should continue taking the progestin.

If you are scheduled for any laboratory tests, tell your health care professional that you are taking a progestin. Progestins can change certain test results.

In some patients, tenderness, swelling, or bleeding of the gums may occur. Brushing and flossing your teeth carefully and regularly and massaging your gums may help prevent this. See your dentist regularly to have your teeth cleaned. Check with your medical doctor or dentist if you have any questions about how to take care of your teeth and gums, or if you notice any tenderness, swelling, or bleeding of your gums.

You will need to use a birth control method while taking progestins for noncontraceptive use if you are fertile and sexually active.

If you are using vaginal progesterone, avoid using other vaginal products for 6 hours before and for 6 hours after inserting the vaginal dose of progesterone.

Since it is possible that certain doses of progestins may cause temporary thinning of the bones by changing your hormone balance, it is important that your doctor know if you have an increased risk of osteoporosis. Some things that can increase your risk for having osteoporosis include cigarette smoking, abusing alcohol, taking or drinking large amounts of caffeine, and having a family history of osteoporosis or easily broken bones. Some medicines, such as glucocorticoids (cortisone-like medicines) or anticonvulsants (seizure medicine), can also cause thinning of the bones. However, it is thought that progestins can help protect against osteoporosis in postmenopausal women.

Megace ES Side Effects

Along with their needed effects, progestins used in high doses sometimes cause some unwanted effects such as blood clots, heart attacks, and strokes, or problems of the liver and eyes. Although these effects are rare, some of them can be very serious and cause death. It is not clear if these problems are due to the progestin. They may be caused by the disease or condition for which progestins are being used.

The following side effects may be caused by blood clots. Although not all of these side effects may occur, if they do occur they need immediate medical attention.

Get emergency help immediately if any of the following side effects occur:

Rare Symptoms of blood clotting problems, usually severe or sudden, such as: headache or migraine loss of or change in speech, coordination, or vision numbness of or pain in chest, arm, or leg unexplained shortness of breath

Check with your doctor as soon as possible if any of the following side effects occur:

More common Changes in vaginal bleeding (increased amounts of menstrual bleeding occurring at regular monthly periods, lighter vaginal bleeding between menstrual periods, heavier vaginal bleeding between regular monthly periods, or stopping of menstrual periods) symptoms of blood sugar problems (dry mouth, frequent urination, loss of appetite, or unusual thirst) Less common Mental depression skin rash unexpected or increased flow of breast milk RareFor megestrol—During chronic treatment Backache dizziness filling or rounding out of the face irritability mental depression nausea or vomiting unusual decrease in sexual desire or ability in men unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common Abdominal pain or cramping bloating or swelling of ankles or feet blood pressure increase (mild) dizziness drowsiness (progesterone only) headache (mild) mood changes nervousness pain or irritation at place of injection site swelling of face, ankles, or feet unusual or rapid weight gain Less common Acne breast pain or tenderness brown spots on exposed skin, possibly long-lasting hot flashes loss or gain of body, facial, or scalp hair loss of sexual desire trouble in sleeping

Not all of the side effects listed above have been reported for each of these medicines, but they have been reported for at least one of them. All of the progestins are similar, so any of the above side effects may occur with any of these medicines.

After you stop using this medicine, your body may need time to adjust. The length of time this takes depends on the amount of medicine you were using and how long you used it. During this period of time check with your doctor if you notice the following side effect:

For megestrol Dizziness nausea or vomiting unusual tiredness or weakness Delayed return to fertility stopping of menstrual periods unusual menstrual bleeding (continuing)

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.


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Alti-Mpa


Generic Name: progestin (Oral route, Parenteral route, Vaginal route)

Commonly used brand name(s)

In the U.S.

Aygestin Camila Crinone Errin First-Progesterone VGS Jolivette Megace Megace ES Next Choice Ovrette Plan B Prochieve Prometrium

In Canada

Alti-Mpa Megace Os

Available Dosage Forms:

Tablet Suspension Capsule, Liquid Filled Gel/Jelly Cream Kit Suppository Uses For Alti-Mpa

Progestins are hormones. They are used by both men and women for different purposes.

Progestins are prescribed for several reasons:

To properly regulate the menstrual cycle and treat unusual stopping of the menstrual periods (amenorrhea). Progestins work by causing changes in the uterus. After the amount of progestins in the blood drops, the lining of the uterus begins to come off and vaginal bleeding occurs (menstrual period). Progestins help other hormones start and stop the menstrual cycle. . To help a pregnancy occur during egg donor or infertility procedures in women who do not produce enough progesterone. Also, progesterone is given to help maintain a pregnancy when not enough of it is made by the body. To prevent estrogen from thickening the lining of the uterus (endometrial hyperplasia) in women around menopause who are being treated with estrogen for ovarian hormone therapy (OHT). OHT is also called hormone replacement therapy (HRT) and estrogen replacement therapy (ERT). To treat pain that is related to endometriosis, a condition where the endometrial tissue which lines the uterus becomes displaced in other female organs. To treat a condition called endometriosis, to help prevent endometrial hyperplasia, or to treat unusual and heavy bleeding of the uterus (dysfunctional uterine bleeding) by starting or stopping the menstrual cycle. To help treat cancer of the breast, kidney, or uterus. Progestins help change the cancer cell's ability to react to other hormones and proteins that cause tumor growth. In this way, progestins can stop the growth of a tumor. To test the body's production of certain hormones such as estrogen. To treat loss of appetite and severe weight or muscle loss in patients with acquired immunodeficiency syndrome (AIDS) or cancer by causing certain proteins to be produced that cause increased appetite and weight gain.

Progestins may also be used for other conditions as determined by your doctor.

Depending on how much and which progestin you use or take, a progestin can have different effects. For instance, high doses of progesterone are necessary for some women to continue a pregnancy while other progestins in low doses can prevent a pregnancy from occurring. Other effects include causing weight gain, increasing body temperature, developing the milk-producing glands for breast-feeding, and relaxing the uterus to maintain a pregnancy.

Progestins can help other hormones work properly. Progestins may help to prevent anemia (low iron in blood), too much menstrual blood loss, and cancer of the uterus.

Progestins are available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, progestins are used in certain patients with the following medical conditions:

Carcinoma of the prostate Corpus luteum insufficiency Hot flashes Polycystic ovary syndrome Precocious puberty Before Using Alti-Mpa Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Although there is no specific information comparing use of progestins in children or teenagers with use in other age groups, this medicine is not expected to cause different side effects or problems in children or teenagers than it does in adults.

Geriatric

This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

Progesterone, a natural hormone that the body makes during pregnancy, has not caused problems. In fact, it is sometimes used in women to treat a certain type of infertility and to aid in egg donor or infertility procedures.

Other progestins have not been studied in pregnant women. Be sure to tell your doctor if you become pregnant while using any of the progestins. It is best to use some kind of birth control method while you are receiving progestins in high doses. High doses of progestins are not recommended for use during pregnancy since there have been some reports that they may cause birth defects in the genitals (sex organs) of a male fetus. Also, some of these progestins may cause male-like changes in a female fetus and female-like changes in a male fetus, but these problems usually can be reversed. Low doses of progestins, such as those doses used for contraception, have not caused major problems when used accidentally during pregnancy.

Breast Feeding

Although progestins pass into the breast milk, they have not been shown to cause problems in nursing babies. However, progestins may change the quality or amount (increase or decrease) of the mother's breast milk. It may be necessary for you to take another medicine or to stop breast-feeding during treatment. Be sure you have discussed the risks and benefits of the medicine with your doctor.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking any of these medicines, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using medicines in this class with any of the following medicines is not recommended. Your doctor may decide not to treat you with a medication in this class or change some of the other medicines you take.

Boceprevir Dofetilide

Using medicines in this class with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Felbamate Isotretinoin Theophylline Tizanidine Tranexamic Acid Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:

Asthma or Epilepsy (or history of) or Heart or circulation problems or Kidney disease (severe) or Migraine headaches—Progestins may cause fluid retention which may cause these conditions to become worse. Bleeding problems, undiagnosed, such as blood in the urine or changes in vaginal bleeding—May make diagnosis of these problems more difficult. Blood clots, or history of or Breast cancer, or history of or Deep vein thrombosis (blood clot in the leg), active or history of or Heart attack, active or history of or Liver disease, including jaundice, or history of or Pulmonary embolism (clot in the lung), active or history of or Stroke , active or history of or Venous thromboembolism (clot in the veins), or history of—Progestins should not be used in patients with these conditions. Breast disease (such as breast lumps or cysts), history of—May make this condition worse for diseases that do not react in a positive way to progestins. Diabetes mellitus—May cause an increase in your blood sugar and a change in the amount of medicine you take for diabetes; progestins in high doses are more likely to cause this problem. Memory loss (dementia)—May make this condition worse. Vision changes—This medicine may cause changes in vision; your medicine may need to be stopped if these conditions become worse. Proper Use of progestin

This section provides information on the proper use of a number of products that contain progestin. It may not be specific to Alti-Mpa. Please read with care.

To make the use of a progestin as safe and reliable as possible, you should understand how and when to take it and what effects may be expected. Progestins usually come with patient directions. Read them carefully before taking or using this medicine.

Take this medicine only as directed by your doctor. Do not take more of it and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects. Try to take the medicine at the same time each day to reduce the possibility of side effects and to allow it to work better.

Progestins are often given together with certain medicines. If you are using a combination of medicines, make sure that you take each one at the proper time and do not mix them. Ask your health care professional to help you plan a way to remember to take your medicines at the right times.

Dosing

The dose medicines in this class will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For medroxyprogesterone For oral dosage form (tablets): For controlling unusual and heavy bleeding of the uterus (dysfunctional uterine bleeding) or treating unusual stopping of menstrual periods (amenorrhea): Adults and teenagers—5 to 10 milligrams (mg) per day for five to ten days as directed by your doctor. For preparing the uterus for the menstrual period: Adults and teenagers—10 milligrams (mg) per day for five or ten days as directed by your doctor. For preventing estrogen from thickening the lining of the uterus (endometrial hyperplasia) when taking estrogen for ovarian hormone therapy in postmenopausal women: Adults—When taking estrogen each day on Days 1 through 25: Oral, 5 to 10 milligrams (mg) of medroxyprogesterone per day for ten to fourteen or more days each month as directed by your doctor. Or, your doctor may want you to take 2.5 or 5 mg per day without stopping. Your doctor will help decide the number of tablets that is best for you and when to take them. For intramuscular injection dosage form: For treating cancer of the kidneys or uterus: Adults and teenagers—At first, 400 to 1000 milligrams (mg) injected into a muscle as a single dose once a week. Then, your doctor may lower your dose to 400 mg or more once a month. For subcutaneous injection dosage form: For treating pain related to endometriosis: Adults and teenagers—104 milligrams (mg) injected under the skin of the anterior thigh or abdomen every three months (12 to 14 weeks) for not more than 2 years. For megestrol For oral dosage form (suspension): For treating loss of appetite (anorexia), muscles (cachexia), or weight caused by acquired immunodeficiency syndrome (AIDS): Adults and teenagers—800 milligrams (mg) a day for the first month. Then your doctor may want you to take 400 or 800 mg a day for three more months. For oral dosage form (tablets): For treating cancer of the breast: Adults and teenagers—160 milligrams (mg) a day as a single dose or in divided doses for two or more months. For treating cancer of the uterus: Adults and teenagers—40 to 320 milligrams (mg) a day for two or more months. For treating loss of appetite (anorexia), muscles (cachexia), or weight caused by cancer: Adults and teenagers—400 to 800 milligrams (mg) a day. For norethindrone For oral dosage form (tablets): For controlling unusual and heavy bleeding of the uterus (dysfunctional uterine bleeding) or treating unusual stopping of menstrual periods (amenorrhea): Adults and teenagers—2.5 to 10 milligrams (mg) a day from Day 5 through Day 25 (counting from the first day of the last menstrual cycle). Or, your doctor may want you to take the medicine only for five to ten days as directed. For treating endometriosis: Adults and teenagers—At first, 5 milligrams (mg) a day for two weeks. Then, your doctor may increase your dose slowly up to 15 mg a day for six to nine months. Let your doctor know if your menstrual period starts. Your doctor may want you to take more of the medicine or may want you to stop taking the medicine for a short period of time. For progesterone For oral dosage form (capsules): For preventing estrogen from thickening the lining of the uterus (endometrial hyperplasia) when taking estrogen for ovarian hormone therapy in postmenopausal women: Adults—200 milligrams (mg) per day at bedtime for 12 continuous days per 28-day cycle of estrogen treatment each month. For treating unusual stopping of menstrual periods (amenorrhea): Adults—400 milligrams (mg) per day at bedtime for ten days. For vaginal dosage form (gel): For treating unusual stopping of menstrual periods (amenorrhea): Adults and teenagers—45 milligrams (mg) (one applicatorful of 4% gel) once every other day for up to six doses. Dose may be increased to 90 mg (one applicatorful of 8% gel) once every other day for up to six doses if needed. For use with infertility procedures: Adults and teenagers—90 milligrams (mg) (one applicatorful of 8% gel) one or two times a day. If pregnancy occurs, treatment can continue for up to ten to twelve weeks. For injection dosage form: For controlling unusual and heavy bleeding of the uterus (dysfunctional uterine bleeding) or treating unusual stopping of menstrual periods (amenorrhea): Adults and teenagers—5 to 10 milligrams (mg) a day injected into a muscle for six to ten days. Or, your doctor may want you to receive 100 or 150 mg injected into a muscle as a single dose. Sometimes your doctor may want you first to take another hormone called estrogen. If your menstrual period starts, your doctor will want you to stop taking the medicine. For vaginal dosage form (suppositories): For maintaining a pregnancy (at ovulation and at the beginning of pregnancy): Adults and teenagers—25 mg to 100 milligrams (mg) (one suppository) inserted into the vagina one or two times a day beginning near the time of ovulation. Your doctor may want you to receive the medicine for up to eleven weeks. Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

For all progestins, except for progesterone capsules for postmenopausal women: If you miss a dose of this medicine, take the missed dose as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

For progesterone capsules for postmenopausal women: If you miss a dose of 200 mg of progesterone capsules at bedtime, take 100 mg in the morning then go back to your regular dosing schedule. If you take 300 mg of progesterone a day and you miss your morning and evening doses, you should not take the missed dose. Return to your regular dosing schedule.

Storage

Keep out of the reach of children.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Alti-Mpa

It is very important that your doctor check your progress at regular visits. This will allow for your dosage to be adjusted and for any unwanted effects to be detected. These visits will usually be every 6 to 12 months, but some doctors require them more often.

The Prometrium® capsules contain peanut oil. If you have an allergy to peanuts, make sure your doctor knows this before you take this brand of progestin.

Progestins may cause some people to become dizzy. For oral or vaginal progesterone, dizziness or drowsiness may occur 1 to 4 hours after taking or using it. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert.

Unusual or unexpected vaginal bleeding of various amounts may occur between your regular menstrual periods during the first 3 months of use. This is sometimes called spotting when slight, or breakthrough menstrual bleeding when heavier. If this should occur, continue on your regular dosing schedule. Check with your doctor:

If unusual or unexpected vaginal bleeding continues for an unusually long time. If your menstrual period has not started within 45 days of your last period.

Missed menstrual periods may occur. If you suspect a pregnancy, you should stop taking this medicine immediately and call your doctor. Your doctor will let you know if you should continue taking the progestin.

If you are scheduled for any laboratory tests, tell your health care professional that you are taking a progestin. Progestins can change certain test results.

In some patients, tenderness, swelling, or bleeding of the gums may occur. Brushing and flossing your teeth carefully and regularly and massaging your gums may help prevent this. See your dentist regularly to have your teeth cleaned. Check with your medical doctor or dentist if you have any questions about how to take care of your teeth and gums, or if you notice any tenderness, swelling, or bleeding of your gums.

You will need to use a birth control method while taking progestins for noncontraceptive use if you are fertile and sexually active.

If you are using vaginal progesterone, avoid using other vaginal products for 6 hours before and for 6 hours after inserting the vaginal dose of progesterone.

Since it is possible that certain doses of progestins may cause temporary thinning of the bones by changing your hormone balance, it is important that your doctor know if you have an increased risk of osteoporosis. Some things that can increase your risk for having osteoporosis include cigarette smoking, abusing alcohol, taking or drinking large amounts of caffeine, and having a family history of osteoporosis or easily broken bones. Some medicines, such as glucocorticoids (cortisone-like medicines) or anticonvulsants (seizure medicine), can also cause thinning of the bones. However, it is thought that progestins can help protect against osteoporosis in postmenopausal women.

Alti-Mpa Side Effects

Along with their needed effects, progestins used in high doses sometimes cause some unwanted effects such as blood clots, heart attacks, and strokes, or problems of the liver and eyes. Although these effects are rare, some of them can be very serious and cause death. It is not clear if these problems are due to the progestin. They may be caused by the disease or condition for which progestins are being used.

The following side effects may be caused by blood clots. Although not all of these side effects may occur, if they do occur they need immediate medical attention.

Get emergency help immediately if any of the following side effects occur:

Rare Symptoms of blood clotting problems, usually severe or sudden, such as: headache or migraine loss of or change in speech, coordination, or vision numbness of or pain in chest, arm, or leg unexplained shortness of breath

Check with your doctor as soon as possible if any of the following side effects occur:

More common Changes in vaginal bleeding (increased amounts of menstrual bleeding occurring at regular monthly periods, lighter vaginal bleeding between menstrual periods, heavier vaginal bleeding between regular monthly periods, or stopping of menstrual periods) symptoms of blood sugar problems (dry mouth, frequent urination, loss of appetite, or unusual thirst) Less common Mental depression skin rash unexpected or increased flow of breast milk RareFor megestrol—During chronic treatment Backache dizziness filling or rounding out of the face irritability mental depression nausea or vomiting unusual decrease in sexual desire or ability in men unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common Abdominal pain or cramping bloating or swelling of ankles or feet blood pressure increase (mild) dizziness drowsiness (progesterone only) headache (mild) mood changes nervousness pain or irritation at place of injection site swelling of face, ankles, or feet unusual or rapid weight gain Less common Acne breast pain or tenderness brown spots on exposed skin, possibly long-lasting hot flashes loss or gain of body, facial, or scalp hair loss of sexual desire trouble in sleeping

Not all of the side effects listed above have been reported for each of these medicines, but they have been reported for at least one of them. All of the progestins are similar, so any of the above side effects may occur with any of these medicines.

After you stop using this medicine, your body may need time to adjust. The length of time this takes depends on the amount of medicine you were using and how long you used it. During this period of time check with your doctor if you notice the following side effect:

For megestrol Dizziness nausea or vomiting unusual tiredness or weakness Delayed return to fertility stopping of menstrual periods unusual menstrual bleeding (continuing)

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.


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Crinone


Generic Name: progestin (Oral route, Parenteral route, Vaginal route)

Commonly used brand name(s)

In the U.S.

Aygestin Camila Crinone Errin First-Progesterone VGS Jolivette Megace Megace ES Next Choice Ovrette Plan B Prochieve Prometrium

In Canada

Alti-Mpa Megace Os

Available Dosage Forms:

Tablet Suspension Capsule, Liquid Filled Gel/Jelly Cream Kit Suppository Uses For Crinone

Progestins are hormones. They are used by both men and women for different purposes.

Progestins are prescribed for several reasons:

To properly regulate the menstrual cycle and treat unusual stopping of the menstrual periods (amenorrhea). Progestins work by causing changes in the uterus. After the amount of progestins in the blood drops, the lining of the uterus begins to come off and vaginal bleeding occurs (menstrual period). Progestins help other hormones start and stop the menstrual cycle. . To help a pregnancy occur during egg donor or infertility procedures in women who do not produce enough progesterone. Also, progesterone is given to help maintain a pregnancy when not enough of it is made by the body. To prevent estrogen from thickening the lining of the uterus (endometrial hyperplasia) in women around menopause who are being treated with estrogen for ovarian hormone therapy (OHT). OHT is also called hormone replacement therapy (HRT) and estrogen replacement therapy (ERT). To treat pain that is related to endometriosis, a condition where the endometrial tissue which lines the uterus becomes displaced in other female organs. To treat a condition called endometriosis, to help prevent endometrial hyperplasia, or to treat unusual and heavy bleeding of the uterus (dysfunctional uterine bleeding) by starting or stopping the menstrual cycle. To help treat cancer of the breast, kidney, or uterus. Progestins help change the cancer cell's ability to react to other hormones and proteins that cause tumor growth. In this way, progestins can stop the growth of a tumor. To test the body's production of certain hormones such as estrogen. To treat loss of appetite and severe weight or muscle loss in patients with acquired immunodeficiency syndrome (AIDS) or cancer by causing certain proteins to be produced that cause increased appetite and weight gain.

Progestins may also be used for other conditions as determined by your doctor.

Depending on how much and which progestin you use or take, a progestin can have different effects. For instance, high doses of progesterone are necessary for some women to continue a pregnancy while other progestins in low doses can prevent a pregnancy from occurring. Other effects include causing weight gain, increasing body temperature, developing the milk-producing glands for breast-feeding, and relaxing the uterus to maintain a pregnancy.

Progestins can help other hormones work properly. Progestins may help to prevent anemia (low iron in blood), too much menstrual blood loss, and cancer of the uterus.

Progestins are available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, progestins are used in certain patients with the following medical conditions:

Carcinoma of the prostate Corpus luteum insufficiency Hot flashes Polycystic ovary syndrome Precocious puberty Before Using Crinone Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Although there is no specific information comparing use of progestins in children or teenagers with use in other age groups, this medicine is not expected to cause different side effects or problems in children or teenagers than it does in adults.

Geriatric

This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

Progesterone, a natural hormone that the body makes during pregnancy, has not caused problems. In fact, it is sometimes used in women to treat a certain type of infertility and to aid in egg donor or infertility procedures.

Other progestins have not been studied in pregnant women. Be sure to tell your doctor if you become pregnant while using any of the progestins. It is best to use some kind of birth control method while you are receiving progestins in high doses. High doses of progestins are not recommended for use during pregnancy since there have been some reports that they may cause birth defects in the genitals (sex organs) of a male fetus. Also, some of these progestins may cause male-like changes in a female fetus and female-like changes in a male fetus, but these problems usually can be reversed. Low doses of progestins, such as those doses used for contraception, have not caused major problems when used accidentally during pregnancy.

Breast Feeding

Although progestins pass into the breast milk, they have not been shown to cause problems in nursing babies. However, progestins may change the quality or amount (increase or decrease) of the mother's breast milk. It may be necessary for you to take another medicine or to stop breast-feeding during treatment. Be sure you have discussed the risks and benefits of the medicine with your doctor.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking any of these medicines, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using medicines in this class with any of the following medicines is not recommended. Your doctor may decide not to treat you with a medication in this class or change some of the other medicines you take.

Boceprevir Dofetilide

Using medicines in this class with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Felbamate Isotretinoin Theophylline Tizanidine Tranexamic Acid Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:

Asthma or Epilepsy (or history of) or Heart or circulation problems or Kidney disease (severe) or Migraine headaches—Progestins may cause fluid retention which may cause these conditions to become worse. Bleeding problems, undiagnosed, such as blood in the urine or changes in vaginal bleeding—May make diagnosis of these problems more difficult. Blood clots, or history of or Breast cancer, or history of or Deep vein thrombosis (blood clot in the leg), active or history of or Heart attack, active or history of or Liver disease, including jaundice, or history of or Pulmonary embolism (clot in the lung), active or history of or Stroke , active or history of or Venous thromboembolism (clot in the veins), or history of—Progestins should not be used in patients with these conditions. Breast disease (such as breast lumps or cysts), history of—May make this condition worse for diseases that do not react in a positive way to progestins. Diabetes mellitus—May cause an increase in your blood sugar and a change in the amount of medicine you take for diabetes; progestins in high doses are more likely to cause this problem. Memory loss (dementia)—May make this condition worse. Vision changes—This medicine may cause changes in vision; your medicine may need to be stopped if these conditions become worse. Proper Use of progestin

This section provides information on the proper use of a number of products that contain progestin. It may not be specific to Crinone. Please read with care.

To make the use of a progestin as safe and reliable as possible, you should understand how and when to take it and what effects may be expected. Progestins usually come with patient directions. Read them carefully before taking or using this medicine.

Take this medicine only as directed by your doctor. Do not take more of it and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects. Try to take the medicine at the same time each day to reduce the possibility of side effects and to allow it to work better.

Progestins are often given together with certain medicines. If you are using a combination of medicines, make sure that you take each one at the proper time and do not mix them. Ask your health care professional to help you plan a way to remember to take your medicines at the right times.

Dosing

The dose medicines in this class will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For medroxyprogesterone For oral dosage form (tablets): For controlling unusual and heavy bleeding of the uterus (dysfunctional uterine bleeding) or treating unusual stopping of menstrual periods (amenorrhea): Adults and teenagers—5 to 10 milligrams (mg) per day for five to ten days as directed by your doctor. For preparing the uterus for the menstrual period: Adults and teenagers—10 milligrams (mg) per day for five or ten days as directed by your doctor. For preventing estrogen from thickening the lining of the uterus (endometrial hyperplasia) when taking estrogen for ovarian hormone therapy in postmenopausal women: Adults—When taking estrogen each day on Days 1 through 25: Oral, 5 to 10 milligrams (mg) of medroxyprogesterone per day for ten to fourteen or more days each month as directed by your doctor. Or, your doctor may want you to take 2.5 or 5 mg per day without stopping. Your doctor will help decide the number of tablets that is best for you and when to take them. For intramuscular injection dosage form: For treating cancer of the kidneys or uterus: Adults and teenagers—At first, 400 to 1000 milligrams (mg) injected into a muscle as a single dose once a week. Then, your doctor may lower your dose to 400 mg or more once a month. For subcutaneous injection dosage form: For treating pain related to endometriosis: Adults and teenagers—104 milligrams (mg) injected under the skin of the anterior thigh or abdomen every three months (12 to 14 weeks) for not more than 2 years. For megestrol For oral dosage form (suspension): For treating loss of appetite (anorexia), muscles (cachexia), or weight caused by acquired immunodeficiency syndrome (AIDS): Adults and teenagers—800 milligrams (mg) a day for the first month. Then your doctor may want you to take 400 or 800 mg a day for three more months. For oral dosage form (tablets): For treating cancer of the breast: Adults and teenagers—160 milligrams (mg) a day as a single dose or in divided doses for two or more months. For treating cancer of the uterus: Adults and teenagers—40 to 320 milligrams (mg) a day for two or more months. For treating loss of appetite (anorexia), muscles (cachexia), or weight caused by cancer: Adults and teenagers—400 to 800 milligrams (mg) a day. For norethindrone For oral dosage form (tablets): For controlling unusual and heavy bleeding of the uterus (dysfunctional uterine bleeding) or treating unusual stopping of menstrual periods (amenorrhea): Adults and teenagers—2.5 to 10 milligrams (mg) a day from Day 5 through Day 25 (counting from the first day of the last menstrual cycle). Or, your doctor may want you to take the medicine only for five to ten days as directed. For treating endometriosis: Adults and teenagers—At first, 5 milligrams (mg) a day for two weeks. Then, your doctor may increase your dose slowly up to 15 mg a day for six to nine months. Let your doctor know if your menstrual period starts. Your doctor may want you to take more of the medicine or may want you to stop taking the medicine for a short period of time. For progesterone For oral dosage form (capsules): For preventing estrogen from thickening the lining of the uterus (endometrial hyperplasia) when taking estrogen for ovarian hormone therapy in postmenopausal women: Adults—200 milligrams (mg) per day at bedtime for 12 continuous days per 28-day cycle of estrogen treatment each month. For treating unusual stopping of menstrual periods (amenorrhea): Adults—400 milligrams (mg) per day at bedtime for ten days. For vaginal dosage form (gel): For treating unusual stopping of menstrual periods (amenorrhea): Adults and teenagers—45 milligrams (mg) (one applicatorful of 4% gel) once every other day for up to six doses. Dose may be increased to 90 mg (one applicatorful of 8% gel) once every other day for up to six doses if needed. For use with infertility procedures: Adults and teenagers—90 milligrams (mg) (one applicatorful of 8% gel) one or two times a day. If pregnancy occurs, treatment can continue for up to ten to twelve weeks. For injection dosage form: For controlling unusual and heavy bleeding of the uterus (dysfunctional uterine bleeding) or treating unusual stopping of menstrual periods (amenorrhea): Adults and teenagers—5 to 10 milligrams (mg) a day injected into a muscle for six to ten days. Or, your doctor may want you to receive 100 or 150 mg injected into a muscle as a single dose. Sometimes your doctor may want you first to take another hormone called estrogen. If your menstrual period starts, your doctor will want you to stop taking the medicine. For vaginal dosage form (suppositories): For maintaining a pregnancy (at ovulation and at the beginning of pregnancy): Adults and teenagers—25 mg to 100 milligrams (mg) (one suppository) inserted into the vagina one or two times a day beginning near the time of ovulation. Your doctor may want you to receive the medicine for up to eleven weeks. Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

For all progestins, except for progesterone capsules for postmenopausal women: If you miss a dose of this medicine, take the missed dose as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

For progesterone capsules for postmenopausal women: If you miss a dose of 200 mg of progesterone capsules at bedtime, take 100 mg in the morning then go back to your regular dosing schedule. If you take 300 mg of progesterone a day and you miss your morning and evening doses, you should not take the missed dose. Return to your regular dosing schedule.

Storage

Keep out of the reach of children.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Crinone

It is very important that your doctor check your progress at regular visits. This will allow for your dosage to be adjusted and for any unwanted effects to be detected. These visits will usually be every 6 to 12 months, but some doctors require them more often.

The Prometrium® capsules contain peanut oil. If you have an allergy to peanuts, make sure your doctor knows this before you take this brand of progestin.

Progestins may cause some people to become dizzy. For oral or vaginal progesterone, dizziness or drowsiness may occur 1 to 4 hours after taking or using it. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert.

Unusual or unexpected vaginal bleeding of various amounts may occur between your regular menstrual periods during the first 3 months of use. This is sometimes called spotting when slight, or breakthrough menstrual bleeding when heavier. If this should occur, continue on your regular dosing schedule. Check with your doctor:

If unusual or unexpected vaginal bleeding continues for an unusually long time. If your menstrual period has not started within 45 days of your last period.

Missed menstrual periods may occur. If you suspect a pregnancy, you should stop taking this medicine immediately and call your doctor. Your doctor will let you know if you should continue taking the progestin.

If you are scheduled for any laboratory tests, tell your health care professional that you are taking a progestin. Progestins can change certain test results.

In some patients, tenderness, swelling, or bleeding of the gums may occur. Brushing and flossing your teeth carefully and regularly and massaging your gums may help prevent this. See your dentist regularly to have your teeth cleaned. Check with your medical doctor or dentist if you have any questions about how to take care of your teeth and gums, or if you notice any tenderness, swelling, or bleeding of your gums.

You will need to use a birth control method while taking progestins for noncontraceptive use if you are fertile and sexually active.

If you are using vaginal progesterone, avoid using other vaginal products for 6 hours before and for 6 hours after inserting the vaginal dose of progesterone.

Since it is possible that certain doses of progestins may cause temporary thinning of the bones by changing your hormone balance, it is important that your doctor know if you have an increased risk of osteoporosis. Some things that can increase your risk for having osteoporosis include cigarette smoking, abusing alcohol, taking or drinking large amounts of caffeine, and having a family history of osteoporosis or easily broken bones. Some medicines, such as glucocorticoids (cortisone-like medicines) or anticonvulsants (seizure medicine), can also cause thinning of the bones. However, it is thought that progestins can help protect against osteoporosis in postmenopausal women.

Crinone Side Effects

Along with their needed effects, progestins used in high doses sometimes cause some unwanted effects such as blood clots, heart attacks, and strokes, or problems of the liver and eyes. Although these effects are rare, some of them can be very serious and cause death. It is not clear if these problems are due to the progestin. They may be caused by the disease or condition for which progestins are being used.

The following side effects may be caused by blood clots. Although not all of these side effects may occur, if they do occur they need immediate medical attention.

Get emergency help immediately if any of the following side effects occur:

Rare Symptoms of blood clotting problems, usually severe or sudden, such as: headache or migraine loss of or change in speech, coordination, or vision numbness of or pain in chest, arm, or leg unexplained shortness of breath

Check with your doctor as soon as possible if any of the following side effects occur:

More common Changes in vaginal bleeding (increased amounts of menstrual bleeding occurring at regular monthly periods, lighter vaginal bleeding between menstrual periods, heavier vaginal bleeding between regular monthly periods, or stopping of menstrual periods) symptoms of blood sugar problems (dry mouth, frequent urination, loss of appetite, or unusual thirst) Less common Mental depression skin rash unexpected or increased flow of breast milk RareFor megestrol—During chronic treatment Backache dizziness filling or rounding out of the face irritability mental depression nausea or vomiting unusual decrease in sexual desire or ability in men unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common Abdominal pain or cramping bloating or swelling of ankles or feet blood pressure increase (mild) dizziness drowsiness (progesterone only) headache (mild) mood changes nervousness pain or irritation at place of injection site swelling of face, ankles, or feet unusual or rapid weight gain Less common Acne breast pain or tenderness brown spots on exposed skin, possibly long-lasting hot flashes loss or gain of body, facial, or scalp hair loss of sexual desire trouble in sleeping

Not all of the side effects listed above have been reported for each of these medicines, but they have been reported for at least one of them. All of the progestins are similar, so any of the above side effects may occur with any of these medicines.

After you stop using this medicine, your body may need time to adjust. The length of time this takes depends on the amount of medicine you were using and how long you used it. During this period of time check with your doctor if you notice the following side effect:

For megestrol Dizziness nausea or vomiting unusual tiredness or weakness Delayed return to fertility stopping of menstrual periods unusual menstrual bleeding (continuing)

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.


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Plan B Oral, Parenteral, Vaginal


Generic Name: progestin (Oral route, Parenteral route, Vaginal route)

Commonly used brand name(s)

In the U.S.

Aygestin Camila Crinone Errin First-Progesterone VGS Jolivette Megace Megace ES Next Choice Ovrette Plan B Prochieve Prometrium

In Canada

Alti-Mpa Megace Os

Available Dosage Forms:

Tablet Suspension Capsule, Liquid Filled Gel/Jelly Cream Kit Suppository Uses For Plan B

Progestins are hormones. They are used by both men and women for different purposes.

Progestins are prescribed for several reasons:

To properly regulate the menstrual cycle and treat unusual stopping of the menstrual periods (amenorrhea). Progestins work by causing changes in the uterus. After the amount of progestins in the blood drops, the lining of the uterus begins to come off and vaginal bleeding occurs (menstrual period). Progestins help other hormones start and stop the menstrual cycle. . To help a pregnancy occur during egg donor or infertility procedures in women who do not produce enough progesterone. Also, progesterone is given to help maintain a pregnancy when not enough of it is made by the body. To prevent estrogen from thickening the lining of the uterus (endometrial hyperplasia) in women around menopause who are being treated with estrogen for ovarian hormone therapy (OHT). OHT is also called hormone replacement therapy (HRT) and estrogen replacement therapy (ERT). To treat pain that is related to endometriosis, a condition where the endometrial tissue which lines the uterus becomes displaced in other female organs. To treat a condition called endometriosis, to help prevent endometrial hyperplasia, or to treat unusual and heavy bleeding of the uterus (dysfunctional uterine bleeding) by starting or stopping the menstrual cycle. To help treat cancer of the breast, kidney, or uterus. Progestins help change the cancer cell's ability to react to other hormones and proteins that cause tumor growth. In this way, progestins can stop the growth of a tumor. To test the body's production of certain hormones such as estrogen. To treat loss of appetite and severe weight or muscle loss in patients with acquired immunodeficiency syndrome (AIDS) or cancer by causing certain proteins to be produced that cause increased appetite and weight gain.

Progestins may also be used for other conditions as determined by your doctor.

Depending on how much and which progestin you use or take, a progestin can have different effects. For instance, high doses of progesterone are necessary for some women to continue a pregnancy while other progestins in low doses can prevent a pregnancy from occurring. Other effects include causing weight gain, increasing body temperature, developing the milk-producing glands for breast-feeding, and relaxing the uterus to maintain a pregnancy.

Progestins can help other hormones work properly. Progestins may help to prevent anemia (low iron in blood), too much menstrual blood loss, and cancer of the uterus.

Progestins are available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, progestins are used in certain patients with the following medical conditions:

Carcinoma of the prostate Corpus luteum insufficiency Hot flashes Polycystic ovary syndrome Precocious puberty Before Using Plan B Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Although there is no specific information comparing use of progestins in children or teenagers with use in other age groups, this medicine is not expected to cause different side effects or problems in children or teenagers than it does in adults.

Geriatric

This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

Progesterone, a natural hormone that the body makes during pregnancy, has not caused problems. In fact, it is sometimes used in women to treat a certain type of infertility and to aid in egg donor or infertility procedures.

Other progestins have not been studied in pregnant women. Be sure to tell your doctor if you become pregnant while using any of the progestins. It is best to use some kind of birth control method while you are receiving progestins in high doses. High doses of progestins are not recommended for use during pregnancy since there have been some reports that they may cause birth defects in the genitals (sex organs) of a male fetus. Also, some of these progestins may cause male-like changes in a female fetus and female-like changes in a male fetus, but these problems usually can be reversed. Low doses of progestins, such as those doses used for contraception, have not caused major problems when used accidentally during pregnancy.

Breast Feeding

Although progestins pass into the breast milk, they have not been shown to cause problems in nursing babies. However, progestins may change the quality or amount (increase or decrease) of the mother's breast milk. It may be necessary for you to take another medicine or to stop breast-feeding during treatment. Be sure you have discussed the risks and benefits of the medicine with your doctor.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking any of these medicines, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using medicines in this class with any of the following medicines is not recommended. Your doctor may decide not to treat you with a medication in this class or change some of the other medicines you take.

Boceprevir Dofetilide

Using medicines in this class with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Felbamate Isotretinoin Theophylline Tizanidine Tranexamic Acid Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:

Asthma or Epilepsy (or history of) or Heart or circulation problems or Kidney disease (severe) or Migraine headaches—Progestins may cause fluid retention which may cause these conditions to become worse. Bleeding problems, undiagnosed, such as blood in the urine or changes in vaginal bleeding—May make diagnosis of these problems more difficult. Blood clots, or history of or Breast cancer, or history of or Deep vein thrombosis (blood clot in the leg), active or history of or Heart attack, active or history of or Liver disease, including jaundice, or history of or Pulmonary embolism (clot in the lung), active or history of or Stroke , active or history of or Venous thromboembolism (clot in the veins), or history of—Progestins should not be used in patients with these conditions. Breast disease (such as breast lumps or cysts), history of—May make this condition worse for diseases that do not react in a positive way to progestins. Diabetes mellitus—May cause an increase in your blood sugar and a change in the amount of medicine you take for diabetes; progestins in high doses are more likely to cause this problem. Memory loss (dementia)—May make this condition worse. Vision changes—This medicine may cause changes in vision; your medicine may need to be stopped if these conditions become worse. Proper Use of progestin

This section provides information on the proper use of a number of products that contain progestin. It may not be specific to Plan B. Please read with care.

To make the use of a progestin as safe and reliable as possible, you should understand how and when to take it and what effects may be expected. Progestins usually come with patient directions. Read them carefully before taking or using this medicine.

Take this medicine only as directed by your doctor. Do not take more of it and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects. Try to take the medicine at the same time each day to reduce the possibility of side effects and to allow it to work better.

Progestins are often given together with certain medicines. If you are using a combination of medicines, make sure that you take each one at the proper time and do not mix them. Ask your health care professional to help you plan a way to remember to take your medicines at the right times.

Dosing

The dose medicines in this class will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For medroxyprogesterone For oral dosage form (tablets): For controlling unusual and heavy bleeding of the uterus (dysfunctional uterine bleeding) or treating unusual stopping of menstrual periods (amenorrhea): Adults and teenagers—5 to 10 milligrams (mg) per day for five to ten days as directed by your doctor. For preparing the uterus for the menstrual period: Adults and teenagers—10 milligrams (mg) per day for five or ten days as directed by your doctor. For preventing estrogen from thickening the lining of the uterus (endometrial hyperplasia) when taking estrogen for ovarian hormone therapy in postmenopausal women: Adults—When taking estrogen each day on Days 1 through 25: Oral, 5 to 10 milligrams (mg) of medroxyprogesterone per day for ten to fourteen or more days each month as directed by your doctor. Or, your doctor may want you to take 2.5 or 5 mg per day without stopping. Your doctor will help decide the number of tablets that is best for you and when to take them. For intramuscular injection dosage form: For treating cancer of the kidneys or uterus: Adults and teenagers—At first, 400 to 1000 milligrams (mg) injected into a muscle as a single dose once a week. Then, your doctor may lower your dose to 400 mg or more once a month. For subcutaneous injection dosage form: For treating pain related to endometriosis: Adults and teenagers—104 milligrams (mg) injected under the skin of the anterior thigh or abdomen every three months (12 to 14 weeks) for not more than 2 years. For megestrol For oral dosage form (suspension): For treating loss of appetite (anorexia), muscles (cachexia), or weight caused by acquired immunodeficiency syndrome (AIDS): Adults and teenagers—800 milligrams (mg) a day for the first month. Then your doctor may want you to take 400 or 800 mg a day for three more months. For oral dosage form (tablets): For treating cancer of the breast: Adults and teenagers—160 milligrams (mg) a day as a single dose or in divided doses for two or more months. For treating cancer of the uterus: Adults and teenagers—40 to 320 milligrams (mg) a day for two or more months. For treating loss of appetite (anorexia), muscles (cachexia), or weight caused by cancer: Adults and teenagers—400 to 800 milligrams (mg) a day. For norethindrone For oral dosage form (tablets): For controlling unusual and heavy bleeding of the uterus (dysfunctional uterine bleeding) or treating unusual stopping of menstrual periods (amenorrhea): Adults and teenagers—2.5 to 10 milligrams (mg) a day from Day 5 through Day 25 (counting from the first day of the last menstrual cycle). Or, your doctor may want you to take the medicine only for five to ten days as directed. For treating endometriosis: Adults and teenagers—At first, 5 milligrams (mg) a day for two weeks. Then, your doctor may increase your dose slowly up to 15 mg a day for six to nine months. Let your doctor know if your menstrual period starts. Your doctor may want you to take more of the medicine or may want you to stop taking the medicine for a short period of time. For progesterone For oral dosage form (capsules): For preventing estrogen from thickening the lining of the uterus (endometrial hyperplasia) when taking estrogen for ovarian hormone therapy in postmenopausal women: Adults—200 milligrams (mg) per day at bedtime for 12 continuous days per 28-day cycle of estrogen treatment each month. For treating unusual stopping of menstrual periods (amenorrhea): Adults—400 milligrams (mg) per day at bedtime for ten days. For vaginal dosage form (gel): For treating unusual stopping of menstrual periods (amenorrhea): Adults and teenagers—45 milligrams (mg) (one applicatorful of 4% gel) once every other day for up to six doses. Dose may be increased to 90 mg (one applicatorful of 8% gel) once every other day for up to six doses if needed. For use with infertility procedures: Adults and teenagers—90 milligrams (mg) (one applicatorful of 8% gel) one or two times a day. If pregnancy occurs, treatment can continue for up to ten to twelve weeks. For injection dosage form: For controlling unusual and heavy bleeding of the uterus (dysfunctional uterine bleeding) or treating unusual stopping of menstrual periods (amenorrhea): Adults and teenagers—5 to 10 milligrams (mg) a day injected into a muscle for six to ten days. Or, your doctor may want you to receive 100 or 150 mg injected into a muscle as a single dose. Sometimes your doctor may want you first to take another hormone called estrogen. If your menstrual period starts, your doctor will want you to stop taking the medicine. For vaginal dosage form (suppositories): For maintaining a pregnancy (at ovulation and at the beginning of pregnancy): Adults and teenagers—25 mg to 100 milligrams (mg) (one suppository) inserted into the vagina one or two times a day beginning near the time of ovulation. Your doctor may want you to receive the medicine for up to eleven weeks. Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

For all progestins, except for progesterone capsules for postmenopausal women: If you miss a dose of this medicine, take the missed dose as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

For progesterone capsules for postmenopausal women: If you miss a dose of 200 mg of progesterone capsules at bedtime, take 100 mg in the morning then go back to your regular dosing schedule. If you take 300 mg of progesterone a day and you miss your morning and evening doses, you should not take the missed dose. Return to your regular dosing schedule.

Storage

Keep out of the reach of children.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Plan B

It is very important that your doctor check your progress at regular visits. This will allow for your dosage to be adjusted and for any unwanted effects to be detected. These visits will usually be every 6 to 12 months, but some doctors require them more often.

The Prometrium® capsules contain peanut oil. If you have an allergy to peanuts, make sure your doctor knows this before you take this brand of progestin.

Progestins may cause some people to become dizzy. For oral or vaginal progesterone, dizziness or drowsiness may occur 1 to 4 hours after taking or using it. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert.

Unusual or unexpected vaginal bleeding of various amounts may occur between your regular menstrual periods during the first 3 months of use. This is sometimes called spotting when slight, or breakthrough menstrual bleeding when heavier. If this should occur, continue on your regular dosing schedule. Check with your doctor:

If unusual or unexpected vaginal bleeding continues for an unusually long time. If your menstrual period has not started within 45 days of your last period.

Missed menstrual periods may occur. If you suspect a pregnancy, you should stop taking this medicine immediately and call your doctor. Your doctor will let you know if you should continue taking the progestin.

If you are scheduled for any laboratory tests, tell your health care professional that you are taking a progestin. Progestins can change certain test results.

In some patients, tenderness, swelling, or bleeding of the gums may occur. Brushing and flossing your teeth carefully and regularly and massaging your gums may help prevent this. See your dentist regularly to have your teeth cleaned. Check with your medical doctor or dentist if you have any questions about how to take care of your teeth and gums, or if you notice any tenderness, swelling, or bleeding of your gums.

You will need to use a birth control method while taking progestins for noncontraceptive use if you are fertile and sexually active.

If you are using vaginal progesterone, avoid using other vaginal products for 6 hours before and for 6 hours after inserting the vaginal dose of progesterone.

Since it is possible that certain doses of progestins may cause temporary thinning of the bones by changing your hormone balance, it is important that your doctor know if you have an increased risk of osteoporosis. Some things that can increase your risk for having osteoporosis include cigarette smoking, abusing alcohol, taking or drinking large amounts of caffeine, and having a family history of osteoporosis or easily broken bones. Some medicines, such as glucocorticoids (cortisone-like medicines) or anticonvulsants (seizure medicine), can also cause thinning of the bones. However, it is thought that progestins can help protect against osteoporosis in postmenopausal women.

Plan B Side Effects

Along with their needed effects, progestins used in high doses sometimes cause some unwanted effects such as blood clots, heart attacks, and strokes, or problems of the liver and eyes. Although these effects are rare, some of them can be very serious and cause death. It is not clear if these problems are due to the progestin. They may be caused by the disease or condition for which progestins are being used.

The following side effects may be caused by blood clots. Although not all of these side effects may occur, if they do occur they need immediate medical attention.

Get emergency help immediately if any of the following side effects occur:

Rare Symptoms of blood clotting problems, usually severe or sudden, such as: headache or migraine loss of or change in speech, coordination, or vision numbness of or pain in chest, arm, or leg unexplained shortness of breath

Check with your doctor as soon as possible if any of the following side effects occur:

More common Changes in vaginal bleeding (increased amounts of menstrual bleeding occurring at regular monthly periods, lighter vaginal bleeding between menstrual periods, heavier vaginal bleeding between regular monthly periods, or stopping of menstrual periods) symptoms of blood sugar problems (dry mouth, frequent urination, loss of appetite, or unusual thirst) Less common Mental depression skin rash unexpected or increased flow of breast milk RareFor megestrol—During chronic treatment Backache dizziness filling or rounding out of the face irritability mental depression nausea or vomiting unusual decrease in sexual desire or ability in men unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common Abdominal pain or cramping bloating or swelling of ankles or feet blood pressure increase (mild) dizziness drowsiness (progesterone only) headache (mild) mood changes nervousness pain or irritation at place of injection site swelling of face, ankles, or feet unusual or rapid weight gain Less common Acne breast pain or tenderness brown spots on exposed skin, possibly long-lasting hot flashes loss or gain of body, facial, or scalp hair loss of sexual desire trouble in sleeping

Not all of the side effects listed above have been reported for each of these medicines, but they have been reported for at least one of them. All of the progestins are similar, so any of the above side effects may occur with any of these medicines.

After you stop using this medicine, your body may need time to adjust. The length of time this takes depends on the amount of medicine you were using and how long you used it. During this period of time check with your doctor if you notice the following side effect:

For megestrol Dizziness nausea or vomiting unusual tiredness or weakness Delayed return to fertility stopping of menstrual periods unusual menstrual bleeding (continuing)

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.


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Next Choice Oral, Parenteral, Vaginal


Generic Name: progestin (Oral route, Parenteral route, Vaginal route)

Commonly used brand name(s)

In the U.S.

Aygestin Camila Crinone Errin First-Progesterone VGS Jolivette Megace Megace ES Next Choice Ovrette Plan B Prochieve Prometrium

In Canada

Alti-Mpa Megace Os

Available Dosage Forms:

Tablet Suspension Capsule, Liquid Filled Gel/Jelly Cream Kit Suppository Uses For Next Choice

Progestins are hormones. They are used by both men and women for different purposes.

Progestins are prescribed for several reasons:

To properly regulate the menstrual cycle and treat unusual stopping of the menstrual periods (amenorrhea). Progestins work by causing changes in the uterus. After the amount of progestins in the blood drops, the lining of the uterus begins to come off and vaginal bleeding occurs (menstrual period). Progestins help other hormones start and stop the menstrual cycle. . To help a pregnancy occur during egg donor or infertility procedures in women who do not produce enough progesterone. Also, progesterone is given to help maintain a pregnancy when not enough of it is made by the body. To prevent estrogen from thickening the lining of the uterus (endometrial hyperplasia) in women around menopause who are being treated with estrogen for ovarian hormone therapy (OHT). OHT is also called hormone replacement therapy (HRT) and estrogen replacement therapy (ERT). To treat pain that is related to endometriosis, a condition where the endometrial tissue which lines the uterus becomes displaced in other female organs. To treat a condition called endometriosis, to help prevent endometrial hyperplasia, or to treat unusual and heavy bleeding of the uterus (dysfunctional uterine bleeding) by starting or stopping the menstrual cycle. To help treat cancer of the breast, kidney, or uterus. Progestins help change the cancer cell's ability to react to other hormones and proteins that cause tumor growth. In this way, progestins can stop the growth of a tumor. To test the body's production of certain hormones such as estrogen. To treat loss of appetite and severe weight or muscle loss in patients with acquired immunodeficiency syndrome (AIDS) or cancer by causing certain proteins to be produced that cause increased appetite and weight gain.

Progestins may also be used for other conditions as determined by your doctor.

Depending on how much and which progestin you use or take, a progestin can have different effects. For instance, high doses of progesterone are necessary for some women to continue a pregnancy while other progestins in low doses can prevent a pregnancy from occurring. Other effects include causing weight gain, increasing body temperature, developing the milk-producing glands for breast-feeding, and relaxing the uterus to maintain a pregnancy.

Progestins can help other hormones work properly. Progestins may help to prevent anemia (low iron in blood), too much menstrual blood loss, and cancer of the uterus.

Progestins are available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, progestins are used in certain patients with the following medical conditions:

Carcinoma of the prostate Corpus luteum insufficiency Hot flashes Polycystic ovary syndrome Precocious puberty Before Using Next Choice Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Although there is no specific information comparing use of progestins in children or teenagers with use in other age groups, this medicine is not expected to cause different side effects or problems in children or teenagers than it does in adults.

Geriatric

This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

Progesterone, a natural hormone that the body makes during pregnancy, has not caused problems. In fact, it is sometimes used in women to treat a certain type of infertility and to aid in egg donor or infertility procedures.

Other progestins have not been studied in pregnant women. Be sure to tell your doctor if you become pregnant while using any of the progestins. It is best to use some kind of birth control method while you are receiving progestins in high doses. High doses of progestins are not recommended for use during pregnancy since there have been some reports that they may cause birth defects in the genitals (sex organs) of a male fetus. Also, some of these progestins may cause male-like changes in a female fetus and female-like changes in a male fetus, but these problems usually can be reversed. Low doses of progestins, such as those doses used for contraception, have not caused major problems when used accidentally during pregnancy.

Breast Feeding

Although progestins pass into the breast milk, they have not been shown to cause problems in nursing babies. However, progestins may change the quality or amount (increase or decrease) of the mother's breast milk. It may be necessary for you to take another medicine or to stop breast-feeding during treatment. Be sure you have discussed the risks and benefits of the medicine with your doctor.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking any of these medicines, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using medicines in this class with any of the following medicines is not recommended. Your doctor may decide not to treat you with a medication in this class or change some of the other medicines you take.

Boceprevir Dofetilide

Using medicines in this class with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Felbamate Isotretinoin Theophylline Tizanidine Tranexamic Acid Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:

Asthma or Epilepsy (or history of) or Heart or circulation problems or Kidney disease (severe) or Migraine headaches—Progestins may cause fluid retention which may cause these conditions to become worse. Bleeding problems, undiagnosed, such as blood in the urine or changes in vaginal bleeding—May make diagnosis of these problems more difficult. Blood clots, or history of or Breast cancer, or history of or Deep vein thrombosis (blood clot in the leg), active or history of or Heart attack, active or history of or Liver disease, including jaundice, or history of or Pulmonary embolism (clot in the lung), active or history of or Stroke , active or history of or Venous thromboembolism (clot in the veins), or history of—Progestins should not be used in patients with these conditions. Breast disease (such as breast lumps or cysts), history of—May make this condition worse for diseases that do not react in a positive way to progestins. Diabetes mellitus—May cause an increase in your blood sugar and a change in the amount of medicine you take for diabetes; progestins in high doses are more likely to cause this problem. Memory loss (dementia)—May make this condition worse. Vision changes—This medicine may cause changes in vision; your medicine may need to be stopped if these conditions become worse. Proper Use of progestin

This section provides information on the proper use of a number of products that contain progestin. It may not be specific to Next Choice. Please read with care.

To make the use of a progestin as safe and reliable as possible, you should understand how and when to take it and what effects may be expected. Progestins usually come with patient directions. Read them carefully before taking or using this medicine.

Take this medicine only as directed by your doctor. Do not take more of it and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects. Try to take the medicine at the same time each day to reduce the possibility of side effects and to allow it to work better.

Progestins are often given together with certain medicines. If you are using a combination of medicines, make sure that you take each one at the proper time and do not mix them. Ask your health care professional to help you plan a way to remember to take your medicines at the right times.

Dosing

The dose medicines in this class will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For medroxyprogesterone For oral dosage form (tablets): For controlling unusual and heavy bleeding of the uterus (dysfunctional uterine bleeding) or treating unusual stopping of menstrual periods (amenorrhea): Adults and teenagers—5 to 10 milligrams (mg) per day for five to ten days as directed by your doctor. For preparing the uterus for the menstrual period: Adults and teenagers—10 milligrams (mg) per day for five or ten days as directed by your doctor. For preventing estrogen from thickening the lining of the uterus (endometrial hyperplasia) when taking estrogen for ovarian hormone therapy in postmenopausal women: Adults—When taking estrogen each day on Days 1 through 25: Oral, 5 to 10 milligrams (mg) of medroxyprogesterone per day for ten to fourteen or more days each month as directed by your doctor. Or, your doctor may want you to take 2.5 or 5 mg per day without stopping. Your doctor will help decide the number of tablets that is best for you and when to take them. For intramuscular injection dosage form: For treating cancer of the kidneys or uterus: Adults and teenagers—At first, 400 to 1000 milligrams (mg) injected into a muscle as a single dose once a week. Then, your doctor may lower your dose to 400 mg or more once a month. For subcutaneous injection dosage form: For treating pain related to endometriosis: Adults and teenagers—104 milligrams (mg) injected under the skin of the anterior thigh or abdomen every three months (12 to 14 weeks) for not more than 2 years. For megestrol For oral dosage form (suspension): For treating loss of appetite (anorexia), muscles (cachexia), or weight caused by acquired immunodeficiency syndrome (AIDS): Adults and teenagers—800 milligrams (mg) a day for the first month. Then your doctor may want you to take 400 or 800 mg a day for three more months. For oral dosage form (tablets): For treating cancer of the breast: Adults and teenagers—160 milligrams (mg) a day as a single dose or in divided doses for two or more months. For treating cancer of the uterus: Adults and teenagers—40 to 320 milligrams (mg) a day for two or more months. For treating loss of appetite (anorexia), muscles (cachexia), or weight caused by cancer: Adults and teenagers—400 to 800 milligrams (mg) a day. For norethindrone For oral dosage form (tablets): For controlling unusual and heavy bleeding of the uterus (dysfunctional uterine bleeding) or treating unusual stopping of menstrual periods (amenorrhea): Adults and teenagers—2.5 to 10 milligrams (mg) a day from Day 5 through Day 25 (counting from the first day of the last menstrual cycle). Or, your doctor may want you to take the medicine only for five to ten days as directed. For treating endometriosis: Adults and teenagers—At first, 5 milligrams (mg) a day for two weeks. Then, your doctor may increase your dose slowly up to 15 mg a day for six to nine months. Let your doctor know if your menstrual period starts. Your doctor may want you to take more of the medicine or may want you to stop taking the medicine for a short period of time. For progesterone For oral dosage form (capsules): For preventing estrogen from thickening the lining of the uterus (endometrial hyperplasia) when taking estrogen for ovarian hormone therapy in postmenopausal women: Adults—200 milligrams (mg) per day at bedtime for 12 continuous days per 28-day cycle of estrogen treatment each month. For treating unusual stopping of menstrual periods (amenorrhea): Adults—400 milligrams (mg) per day at bedtime for ten days. For vaginal dosage form (gel): For treating unusual stopping of menstrual periods (amenorrhea): Adults and teenagers—45 milligrams (mg) (one applicatorful of 4% gel) once every other day for up to six doses. Dose may be increased to 90 mg (one applicatorful of 8% gel) once every other day for up to six doses if needed. For use with infertility procedures: Adults and teenagers—90 milligrams (mg) (one applicatorful of 8% gel) one or two times a day. If pregnancy occurs, treatment can continue for up to ten to twelve weeks. For injection dosage form: For controlling unusual and heavy bleeding of the uterus (dysfunctional uterine bleeding) or treating unusual stopping of menstrual periods (amenorrhea): Adults and teenagers—5 to 10 milligrams (mg) a day injected into a muscle for six to ten days. Or, your doctor may want you to receive 100 or 150 mg injected into a muscle as a single dose. Sometimes your doctor may want you first to take another hormone called estrogen. If your menstrual period starts, your doctor will want you to stop taking the medicine. For vaginal dosage form (suppositories): For maintaining a pregnancy (at ovulation and at the beginning of pregnancy): Adults and teenagers—25 mg to 100 milligrams (mg) (one suppository) inserted into the vagina one or two times a day beginning near the time of ovulation. Your doctor may want you to receive the medicine for up to eleven weeks. Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

For all progestins, except for progesterone capsules for postmenopausal women: If you miss a dose of this medicine, take the missed dose as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

For progesterone capsules for postmenopausal women: If you miss a dose of 200 mg of progesterone capsules at bedtime, take 100 mg in the morning then go back to your regular dosing schedule. If you take 300 mg of progesterone a day and you miss your morning and evening doses, you should not take the missed dose. Return to your regular dosing schedule.

Storage

Keep out of the reach of children.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Next Choice

It is very important that your doctor check your progress at regular visits. This will allow for your dosage to be adjusted and for any unwanted effects to be detected. These visits will usually be every 6 to 12 months, but some doctors require them more often.

The Prometrium® capsules contain peanut oil. If you have an allergy to peanuts, make sure your doctor knows this before you take this brand of progestin.

Progestins may cause some people to become dizzy. For oral or vaginal progesterone, dizziness or drowsiness may occur 1 to 4 hours after taking or using it. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert.

Unusual or unexpected vaginal bleeding of various amounts may occur between your regular menstrual periods during the first 3 months of use. This is sometimes called spotting when slight, or breakthrough menstrual bleeding when heavier. If this should occur, continue on your regular dosing schedule. Check with your doctor:

If unusual or unexpected vaginal bleeding continues for an unusually long time. If your menstrual period has not started within 45 days of your last period.

Missed menstrual periods may occur. If you suspect a pregnancy, you should stop taking this medicine immediately and call your doctor. Your doctor will let you know if you should continue taking the progestin.

If you are scheduled for any laboratory tests, tell your health care professional that you are taking a progestin. Progestins can change certain test results.

In some patients, tenderness, swelling, or bleeding of the gums may occur. Brushing and flossing your teeth carefully and regularly and massaging your gums may help prevent this. See your dentist regularly to have your teeth cleaned. Check with your medical doctor or dentist if you have any questions about how to take care of your teeth and gums, or if you notice any tenderness, swelling, or bleeding of your gums.

You will need to use a birth control method while taking progestins for noncontraceptive use if you are fertile and sexually active.

If you are using vaginal progesterone, avoid using other vaginal products for 6 hours before and for 6 hours after inserting the vaginal dose of progesterone.

Since it is possible that certain doses of progestins may cause temporary thinning of the bones by changing your hormone balance, it is important that your doctor know if you have an increased risk of osteoporosis. Some things that can increase your risk for having osteoporosis include cigarette smoking, abusing alcohol, taking or drinking large amounts of caffeine, and having a family history of osteoporosis or easily broken bones. Some medicines, such as glucocorticoids (cortisone-like medicines) or anticonvulsants (seizure medicine), can also cause thinning of the bones. However, it is thought that progestins can help protect against osteoporosis in postmenopausal women.

Next Choice Side Effects

Along with their needed effects, progestins used in high doses sometimes cause some unwanted effects such as blood clots, heart attacks, and strokes, or problems of the liver and eyes. Although these effects are rare, some of them can be very serious and cause death. It is not clear if these problems are due to the progestin. They may be caused by the disease or condition for which progestins are being used.

The following side effects may be caused by blood clots. Although not all of these side effects may occur, if they do occur they need immediate medical attention.

Get emergency help immediately if any of the following side effects occur:

Rare Symptoms of blood clotting problems, usually severe or sudden, such as: headache or migraine loss of or change in speech, coordination, or vision numbness of or pain in chest, arm, or leg unexplained shortness of breath

Check with your doctor as soon as possible if any of the following side effects occur:

More common Changes in vaginal bleeding (increased amounts of menstrual bleeding occurring at regular monthly periods, lighter vaginal bleeding between menstrual periods, heavier vaginal bleeding between regular monthly periods, or stopping of menstrual periods) symptoms of blood sugar problems (dry mouth, frequent urination, loss of appetite, or unusual thirst) Less common Mental depression skin rash unexpected or increased flow of breast milk RareFor megestrol—During chronic treatment Backache dizziness filling or rounding out of the face irritability mental depression nausea or vomiting unusual decrease in sexual desire or ability in men unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common Abdominal pain or cramping bloating or swelling of ankles or feet blood pressure increase (mild) dizziness drowsiness (progesterone only) headache (mild) mood changes nervousness pain or irritation at place of injection site swelling of face, ankles, or feet unusual or rapid weight gain Less common Acne breast pain or tenderness brown spots on exposed skin, possibly long-lasting hot flashes loss or gain of body, facial, or scalp hair loss of sexual desire trouble in sleeping

Not all of the side effects listed above have been reported for each of these medicines, but they have been reported for at least one of them. All of the progestins are similar, so any of the above side effects may occur with any of these medicines.

After you stop using this medicine, your body may need time to adjust. The length of time this takes depends on the amount of medicine you were using and how long you used it. During this period of time check with your doctor if you notice the following side effect:

For megestrol Dizziness nausea or vomiting unusual tiredness or weakness Delayed return to fertility stopping of menstrual periods unusual menstrual bleeding (continuing)

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.


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urofollitropin Intramuscular, Subcutaneous, Injection


ure-oh-FOL-li-troe-pin

Commonly used brand name(s)

In the U.S.

Bravelle Fertinex

In Canada

Fertinorm Hp Metrodin

Available Dosage Forms:

Powder for Solution

Therapeutic Class: Female Reproductive Agent

Pharmacologic Class: Human Follicle Stimulating Hormone

Uses For urofollitropin

Urofollitropin is a fertility drug that is identical to the hormone called follicle-stimulating hormone (FSH) that is produced naturally by the pituitary gland.

FSH is primarily responsible for stimulating growth of the ovarian follicle, which includes the developing egg, the cells surrounding the egg that produce the hormones needed to support a pregnancy, and the fluid around the egg. As the ovarian follicle grows, an increasing amount of the hormone estrogen is produced by the cells in the follicle and released into the bloodstream. Estrogen causes the endometrium (lining of the uterus) to thicken before ovulation occurs. The higher blood levels of estrogen will also provide a cue to the hypothalamus and pituitary gland to slow the production and release of FSH.

Another pituitary hormone, luteinizing hormone (LH), also helps to increase the amount of estrogen produced by the follicle cells. However, the main function of LH is to cause ovulation. The sharp rise in the blood level of LH that triggers ovulation is sometimes called the LH surge. After ovulation, the group of hormone-producing follicle cells become what is called the corpus luteum and will produce estrogen and large amounts of another hormone, progesterone. Progesterone causes the endometrium to mature so that it can support the egg after it is fertilized. If implantation of a fertilized egg does not occur, the levels of estrogen and progesterone decrease, the endometrium sloughs off, and menstruation occurs.

Urofollitropin is usually given in combination with human chorionic gonadotropin (hCG). The actions of hCG are almost identical to those of LH. It is given to simulate the natural LH surge. This results in predictable ovulation.

Urofollitropin is often used in women who have low levels of FSH and too-high levels of LH. Women with polycystic ovary syndrome usually have hormone levels such as this and are treated with urofollitropin to make up for the low amounts of FSH. Many women being treated with urofollitropin have already tried clomiphene (e.g., Serophene) and have not been able to conceive yet. Urofollitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).

Urofollitropin is to be given only by or under the supervision of your doctor.

Before Using urofollitropin

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For urofollitropin, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to urofollitropin or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pregnancy Pregnancy Category Explanation All Trimesters X Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit. Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of urofollitropin. Make sure you tell your doctor if you have any other medical problems, especially:

Cyst on ovary—Urofollitropin can cause further growth of cysts on the ovary Unusual vaginal bleeding—Some irregular vaginal bleeding is a sign that the endometrium is growing too rapidly, possibly of endometrial cancer, or some hormone imbalances; the increases in estrogen production caused by urofollitropin can make these problems worse. If a hormonal imbalance is present, it should be treated before beginning menotropins therapy Proper Use of urofollitropin Dosing

The dose of urofollitropin will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of urofollitropin. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For injection dosage form: For becoming pregnant while having a condition called polycystic ovary syndrome: Adults—75 Units injected under the skin or into a muscle once a day for seven or more days. Usually, another medicine called chorionic gonadotropin (hCG) will be given the day after the last dose. If needed, your doctor may then increase your dose of urofollitropin to 150 Units a day for another seven or more days. Higher doses may be prescribed by your doctor. For becoming pregnant while using other pregnancy-promoting methods (assisted reproductive technology [ART]): Adults—150 Units injected under the skin or into a muscle once a day. Your treatment will probably begin on Day 2 or Day 3 after your menstrual period begins. Usually, another medicine called chorionic gonadotropin (hCG) will be given the day after the last dose. Precautions While Using urofollitropin

It is very important that your doctor check your progress at regular visits to make sure that the medicine is working properly and to check for unwanted effects. Your doctor will likely want to monitor the development of the ovarian follicle(s) by measuring the amount of estrogen in your bloodstream and by checking the size of the follicle(s) with ultrasound examinations.

If your doctor has asked you to record your basal body temperature (BBT) daily, make sure that you do this every day. It is important that intercourse take place around the time of ovulation to give you the best chance of becoming pregnant.

urofollitropin Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

More common Abdominal or pelvic pain bloating (mild) redness, pain, or swelling at the injection site Less common or rare Abdominal or stomach pain (severe) bloating (moderate to severe) decreased amount of urine feeling of indigestion fever and chills nausea, vomiting, or diarrhea (continuing or severe) pelvic pain (severe) shortness of breath skin rash or hives swelling of lower legs weight gain (rapid)

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common or rare Breast tenderness diarrhea (mild) nausea vomiting

After you stop using urofollitropin, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

Abdominal or stomach pain (severe) bloating (moderate to severe) decreased amount of urine feeling of indigestion nausea, vomiting, or diarrhea (continuing or severe) pelvic pain (severe) shortness of breath swelling of lower legs weight gain (rapid)

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: urofollitropin Intramuscular, Subcutaneous, Injection side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More urofollitropin Intramuscular, Subcutaneous, Injection resources Urofollitropin Intramuscular, Subcutaneous, Injection Side Effects (in more detail)Urofollitropin Intramuscular, Subcutaneous, Injection Use in Pregnancy & BreastfeedingUrofollitropin Intramuscular, Subcutaneous, Injection Drug InteractionsUrofollitropin Intramuscular, Subcutaneous, Injection Support Group0 Reviews for Urofollitropin Intramuscular, Subcutaneous, Injection - Add your own review/rating Compare urofollitropin Intramuscular, Subcutaneous, Injection with other medications Female InfertilityFollicle Stimulation
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