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Hypoestrogenism Medications


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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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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Bladder Infection Medications


Definition of Bladder Infection: Inflammation of the urinary bladder.

Drugs associated with Bladder Infection

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

See sub-topics

Topics under Bladder Infection Alkylating Agent Cystitis (0 drugs) Hemorrhagic Cystitis Prophylaxis (1 drug) Prevention of Bladder infection (19 drugs) Learn more about Bladder Infection

Medical Encyclopedia:

Cystitis - acute Cystitis - noninfectious Cystitis - recurrent Urinary tract infection - adults Urinary tract infection - children

Harvard Health Guide:

Symptoms and treatment for Bladder Infection (Cystitis)
Drug List: Ala-Tet Amoxil Bio-Cef Cedax Cefizox Ceftin Cefzil Ceptaz Cinobac Cipro Cipro-I-V Cipro-Xr-Extended-Release-Tablets Cloxapen Dispermox Elmiron Floxin Fortaz Furadantin-Suspension Gantrisin-Suspension Gantrisin-Pediatric Geocillin Hiprex Keflex Levaquin Levaquin-Leva-Pak Lithostat Lorabid Lorabid-Pulvules Macrobid Macrodantin Mandelamine Maxaquin Monurol Neggram Noroxin Panixine Primsol-Solution Proloprim Proquin_Xr Raniclor Spectrobid Sumycin Suprax Tazicef Tegopen Tequin Tequin-Teqpaq Trimox Trimpex Truxazole Urex Vantin Velosef Zinacef
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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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Urinary anti-infectives


A drug may be classified by the chemical type of the active ingredient or by the way it is used to treat a particular condition. Each drug can be classified into one or more drug classes.

Urinary anti-infectives are drugs that are used to prevent or treat urinary tract infections. There are several classes of antibacterial agents in this category and they have different mechanisms of action. However, majority of these drugs tend to have high concentration in the urine and therefore are ideal to treat urinary tract infections, or used as prophylaxis for urinary tract infections.

See also

Medical conditions associated with urinary anti-infectives:

Bladder Infection Methemoglobinemia Otitis Media Pneumocystis Pneumonia Prevention of Bladder infection Transurethral Prostatectomy Urinary Tract Infection Drug List: Monurol Hiprex Mandelamine Macrodantin Macrobid Cinobac Furadantin-Suspension Neggram Primsol-Solution Proloprim Trimpex Urex Urolene-Blue-Oral-And-Injection
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Urinary Tract Tumors Medications


Drugs associated with Urinary Tract Tumors

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

Learn more about Urinary Tract Tumors

Micromedex Care Notes:

Bladder Cancer

Medical Encyclopedia:

Bladder cancer Cancer Cancer - renal pelvis or ureter Tumor
Drug List: Theracys Tice-Bcg Tice-Bcg-Vaccine Valstar
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hexaminolevulinate Urinary bladder


hex-a-mee-noe-LEV-ue-lin-ate hye-droe-KLOR-ide

Commonly used brand name(s)

In the U.S.

Cysview

Available Dosage Forms:

Powder for Solution

Therapeutic Class: Diagnostic Agent, Radiopharmaceutical Imaging

Uses For hexaminolevulinate

Hexaminolevulinate is an imaging agent that is used in a procedure for the bladder called cystoscopy. Imaging agents help create an image or picture of body parts, such as the bladder. Hexaminolevulinate is used to check for cancer cells in the bladder.

hexaminolevulinate is to be used only by or under the direct supervision of a doctor.

Before Using hexaminolevulinate

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 hexaminolevulinate, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to hexaminolevulinate 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

Appropriate studies have not been performed on the relationship of age to the effects of hexaminolevulinate in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of hexaminolevulinate in the elderly.

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 hexaminolevulinate. Make sure you tell your doctor if you have any other medical problems, especially:

Bladder cancer that was treated with BCG (Bacillus Calmette-Guerin) solution in the past 90 days or Blood in the urine or Porphyria (an enzyme problem)—Should not be used in patients with these conditions. Bladder pain or Bladder spasm—Use with caution. May make these conditions worse. Proper Use of hexaminolevulinate

A nurse or other trained health professional will give you hexaminolevulinate in a hospital or clinic. hexaminolevulinate is given through a tube (catheter) that is placed in your bladder.

The tube will be taken out and the medicine must be held in the bladder for at least 1 hour. You may stand, sit, or move during this time. If you feel you cannot hold the medicine in the bladder for 1 hour, tell your doctor or nurse right away.

Precautions While Using hexaminolevulinate

hexaminolevulinate may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor or nurse right away if you have a rash; itching; hoarseness; swelling of your hands, face, or mouth; trouble with breathing or swallowing; or chest pain after you receive the medicine.

hexaminolevulinate 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 or nurse immediately if any of the following side effects occur:

More common Blood in the urine burning while urinating difficult or painful urination frequent urge to urinate lower stomach pain or spasm Incidence not known Bloody or cloudy urine cough difficulty with breathing or swallowing dizziness fast heartbeat fever hives itching nausea puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue reddening of the skin, especially around the ears shortness of breath skin rash tightness in the chest unusual tiredness or weakness wheezing

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.

More hexaminolevulinate Urinary bladder resources Hexaminolevulinate Urinary bladder Support Group 0 Reviews for Hexaminolevulinate Urinary bladder - Add your own review/rating Compare hexaminolevulinate Urinary bladder with other medications Diagnosis and Investigation
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flavoxate


Generic Name: flavoxate (flah VOX ate)
Brand Names: Urispas

What is flavoxate?

Flavoxate reduces muscle spasms of the bladder and urinary tract.

Flavoxate is used to treat bladder symptoms such as frequent or urgent urination, increased night-time urination, bladder pain, and incontinence (urine leakage). These bladder symptoms are often caused by overactive bladder, prostate enlargement, bladder infections, or irritation of the urethra.

Flavoxate will not treat a bacterial or fungal bladder infection. Infections must be treated with an antibiotic.

Flavoxate may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about flavoxate? You should not use this medication if you are allergic to flavoxate, or if you have untreated or uncontrolled narrow-angle glaucoma, a blockage in your digestive tract (stomach or intestines), or if you are unable to urinate.

Before using flavoxate, tell your doctor if you have glaucoma or urinary problems.

Flavoxate can cause drowsiness or blurred vision. Be careful if you drive or do anything that requires you to be alert and able to see clearly. There may be other medicines that can interact with flavoxate. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

Stop using this medication and call your doctor if you have serious side effects such as hot and dry skin, confusion, pounding heartbeats, fluttering in your chest, or if you stop urinating.

What should I discuss with my health care provider before taking flavoxate? You should not use this medication if you are allergic to flavoxate, or have certain conditions. Be sure your doctor knows if you have:

a blockage in your stomach or intestines;

a history of stomach ulcer or bleeding; or

if you are unable to urinate.

Before using flavoxate, tell your doctor if you are allergic to any drugs, or if you have:

glaucoma; or

urinary problems.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take flavoxate.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether flavoxate passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How should I take flavoxate?

Take this medication exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Take this medicine with water. Store flavoxate at room temperature away from moisture, heat, and light.

See also: Flavoxate dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose? Seek emergency medical attention if you think you have used too much of this medicine.

Symptoms of a flavoxate overdose are not known.

What should I avoid while taking flavoxate? Flavoxate can cause drowsiness or blurred vision. Be careful if you drive or do anything that requires you to be alert and able to see clearly. Flavoxate side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using flavoxate and call your doctor at once if you have any of these serious side effects:

hot, dry skin and extreme thirst;

confusion;

pounding heartbeats, fluttering in your chest; or

urinating less than usual or not at all.

Less serious side effects may include:

dry mouth;

blurred vision;

nausea, vomiting;

drowsiness, nervousness;

spinning sensation;

headache; or

fever.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Flavoxate Dosing Information

Usual Adult Dose for Urinary Incontinence:

100 to 200 mg orally 3 to 4 times daily. As symptoms improve dose may be reduced.

Usual Adult Dose for Urinary Frequency:

100 to 200 mg orally 3 to 4 times daily. As symptoms improve dose may be reduced.

Usual Adult Dose for Dysuria:

100 to 200 mg orally 3 to 4 times daily. As symptoms improve dose may be reduced.

Usual Pediatric Dose for Urinary Incontinence:

Greater than 12 years: 100 to 200 mg orally 3 to 4 times daily. As symptoms improve dose may be reduced.

Usual Pediatric Dose for Urinary Frequency:

Greater than 12 years: 100 to 200 mg orally 3 to 4 times daily. As symptoms improve dose may be reduced.

Usual Pediatric Dose for Dysuria:

Greater than 12 years: 100 to 200 mg orally 3 to 4 times daily. As symptoms improve dose may be reduced.

What other drugs will affect flavoxate?

Tell your doctor if you are using any other bladder or urinary medications such as darifenacin (Enablex), oxybutynin (Ditropan, Oxytrol), tolterodine (Detrol), or solifenacin (Vesicare).

There may be other drugs that can interact with flavoxate. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More flavoxate resources Flavoxate Side Effects (in more detail) Flavoxate Dosage Flavoxate Use in Pregnancy & Breastfeeding Drug Images Flavoxate Drug Interactions Flavoxate Support Group 1 Review for Flavoxate - Add your own review/rating flavoxate Advanced Consumer (Micromedex) - Includes Dosage Information Flavoxate Professional Patient Advice (Wolters Kluwer) Flavoxate MedFacts Consumer Leaflet (Wolters Kluwer) Flavoxate Prescribing Information (FDA) Flavoxate Hydrochloride Monograph (AHFS DI) Urispas Prescribing Information (FDA) Compare flavoxate with other medications Dysuria Overactive Bladder Urinary Incontinence Where can I get more information? Your pharmacist can provide more information about flavoxate.

See also: flavoxate side effects (in more detail)


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OncoTICE


OncoTICE powder for suspension

2-8 X 108 CFU Tice BCG

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 further questions, please 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 gets serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What Oncotice is and what it is used for 2. Before you are given Oncotice 3. How Oncotice is given 4. Possible side effects 5. How to store Oncotice 6. Further information What Oncotice is and what it is used for

Oncotice contains something called ‘BCG’ (‘Bacillus Calmette-Gu?rin’). This is a bacteria which has been specially altered, so that it can be used as a medicine.

Oncotice is used to: treat bladder cancer prevent bladder cancer from coming back after bladder surgery.

It comes as a powder which is mixed with saline (salt water). It is then run into your bladder through a tube.

BCG is also used as a vaccine for TB (tuberculosis). Oncotice is a much stronger sort of BCG that can’t be used as a vaccine.

Before you are given Oncotice Oncotice should not be given if: You have a urinary tract infection (UTI). This must be treated first. You have blood in your urine. You have or think you have TB (tuberculosis). Before you have Oncotice, your doctor may do a skin reaction test, to see if you have TB. This is called a Tuberculin Test. If you have had Oncotice before, this may give you a positive result in this test. You are HIV-positive. You may need to have a blood test for HIV. Tell your doctor if any of the following apply to you: you have been a drug user and have shared a needle you have had unsafe sex you have had a blood transfusion. You have problems with your immune system. This could be something which runs in the family, or is caused by an illness or other medicines you are taking.

Do not have Oncotice if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before being given Oncotice.

Take special care with Oncotice

Check with your doctor or pharmacist before being given the medicine if:

Your bladder wall or the tube coming into your bladder from your kidneys (called the ‘ureter’) have been damaged during previous treatment.

Treatment with Oncotice will not be given until this has healed.

If you are not sure if any of the above apply to you talk to your doctor or pharmacist before being given Oncotice.

Taking other medicines

Please tell your doctor or pharmacist if you are taking, or have recently taken any other medicine. This includes medicines obtained without a prescription, including herbal medicines.

Do not have Oncotice and talk to your doctor straight away if:

You are taking medicines for TB.

The following can lower the effect of Oncotice:

antibiotics medicines which affect the immune system (immuno-suppressants) medicines which affect the production of bone marrow cells (bone marrow suppressants) radiation treatment.

If you are having any of these medicines or are having radiation treatment, your doctor will probably delay giving you Oncotice.

Using Oncotice with food and drink Do not drink any liquid for 4 hours before you are given Oncotice. Do not drink any liquid for 2 hours after you have been given Oncotice. Pregnancy and breast-feeding

Do not have Oncotice if you are pregnant or breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.

Driving and using machines

Oncotice will not affect your being able to drive or use any tools or machines.

Important information about some of the ingredients of Oncotice Oncotice contains lactose (a type of sugar). If you have been told by your doctor that you cannot tolerate or digest some sugars, talk to your doctor before being given this medicine. This medicine contains a very small amount of potassium (less than 1mmol or 39mg per dose). This means it is essentially ‘potassium-free’. How Oncotice is given

You will always be given Oncotice by a doctor or nurse.

Before it is given Do not drink any liquid the 4 hours before Oncotice is given to you. You will be asked to pass water immediately before Oncotice is given to you. Being given your medicine First your genital area will be cleaned with a sterile solution. A nurse will then pass a small flexible tube into your bladder. This will remove any urine that is still in your bladder. Oncotice is then run into your bladder through this tube. This will only take a few minutes. The tube will then be removed. After it has been given Oncotice will be left in your bladder for 2 hours. During this time you should move around a little. This makes sure that the Oncotice is spread around all of your bladder. Do not drink any liquid for 2 hours after you have been given Oncotice. After 2 hours you will be asked to pass water, to empty your bladder. You should do this while sitting down to avoid splashing your urine around the toilet. During the next 6 hours If you need to pass water again, also do this while sitting down. Every time you pass water, add two cups of household bleach to the toilet. Leave the bleach and urine to stand in the toilet for 15 minutes before flushing. How often Oncotice is given

Oncotice is usually given once a week for 6 weeks. After this some people have ‘maintenance therapy’, where you may be given more doses. Your doctor will talk to you about this.

Having sex in the week after having Oncotice

If you have sexual intercourse during the week after being given the medicine, you must use a condom. This will lower the chance of the BCG bacteria being passed to your partner.

If you have more Oncotice than you should

Oncotice is made up from a standard bottle by your doctor, pharmacist or nurse. It is unlikely that you will receive too much Oncotice. If you do have too much, your doctor will check carefully to see whether you have BCG infection.

If necessary you will need to have treatment for TB.

OncoTICE Side Effects

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

If you notice the following side effects, see your doctor straight away: a high temperature (fever) above 39 °C that lasts for more than 12 hours, even after taking medicines like paracetamol to lower your temperature. signs of a BCG or TB infection: cough or bronchitis chest pain or tightness sweating sore throat cold in the nose swelling of your lymph glands.

See your doctor straight away if you notice any of these side effects.

Other side effects include:

Very common

(affects more than 1 in 10 people)

bladder infection, pain when passing water, having to pass water often, feeling the need to pass water and bloody urine. Usually this goes away within two days. flu-like symptoms such as fever and feeling off-colour and tired (malaise). This usually happens about 4 hours after treatment and last for 24 to 48 hours.

Common

(affects less than 1 in 10 people)

painful joints or arthritis muscle pain or stiffness feeling sick (nausea) and being sick (vomiting) abdominal pain or diarrhoea chest infection anaemia problems with passing water or having a large amount of blood in your urine shivering with a high temperature (fever).

Uncommon

(affects less than 1 in 100 people)

skin rash jaundice (yellow colour of your skin or eyes) pus in your urine difficulty passing water low blood count (shown in blood tests)

Rare

(affects less than 1 in every 1,000 people)

inflammation of the genitals or prostate.

Very Rare

(affects less than 1 in every 10,000 people)

headache back pain increased muscle tension swollen legs or arms low blood pressure blood problems (shown in blood tests) flatulence or discomfort following meals loss of appetite or weight loss hair loss prickling or itching skin open sores on your skin eye infection feeling confused, sleepy or dizzy kidney problems

Tell your doctor if any side effect is severe or lasts longer than 48 hours.

If you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

How to store Oncotice

Keep Oncotice out of the reach and sight of children.

Oncotice will be stored in the hospital according to the instructions given by the manufacturer on the packaging.

Store at 2 °C to 8 °C (in a refrigerator).

Do not use Oncotice after the expiry date which is stated on the carton and label.

Further information What Oncotice contains The active substance is Bacillus Calmette-Gu?rin (BCG). It is a specially treated bacteria to be used as a medicine. The other ingredients are: lactose, asparagine, citric acid (E330), potassium phosphate, magnesium sulfate, iron ammonium citrate, glycerol (E422), ammonium hydroxide (E527), zinc formate. What Oncotice looks like and contents of the pack

Oncotice is a freeze-dried powder, packed in 2 ml glass vials (available in packs of 1), each containing 1 dose of 12.5 mg (equivalent to 2 to 8 x 108 CFU) of BCG.

The Marketing authorisation holder is: N.V. Organon PO Box 20 5340 BH Oss The Netherlands The Manufacturer is: Organon Teknika Corporation 100 Rodolphe Street Building 1300 Durham NC27712 USA

This leaflet was last updated in December 2007.

To listen to or request a copy of this leaflet in braille, large print or audio please call, free of charge: 0800 198 5000 (UK Only)

Please be ready to give the following information:

Product name: Oncotice

Reference Number: PL 05003/0046

This is a service provided by the Royal National Institute for Blind People

OncoTICE (Tice BCG)

June 2004

REF: USoncviV5.2


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Valstar


Generic Name: valrubicin (val ROO bi sin)
Brand Names: Valstar

What is Valstar (valrubicin)?

Valrubicin is a cancer (antineoplastic) medication. Valrubicin interferes with the growth of cancer cells and slows their growth and spread in the body.

Valrubicin is used to treat bladder cancer.

Valrubicin may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Valstar (valrubicin)?

Valrubicin should only be administered under the supervision of a qualified healthcare provider experienced in the use of cancer chemotherapeutic agents.

Serious side effects have been reported with the use of valrubicin including: allergic reactions (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives); severe heart damage with prolonged use; decreased bone marrow function and blood problems (extreme fatigue; easy bruising or bleeding; black, bloody or tarry stools; fever or chills; or signs of infection); severe nausea, vomiting, diarrhea, and loss of appetite; and others. Talk to your doctor about the possible side effects from treatment with valrubicin.

Who should not use Valstar (valrubicin)? Do not use valrubicin without first talking to your doctor if you have

a urinary tract infection;

a perforated or otherwise damaged bladder;

kidney disease; or

irritable bladder disorder.

The use of valrubicin may be dangerous if you have any of the conditions listed above.

Valrubicin is in the FDA pregnancy category C. Systemic exposure to valrubicin may result in harm to an unborn baby. Do not use valrubicin without first talking to your doctor if you are pregnant. Men and women being treated with valrubicin should discuss with their doctor the appropriate use of birth control during treatment with valrubicin if necessary. Because of the potential for serious side effects in a nursing infant, breast-feeding should be avoided during treatment with valrubicin. The safety and effectiveness of valrubicin in children has not been established. How should I use Valstar (valrubicin)?

Valrubicin should only be administered under the supervision of a qualified healthcare provider experienced in the use of cancer chemotherapeutic agents.

Your doctor will determine the correct amount and frequency of treatment with valrubicin depending upon the type of cancer being treated and other factors. Valrubicin has caused a complete response in only about 1 in 5 patients and delaying surgery could lead to wide-spread bladder cancer, which is lethal. Talk to your doctor if you have any questions or concerns regarding the treatment schedule.

Your doctor will probably want you to have regularly scheduled blood tests and other medical evaluations during treatment with valrubicin to monitor progress and side effects.

Skin accidentally exposed to valrubicin should be rinsed thoroughly with soap and warm water.

Your healthcare provider will store valrubicin as directed by the manufacturer. If you are storing valrubicin at home, follow the directions provided by your healthcare provider.

What happens if I miss a dose?

Contact your doctor if you miss a dose of valrubicin.

What happens if I overdose? If for any reason an overdose of valrubicin is suspected, seek emergency medical attention or contact your healthcare provider immediately.

Symptoms of a valrubicin overdose tend to be similar to side effects caused by the medication, although often more severe.

What should I avoid while using Valstar (valrubicin)?

Valrubicin can lower the activity of your immune system making you susceptible to infections. Avoid contact with people who have colds, the flu, or other contagious illnesses and do not receive vaccines that contain live strains of a virus (e.g., live oral polio vaccine) during treatment with valrubicin. In addition, avoid contact with individuals who have recently been vaccinated with a live vaccine. There is a chance that the virus can be passed on to you.

Skin accidentally exposed to valrubicin should be rinsed thoroughly with soap and warm water.

Valstar (valrubicin) side effects

If you experience an allergic reaction (including difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives) to valrubicin, seek emergency medical attention.

Other, less serious side effects may be more likely to occur. Continue taking valrubicin and talk to your doctor if you experience:

bladder irritation (increased frequency of urination, painful urination, a very strong feeling of needing to urinate, blood in the urine);

urinary incontinence;

urinary tract infection;

red colored urine for 24 hours following a dose; or

nausea.

Talk to your doctor immediately if you have prolonged (longer than 24 hours after a dose) red-colored urine or prolonged bladder irritation.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Valstar (valrubicin)? Do not receive "live" vaccines during treatment with valrubicin. Administration of a live vaccine may be dangerous during treatment with valrubicin.

Other drugs may interact with valrubicin. Talk to your doctor and pharmacist before taking any other prescription or over-the-counter medicines, including herbal products, during treatment with valrubicin.

More Valstar resources Valstar Side Effects (in more detail) Valstar Use in Pregnancy & Breastfeeding Valstar Drug Interactions Valstar Support Group 0 Reviews for Valstar - Add your own review/rating Valstar Prescribing Information (FDA) Valstar Advanced Consumer (Micromedex) - Includes Dosage Information Valstar MedFacts Consumer Leaflet (Wolters Kluwer) Valrubicin Professional Patient Advice (Wolters Kluwer) Compare Valstar with other medications Urinary Tract Tumors Where can I get more information? Your healthcare provider may have additional information about valrubicin that you may read.

See also: Valstar side effects (in more detail)


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valrubicin


Generic Name: valrubicin (val ROO bi sin)
Brand Names: Valstar

What is valrubicin?

Valrubicin is a cancer (antineoplastic) medication. Valrubicin interferes with the growth of cancer cells and slows their growth and spread in the body.

Valrubicin is used to treat bladder cancer.

Valrubicin may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about valrubicin?

Valrubicin should only be administered under the supervision of a qualified healthcare provider experienced in the use of cancer chemotherapeutic agents.

Serious side effects have been reported with the use of valrubicin including: allergic reactions (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives); severe heart damage with prolonged use; decreased bone marrow function and blood problems (extreme fatigue; easy bruising or bleeding; black, bloody or tarry stools; fever or chills; or signs of infection); severe nausea, vomiting, diarrhea, and loss of appetite; and others. Talk to your doctor about the possible side effects from treatment with valrubicin.

Who should not use valrubicin? Do not use valrubicin without first talking to your doctor if you have

a urinary tract infection;

a perforated or otherwise damaged bladder;

kidney disease; or

irritable bladder disorder.

The use of valrubicin may be dangerous if you have any of the conditions listed above.

Valrubicin is in the FDA pregnancy category C. Systemic exposure to valrubicin may result in harm to an unborn baby. Do not use valrubicin without first talking to your doctor if you are pregnant. Men and women being treated with valrubicin should discuss with their doctor the appropriate use of birth control during treatment with valrubicin if necessary. Because of the potential for serious side effects in a nursing infant, breast-feeding should be avoided during treatment with valrubicin. The safety and effectiveness of valrubicin in children has not been established. How should I use valrubicin?

Valrubicin should only be administered under the supervision of a qualified healthcare provider experienced in the use of cancer chemotherapeutic agents.

Your doctor will determine the correct amount and frequency of treatment with valrubicin depending upon the type of cancer being treated and other factors. Valrubicin has caused a complete response in only about 1 in 5 patients and delaying surgery could lead to wide-spread bladder cancer, which is lethal. Talk to your doctor if you have any questions or concerns regarding the treatment schedule.

Your doctor will probably want you to have regularly scheduled blood tests and other medical evaluations during treatment with valrubicin to monitor progress and side effects.

Skin accidentally exposed to valrubicin should be rinsed thoroughly with soap and warm water.

Your healthcare provider will store valrubicin as directed by the manufacturer. If you are storing valrubicin at home, follow the directions provided by your healthcare provider.

What happens if I miss a dose?

Contact your doctor if you miss a dose of valrubicin.

What happens if I overdose? If for any reason an overdose of valrubicin is suspected, seek emergency medical attention or contact your healthcare provider immediately.

Symptoms of a valrubicin overdose tend to be similar to side effects caused by the medication, although often more severe.

What should I avoid while using valrubicin?

Valrubicin can lower the activity of your immune system making you susceptible to infections. Avoid contact with people who have colds, the flu, or other contagious illnesses and do not receive vaccines that contain live strains of a virus (e.g., live oral polio vaccine) during treatment with valrubicin. In addition, avoid contact with individuals who have recently been vaccinated with a live vaccine. There is a chance that the virus can be passed on to you.

Skin accidentally exposed to valrubicin should be rinsed thoroughly with soap and warm water.

Valrubicin side effects

If you experience an allergic reaction (including difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives) to valrubicin, seek emergency medical attention.

Other, less serious side effects may be more likely to occur. Continue taking valrubicin and talk to your doctor if you experience:

bladder irritation (increased frequency of urination, painful urination, a very strong feeling of needing to urinate, blood in the urine);

urinary incontinence;

urinary tract infection;

red colored urine for 24 hours following a dose; or

nausea.

Talk to your doctor immediately if you have prolonged (longer than 24 hours after a dose) red-colored urine or prolonged bladder irritation.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Valrubicin Dosing Information

Usual Adult Dose for Urinary Tumor:

For intravesical therapy of BCG-refractory carcinoma in situ (CIS) of the urinary bladder in patients for whom immediate cystectomy would be associated with unacceptable morbidity or mortality:
Valrubicin is recommended at a dose of 800 mg administered intravesically once a week for six weeks. Administration should be delayed at least two weeks after transurethral resection and/or fulguration. For each instillation, four 5 mL vials (200 mg valrubicin/5 mL vial) should be allowed to warm slowly to room temperature, but should not be heated. Twenty milliliters of valrubicin should then be withdrawn from the four vials and diluted with 55 mL 0.9% Sodium Chloride Injection, USP providing 75 mL of a diluted valrubicin solution. A urethral catheter should then be inserted into the patient's bladder under aseptic conditions, the bladder drained, and the diluted 75 mL valrubicin solution instilled slowly via gravity flow over a period of several minutes. The catheter should then be withdrawn. The patient should retain the drug for two hours before voiding. At the end of two hours, all patients should void. (Some patients will be unable to retain the drug for the full two hours.) Patients should be instructed to maintain adequate hydration following treatment.

What other drugs will affect valrubicin? Do not receive "live" vaccines during treatment with valrubicin. Administration of a live vaccine may be dangerous during treatment with valrubicin.

Other drugs may interact with valrubicin. Talk to your doctor and pharmacist before taking any other prescription or over-the-counter medicines, including herbal products, during treatment with valrubicin.

More valrubicin resources Valrubicin Side Effects (in more detail) Valrubicin Dosage Valrubicin Use in Pregnancy & Breastfeeding Valrubicin Drug Interactions Valrubicin Support Group 0 Reviews for Valrubicin - Add your own review/rating valrubicin Intravesical Advanced Consumer (Micromedex) - Includes Dosage Information Valrubicin MedFacts Consumer Leaflet (Wolters Kluwer) Valrubicin Professional Patient Advice (Wolters Kluwer) Valstar Prescribing Information (FDA) Compare valrubicin with other medications Urinary Tract Tumors Where can I get more information? Your healthcare provider may have additional information about valrubicin that you may read.

See also: valrubicin side effects (in more detail)


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Urinary Incontinence Medications


Definition of Urinary Incontinence:

Incontinence is the inability to control the passage of urine. This can range from an occasional leakage of urine, to a complete inability to hold any urine.

The three main types of urinary incontinence are:

Stress incontinence -- occurs during certain activities like coughing, sneezing, laughing, or exercise.

Stress incontinence is a bladder storage problem in which the strength of the muscles (urethral sphincter) that help control urination is reduced. The sphincter is not able to prevent urine flow when there is increased pressure from the abdomen.

Stress incontinence may occur as a result of weakened pelvic muscles that support the bladder and urethra or because of a malfunction of the urethral sphincter.

Treatment for stress incontinence may include behavioral changes, medication, pelvic floor muscle training or surgery.

Urge incontinence -- involves a strong, sudden need to urinate followed by instant bladder contraction and involuntary loss of urine. You don't have enough time between when you recognize the need to urinate and when you actually do urinate.

In most cases of urge incontinence, no specific cause can be identified.Although urge incontinence may occur in anyone at any age, it is more common in women and the elderly.

Treatment for urge incontinence may include medication, retraining, and surgery.

Mixed incontinence -- contains components of both stress and urge incontinence.

Drugs associated with Urinary Incontinence

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

See sub-topics

Topics under Urinary IncontinenceOveractive Bladder (18 drugs) Learn more about Urinary Incontinence

Medical Encyclopedia:

Urinary incontinence

Harvard Health Guide:

Symptoms and treatment for Urinary Incontinence
Drug List:/tags/a-spaz/
/tags/azo-cranberry/
/tags/colidrops-drops/
/tags/cystospaz/
/tags/detrol-la-extended-release-capsules/
/tags/ditropan-xl-extended-release-tablets/
/tags/elavil/
/tags/gelnique/
/tags/hyomax-dt/
/tags/hyomax-sl/
/tags/hyospaz/
/tags/ib-stat-spray/
/tags/levsin/
/tags/levsinex-extended-release-capsules/
/tags/nulev-orally-disintegrating-tablets/
/tags/sanctura/
/tags/spasdel-drops/
/tags/symax-fastabs-orally-disintegrating-tablets/
/tags/symax-sr-extended-release-tablets/
/tags/urispas/
/tags/vanatrip/

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Primsol


Generic Name: trimethoprim (trye METH oh prim)
Brand Names: Primsol, Proloprim

What is Primsol (trimethoprim)?

Trimethoprim is an antibiotic that fights bacteria in the body.

Trimethoprim is used to treat bladder infection caused by certain bacteria.

Trimethoprim may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Primsol (trimethoprim)? You should not use this medication if you are allergic to trimethoprim, or if you have any type of anemia (lack of red blood cells).

Before using trimethoprim, tell your doctor if you have kidney disease, liver disease, or a folic acid deficiency.

Take this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Trimethoprim will not treat a viral infection such as the common cold or flu. Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Trimethoprim can make your skin more sensitive to sunlight and sunburn may result. Use a sunscreen (minimum SPF 15) and wear protective clothing if you must be out in the sun. What should I discuss with my healthcare provider before taking Primsol (trimethoprim)? You should not use this medication if you are allergic to trimethoprim, or have certain conditions. Be sure your doctor knows if you have any type of anemia (lack of red blood cells).

Before using trimethoprim, tell your doctor if you are allergic to any drugs, or if you have:

kidney disease;

liver disease; or

a folate (folic acid) deficiency.

If you have any of these conditions, you may need a dose adjustment or special tests to safely use trimethoprim.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Trimethoprim can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How should I take Primsol (trimethoprim)?

Take this medication exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Take your medicine with a full glass of water.

Measure liquid medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Take this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Trimethoprim will not treat a viral infection such as the common cold or flu.

This medication can cause you to have unusual results with certain medical tests. Tell any doctor who treats you that you are using trimethoprim.

Store trimethoprim at room temperature away from moisture and heat. What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose? Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include nausea, vomiting, dizziness, headache, confusion, weakness, or flu symptoms.

What should I avoid while taking Primsol (trimethoprim)? Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Trimethoprim can make your skin more sensitive to sunlight and sunburn may result. Use a sunscreen (minimum SPF 15) and wear protective clothing if you must be out in the sun. Primsol (trimethoprim) side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

pale skin, easy bruising or bleeding;

fever, chills, sore throat, flu symptoms; or

severe blistering, peeling, and red skin rash.

Less serious side effects may include:

nausea, vomiting;

sore or swollen tongue; or

mild itching or skin rash.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Primsol (trimethoprim)?

Tell your doctor about all other medications you use, especially phenytoin (Dilantin).

This list is not complete and there may be other drugs that can interact with trimethoprim. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More Primsol resources Primsol Side Effects (in more detail) Primsol Use in Pregnancy & Breastfeeding Primsol Drug Interactions Primsol Support Group 0 Reviews for Primsol - Add your own review/rating Primsol Solution MedFacts Consumer Leaflet (Wolters Kluwer) Primsol Advanced Consumer (Micromedex) - Includes Dosage Information Trimethoprim Prescribing Information (FDA) Trimethoprim Monograph (AHFS DI) Proloprim MedFacts Consumer Leaflet (Wolters Kluwer) Proloprim Prescribing Information (FDA) Compare Primsol with other medications Bladder Infection Otitis Media Pneumocystis Pneumonia Prevention of Bladder infection Where can I get more information? Your pharmacist can provide more information about trimethoprim.

See also: Primsol side effects (in more detail)


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Genitourinary tract agents


Genitourinary tract agents are medicines, which are used to treat conditions of the reproductive organs and excretory system or urinary tract. They include medicines used for bladder spasms, urinary pH modifiers, medicines for erectile dysfunction in men and medicines that suppress uterine contractions to prevent preterm labor.

See also impotence agents miscellaneous genitourinary tract agents tocolytic agents urinary antispasmodics urinary pH modifiers uterotonic agents Drug List:
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Miscellaneous antibiotics


A drug may be classified by the chemical type of the active ingredient or by the way it is used to treat a particular condition. Each drug can be classified into one or more drug classes.

Antibiotics are drugs that can either kill an infectious bacteria or inhibit its growth. Different antibiotics work by different mechanisms and are used to treat infections caused by bacteria that are sensitive to that particular antibiotic.

See also

Medical conditions associated with miscellaneous antibiotics:

Acne Amebiasis Anthrax Aspiration Pneumonia Babesiosis Bacteremia Bacterial Infection Bacterial Skin Infection Bacterial Vaginitis Bone infection Bronchitis Brucellosis Cholera Clostridial Infection Crohn's Disease Crohn's Disease, Acute Crohn's Disease, Maintenance Cystic Fibrosis Deep Neck Infection Dental Abscess Diarrhea Diverticulitis Dracunculiasis Endocarditis Epiglottitis Febrile Neutropenia Giardiasis Glanders Gonococcal Infection Gonococcal Infection, Disseminated Gonococcal Infection, Uncomplicated Gram Negative Infection Granuloma Inguinale Helicobacter Pylori Infection Hepatic Encephalopathy Infection Prophylaxis Intraabdominal Infection Irritable Bowel Syndrome Joint Infection Kidney Infections Leishmaniasis Malaria Melioidosis Meningitis Methicillin-Resistant Staphylococcus Aureus Infection Nocardiosis Nosocomial Pneumonia Ornithosis Otitis Media Pelvic Inflammatory Disease Peritonitis Plague Pneumocystis Pneumonia Pneumocystis Pneumonia Prophylaxis Pneumonia Pneumonia with Cystic Fibrosis Prevention of Bladder infection Prostatitis Pseudomembranous Colitis Psittacosis Rabbit Fever Rickettsial Infection Shigellosis Sinusitis Skin and Structure Infection Skin Infection Surgical Prophylaxis Toxoplasmosis Toxoplasmosis, Prophylaxis Traveler's Diarrhea Trichomoniasis Trypanosomiasis Upper Respiratory Tract Infection Urinary Tract Infection Drug List: Sulfatrim-Suspension Zyvox Xifaxan Septra Chloromycetin-Oral-Intravenous-Injection Smz-Tmp-Ds Septra-Ds Flagyl Bactrim-Ds Flagyl-Er-Extended-Release-Tablets Bactrim Metro Azactam Baci-Im-Injection Cayston Chloromycetin-Sodium-Succinate Co-Trimoxazole Coly-Mycin-M Cotrim Cubicin Eryzole Flagyl-375 Flagyl-I-V Mepron Nebupent-Solution Neutrexin Pediazole Pentam Pentam-300 Sulfatrim-Pediatric Sulfimycin Synercid Trobicin
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Neomycin and Polymyxin B Sulfates



Dosage Form: solution for irrigation
Neomycin and Polymyxin B Sulfates
SOLUTION FOR IRRIGATION USP
NOT FOR INJECTION
Rx only
695308010591*B1 Neomycin and Polymyxin B Sulfates Description

Neomycin and Polymyxin B Sulfates Solution for Irrigation is a concentrated sterile antibiotic solution to be diluted for urinary bladder irrigation. Each mL contains neomycin sulfate equivalent to 40 mg neomycin base, 200,000 units polymyxin B sulfate, and water for injection.

Neomycin sulfate, an antibiotic of the aminoglycoside group, is the sulfate salt of neomycin B and C produced by Streptomyces fradiae. It has a potency equivalent to not less than 600µg of neomycin per mg. The structural formulae are:

Polymyxin B sulfate, a polypeptide antibiotic, is the sulfate salt of polymyxin B1 and B2 produced by the growth of Bacillus polymyxa. It has a potency of not less than 6,000 polymyxin B units per mg. The structural formulae are:

Neomycin and Polymyxin B Sulfates - Clinical Pharmacology

After prophylactic irrigation of the intact urinary bladder, neomycin and polymyxin B are absorbed in clinically insignificant quantities. A neomycin serum level of 0.1 µg/mL was observed in three of 33 patients receiving the rinse solution. This level is well below that which has been associated with neomycin-induced toxicity.

When used topically, polymyxin B sulfate and neomycin are rarely irritating.

Microbiology: The prepared Neomycin and Polymyxin B Sulfates Solution for Irrigation solution is bactericidal. The aminoglycosides act by inhibiting normal protein synthesis in susceptible microorganisms. Polymyxins increase the permeability of bacterial cell wall membranes. The solution is active in vitro against

Escherichia coli
Staphylococcus aureus
Haemophilus influenzae
Klebsiella and Enterobacter species
Neisseria species, and
Pseudomonas aeruginosa.

It is not active in vitro against Serratia marcescens and streptococci.

Bacterial resistance may develop following the use of the antibiotics in the catheter-rinse solution.

Indications and Usage for Neomycin and Polymyxin B Sulfates

Neomycin and Polymyxin B Sulfates Solution for Irrigation is indicated for short-term use (up to 10 days) as a continuous irrigant or rinse in the urinary bladder of abacteriuric patients to help prevent bacteriuria and gram-negative rod septicemia associated with the use of indwelling catheters.

Since organisms gain entrance to the bladder by way of, through, and around the catheter, significant bacteriuria is induced by bacterial multiplication in the bladder urine, in the mucoid film often present between catheter and urethra, and in other sites. Urinary tract infection may result from the repeated presence in the urine of large numbers of pathogenic bacteria. The use of closed systems with indwelling catheters has been shown to reduce the risk of infection. A three-way closed catheter system with constant neomycin-polymyxin B bladder rinse is indicated to prevent the development of infection while using indwelling catheters.

If uropathogens are isolated, they should be identified and tested for susceptibility so that appropriate antimicrobial therapy for systemic use can be initiated.

Contraindications

Hypersensitivity to neomycin, the polymyxins, or any ingredient in the solution is a contraindication to its use. A history of hypersensitivity or serious toxic reaction to an aminoglycoside may also contraindicate the use of any other aminoglycoside because of the known cross-sensitivity of patients to drugs of this class.

Warnings

PROPHYLACTIC BLADDER CARE WITH Neomycin and Polymyxin B Sulfates SOLUTION FOR IRRIGATION SHOULD NOT BE GIVEN WHERE THERE IS A POSSIBILITY OF SYSTEMIC ABSORPTION. Neomycin and Polymyxin B Sulfates SOLUTION FOR IRRIGATION SHOULD NOT BE USED FOR IRRIGATION OTHER THAN FOR THE URINARY BLADDER. Systemic absorption after topical application of neomycin to open wounds, burns, and granulating surfaces is significant and serum concentrations comparable to and often higher than those attained following oral and parenteral therapy have been reported. Absorption of neomycin from the denuded bladder surface has been reported.

However, the likelihood of toxicity following topical irrigation of the intact urinary bladder with Neomycin and Polymyxin B Sulfates Solution for Irrigation is low since no appreciable amounts of these antibiotics enter the systemic circulation by this route if irrigation does not exceed 10 days.

Neomycin and Polymyxin B Sulfates Solution for Irrigation is intended for continuous prophylactic irrigation of the lumen of the intact urinary bladder of patients with indwelling catheters. Patients should be under constant supervision by a physician. Irrigation should be avoided in patients with defects in the bladder mucosa or bladder wall, such as vesical rupture, or in association with operative procedures on the bladder wall, because of the risk of toxicity due to systemic absorption following diffusion into absorptive tissues and spaces. When absorbed, neomycin and polymyxin B are nephrotoxic antibiotics, and the nephrotoxic potentials are additive. In addition, both antibiotics, when absorbed, are neurotoxins: neomycin can destroy fibers of the acoustic nerve causing permanent bilateral deafness; neomycin and polymyxin B are additive in their neuromuscular blocking effects, not only in terms of potency and duration, but also in terms of characteristics of the blocks produced.

Aminoglycosides, when absorbed, can cause fetal harm when administered to a pregnant woman. Aminoglycoside antibiotics cross the placenta and there have been several reports of total, irreversible, bilateral, congenital deafness in children whose mothers received streptomycin during pregnancy. Although serious side effects have not been reported in the treatment of pregnant women with other aminoglycosides, the potential for harm exists. If Neomycin and Polymyxin B Sulfates Solution for Irrigation is used during pregnancy, the patient should be apprised of the potential hazard to the fetus (SeePRECAUTIONS).

Precautions General

Ototoxicity, nephrotoxicity, and neuromuscular blockade may occur if Neomycin and Polymyxin B Sulfates Solution for Irrigation ingredients are systemically absorbed (SeeWARNINGS). Absorption of neomycin from the denuded bladder surface has been reported. Patients with impaired renal function, infants, dehydrated patients, elderly patients, and patients receiving high doses of prolonged treatment are especially at risk for the development of toxicity.

Irrigation of the bladder with Neomycin and Polymyxin B Sulfates Solution for Irrigation may result in overgrowth of nonsusceptible organisms, including fungi. Appropriate measures should be taken if this occurs. The safety and effectiveness of the preparation for use in the care of patients with recent lower urinary tract surgery have not been established.

Urine specimens should be collected during prophylactic bladder care for urinalysis, culture, and susceptibility testing. Positive cultures suggest the presence of organisms which are resistant to the bladder rinse antibiotics.

Pregnancy Teratogenic Effects

Pregnancy Category D. SeeWARNINGS section.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Adverse Reactions

Neomycin occasionally causes skin sensitization when applied topically; however, topical application to mucus membranes rarely results in local or systemic hypersensitivity reactions.

Irritation of the urinary bladder mucosa has been reported.

Signs of ototoxicity and nephrotoxicity have been reported following parenteral use of these drugs and following the oral and topical use of neomycin (SeeWARNINGS).

Neomycin and Polymyxin B Sulfates Dosage and Administration

This preparation is specifically designed for use with “three-way” catheters or with other catheter systems permitting continuous irrigation of the urinary bladder. The usual irrigation dose is one 1-mL ampule a day for up to 10 days.

Using strict aseptic techniques, the contents of one 1-mL ampule of Neomycin and Polymyxin B Sulfates Solution for Irrigation should be added to a 1,000-mL container of isotonic saline solution. This container should then be connected to the inflow lumen of the “three-way” catheter which has been inserted with full aseptic precautions; use of a sterile lubricant is recommended during insertion of the catheter. The outflow lumen should be connected, via a sterile disposable plastic tube, to a disposable plastic collection bag. Stringent procedures, such as taping the inflow and outflow junction at the catheter, should be observed when necessary to insure the junctional integrity of the system.

For most patients, the inflow rate of the 1,000-mL saline solution of neomycin and polymyxin B should be adjusted to a slow drip to deliver about 1,000 mL every 24 hours. If the patient’s urine output exceeds 2 liters per day, it is recommended that the inflow rate be adjusted to deliver 2,000 mL of the solution in a 24 hour period.

It is important that the rinse of the bladder be continuous; the inflow or rinse solution should not be interrupted for more than a few minutes.

Preparation of the irrigation solution should be performed with strict aseptic techniques. The prepared solution should be stored at 4° C, and should be used within 48 hours following preparation to reduce the risk of contamination with resistant microorganisms.

How is Neomycin and Polymyxin B Sulfates Supplied

Sterile Neomycin and Polymyxin B Sulfate Solution for Irrigation is available in 1 mL ampules, cartons of 10 and 50.

Refrigerate at 2°-8° C (36°-46° F).

Literature Revised: January 2008

Product No.: 0801-81

Mfd. by Abraxis BioScience
Phoenix, AZ 85043 USA
Dist. by Watson Pharma, Inc.
Corona, CA 92880 USA

PRINCIPAL DISPLAY PANEL

0591-2190-50
Sterile 50 x 1 mL Ampules
Neomycin and Polymyxin B
Sulfates Solution
for Irrigation USP
NOT FOR INJECTION
Rx Only

PRINCIPAL DISPLAY PANEL

0591-2190-45
Sterile 10 x 1 mL Ampules
Neomycin and Polymyxin B
Sulfates Solution
for Irrigation USP
NOT FOR INJECTION
Rx Only


Neomycin and Polymyxin B Sulfates 
Neomycin and Polymyxin B Sulfates  irrigant Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0591-2190 Route of Administration IRRIGATION DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NEOMYCIN SULFATE (NEOMYCIN) NEOMYCIN SULFATE 40 mg  in 1 mL POLYMYXIN B SULFATE (POLYMYXIN B) POLYMYXIN B SULFATE 200000 [USP'U]  in 1 mL Inactive Ingredients Ingredient Name Strength WATER   Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 0591-2190-45 10 AMPULE In 1 CARTON contains a AMPULE 1 1 mL In 1 AMPULE This package is contained within the CARTON (0591-2190-45) 2 0591-2190-50 50 AMPULE In 1 CARTON contains a AMPULE 2 1 mL In 1 AMPULE This package is contained within the CARTON (0591-2190-50)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA062664 04/08/1986
Labeler - Watson Laboratories, Inc. (023932721) Establishment Name Address ID/FEI Operations Abraxis BioScience, LLC - Phoenix 831637074 MANUFACTURE Revised: 08/2010Watson Laboratories, Inc. More Neomycin and Polymyxin B Sulfates resources Neomycin and Polymyxin B Sulfates Use in Pregnancy & Breastfeeding Neomycin and Polymyxin B Sulfates Drug Interactions Neomycin and Polymyxin B Sulfates Support Group 0 Reviews · Be the first to review/rate this drug
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Anticholinergics/antispasmodics


A drug may be classified by the chemical type of the active ingredient or by the way it is used to treat a particular condition. Each drug can be classified into one or more drug classes.

Anticholinergic/antispasmodic agents inhibit the action of acetylcholine. They stop the transmission of parasympathetic nerve impulses therefore lessen the spasms of smooth muscle, such as in the gastrointestinal tract and in the bladder. They are used to treat spasms or conditions with disturbances in the bladder or gastrointestinal motility.

See also

Medical conditions associated with anticholinergics/antispasmodics:

Anesthesia Anticholinesterase Poisoning AV Heart Block Bradyarrhythmia Colitis Crohn's Disease Duodenal Ulcer Endoscopy or Radiology Premedication Enterocolitis Enuresis Excessive Salivation Gas GERD Hot Flashes Irritable Bowel Syndrome Menopausal Disorders Motion Sickness Nausea/Vomiting Organophosphate Poisoning Overactive Bladder Parkinson's Disease Parkinsonian Tremor Peptic Ulcer Perimenopausal Symptoms Postmenopausal Symptoms Urinary Incontinence Drug List: Levsin-Sl Pamine Donnatal Belladonna-Tincture Donnatal-Extentabs-Controlled-Release-Tablets Hyomax-Sl Levbid-Extended-Release-Tablets Levsin Scopace Bentyl Librax Symax-Duotab-Controlled-Release-Tablets Hyomax Hyomax-Sr Robinul Transderm-Scop-Patch Hyosyne-Drops Pamine-Forte A-Spaz Alkabel-Sr-Controlled-Release-Tablets Anaspaz Antispasmodic Atreza Atropen Bel-Phen-Ergot Bellamine Bellamine-S Bellamor Bellaphen-S Bellaspas Bellatal Bellergal-S Cantil Colidrops-Drops Cuvposa Cystospaz D-Tal Digex-Nf Duragal-S Ed-Spaz Eperbel-S Hyomax-Dt Hyomax-Ft Hyosophen Hyospaz Ib-Stat-Spray Levsinex-Extended-Release-Capsules Levsinex-Sr Maldemar Nulev-Orally-Disintegrating-Tablets Pb-Hyos-Elixir Pro-Banthine Quadrapax-Elixir Quarzan Re-Pb-Hyos-Elixir Robinul-Forte Sal-Tropine Servira Spasdel-Drops Spasmolin Spastrin Symax-Fastabs-Orally-Disintegrating-Tablets Symax-Sl Symax-Sr-Extended-Release-Tablets
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Theracys


Generic Name: bacillus of calmette and guerin vaccine, live (Intravesical route)

ba-SILL-us of KAL-met and GARE-in VAX-een, lyve

Intravesical route(Powder for Suspension)

Bacillus of calmette and guerin infections have been reported in health care workers and patients due to exposure to the vaccine during preparation and administration. Bacillus of calmette and guerin is capable of dissemination when administered by the intravesical route, and serious infections, including fatal infections, have been reported in patients receiving intravesical bacillus of calmette and guerin. THERACYS(R) and TICE(R) BCG contains live, attenuated mycobacteria and because of the potential risk for transmission, it should be prepared, handled, and disposed of as a biohazard material .

Commonly used brand name(s)

In the U.S.

Theracys Tice BCG

Available Dosage Forms:

Powder for Solution Powder for Suspension

Therapeutic Class: Vaccine

Uses For Theracys

Bacillus Calmette-Gu?rin (BCG) is used as a solution that is run through a tube (instilled through a catheter) into the bladder to treat bladder cancer. The exact way it works against cancer is not known, but it may work by stimulating the body's immune system.

BCG is to be administered only by or under the immediate supervision of your doctor.

Before Using Theracys

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 this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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

There is no specific information comparing use of BCG for treatment of cancer in children with use in other age groups.

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 Pregnancy Category Explanation All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during 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. When you are receiving this medicine, 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 this medicine 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.

Aclarubicin Adalimumab Aldesleukin Altretamine Amonafide Amsacrine Asparaginase Azacitidine Azathioprine Bleomycin Broxuridine Busulfan Capecitabine Carboplatin Carmustine Certolizumab Pegol Chlorambucil Cisplatin Cladribine Cyclophosphamide Cytarabine Cytarabine Liposome Dacarbazine Dactinomycin Daunorubicin Daunorubicin Citrate Liposome Decitabine Docetaxel Doxifluridine Doxorubicin Hydrochloride Doxorubicin Hydrochloride Liposome Edatrexate Eflornithine Epirubicin Estramustine Etanercept Etoposide Everolimus Fingolimod Floxuridine Fludarabine Fluorouracil Fotemustine Gallium Nitrate Gemcitabine Golimumab Hydroxyurea Idarubicin Ifosfamide Irinotecan Lomustine Mechlorethamine Melphalan Mercaptopurine Methotrexate Mitolactol Mitomycin Mitotane Mitoxantrone Mycophenolic Acid Oxaliplatin Paclitaxel Pegaspargase Pentostatin Pipobroman Pirarubicin Plicamycin Procarbazine Raltitrexed Rilonacept Rituximab Sirolimus Streptozocin Tacrolimus Teceleukin Tegafur Temsirolimus Teniposide Thioguanine Thiotepa Topotecan Treosulfan Trimetrexate Trofosfamide Uracil Mustard Ustekinumab Vinblastine Vincristine Vincristine Liposome Vindesine Vinorelbine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Abatacept Leflunomide 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 this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Fever—Infection may be present and could cause problems Immunity problems—BCG treatment is less effective and there is a risk of infection Urinary tract infectionInfection and irritation of the bladder may occur Proper Use of bacillus of calmette and guerin vaccine, live

This section provides information on the proper use of a number of products that contain bacillus of calmette and guerin vaccine, live. It may not be specific to Theracys. Please read with care.

Your doctor will ask you to empty your bladder completely before the solution is instilled into it.

Follow your doctor's instructions carefully about how long to hold the solution in your bladder:

The solution should be held in your bladder for 2 hours. If you think you cannot hold it, tell your health care professional. During the first hour, your doctor may have you lie for 15 minutes each on your stomach, back, and each side. When you do empty your bladder, you should be sitting down.

It is important that you drink extra fluids for several hours after each treatment with BCG so that you will pass more urine. Also, empty your bladder frequently. This will help prevent bladder problems.

BCG is a live product. In other words, it contains active bacteria that can cause infection. Some bacteria will be present for several hours in urine that you pass after each treatment with BCG. Any urine that you pass during the first 6 hours after each treatment should be disinfected with an equal amount (usually about 1 cup) of undiluted household bleach. After the bleach is added to the urine, it should be allowed to sit for 15 minutes before it is flushed. If you have any questions about this, check with your doctor.

Dosing

The dose of this medicine 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 this medicine. 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.

Precautions While Using Theracys

While you are being treated with BCG, and for 6 to 12 weeks after you stop treatment with it, avoid contact with people who have tuberculosis. If you think you have been exposed to someone with tuberculosis, tell your doctor.

While you are being treated with BCG and for a few weeks after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor's approval.

Theracys 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 Blood in urine fever and chills frequent urge to urinate increased frequency of urination joint pain nausea and vomiting painful urination (severe or continuing) Rare Cough skin rash

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 Burning during first urination after treatment

After you stop using this medicine, 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:

Cough fever

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: Theracys 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 Theracys resources Theracys Side Effects (in more detail) Theracys Use in Pregnancy & Breastfeeding Theracys Drug Interactions Theracys Support Group 0 Reviews for Theracys - Add your own review/rating BCG Vaccine Prescribing Information (FDA) TheraCys Concise Consumer Information (Cerner Multum) TheraCys MedFacts Consumer Leaflet (Wolters Kluwer) Compare Theracys with other medications Tuberculosis, Prophylaxis Urinary Tract Tumors
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thiotepa


Generic Name: thiotepa (THYE oh TEP a)
Brand Names: Thioplex

What is thiotepa?

Thiotepa is a cancer (antineoplastic) medication. Thiotepa interferes with the growth of cancer cells and slows their growth and spread in the body.

Thiotepa is used in the treatment of cancers of the breast, ovary, bladder, and others.

Thiotepa may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about thiotepa?

Thiotepa should only be administered under the supervision of a qualified healthcare provider experienced in the use of cancer chemotherapeutic agents.

Serious side effects have been reported with the use of thiotepa including: allergic reactions (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives); severe heart damage with prolonged use; decreased bone marrow function and blood problems (extreme fatigue; easy bruising or bleeding; black, bloody or tarry stools; fever or chills; or signs of infection); severe nausea, vomiting, diarrhea, and loss of appetite; and others. Talk to your doctor about the possible side effects from treatment with thiotepa.

What should I discuss with my healthcare provider before using thiotepa? Do not use thiotepa without first talking to your doctor if you have kidney disease; liver disease; or

poor bone marrow function.

The use of thiotepa may be dangerous if you have any of the conditions listed above.

Thiotepa is in the FDA pregnancy category D. This means that thiotepa is known to be harmful to an unborn baby. Do not use thiotepa without first talking to your doctor if you are pregnant. Discuss with your doctor the appropriate use of birth control during treatment with thiotepa if either you or your partner is of childbearing potential. It is not known whether thiotepa passes into breast milk. Do not take thiotepa without first talking to your doctor if you are breast-feeding a baby. The safety and effectiveness of thiotepa in children has not been established. How should I use thiotepa?

Thiotepa should only be administered under the supervision of a qualified healthcare provider experienced in the use of cancer chemotherapeutic agents.

Your doctor will determine the correct amount and frequency of treatment with thiotepa depending upon the type of cancer being treated and other factors. Talk to your doctor if you have any questions or concerns regarding the treatment schedule.

Your doctor will probably want you to have regularly scheduled blood tests and other medical evaluations during treatment with thiotepa to monitor progress and side effects.

Skin accidentally exposed to thiotepa should be rinsed thoroughly with soap and warm water.

Your healthcare provider will store thiotepa as directed by the manufacturer. If you are storing thiotepa at home, follow the directions provided by your healthcare provider.

What happens if I miss a dose?

Contact your doctor if you miss a dose of thiotepa.

What happens if I overdose? If for any reason an overdose of thiotepa is suspected, seek emergency medical attention or contact your healthcare provider immediately.

Symptoms of a thiotepa overdose tend to be similar to side effects caused by the medication, although often more severe.

What should I avoid while using thiotepa?

Thiotepa can lower the activity of your immune system making you susceptible to infections. Avoid contact with people who have colds, the flu, or other contagious illnesses and do not receive vaccines that contain live strains of a virus (e.g., live oral polio vaccine) during treatment with thiotepa. In addition, avoid contact with individuals who have recently been vaccinated with a live vaccine. There is a chance that the virus can be passed on to you.

Skin accidentally exposed to thiotepa should be rinsed thoroughly with soap and warm water.

Thiotepa side effects

If you experience any of the following serious side effects from thiotepa, seek emergency medical attention or contact your doctor immediately:

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

decreased bone marrow function and blood problems (extreme fatigue; easy bruising or bleeding; black, bloody or tarry stools; or fever, chills, or signs of infection);

tissue or vein reactions near the site of administration;

liver damage (abdominal pain, yellowing of the skin or eyes);

severe nausea, vomiting, or loss of appetite;

fever, chills, or other signs of infection; or

painful or difficult urination.

Other, less serious side effects may be more likely to occur. Continue taking thiotepa and talk to your doctor if you experience:

fatigue or weakness;

mild to moderate nausea, vomiting, or loss of appetite;

redness or inflammation of the eyes;

dizziness, headache, or blurred vision;

temporary hair loss;

a loss of skin coloration; or

decreased menstruation in women and decreased sperm production in men.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Thiotepa Dosing Information

Usual Adult Dose for Breast Cancer:

0.3 to 0.4 mg/kg by rapid IV administration once.

Usual Adult Dose for Ovarian Cancer:

0.3 to 0.4 mg/kg by rapid intravenous administration once.

Usual Adult Dose for Serosal Cavity Neoplastic Disease:

0.6 to 0.8 mg/kg by intracavitary injection once

Usual Adult Dose for Bladder Cancer:

30 to 60 mg by intravesical instillation once, for the treatment of superficial bladder tumors

Usual Adult Dose for Lymphoma:

500 to 1000 mg intravenously once, for the treatment of refractory lymphomas

Usual Adult Dose for Malignant Disease:

0.3 to 0.4 mg/kg by rapid IV administration once.
or
0.6 to 0.8 mg/kg by intracavitary injection once.
or
0.6 to 0.8 mg/kg by intratumor injection once.
or
30 to 60 mg by intravesical instillation once.
or
10 to 15 mg by intrathecal injection once.
or
500 to 1000 mg IV once.

Usual Pediatric Dose for Malignant Disease:

Sarcomas: 25 to 65 mg/m2 IV as a single dose every 3 to 4 weeks.
Autologous bone marrow transplantation: 300 mg/m2 IV over 3 hours, repeat every 24 hours for 3 doses. The maximum tolerated dose is 1125 mg/m2 over 3 days.

What other drugs will affect thiotepa? Do not receive "live" vaccines during treatment with thiotepa. Administration of a live vaccine may be dangerous during treatment with thiotepa.

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

More thiotepa resources Thiotepa Side Effects (in more detail) Thiotepa Use in Pregnancy & Breastfeeding Thiotepa Drug Interactions Thiotepa Support Group 0 Reviews for Thiotepa - Add your own review/rating thiotepa Injection Advanced Consumer (Micromedex) - Includes Dosage Information Thiotepa Prescribing Information (FDA) Thiotepa Professional Patient Advice (Wolters Kluwer) Thiotepa MedFacts Consumer Leaflet (Wolters Kluwer) Compare thiotepa with other medications Bladder Cancer Breast Cancer Cancer Lymphoma Ovarian Cancer Serosal Cavity Neoplastic Disease Where can I get more information? Your healthcare provider may have additional information about thiotepa that you may read.

See also: thiotepa side effects (in more detail)


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