Generic Version of Generess Fe
 

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ED Pills

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Generess Fe


Generic Name: ethinyl estradiol and norethindrone (ETH in il ess tra DYE ole and nor ETH in drone)
Brand Names: Aranelle, Balziva, Brevicon, Briellyn, Cyclafem 1/35, Cyclafem 7/7/7, Estrostep Fe, Femcon FE, Generess Fe, Gildess FE 1.5/0.03, Gildess FE 1/0.2, Junel 1.5/30, Junel 1/20, Junel Fe 1.5/30, Junel Fe 1/20, Leena, Lo Loestrin Fe, Loestrin 21 1.5/30, Loestrin 21 1/20, Loestrin 24 Fe, Loestrin Fe 1.5/30, Loestrin Fe 1/20, Microgestin 1.5/30, Microgestin 1/20, Microgestin FE 1.5/30, Microgestin FE 1/20, Modicon, Necon 0.5/35, Necon 1/35, Necon 10/11, Necon 7/7/7, Norinyl 1+35, Nortrel 0.5/35, Nortrel 1/35, Nortrel 7/7/7, Ortho-Novum 1/35, Ortho-Novum 7/7/7, Ovcon 35, Ovcon 35 Fe, Ovcon 50, Tilia Fe, Tri-Legest Fe, Tri-Norinyl, Zenchent Fe, Zeosa

What is Generess Fe (ethinyl estradiol and norethindrone)?

Ethinyl estradiol and norethindrone contains a combination of female hormones that prevent ovulation (the release of an egg from an ovary). This medication also causes changes in your cervical mucus and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.

Ethinyl estradiol and norethindrone are used as contraception to prevent pregnancy. It is also used to treat severe acne.

Ethinyl estradiol and norethindrone may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Generess Fe (ethinyl estradiol and norethindrone)? Do not use birth control pills if you are pregnant or if you have recently had a baby. Do not use this medication if you have any of the following conditions: a history of stroke or blood clot, circulation problems, a hormone-related cancer such as breast or uterine cancer, abnormal vaginal bleeding, liver disease or liver cancer, or a history of jaundice caused by birth control pills.

You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medication. Follow your doctor's instructions.

Taking hormones can increase your risk of blood clots, stroke, or heart attack, especially if you smoke and are older than 35.

Some drugs can make birth control pills less effective, which may result in pregnancy. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

What should I discuss with my healthcare provider before taking Generess Fe (ethinyl estradiol and norethindrone)? This medication can cause birth defects. Do not use if you are pregnant. Tell your doctor right away if you become pregnant, or if you miss two menstrual periods in a row. If you have recently had a baby, wait at least 4 weeks before taking birth control pills (6 weeks if you are breast-feeding). You should not take birth control pills if you have:

coronary artery disease, a severe or uncontrolled heart valve disorder, untreated or uncontrolled high blood pressure;

a history of a stroke, blood clot, or circulation problems;

a hormone-related cancer such as breast or uterine cancer;

unusual vaginal bleeding that has not been checked by a doctor;

liver disease or liver cancer;

severe migraine headaches; or

a history of jaundice caused by pregnancy or birth control pills.

To make sure you can safely take this medication, tell your doctor if you have any of these other conditions:

high blood pressure or a history of heart disease;

high cholesterol, gallbladder disease, or diabetes;

migraine headaches or a history of depression; or

a history of breast cancer or an abnormal mammogram.

The hormones in birth control pills can pass into breast milk and may harm a nursing baby. This medication may also slow breast milk production. Do not use if you are breast-feeding a baby. How should I take Generess Fe (ethinyl estradiol and norethindrone)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Take your first pill on the first day of your period or on the first Sunday after your period begins (follow your doctor's instructions).

You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medication. Follow your doctor's instructions.

The 28-day birth control pack contains seven "reminder" pills to keep you on your regular cycle. Your period will usually begin while you are using these reminder pills.

You may have breakthrough bleeding, especially during the first 3 months. Tell your doctor if this bleeding continues or is very heavy.

Take one pill every day, no more than 24 hours apart. When the pills run out, start a new pack the following day. You may get pregnant if you do not use this medication regularly. Get your prescription refilled before you run out of pills completely.

The chewable tablet may be chewed or swallowed whole. If chewed, drink a full glass of water just after you swallow the pill.

If you need surgery or medical tests or if you will be on bed rest, you may need to stop using this medication for a short time. Any doctor or surgeon who treats you should know that you are using birth control pills.

Your doctor will need to check your progress on a regular basis. Do not miss any scheduled appointments.

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

Missing a pill increases your risk of becoming pregnant. If you miss one "active" pill, take two pills on the day that you remember. Then take one pill per day for the rest of the pack.

If you miss two "active" pills in a row in week one or two, take two pills per day for two days in a row. Then take one pill per day for the rest of the pack. Use back-up birth control for at least 7 days following the missed pills.

If you miss two "active" pills in a row in week three, or if you miss three pills in a row during any of the first 3 weeks, throw out the rest of the pack and start a new one the same day if you are a Day 1 starter. If you are a Sunday starter, keep taking a pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new one that day.

If you miss two or more pills, you may not have a period during the month. If you miss a period for two months in a row, call your doctor because you might be pregnant.

If you miss any reminder pills, throw them away and keep taking one pill per day until the pack is empty. You do not need back-up birth control if you miss a reminder pill.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include nausea, vomiting, and vaginal bleeding. What should I avoid while taking Generess Fe (ethinyl estradiol and norethindrone)? Do not smoke while using birth control pills, especially if you are older than 35. Smoking can increase your risk of blood clots, stroke, or heart attack caused by birth control pills.

Birth control pills will not protect you from sexually transmitted diseases--including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.

Generess Fe (ethinyl estradiol and norethindrone) 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 this medication and call your doctor at once if you have any of these serious side effects:

sudden numbness or weakness, especially on one side of the body;

sudden severe headache, confusion, problems with vision, speech, or balance;

sudden cough, wheezing, rapid breathing, coughing up blood;

pain, swelling, warmth, or redness in one or both legs;

chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

a change in the pattern or severity of migraine headaches;

pain in your upper stomach, jaundice (yellowing of the skin or eyes);

a lump in your breast;

swelling in your hands, ankles, or feet; or

symptoms of depression (sleep problems, weakness, mood changes).

Less serious side effects may include:

mild nausea or vomiting, appetite or weight changes;

breast swelling or tenderness;

headache, nervousness, dizziness;

problems with contact lenses;

freckles or darkening of facial skin, loss of scalp hair; or

vaginal itching or discharge.

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 Generess Fe (ethinyl estradiol and norethindrone)?

Some drugs can make ethinyl estradiol and norethindrone less effective, which may result in pregnancy. Before using ethinyl estradiol and norethindrone, tell your doctor if you are using any of the following drugs:

acetaminophen (Tylenol) or ascorbic acid (vitamin C);

bosentan (Tracleer);

prednisolone (Orapred);

St. John's wort;

theophylline (Elixophyllin, Theo-24, Uniphyl);

an antibiotic;

HIV or AIDS medications;

phenobarbital (Solfoton) and other barbiturates; or

seizure medication.

This list is not complete and other drugs may interact with birth control pills. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Generess Fe resources Generess Fe Side Effects (in more detail) Generess Fe Use in Pregnancy & Breastfeeding Generess Fe Drug Interactions 0 Reviews for Generess Fe - Add your own review/rating Aranelle Prescribing Information (FDA) Balziva Prescribing Information (FDA) Brevicon Prescribing Information (FDA) Briellyn Prescribing Information (FDA) Cyclafem 1/35 Prescribing Information (FDA) Cyclafem 7/7/7 Prescribing Information (FDA) Estrostep Fe Prescribing Information (FDA) Femcon FE Prescribing Information (FDA) Femcon Fe Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer) Femhrt Consumer Overview Femhrt Prescribing Information (FDA) Femhrt MedFacts Consumer Leaflet (Wolters Kluwer) Jevantique Prescribing Information (FDA) Jinteli Prescribing Information (FDA) Leena Prescribing Information (FDA) Lo Loestrin Fe MedFacts Consumer Leaflet (Wolters Kluwer) Lo Loestrin Fe Consumer Overview Lo Loestrin Fe Advanced Consumer (Micromedex) - Includes Dosage Information Lo Loestrin Fe Prescribing Information (FDA) Loestrin 24 FE Prescribing Information (FDA) Loestrin 24 Fe Consumer Overview Loestrin Fe 1/20 MedFacts Consumer Leaflet (Wolters Kluwer) Ovcon 35 MedFacts Consumer Leaflet (Wolters Kluwer) Tilia FE Prescribing Information (FDA) Tri-Norinyl Prescribing Information (FDA) Zenchent FE Prescribing Information (FDA) Zeosa Prescribing Information (FDA) Compare Generess Fe with other medications Birth Control Where can I get more information? Your pharmacist can provide more information about ethinyl estradiol and norethindrone.

See also: Generess Fe side effects (in more detail)


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Sex hormone combinations


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.

Sex hormone combinations are products that contain more than one sex hormone, either estrogen and progestin or estrogen and androgen.

Estrogens are a group of hormones that are synthesized mainly by the ovaries and a small amount is synthesized by the testes in males and by the adrenal cortex in both sexes. The placenta produces a fairly large amount of estrogen as well. The three main endogenous estrogens are estradiol, estriol and estrone.

Progestins are a group of naturally occurring or synthetic steroid hormones. The naturally occurring progestin is progesterone, which is secreted by the corpus luteum of the ovary, the placenta and also (in small amounts) by the adrenal cortex and testes. It prepares the inner lining of the uterus for pregnancy, and if pregnancy occurs it maintains the uterus through the pregnancy and prevents ovulation by the ovaries during pregnancy.

Androgens are steroid hormones that stimulate development of male sex organs and sexual characteristics. Androgens are mainly released by the testes and small amounts are released by the adrenal cortex and ovaries.

The combinations, which have estrogen and progestin are used as birth control or to treat menopausal symptoms. Combinations with estrogen and androgen are used control menopausal symptoms.

See also

Medical conditions associated with sex hormone combinations:

Abnormal Uterine BleedingAcneAtrophic UrethritisAtrophic VaginitisBirth ControlEndometriosisGonadotropin InhibitionHot FlashesHypoestrogenismMenopausal DisordersMenstrual DisordersOophorectomyOsteoporosisPolycystic Ovary SyndromePostmenopausal SymptomsPrevention of OsteoporosisPrimary Ovarian Failure Drug List:/tags/estratest/
/tags/norinyl-1-35/
/tags/estratest-h-s/
/tags/angeliq/
/tags/ovcon-35/
/tags/ortho-novum-7-7-7/
/tags/aranelle/
/tags/modicon/
/tags/junel-1-20/
/tags/lo-loestrin-fe/
/tags/microgestin-fe-1-5-30/
/tags/climara_pro/
/tags/junel-fe-1-5-30/
/tags/microgestin-fe-1-20/
/tags/necon-7-7-7/
/tags/nortrel-7-7-7/
/tags/nortrel-1-35/
/tags/loestrin-21-1-20/
/tags/brevicon/
/tags/covaryx-hs/
/tags/cyclafem-7-7-7/
/tags/eemt-ds/
/tags/essian/
/tags/estrostep-fe/
/tags/genora-1-35/
/tags/jenest/
/tags/jinteli/
/tags/loestrin-21-1-5-30/
/tags/lunelle/
/tags/microgestin-1-5-30/
/tags/necon-0-5-35/
/tags/nelova-0-5-35/
/tags/nortrel-0-5-35/
/tags/ovcon-50/
/tags/premphase/
/tags/syntest-hs/
/tags/tri-legest/
/tags/zenchent/

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Birth Control (Contraception) Medications


Definition of Birth Control: The prevention of conception or impregnation. More...

Drugs associated with Birth Control

The following drugs and medications are in some way related to, or used in the treatment of Birth Control. 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 Birth Control Emergency Contraception (14 drugs) Learn more about Birth Control (Contraception)

Medical Encyclopedia:

Birth control and family planning Emergency contraception Over-the-counter birth control
Drug List: Alesse Altavera Amethia Amethia-Lo Amethyst Apri Aranelle Aviane Balziva Beyaz Brevicon Briellyn Camila Camrese Caziant Cesia Cryselle-28 Cyclafem-1-35 Cyclafem-7-7-7 Cyclessa Demulen Depo-Provera Depo-Provera-Contraceptive-Injectable Depo-Subq-Provera-104-Injectable-Suspension-Subcutaneous Desogen Ella Emoquette Enpresse Errin Estrostep-Fe Femcon-Fe-Chewable-Tablets Femhrt Generess-Fe Genora-1-35 Gianvi Gildess-Fe-1-5-0-03 Gildess-Fe-1-0-2 Implanon Jenest Jevantique Jolessa Jolivette Junel-1-5-30 Junel-1-20 Junel-Fe-1-5-30 Junel-Fe-1-20 Kariva Kelnor Leena Lessina Levlen Levlite Levonest Levora Lo-Loestrin-Fe Lo-Ovral Lo-Ovral-28 Loestrin-1-20 Loestrin-21-1-5-30 Loestrin-21-1-20 Loestrin_24_Fe Loestrin-Fe-1-5-30 Loestrin-Fe-1-20 Loryna Loseasonique Low-Ogestrel Low-Ogestrel-28 Lunelle Lutera Lybrel Microgestin-1-5-30 Microgestin-1-20 Microgestin-Fe-1-5-30 Microgestin-Fe-1-20 Mircette Mirena Modicon Mononessa Natazia Necon-0-5-35 Necon-1-35 Necon-1-50 Necon-10-11 Necon-7-7-7 Nelova-0-5-35 Nexplanon Nor-Qd Nora-Be Nordette Norethin-1-35-E Norinyl-1-35 Norinyl-1-50 Norplant-System Nortrel-0-5-35 Nortrel-1-35 Nortrel-7-7-7 Nuvaring Ocella Ogestrel Ogestrel-28 Orsythia Ortho_Cyclen Ortho_Evra Ortho-Micronor Ortho-Tri-Cyclen Ortho-Tri-Cyclen-Lo Ortho-Cept Ortho-Novum-1-35 Ortho-Novum-1-50 Ortho-Novum-7-7-7 Ovcon-35 Ovcon-35-Fe Ovcon-50 Portia Previfem Provera Quasense-Extended-Cycle Reclipsen Safyral Seasonale Seasonique Solia Sprintec Sronyx Syeda Tilia-Fe Tri-Legest Tri-Legest-Fe Tri-Levlen Tri-Lo-Sprintec Tri-Norinyl Tri-Previfem Tri-Sprintec Trinessa Trinessa-Lo Triphasil Triphasil-21 Triphasil-28 Trivora Trivora-28 Velivet Vestura Yasmin Yaz Zarah Zenchent Zenchent-Fe Zeosa Zovia Zovia-1-35 Zovia-1-50
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Contraceptives


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.

Contraceptives are used to prevent unwanted pregnancy. Hormonal contraceptives consist of one or more synthetic female sex hormones (estrogen and progestin or progestin only). These sex hormones prevent pregnancy by blocking the normal process of ovulation. They may also alter the lining of the uterus (endometrium) so that it is unable to support a fertilized egg and they change the mucus in the cervix so that it is hard for the sperm to travel hence conception is less likely should ovulation occur.

These hormones are either taken as regular doses in pill form (oral contraceptives), or are administered through the skin by means of a patch impregnated with hormones. They can also be given by three monthly injections of a long acting progestin, or by subcutaneous implants of progestin. They are also available as hormonal intrauterine devices and vaginal rings.

See also

Medical conditions associated with contraceptives:

Abnormal Uterine Bleeding Acne Amenorrhea Birth Control Emergency Contraception Endometrial Cancer Endometrial Hyperplasia, Prophylaxis Endometriosis Gonadotropin Inhibition Menstrual Disorders Ovarian Cysts Polycystic Ovary Syndrome Postmenopausal Symptoms Premenstrual Dysphoric Disorder Premenstrual Syndrome Prevention of Osteoporosis Renal Cell Carcinoma Drug List: Junel-1-5-30 Nordette Norinyl-1-35 Zeosa Plan-B Triphasil Ortho-Novum-1-35 Loestrin-1-20 Plan-B-One-Step Demulen Zarah Ovcon-35 Trivora Lybrel Low-Ogestrel-28 Necon-1-35 Ortho-Novum-7-7-7 Aranelle Gildess-Fe-1-5-0-03 Modicon Nexplanon Next-Choice Tri-Legest-Fe Ortho_Cyclen Lutera Ortho_Evra Junel-1-20 Seasonale Yasmin Femcon-Fe-Chewable-Tablets Lo-Ovral Mircette Desogen Lo-Loestrin-Fe Low-Ogestrel Nora-Be Microgestin-1-20 Camila Kelnor Mirena Nuvaring Portia Provera Aviane Quasense-Extended-Cycle Trinessa Jolessa Lo-Ovral-28 Mononessa Yaz Alesse Beyaz Cryselle-28 Kariva Levlen Ocella Depo-Provera-Contraceptive-Injectable Loestrin_24_Fe Microgestin-Fe-1-5-30 Apri Aygestin Implanon Zovia-1-35 Depo-Provera Femhrt Ortho-Tri-Cyclen Ortho-Tri-Cyclen-Lo Tri-Lo-Sprintec Levora Natazia Sronyx Junel-Fe-1-5-30 Junel-Fe-1-20 Tri-Sprintec Seasonique Sprintec Cyclessa Microgestin-Fe-1-20 Safyral Necon-7-7-7 Ortho-Cept Loseasonique Ortho-Micronor Gianvi Jolivette Reclipsen Errin Lessina Zovia Tri-Previfem Briellyn Nortrel-7-7-7 Velivet Ogestrel-28 Loestrin-Fe-1-20 Nortrel-1-35 Loestrin-21-1-20 Orsythia Triphasil-28 Altavera Amethia Amethia-Lo Amethyst Balziva Brevicon Camrese Caziant Cesia Cyclafem-1-35 Cyclafem-7-7-7 Depo-Subq-Provera-104-Injectable-Suspension-Subcutaneous Emoquette Enpresse Estrostep-Fe Generess-Fe Genora-1-35 Gildess-Fe-1-0-2 Jenest Jevantique Jinteli Leena Levlite Levonest Loestrin-21-1-5-30 Loestrin-Fe-1-5-30 Loryna Lunelle Microgestin-1-5-30 Necon-0-5-35 Necon-1-50 Necon-10-11 Nelova-0-5-35 Nor-Qd Norethin-1-35-E Norinyl-1-50 Norplant-System Nortrel-0-5-35 Ogestrel Ortho-Novum-1-50 Ovcon-35-Fe Ovcon-50 Preven-Ec Previfem Solia Syeda Tilia-Fe Tri-Legest Tri-Levlen Tri-Norinyl Trinessa-Lo Triphasil-21 Trivora-28 Vestura Zenchent Zenchent-Fe Zovia-1-50
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Velosef for Injection


The wording of leaflets is regularly updated. This electronic text is the most up-to-date version and may differ from the leaflet in your pack. If you have any questions about the information provided, please ask your doctor or pharmacist.

VELOSEF FOR INJECTION

Cefradine

Your doctor has prescribed Velosef for Injection for you. This leaflet gives a summary of information about your medicine. If you want to know more, or are not sure about anything, ask your doctor or pharmacist.

What Is In Velosef Injection?

The active ingredient in Velosef is cefradine. Velosef is available in two strengths and each vial contains either 500mg or 1g cefradine. Cefradine is an antibiotic and a member of the family of medicines called cephalosporins. The other ingredient is L-arginine. The powder in the vial is dissolved in water for injections or another infusion fluid before administration.

Who Supplies Velosef Injection? U.K. PRODUCT LICENCE held by: E.R. Squibb & Sons Limited Uxbridge Business Park Sanderson Road Uxbridge Middlesex UB8 1DH IRISH PRODUCT AUTHORISATION held by: Bristol-Myers Squibb Pharmaceuticals Limited Co Dublin Ireland Manufacturer Bristol-Myers Squibb Srl Via Del Murillo Sermoneta Latina Italy What Is This Medicine For?

Velosef is used to treat bacterial infections in the chest, urinary tract or skin. The injection is given when patients are unable to take an oral antibiotic medicine or when the infection needs to be treated quickly. Velosef is also used to treat infections after surgery.

Before Your Medicine Is Administered What Should My Doctor Know Before I Receive Velosef Injection?

Tell your doctor if you are allergic to any of the ingredients in Velosef or similar medicines such as other cephalosporins and penicillins.

What If I Am Pregnant Or Think I Might Be Pregnant?What If Am Breast-Feeding?

If you are pregnant, planning to become pregnant or breast feeding, speak to your doctor.

What If I Have Problems With My Liver Or Kidneys?

Tell your doctor about any previous problems with your liver or kidneys, as the dose of Velosef may need to be adjusted. Your doctor may want to monitor your liver or kidney function whilst you are taking Velosef.

What If I Am A Diabetic?

If you use chemical tests to check for sugar in the urine, Velosef may cause a false positive reaction. This does not occur with dipstick type tests. Ask your doctor which type of test kit you should use.

Can I Take Other Medicines?

If you are taking any other medicines it is important to discuss this with your doctor or pharmacist. These include furosemide (‘water tablets’) or probenecid and medicines bought at a pharmacy or elsewhere e.g. supermarket.

Is It All Right To Drink Alcohol?

There is no interaction between Velosef and moderate amounts of alcohol. However, you should check with your doctor whether drinking is advisable for you.

Administration Of Your Medicine What Is The Dose Of Velosef Injection And How Will It Be Given?

Velosef will be given by injection into a large muscle, or slow injection into a vein, or as an intravenous drip. Your doctor will decide what dose is required and how long the treatment should continue, based on your symptoms and the results of blood tests. The usual dose for treatment of infections is 2-4g daily, given in four equally divided doses. The dose given for prevention of infections after surgery is 1-2g. The usual dose for children is 50-100mg/kg bodyweight/day.

Undesirable Effects What Are The Unwanted Effects Of Velosef Injection?

In a few patients, especially those with a history of allergy, asthma, hay fever or nettle rash, Velosef may cause diarrhoea or a rash. Skin and hypersensitivity reactions may include unexpected itchy red swelling on skin, fever, joint pain or fluid retention. More rarely, there have been reports of inflammation of the tongue, heartburn, headache, dizziness, shortness of breath, pins and needles, nausea, vomiting, abdominal pain, fungal infections, vaginal inflammation. Occasionally, patients complain of pain, bruising and inflammation at the injection site. Very rarely, blood/liver disorders occur and any diarrhoea with blood and mucus should be reported to your doctor, nurse or pharmacist. There have also been very rare reports of more serious allergic reactions including anaphylaxis and Stevens Johnson syndrome. If you notice any other unusual or unexpected symptoms tell your doctor or pharmacist.

Looking After Your Medicine

This medicine will be stored in the pharmacy until it is given to you by your doctor or nurse. It should not be stored above 25°C. It should not be used after the expiry date shown on the outer packaging.

DATE OF PREPARATION October 2005

PLEASE DETACH BEFORE HANDING ABOVE SECTION TO THE PATIENT

VELOSEF FOR INJECTION


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D-GAM, Solution for Injection 1,500 and 2,500iu vials


1. Name Of The Medicinal Product

D-GAM ®, Human Anti-D Immunoglobulin, 1,500 and 2,500 IU, solution for injection.

2. Qualitative And Quantitative Composition

Each vial contains either 1500 IU or 2500 IU human Anti-D immunoglobulin

One mL contains 1250 IU/mL human Anti-D immunoglobulin.

*100 micrograms of human anti-D immunoglobulin correspond to 500 international units (IU).

Human protein content 20 - 180 g/L of which at least 95% is IgG.

For excipients see 6.1.

3. Pharmaceutical Form

A solution for injection.

4. Clinical Particulars 4.1 Therapeutic Indications

Prevention of RhD immunisation in RhD negative women:

i. Pregnancy/delivery of a RhD positive baby.

ii. Abortion/threatened abortion, ectopic pregnancy or hydatidiform mole.

iii. After ante-partum haemorrhage (APH), amniocentesis, chorionic biopsy or obstetric manipulative procedure e.g. external version, or abdominal trauma, which may cause transplacental haemorrhage (TPH).

Treatment of RhD negative patients after transfusions of RhD positive blood or other products containing RhD positive red blood cells (e.g. platelets).

4.2 Posology And Method Of Administration

Posology

a) Post-Natal Dosage:

The recommended dose is 500 IU.

For postnatal use, the product should be administered as soon as possible within 72 hours of delivery.

If a large fetomaternal haemorrhage is suspected, its extent should be determined by a suitable method and additional doses of anti-D should be administered as indicated.

b) Ante-Natal Prophylaxis:

A single dose of 1,500 IU at 28 weeks of gestation, or

500 IU given at both 28 and 34 weeks of gestation.

c) Following a Potentially Sensitising Event During Pregnancy:

D-GAM ® should be administered as soon as possible and no later than 72 hours after the event.

Up to 20 weeks gestation: recommended dose is 250 IU per incident.

After 20 weeks gestation: recommended dose is 500 IU per incident. A test for the size of the FMH should be performed when anti-D is given after 20 weeks and additional doses of anti-D should be administered as indicated.

d) Prevention of Immunisation in RhD Negative Patients Given Blood Components Containing RhD Positive Cells:

Recommended doses: 125 IU per mL of transfused RhD positive red cells; 250 IU per three adult doses of platelets.

Method of administration

For intramuscular use (preferably into the deltoid muscle).

D-GAM ® vials are for single use only.

In the case of haemorrhagic disorders, where intramuscular injections are contra-indicated, Anti-D immunoglobulin may be administered subcutaneously. Careful manual pressure with a compress should be applied to the site after injection.

If large total doses (>5 mL) are required, it is advisable to administer them in divided doses at different sites.

4.3 Contraindications

Hypersensitivity to any of the components.

4.4 Special Warnings And Precautions For Use

Do not administer this product intravenously (risk of shock).

In the case of post-partum use, the product is intended for maternal administration. It should not be given to the newborn infant.

The product is not intended for use in RhD positive individuals.

Patients should be observed for at least 20 minutes after administration.

If symptoms of allergic or anaphylactic type reactions occur, immediate discontinuation of the administration is required.

True hypersensitivity reactions are rare but allergic type responses to Anti-D immunoglobulin may occur. Patients should be informed of the early signs of hypersensitivity reactions including hives, generalised urticaria, tightness of the chest, wheezing, hypotension and anaphylaxis. The treatment required depends on the nature and severity of the side effect. In case of shock, the current medical standards for shock treatment should be observed.

D-GAM ® contains a small quantity of IgA. Although anti-D immunoglobulin has been used successfully to treat selected IgA deficient individuals, the attending physician must weigh the benefit against the potential risks of hypersensitivity reactions. Individuals deficient in IgA have a potential for development of IgA antibodies and anaphylactic reactions after administration of blood components containing IgA.

Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses. Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded. This also applies to unknown or emerging viruses and other pathogens.

The viral removal/inactivation procedures may be of limited value against non-enveloped viruses such as hepatitis A virus or parvovirus B19.

In the interest of patients, it is recommended that, whenever possible, every time that D-GAM ® is administered to them, the name and batch number of the product is registered.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Active immunisation with live virus vaccines (e.g. measles, mumps or rubella) should be postponed until 3 months after the administration of Anti-D immunoglobulin, as the efficacy of the live virus vaccine may be impaired. If Anti-D immunoglobulin needs to be administered within 2-4 weeks of a live virus vaccination, then the efficacy of such a vaccination may be impaired.

After injection of immunoglobulin, the transitory rise of the various passively transferred antibodies in the patient's blood may result in misleading positive results in serological testing.

The results of blood typing and antibody testing, including the Coombs' or antiglobulin test, are significantly affected by the administration of anti-D immunoglobulin.

4.6 Pregnancy And Lactation

This medicinal product is used in pregnancy.

4.7 Effects On Ability To Drive And Use Machines

No effects on ability to drive and use machines have been observed.

4.8 Undesirable Effects

Local pain and tenderness can be observed at the injection site; this can be prevented by dividing larger doses over several injection sites.

The following side effects are known to be associated with Anti-D (the incidence has not been quantified): Occasionally fever, malaise, headache, cutaneous reactions and chills occur. In rare cases: nausea, vomiting, hypotension, tachycardia and allergic or anaphylactic type reactions, including dyspnoea and shock, are reported, even when the patient has shown no hypersensitivity to previous administration.

For information on viral safety see 4.4.

4.9 Overdose

No data are available on overdosage. RhD negative patients who are given RhD positive blood or other products containing RhD positive red blood cells and receive anti-D immunoglobulin should be monitored clinically and by biological parameters, because of the risk of haemolytic reaction.

In other RhD negative individuals, overdosage should not lead to more frequent or more severe undesirable effects than the normal dose.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: immune sera and immunoglobulins: Anti-D (Rh) immunoglobulin. ATC code: J06B B01.

Anti-D immunoglobulin contains specific antibodies (IgG) against the RhD antigen of human erythrocytes.

5.2 Pharmacokinetic Properties

Measurable levels of antibodies are obtained approximately 8 hours after intramuscular injection. Peak serum levels are usually achieved 2 to 4 days later.

The half-life in the circulation of individuals with normal IgG levels is 3 to 5 weeks.

IgG and IgG-complexes are broken down in cells of the reticuloendothelial system.

5.3 Preclinical Safety Data

D-GAM ® is a preparation of human plasma proteins, so safety testing in animals is not particularly relevant to the safety of use in man. Acute toxicity studies in rat and mouse showed species specific reactions, which bear no relevance to administration in humans.

Repeated dose safety testing is impracticable due to the induction of and interference with antibodies to human protein. Clinical experience provides no sign of tumourigenic and mutagenic effects.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Sodium chloride

Glycine

Sodium acetate trihydrate

Sodium hydroxide

6.2 Incompatibilities

This medicinal product must not be mixed with other medicinal products.

6.3 Shelf Life

Stored at 2° - 8°C:

2 years.

Stored at 25°C:

1 week.

6.4 Special Precautions For Storage

D-GAM ® should be stored in the original container at 2°C to 8°C. Storage for up to one week at ambient temperatures (25°C) in the original container is not detrimental. DO NOT FREEZE.

The condition of date-expired, or incorrectly stored product cannot be guaranteed. Such product may be unsafe, and should not be used.

6.5 Nature And Contents Of Container

Neutral borosilicate glass vial (Type I Ph.Eur.) with overseal consisting of a halobutyl rubber wad (Type I Ph.Eur.), clear lacquered aluminium skirt and flip-off polypropylene cap.

6.6 Special Precautions For Disposal And Other Handling

The product should be brought to room or body temperature before use.

The solution should be clear or slightly opalescent. Do not use solutions which are cloudy or have deposits.

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

7. Marketing Authorisation Holder

Bio Products Laboratory

Dagger Lane

Elstree

Hertfordshire

WD6 3BX

United Kingdom.

8. Marketing Authorisation Number(S)

PL 08801/0049 - 1,500 IU and 2,500 IU dose sizes.

9. Date Of First Authorisation/Renewal Of The Authorisation

31 July 2000

10. Date Of Revision Of The Text

11th August 2011

Version Code: SDS5C

POM

 

 


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Tri-Adcortyl Otic Ointment


The wording of leaflets is regularly updated. This electronic text is the most up-to-date version and may differ from the leaflet in your pack. If you have any questions about the information provided, please ask your doctor or pharmacist.

TRI-ADCORTYL OTIC OINTMENT

Your doctor has prescribed Tri-Adcortyl Otic Ointment for you. This leaflet gives a summary of information about your medicine. If you want to know more, or are not sure about anything, ask your doctor or pharmacist.

REMEMBER: This medicine is for YOU. Only a doctor can prescribe it. Never give it to anyone else. It may harm them even if they have the same symptoms as you.

What Is In Tri-Adcortyl Otic Ointment?

This ointment contains four active ingredients: triamcinolone acetonide which belongs to a group of medicines called steroids which are used to reduce inflammation, nystatin which is a member of a group of medicines called anti-fungal agents, neomycin and gramicidin which are antibiotics.

Each gram of Tri-Adcortyl Otic contains 0.1% of triamcinolone acetonide, nystatin 100,000 units, Neomycin 1625 units (0.25%) and Gramicidin 0.025% and is supplied in tubes of 10g. The other ingredients are: liquid paraffin and polyethylene resin.

Product Licence Holder: E. R. Squibb & Sons Ltd. Uxbridge Business Park Sanderson Road Uxbridge Middlesex UB8 1DH England Tel:0800 7311736 Manufacturer: Bristol-Myers Squibb SpA Contrada Fontana del Ceraso 03012 Anagni (Fr) Italy What Is This Medicine For ?

Tri-Adcortyl Otic ointment is prescribed to treat infection and inflammation of the external ear.

Before Using Your Medicine Should you be using Tri-Adcortyl Otic ointment?

This ointment has been prescribed to treat the skin problem that you showed your doctor. DO NOT use it on any other skin problems as it may make them worse.

This ointment is NOT for Use in the Eyes

DO NOT use Tri-Adcortyl Otic ointment if you have any of the following skin conditions:

Tuberculosis (TB) of the skin; viral infections e.g. cold sores, herpes, chickenpox fungal skin conditions unless a suitable antifungal preparation has also been given acne inflammation around the mouth (perioral dermatitis) a condition called rosacea (flushed, red face)

Tri-Adcortyl Otic ointment should not be used

inside the ears of patients with perforated eardrums (holes in eardrums) for long periods of time over large areas of the body in the eyes.

This ointment should not be used if you have had an allergic reaction to any product containing the same ingredients as Tri-Adcortyl Otic ointment.

If Tri-Adcortyl Otic ointment is to be used on the face, or on children, treatment should not be longer than 5 days and the treated area should not be covered with any airtight or waterproof plasters/dressings.

This medicine should not be used in children under one year of age.

What if I am pregnant or breast feeding ?

You should always tell your doctor if you are pregnant, planning to become pregnant or breast feeding and let him decide if it is wise for you to use this medicine.

Do you have problems with your ears or hearing?

Make sure that your doctor knows about any problems you have with your ears before you start using Tri-Adcortyl Otic ointment. Neomycin, which is one of the active ingredients, may be harmful to the ears, particularly if used in large amounts and for long periods of time.

Using Your Medicine How should I apply Tri-Adcortyl Otic ointment?

This ointment should be applied to the affected area two or occasionally three times daily. In the elderly this ointment should be used sparingly and for short periods of time. If after 7 days little or no improvement occurs then tell your doctor.

If you are using this ointment on burnt skin that has become infected or ulcerated skin, make sure you use a small amount of ointment, as these skin conditions may make it easier for the active ingredient in the ointment to pass through the skin into the blood stream and may increase the possibility of side-effects.

Are there special directions for children?.

As children are more likely to get side effects, they should not normally be treated for longer than 5 days, unless your doctor has told you to to do so.

What if Tri-Adcortyl Otic ointment is swallowed?

If this ointment is swallowed tell your doctor immediately or go to your nearest hospital casualty department.

What happens if you miss an application?

If you forget to use your ointment, apply it as soon as possible. However, if it is nearly time for your next application skip the missed dose and continue as before.

What should you do if you put Tri-Adcortyl Otic ointment on areas of normal or healthy skin?

Remove the ointment with a clean tissue and wash the area with plenty of water.

Undesirable Effects Are there any unwanted effects of Tri-Adcortyl Otic ointment?

If absorbed into the bloodstream, the active ingredient neomycin can damage the ears or the kidneys.

Check with your doctor if you notice any of the following side effects: blistering, burning, itching, peeling, dryness or other signs of skin irritation not present before using this ointment.

If the ointment is used for a long time additional side effects may occur. Check with your doctor as soon as possible if you notice any of these: acne or oily skin, increased facial hair growth, increased sweating, lightheadedness on standing, reddish purple lines on arms, face, legs, trunk or groin; thinning of skin with easy bruising or wounds that are slow to heal, rashes consisting of slightly raised rounded red patches. It may also cause changes in your body's sugar levels. If you have skin reaction tests, eg. for allergies, the steroid contained in this ointment may affect the result by reducing the reaction. If you notice any other unwanted effect tell your doctor or pharmacist.

Looking After Your Medicine

Do not use your medicine after the expiry date which you will find on both the Ointment tube and box.

Keep all your medicines where children cannot reach them, preferably in a locked cupboard or medicine cabinet. Do not store Tri-Adcortyl Otic ointment above 25°C.

If your doctor decides to stop the ointment, ask your pharmacist to tell you what to do with any you have left.

DATE OF LAST REVISION June 2005


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Tri-Adcortyl Cream


The wording of leaflets is regularly updated. This electronic text is the most up-to-date version and may differ from the leaflet in your pack. If you have any questions about the information provided, please ask your doctor or pharmacist.

TRI-ADCORTYL CREAM

Your doctor has prescribed Tri-Adcortyl cream for you. This leaflet gives a summary of information about your medicine. If you want to know more, or are not sure about anything, ask your doctor or pharmacist.

REMEMBER: This medicine is for YOU. Only a doctor can prescribe it. Never give it to anyone else. It may harm them even if they have the same symptoms as you.

What Is In Tri-Adcortyl Cream?

This cream contains four active ingredients: triamcinolone acetonide which belongs to a group of medicines called steroids which are used to reduce inflammation, nystatin which is a member of a group of medicines called anti-fungal agents, neomycin and gramicidin which are antibiotics.

Each gram of Tri-Adcortyl contains 0.1% of triamcinolone acetonide, nystatin 100,000 units, neomycin 1625 units (0.25%) and gramicidin 0.025% and is supplied in tubes of 30g.

The other ingredients are: aluminium hydroxide, antifoam emulsion, benzyl alcohol, ethanol, ethylenediamine, hydrochloric acid, macrogol ether, perfume verley, polysorbate 60, propylene glycol, sorbitol, titanium dioxide, white soft paraffin, water.

Who Supplies This Cream? Product Licence Holder: E. R. Squibb & Sons Ltd Uxbridge Business Park Sanderson Road Uxbridge Middlesex UB8 1DH England Tel:0800 7311736 Manufacturer: Bristol-Myers Squibb SpA Contrada Fontana Del Ceraso 03012 Anagni (Fr) Italy What is this medicine for ?

Tri-Adcortyl cream is prescribed for infected and inflammed skin conditions including eczema.

Before Using Your Medicine Should you be using Tri-Adcortyl cream?

This cream has been prescribed to treat the skin problem that you showed your doctor. DO NOT use it on any other skin problems as it may make them worse.

DO NOT use Tri-Adcortyl cream if you have any of the following skin conditions:

Tuberculosis (TB) of the skin; viral infections e.g. cold sores, herpes, chickenpox acne inflammation around the mouth (perioral dermatitis) a condition called rosacea (flushed, red face)

Tri-Adcortyl cream should not be used:

inside the ears of patients with perforated eardrums (holes in eardrums) for long periods of time over large areas of the body in the eyes

This cream should not be used if you have had an allergic reaction to any product containing the same ingredients as Tri-Adcortyl cream. If Tri-Adcortyl cream is to be used on the face, or on children, treatment should not be longer than 5 days and the treated area should not be covered with any airtight or waterproof plasters/dressings.

This medicine should not be used in children under one year of age.

What if I am pregnant or breast feeding ?

You should always tell your doctor if you are pregnant, planning to become pregnant or breast feeding and let him decide if it is wise for you to use this medicine.

Do you have problems with your ears or hearing?

Make sure that your doctor knows about any problems you have with your ears before you start using Tri-Adcortyl. Neomycin, which is one of the active ingredients, may be harmful to the ears, particularly if used in large amounts and for long periods of time.

Using Your Medicine How should I apply Tri-Adcortyl cream?

This cream should be applied to the affected area two or occasionally three times daily. In the elderly this cream should be used sparingly and for short periods of time. If after 7 days little or no improvement occurs then tell your doctor.

If you are using this cream on burnt skin that has become infected or ulcerated skin, make sure you use a small amount of cream, as these skin conditions may make it easier for the active ingredients in the cream to pass through the skin into the blood stream and may increase the possibility of side-effects.

Are there special directions for children?

As children are more likely to get side effects, they should not normally be treated for longer than 5 days, unless your doctor has told you to to do so.

What if Tri-Adcortyl cream is swallowed?

If this cream is swallowed tell your doctor immediately or go to your nearest hospital casualty department.

What happens if you miss an application?

If you forget to use your cream, apply it as soon as possible. However, if it is nearly time for your next application skip the missed dose and continue as before.

What should you do if you put Tri-Adcortyl cream on areas of normal or healthy skin?

Remove the cream with a clean tissue and wash the area with plenty of water.

Undesirable Effects Are there any unwanted effects of Tri-Adcortyl cream?

If absorbed into the bloodstream, the active ingredient neomycin can damage the ears or kidney. Check with your doctor if you notice any of the following side effects: blistering, burning, itching, peeling, dryness or other signs of skin irritation not present before using this cream.

If the cream is used for a long time additional side effects may occur. Check with your doctor as soon as possible if you notice any of these: acne or oily skin, increased facial hair growth, increased sweating, lightheadedness on standing, reddish purple lines on arms, face, legs, trunk or groin; thinning of skin with easy bruising or wounds that are slow to heal, rashes consisting of slightly raised rounded red patches. It may also cause changes in your body's sugar levels. If you have skin reaction tests, eg for allergies, the steroid contained in this cream may affect the result by reducing the reaction. If you notice any other unwanted effect tell your doctor or pharmacist.

Looking After Your Medicine

Do not use your medicine after the expiry date which you will find on both the Cream tube and carton.

Keep all your medicines out of reach and sight of children, preferably in a locked cupboard or medicine cabinet. Do not store Tri-Adcortyl cream above 25°C and avoid freezing.

If your doctor decides to stop the cream, ask your pharmacist to tell you what to do with any you have left.

DATE OF LAST REVISION June 2005


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Geref Diagnostic


Generic Name: sermorelin (Injection route)

ser-moe-REL-in

Commonly used brand name(s)

In the U.S.

Geref Geref Diagnostic

Available Dosage Forms:

Powder for Solution

Therapeutic Class: Endocrine-Metabolic Agent

Pharmacologic Class: Growth Hormone Releasing Hormone Analog

Uses For Geref Diagnostic

Sermorelin is a synthetic (man-made) version of a naturally occurring substance that causes release of growth hormone from the pituitary gland. Growth hormone is naturally produced by the pituitary gland and is necessary for growth in children. In children who fail to grow normally because their bodies are not producing enough growth hormone, this medicine may be used to increase the amount of growth hormone produced by the pituitary gland.

This medicine is available only with your doctor's prescription.

Before Using Geref Diagnostic

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.

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

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

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

Other Medical Problems

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

Underactive thyroid—This condition can interfere with the effects of sermorelin Proper Use of sermorelin

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

If you are injecting this medicine yourself, use it exactly as directed by your doctor. Do not use more or less of it, and do not use it more often than your doctor ordered. The exact amount of medicine needed has been carefully worked out. Using too much will increase the risk of side effects, while using too little may not improve the condition.

Each package of sermorelin contains a patient instruction sheet. Read this sheet carefully and make sure you understand:

How to prepare the injection. Proper use of disposable syringes and needles, including safe handling and disposal. How to give the injection. How long the injection is safe to use.

It is best to use a different place on the body for each injection (for example, abdomen, hip, thigh, or upper arm). To help you remember to do this, you may want to keep a record of the date and location for each injection.

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.

Storage

Store in the refrigerator. Do not freeze.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Geref Diagnostic

It is very important that your doctor check your progress at regular visits.

Geref Diagnostic 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 Pain, redness, or swelling at the place of injection Rare Itching trouble in swallowing

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:

Rare Dizziness flushing headache sleepiness trouble sitting still

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 Geref Diagnostic resources Geref Diagnostic Use in Pregnancy & BreastfeedingGeref Diagnostic Support Group0 Reviews · Be the first to review/rate this drug Geref MedFacts Consumer Leaflet (Wolters Kluwer)
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Sutent


sunitinib malate
Dosage Form: capsule
FULL PRESCRIBING INFORMATION WARNING: HEPATOTOXICITY

 Hepatotoxicity has been observed in clinical trials and post-marketing experience. This hepatotoxicity may be severe, and deaths have been reported. [See Warnings and Precautions (5.1)]

Indications and Usage for Sutent Gastrointestinal Stromal Tumor (GIST)

Sutent is indicated for the treatment of gastrointestinal stromal tumor after disease progression on or intolerance to imatinib mesylate.

Advanced Renal Cell Carcinoma (RCC)

Sutent is indicated for the treatment of advanced renal cell carcinoma.

Advanced Pancreatic Neuroendocrine Tumors (pNET)

 Sutent is indicated for the treatment of progressive, well-differentiated pancreatic neuroendocrine tumors in patients with unresectable locally advanced or metastatic disease.

Sutent Dosage and Administration Recommended Dose for GIST and RCC

The recommended dose of Sutent for gastrointestinal stromal tumor (GIST) and advanced renal cell carcinoma (RCC) is one 50 mg oral dose taken once daily, on a schedule of 4 weeks on treatment followed by 2 weeks off (Schedule 4/2). Sutent may be taken with or without food.

Recommended Dose for pNET

 The recommended dose of Sutent for pancreatic neuroendocrine tumors (pNET) is 37.5 mg taken orally once daily continuously without a scheduled off-treatment period. Sutent may be taken with or without food.

Dose Modification

 Dose interruption and/or dose modification in 12.5 mg increments or decrements is recommended based on individual safety and tolerability. The maximum dose administered in the Phase 3 pNET study was 50 mg daily.

 Strong CYP3A4 inhibitors such as ketoconazole may increase sunitinib plasma concentrations. Selection of an alternate concomitant medication with no or minimal enzyme inhibition potential is recommended. A dose reduction for Sutent to a minimum of 37.5 mg (GIST and RCC) or 25 mg (pNET) daily should be considered if Sutent must be co-administered with a strong CYP3A4 inhibitor [see Drug Interactions (7.1) and Clinical Pharmacology (12.3)].

 CYP3A4 inducers such as rifampin may decrease sunitinib plasma concentrations. Selection of an alternate concomitant medication with no or minimal enzyme induction potential is recommended. A dose increase for Sutent to a maximum of 87.5 mg (GIST and RCC) or 62.5 mg (pNET) daily should be considered if Sutent must be co-administered with a CYP3A4 inducer. If dose is increased, the patient should be monitored carefully for toxicity [see Drug Interactions (7.2) and Clinical Pharmacology (12.3)].

Dosage Forms and Strengths

12.5 mg capsules
Hard gelatin capsule with orange cap and orange body, printed with white ink "Pfizer" on the cap and "STN 12.5 mg" on the body.

25 mg capsules
Hard gelatin capsule with caramel cap and orange body, printed with white ink "Pfizer" on the cap and "STN 25 mg" on the body.

50 mg capsules
Hard gelatin capsule with caramel top and caramel body, printed with white ink "Pfizer" on the cap and "STN 50 mg" on the body.

Contraindications

None

Warnings and Precautions Hepatotoxicity

 Sutent has been associated with hepatotoxicity, which may result in liver failure or death. Liver failure has been observed in clinical trials (7/2281 [0.3%]) and post-marketing experience. Liver failure signs include jaundice, elevated transaminases and/or hyperbilirubinemia in conjunction with encephalopathy, coagulopathy, and/or renal failure. Monitor liver function tests (ALT, AST, bilirubin) before initiation of treatment, during each cycle of treatment, and as clinically indicated. Sutent should be interrupted for Grade 3 or 4 drug-related hepatic adverse events and discontinued if there is no resolution. Do not restart Sutent if patients subsequently experience severe changes in liver function tests or have other signs and symptoms of liver failure.

 Safety in patients with ALT or AST >2.5 ? ULN or, if due to liver metastases, >5.0 ? ULN has not been established.

Pregnancy

 Sutent can cause fetal harm when administered to a pregnant woman. As angiogenesis is a critical component of embryonic and fetal development, inhibition of angiogenesis following administration of Sutent should be expected to result in adverse effects on pregnancy. In animal reproductive studies in rats and rabbits, sunitinib was teratogenic, embryotoxic, and fetotoxic. There are no adequate and well-controlled studies of Sutent in pregnant women. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus. Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with Sutent.

Left Ventricular Dysfunction

In the presence of clinical manifestations of congestive heart failure (CHF), discontinuation of Sutent is recommended. The dose of Sutent should be interrupted and/or reduced in patients without clinical evidence of CHF but with an ejection fraction <50% and >20% below baseline.

 Cardiovascular events, including heart failure, myocardial disorders and cardiomyopathy, some of which were fatal, have been reported through post-marketing experience. For GIST and RCC, more patients treated with Sutent experienced decline in left ventricular ejection fraction (LVEF) than patients receiving either placebo or interferon-? (IFN-?). In the double-blind treatment phase of GIST Study A, 22/209 patients (11%) on Sutent and 3/102 patients (3%) on placebo had treatment-emergent LVEF values below the lower limit of normal (LLN). Nine of 22 GIST patients on Sutent with LVEF changes recovered without intervention. Five patients had documented LVEF recovery following intervention (dose reduction: one patient; addition of antihypertensive or diuretic medications: four patients). Six patients went off study without documented recovery. Additionally, three patients on Sutent had Grade 3 reductions in left ventricular systolic function to LVEF <40%; two of these patients died without receiving further study drug. No GIST patients on placebo had Grade 3 decreased LVEF. In the double-blind treatment phase of GIST Study A, 1 patient on Sutent and 1 patient on placebo died of diagnosed heart failure; 2 patients on Sutent and 2 patients on placebo died of treatment-emergent cardiac arrest.

In the treatment-na?ve RCC study, 103/375 (27%) and 54/360 (15%) patients on Sutent and IFN-?, respectively, had an LVEF value below the LLN. Twenty-six patients on Sutent (7%) and seven on IFN-? (2%) experienced declines in LVEF to >20% below baseline and to below 50%. Left ventricular dysfunction was reported in four patients (1%) and CHF in two patients (<1%) who received Sutent.

 In the Phase 3 pNET study, cardiac failure leading to death was reported in 2/83 (2%) patients on Sutent and no patients on placebo.

Patients who presented with cardiac events within 12 months prior to Sutent administration, such as myocardial infarction (including severe/unstable angina), coronary/peripheral artery bypass graft, symptomatic CHF, cerebrovascular accident or transient ischemic attack, or pulmonary embolism were excluded from Sutent clinical studies. It is unknown whether patients with these concomitant conditions may be at a higher risk of developing drug-related left ventricular dysfunction. Physicians are advised to weigh this risk against the potential benefits of the drug. These patients should be carefully monitored for clinical signs and symptoms of CHF while receiving Sutent. Baseline and periodic evaluations of LVEF should also be considered while these patients are receiving Sutent. In patients without cardiac risk factors, a baseline evaluation of ejection fraction should be considered.

QT Interval Prolongation and Torsade de Pointes

Sutent has been shown to prolong the QT interval in a dose dependent manner, which may lead to an increased risk for ventricular arrhythmias including Torsade de Pointes. Torsade de Pointes has been observed in <0.1% of Sutent-exposed patients.

Sutent should be used with caution in patients with a history of QT interval prolongation, patients who are taking antiarrhythmics, or patients with relevant pre-existing cardiac disease, bradycardia, or electrolyte disturbances. When using Sutent, periodic monitoring with on-treatment electrocardiograms and electrolytes (magnesium, potassium) should be considered. Concomitant treatment with strong CYP3A4 inhibitors, which may increase sunitinib plasma concentrations, should be used with caution and dose reduction of Sutent should be considered [see Dosage and Administration (2.2)].

Hypertension

Patients should be monitored for hypertension and treated as needed with standard anti-hypertensive therapy. In cases of severe hypertension, temporary suspension of Sutent is recommended until hypertension is controlled.

 Of patients receiving Sutent for treatment-na?ve RCC, 127/375 patients (34%) receiving Sutent compared with 13/360 patients (4%) on IFN-? experienced hypertension. Grade 3 hypertension was observed in 50/375 treatment-na?ve RCC patients (13%) on Sutent compared to 1/360 patients (<1%) on IFN-?. While all-grade hypertension was similar in GIST patients on Sutent compared to placebo, Grade 3 hypertension was reported in 9/202 GIST patients on Sutent (4%), and none of the GIST patients on placebo. Of patients receiving Sutent in the Phase 3 pNET study, 22/83 patients (27%) on Sutent and 4/82 patients (5%) on placebo experienced hypertension. Grade 3 hypertension was reported in 8/83 pNET patients (10%) on Sutent, and 1/82 patient (1%) on placebo. No Grade 4 hypertension was reported. Sutent dosing was reduced or temporarily delayed for hypertension in 21/375 patients (6%) on the treatment-naive RCC study and 7/83 pNET patients (8%). Four treatment-na?ve RCC patients, including one with malignant hypertension, one patient with pNET, and no GIST patients discontinued treatment due to hypertension. Severe hypertension (>200 mmHg systolic or 110 mmHg diastolic) occurred in 8/202 GIST patients on Sutent (4%), 1/102 GIST patients on placebo (1%), in 32/375 treatment-na?ve RCC patients (9%) on Sutent, in 3/360 patients (1%) on IFN-?, and in 8/80 pNET patients (10%) on Sutent and 2/76 pNET patients (3%) on placebo.

Hemorrhagic Events

 Hemorrhagic events reported through post-marketing experience, some of which were fatal, have included GI, respiratory, tumor, urinary tract and brain hemorrhages. In patients receiving Sutent in a clinical trial for treatment-na?ve RCC, 140/375 patients (37%) had bleeding events compared with 35/360 patients (10%) receiving IFN-?. Bleeding events occurred in 37/202 patients (18%) receiving Sutent in the double-blind treatment phase of GIST Study A, compared to 17/102 patients (17%) receiving placebo. Epistaxis was the most common hemorrhagic adverse event reported. Bleeding events, excluding epistaxis, occurred in 18/83 patients (22%) receiving Sutent in the Phase 3 pNET study, compared to 8/82 patients (10%) receiving placebo. Epistaxis was reported in 17/83 patients (20%) receiving Sutent for pNET and 4 patients (5%) receiving placebo. Less common bleeding events in GIST, RCC and pNET patients included rectal, gingival, upper gastrointestinal, genital, and wound bleeding. In the double-blind treatment phase of GIST Study A, 14/202 patients (7%) receiving Sutent and 9/102 patients (9%) on placebo had Grade 3 or 4 bleeding events. In addition, one patient in GIST Study A taking placebo had a fatal gastrointestinal bleeding event during Cycle 2. Most events in RCC patients were Grade 1 or 2; there was one Grade 5 event of gastric bleed in a treatment-na?ve patient. In the pNET study, 1/83 patients (1%) receiving Sutent had Grade 3 epistaxis, and no patients had other Grade 3 or 4 bleeding events. In pNET patients receiving placebo, 3/82 patients (4%) had Grade 3 or 4 bleeding events.

Tumor-related hemorrhage has been observed in patients treated with Sutent. These events may occur suddenly, and in the case of pulmonary tumors may present as severe and life-threatening hemoptysis or pulmonary hemorrhage. Fatal pulmonary hemorrhage occurred in 2 patients receiving Sutent on a clinical trial of patients with metastatic non-small cell lung cancer (NSCLC). Both patients had squamous cell histology. Sutent is not approved for use in patients with NSCLC. Treatment-emergent Grade 3 and 4 tumor hemorrhage occurred in 5/202 patients (3%) with GIST receiving Sutent on Study A. Tumor hemorrhages were observed as early as Cycle 1 and as late as Cycle 6. One of these five patients received no further drug following tumor hemorrhage. None of the other four patients discontinued treatment or experienced dose delay due to tumor hemorrhage. No patients with GIST in the Study A placebo arm were observed to undergo intratumoral hemorrhage. Clinical assessment of these events should include serial complete blood counts (CBCs) and physical examinations.

Serious, sometimes fatal gastrointestinal complications including gastrointestinal perforation, have occurred rarely in patients with intra-abdominal malignancies treated with Sutent.

Thyroid Dysfunction

Baseline laboratory measurement of thyroid function is recommended and patients with hypothyroidism or hyperthyroidism should be treated as per standard medical practice prior to the start of Sutent treatment. All patients should be observed closely for signs and symptoms of thyroid dysfunction on Sutent treatment. Patients with signs and/or symptoms suggestive of thyroid dysfunction should have laboratory monitoring of thyroid function performed and be treated as per standard medical practice.

 Treatment-emergent acquired hypothyroidism was noted in eight GIST patients (4%) on Sutent versus one (1%) on placebo. Hypothyroidism was reported as an adverse reaction in sixty-one patients (16%) on Sutent in the treatment-na?ve RCC study and in three patients (1%) in the IFN-? arm. Hypothyroidism was reported as an adverse reaction in 6/83 patients (7%) on Sutent in the Phase 3 pNET study and in 1/82 patients (1%) in the placebo arm.

Cases of hyperthyroidism, some followed by hypothyroidism, have been reported in clinical trials and through post-marketing experience.

Wound Healing

 Cases of impaired wound healing have been reported during Sutent therapy. Temporary interruption of Sutent therapy is recommended for precautionary reasons in patients undergoing major surgical procedures. There is limited clinical experience regarding the timing of reinitiation of therapy following major surgical intervention. Therefore, the decision to resume Sutent therapy following a major surgical intervention should be based upon clinical judgment of recovery from surgery.

Adrenal Function

Physicians prescribing Sutent are advised to monitor for adrenal insufficiency in patients who experience stress such as surgery, trauma or severe infection.

Adrenal toxicity was noted in non-clinical repeat dose studies of 14 days to 9 months in rats and monkeys at plasma exposures as low as 0.7 times the AUC observed in clinical studies. Histological changes of the adrenal gland were characterized as hemorrhage, necrosis, congestion, hypertrophy and inflammation. In clinical studies, CT/MRI obtained in 336 patients after exposure to one or more cycles of Sutent demonstrated no evidence of adrenal hemorrhage or necrosis. ACTH stimulation testing was performed in approximately 400 patients across multiple clinical trials of Sutent. Among patients with normal baseline ACTH stimulation testing, one patient developed consistently abnormal test results during treatment that are unexplained and may be related to treatment with Sutent. Eleven additional patients with normal baseline testing had abnormalities in the final test performed, with peak cortisol levels of 12–16.4 mcg/dL (normal >18 mcg/dL) following stimulation. None of these patients were reported to have clinical evidence of adrenal insufficiency.

Laboratory Tests

CBCs with platelet count and serum chemistries including phosphate should be performed at the beginning of each treatment cycle for patients receiving treatment with Sutent.

Adverse Reactions

The data described below reflect exposure to Sutent in 660 patients who participated in the double-blind treatment phase of a placebo-controlled trial (n=202) for the treatment of GIST [see Clinical Studies (14.1)], an active-controlled trial (n=375) for the treatment of RCC [see Clinical Studies (14.2)] or a placebo-controlled trial (n=83) for the treatment of pNET [see Clinical Studies (14.3)]. The GIST and RCC patients received a starting oral dose of 50 mg daily on Schedule 4/2 in repeated cycles, and the pNET patients received a starting oral dose of 37.5 mg daily without scheduled off-treatment periods.

The most common adverse reactions (?20%) in patients with GIST, RCC or pNET are fatigue, asthenia, fever, diarrhea, nausea, mucositis/stomatitis, vomiting, dyspepsia, abdominal pain, constipation, hypertension, peripheral edema, rash, hand-foot syndrome, skin discoloration, dry skin, hair color changes, altered taste, headache, back pain, arthralgia, extremity pain, cough, dyspnea, anorexia, and bleeding. The potentially serious adverse reactions of hepatotoxicity, left ventricular dysfunction, QT interval prolongation, hemorrhage, hypertension, thyroid dysfunction, and adrenal function are discussed in Warnings and Precautions (5). Other adverse reactions occurring in GIST, RCC and pNET studies are described below.

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

Adverse Reactions in GIST Study A

Median duration of blinded study treatment was two cycles for patients on Sutent (mean 3.0, range 1–9) and one cycle (mean 1.8, range 1–6) for patients on placebo at the time of the interim analysis. Dose reductions occurred in 23 patients (11%) on Sutent and none on placebo. Dose interruptions occurred in 59 patients (29%) on Sutent and 31 patients (30%) on placebo. The rates of treatment-emergent, non-fatal adverse reactions resulting in permanent discontinuation were 7% and 6% in the Sutent and placebo groups, respectively.

Most treatment-emergent adverse reactions in both study arms were Grade 1 or 2 in severity. Grade 3 or 4 treatment-emergent adverse reactions were reported in 56% versus 51% of patients on Sutent versus placebo, respectively, in the double-blind treatment phase of the trial. Table 1 compares the incidence of common (?10%) treatment-emergent adverse reactions for patients receiving Sutent and reported more commonly in patients receiving Sutent than in patients receiving placebo.

Table 1. Adverse Reactions Reported in Study A in at Least 10% of GIST Patients who Received Sutent in the Double-Blind Treatment Phase and More Commonly Than in Patients Given Placebo* Adverse Reaction,
n (%) GIST Sutent (n=202) Placebo (n=102) All Grades Grade 3/4 All Grades Grade 3/4 * Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0 † Includes decreased appetite Any 114 (56) 52 (51) Gastrointestinal   Diarrhea 81 (40) 9 (4) 27 (27) 0 (0)   Mucositis/stomatitis 58 (29) 2 (1) 18 (18) 2 (2)   Constipation 41 (20) 0 (0) 14 (14) 2 (2) Cardiac   Hypertension 31 (15) 9 (4) 11 (11) 0 (0) Dermatology   Skin discoloration 61 (30) 0 (0) 23 (23) 0 (0)   Rash 28 (14) 2 (1) 9 (9) 0 (0)   Hand-foot syndrome 28 (14) 9 (4) 10 (10) 3 (3) Neurology   Altered taste 42 (21) 0 (0) 12 (12) 0 (0) Musculoskeletal   Myalgia/limb pain 28 (14) 1 (1) 9 (9) 1 (1) Metabolism/Nutrition   Anorexia† 67 (33) 1 (1) 30 (29) 5 (5)   Asthenia 45 (22) 10 (5) 11 (11) 3 (3)

In the double-blind treatment phase of GIST Study A, oral pain other than mucositis/stomatitis occurred in 12 patients (6%) on Sutent versus 3 (3%) on placebo. Hair color changes occurred in 15 patients (7%) on Sutent versus 4 (4%) on placebo. Alopecia was observed in 10 patients (5%) on Sutent versus 2 (2%) on placebo.

Table 2 provides common (?10%) treatment-emergent laboratory abnormalities.

Table 2. Laboratory Abnormalities Reported in Study A in at Least 10% of GIST Patients Who Received Sutent or Placebo in the Double-Blind Treatment Phase* Laboratory Parameter, n (%) GIST Sutent (n=202) Placebo (n=102) All Grades* Grade 3/4*† All Grades* Grade 3/4*‡ LVEF=Left ventricular ejection fraction * Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0 † Grade 4 laboratory abnormalities in patients on Sutent included alkaline phosphatase (1%), lipase (2%), creatinine (1%), potassium decreased (1%), neutrophils (2%), hemoglobin (2%), and platelets (1%). ‡ Grade 4 laboratory abnormalities in patients on placebo included amylase (1%), lipase (1%), and hemoglobin (2%). Any 68 (34) 22 (22) Gastrointestinal   AST / ALT 78 (39) 3 (2) 23 (23) 1 (1)   Lipase 50 (25) 20 (10) 17 (17) 7 (7)   Alkaline phosphatase 48 (24) 7 (4) 21 (21) 4 (4)   Amylase 35 (17) 10 (5) 12 (12) 3 (3)   Total bilirubin 32 (16) 2 (1) 8 (8) 0 (0)   Indirect bilirubin 20 (10) 0 (0) 4 (4) 0 (0) Cardiac   Decreased LVEF 22 (11) 2 (1) 3 (3) 0 (0) Renal/Metabolic   Creatinine 25 (12) 1 (1) 7 (7) 0 (0)   Potassium decreased 24 (12) 1 (1) 4 (4) 0 (0)   Sodium increased 20 (10) 0 (0) 4 (4) 1 (1) Hematology   Neutrophils 107 (53) 20 (10) 4 (4) 0 (0)   Lymphocytes 76 (38) 0 (0) 16 (16) 0 (0)   Platelets 76 (38) 10 (5) 4 (4) 0 (0)   Hemoglobin 52 (26) 6 (3) 22 (22) 2 (2)

After an interim analysis, the study was unblinded, and patients on the placebo arm were given the opportunity to receive open-label Sutent treatment [see Clinical Studies (14.1)]. For 241 patients randomized to the Sutent arm, including 139 who received Sutent in both the double-blind and open-label treatment phases, the median duration of Sutent treatment was 6 cycles (mean 8.5, range 1 – 44). For the 255 patients who ultimately received open-label Sutent treatment, median duration of study treatment was 6 cycles (mean 7.8, range 1 – 37) from the time of the unblinding. A total of 118 patients (46%) required dosing interruptions, and a total of 72 patients (28%) required dose reductions. The incidence of treatment-emergent adverse reactions resulting in permanent discontinuation was 20%. The most common Grade 3 or 4 treatment-related adverse reactions experienced by patients receiving Sutent in the open-label treatment phase were fatigue (10%), hypertension (8%), asthenia (5%), diarrhea (5%), hand-foot syndrome (5%), nausea (4%), abdominal pain (3%), anorexia (3%), mucositis (2%), vomiting (2%), and hypothyroidism (2%).

Adverse Reactions in the Treatment-Na?ve RCC Study

The as-treated patient population for the treatment-naive RCC study included 735 patients, 375 randomized to Sutent and 360 randomized to IFN-?. The median duration of treatment was 11.1 months (range: 0.4 – 46.1) for Sutent treatment and 4.1 months (range: 0.1 – 45.6) for IFN-? treatment. Dose interruptions occurred in 202 patients (54%) on Sutent and 141 patients (39%) on IFN-?. Dose reductions occurred in 194 patients (52%) on Sutent and 98 patients (27%) on IFN-?. Discontinuation rates due to adverse reactions were 20% for Sutent and 24% for IFN-?. Most treatment-emergent adverse reactions in both study arms were Grade 1 or 2 in severity. Grade 3 or 4 treatment-emergent adverse reactions were reported in 77% versus 55% of patients on Sutent versus IFN-?, respectively.

Table 3 compares the incidence of common (?10%) treatment-emergent adverse reactions for patients receiving Sutent versus IFN-?.

Table 3. Adverse Reactions Reported in at Least 10% of Patients with RCC Who Received Sutent or IFN-?* Adverse Reaction,
n (%) Treatment-Na?ve RCC Sutent (n=375) IFN-? (n=360) All Grades Grade 3/4† All Grades Grade 3/4‡ * Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0 † Grade 4 ARs in patients on Sutent included back pain (1%), arthralgia (<1%), dyspnea (<1%), asthenia (<1%), fatigue (<1%), limb pain (<1%) and rash (<1%). ‡ Grade 4 ARs in patients on IFN-? included dyspnea (1%), fatigue (1%), abdominal pain (<1%) and depression (<1%). § Includes flank pain ¶ Includes ageusia, hypogeusia and dysgeusia # Includes decreased appetite ? Includes one patient with Grade 5 gastric hemorrhage ? Includes depressed mood Any 372 (99) 290 (77) 355 (99) 197 (55) Constitutional   Fatigue 233 (62) 55 (15) 202 (56) 54 (15)   Asthenia 96 (26) 42 (11) 81 (22) 21 (6)   Fever 84 (22) 3 (1) 134 (37) 1 (<1)   Weight decreased 60 (16) 1 (<1) 60 (17) 3 (1)   Chills 53 (14) 3 (1) 111 (31) 0 (0)   Chest Pain 50 (13) 7 (2) 24 (7) 3 (1)   Influenza like illness 18 (5) 0 (0) 54 (15) 1 (<1) Gastrointestinal   Diarrhea 246 (66) 37 (10) 76 (21) 1 (<1)   Nausea 216 (58) 21 (6) 147 (41) 6 (2)   Mucositis/stomatitis 178 (47) 13 (3) 19 (5) 2 (<1)   Vomiting 148 (39) 19 (5) 62 (17) 4 (1)   Dyspepsia 128 (34) 8 (2) 16 (4) 0 (0)   Abdominal pain§ 113 (30) 20 (5) 42 (12) 5 (1)   Constipation 85 (23) 4 (1) 49 (14) 1 (<1)   Dry mouth 50 (13) 0 (0) 27 (7) 1 (<1)   GERD/reflux esophagitis 47 (12) 1 (<1) 3 (1) 0(0)   Flatulence 52 (14) 0 (0) 8 (2) 0 (0)   Oral pain 54 (14) 2 (<1) 2 (1) 0 (0)   Glossodynia 40 (11) 0 (0) 2 (1) 0 (0)   Hemorrhoids 38 (10) 0 (0) 6 (2) 0 (0) Cardiac   Hypertension 127 (34) 50 (13) 13 (4) 1 (<1)   Edema, peripheral 91 (24) 7 (2) 17 (5) 2 (1)   Ejection fraction decreased 61 (16) 10 (3) 19 (5) 6 (2) Dermatology   Rash 109 (29) 6 (2) 39 (11) 1 (<1)   Hand-foot syndrome 108 (29) 32 (8) 3 (1) 0 (0)   Skin discoloration/ yellow skin 94 (25) 1 (<1) 0 (0) 0 (0)   Dry skin 85 (23) 1 (<1) 26 (7) 0 (0)   Hair color changes 75 (20) 0 (0) 1 (<1) 0 (0)   Alopecia 51 (14) 0 (0) 34 (9) 0 (0)   Erythema 46 (12) 2 (<1) 5 (1) 0 (0)   Pruritus 44 (12) 1 (<1) 24 (7) 1 (<1) Neurology   Altered taste¶ 178 (47) 1 (<1) 54 (15) 0 (0)   Headache 86 (23) 4 (1) 69 (19) 0 (0)   Dizziness 43 (11) 2 (<1) 50 (14) 2 (1) Musculoskeletal   Back pain 105 (28) 19 (5) 52 (14) 7 (2)   Arthralgia 111 (30) 10 (3) 69 (19) 4 (1)   Pain in extremity/ limb discomfort 150 (40) 19 (5) 107 (30) 7 (2) Endocrine   Hypothyroidism 61 (16) 6 (2) 3 (1) 0 (0) Respiratory   Cough 100 (27) 3 (1) 51 (14) 1 (<1)   Dyspnea 99 (26) 24
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Octreotide Mayne


Octreotide Mayne 50 micrograms/1ml solution for injection

Octreotide Mayne 100 micrograms/1ml solution for injection

Octreotide Mayne 200 micrograms/ml solution for injection

Octreotide Mayne 500 micrograms/1 ml solution for injection

Octreotide acetate

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, 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 effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet 1. What Octreotide Mayne is and what it is used for 2. Before you use Octreotide Mayne 3. How to use Octreotide Mayne 4. Possible side effects 5. How to store Octreotide Mayne 6. Further information What Octreotide Mayne is and what it is used for

Octreotide Mayne is a synthetic version of a hormone that occurs naturally in the body, called somatostatin. Octreotide inhibits the release of growth hormone and some gut hormones and secretions.

Octreotide Mayne is used:

To treat the symptoms that occurs with hormone producing gastrointestinal tumours. These symptoms are associated with the over-production of some of the body's natural substances which may result in an imbalance of your natural hormone levels. This imbalance may cause a variety of symptoms in the stomach, pancreas or intestines (gut). To reduce the levels of growth hormone and Insulin-like growth factor number 1 (IGF-1) if you have acromegaly and to improve symptoms that you may have due to over-production of these hormones. Prior to having an operation on the pancreas, to prevent further complications. Before you use Octreotide Mayne Octreotide Mayne should not be used if you are: allergic to octreotide or any of the ingredients in Octreotide Mayne (see Section 6). Special care will be taken: as Octreotide may affect your blood sugar levels. You or your doctor should closely monitor your blood sugar levels. if you have a tumour (growth) that produces insulin (insulinoma). You or your doctor should closely monitor your blood sugar levels. if you have any thyroid problems if you have gallstones if you have liver disease if you are pregnant or planning to become pregnant. If you do become pregnant, tell your doctor immediately. if you are breast-feeding Taking other medicines:

Please tell your doctor if you are taking any of the following medicines;

ciclosporin (a drug used after a transplant) cimetidine (a drug used to reduce stomach acid) bromocriptine (a drug used in Parkinson's disease or in acromegaly or to suppress breast milk) terfenadine (to relieve allergic symptoms) carbamazepine (a drug used in psychiatric disorders, epilepsy, trigeminal neuralgia and neuropathy) digoxin (medicine for certain heart problems) warfarin (a drug used to thin the blood)

Other medicines that are metabolised by the liver can also be affected, so tell your doctor or pharmacist about all the medicines you are taking.

Pregnancy and breastfeeding

Ask your doctor or pharmacist for advice before taking any medicine. You should not use Octreotide if you are pregnant, unless you have been told by your doctor that it is absolutely necessary for you to do so.

You should not breastfeed your infant whilst receiving treatment with Octreotide, unless you have been told to do so.

How to use Octreotide Mayne injection

Always use Octreotide exactly as your doctor has told you. You should check with your doctor or pharmacist if you are unsure of anything.

A doctor or nurse will usually give you this medicine.

The medicine will be given to your either as a subcutaneous injection (underneath the skin) or as a slow intravenous injection (via a drip into the vein).

The usual dosages are given below; however your doctor will decide what dosage to give to you, as this depends on the nature of your treatment, your age and your medical condition:

To treat the symptoms that occur with hormone producing gastrointestinal tumours: 50 micrograms each 24 hours or each 12 hours, depending on your response, the dose may be increased to 100 to 200 micrograms every 8 hours. The usual recommended maximum daily dosage is 600 micrograms. If you have acromegaly: initial doses of 50 to 100 micrograms, every 8 hours. For most patients the dosage is 200 to 300 micrograms per day and the maximum daily dosage is 1500 micrograms. Prior to having an operation on the pancreas: 100 micrograms every 8 hours for 7 days, starting on the day of the operation.

Your injection should be given between meals or at bedtime in order to reduce stomach and intestinal (gut) side effects.

To reduce discomfort, Octreotide Mayne solution for injection should reach room temperature before administration. Multiple subcutaneous injections at short intervals at the same administration site should be avoided.

If you use more Octreotide Mayne than advised: if you think you have had too much Octreotide, tell your doctor or nurse immediately.

Octreotide Mayne Side Effects

As other medicinal products, Octreotide Mayne injection can cause side effects although not everybody gets them.

If any of the following happen, tell your doctor immediately: severe allergic reaction - you may experience a sudden itchy rash (hives), swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty in swallowing or breathing). pancreatitis - this may give you sudden severe pains in your abdomen. It may occur in the first few hours or days of treatment. intestinal obstruction - you may feel constipation and pains.

These are very serious side effects. You may need urgent medical attention. These side effects are rare (occur in less than 1 in 1000 patients but more than 1 in 10,000).

Tell your doctor as soon as possible if you notice any of the following side effects:

Common (occurs in less than 1 in 10 patients but more than 1 in 100):

changes in blood sugar levels (both high or low levels may occur) diarrhoea vomiting steatorrhea (fatty material in the faeces) flatulence - excessive gas in your stomach or bowels feeling sick stomach pain gallstones that could gives gallbladder pain pain where the injection has been given

Uncommon (occurs in less than 1 in 100 patients but more than 1 in 1000):

severe loss of appetite (anorexia) being sick epigastric pain (pain in upper part of stomach)

Rare (occurs in less than 1 in 1000 patients but more than 1 in 10,000):

ileus-like conditions (your gut may not work properly) loss of hair rashes heart beating slower than normal

Your doctor will take blood tests to check for changes in liver function, which is a side effect of treatment with Octreotide.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How to store Octreotide Mayne

Store in a refrigerator (2°C - 8°C). Do not freeze. Store the vial in the outer carton in order to protect the product from light.

The multidose vials of Octreotide 200 micrograms/ml solution for injection for daily use may be stored for two weeks below 25°C.

Octreotide Mayne, diluted in 0.9% sodium chloride would not normally be stored for longer than 24 hours in a refrigerator.

Keep out of the reach and sight of children.

Do not use Octreotide after the expiry date stated on the carton and label.

The injection should only be used if it is clear and free of particles.

Medicines should not be disposed of via wastewater or household waste. These measures will help to protect the environment.

Other information

Octreotide Mayne is available as vials containing a clear, colourless solution for injection. It contains octreotide as the active ingredient.

The vials also contain Glacial Acetic Acid, Sodium Acetate Trihydrate, Sodium Chloride and Water for Injections. The multi-dose vials additionally contain Phenol (a preservative).

This medicinal product contains less than 1 mmol (23 mg) of sodium (i.e., essentially sodium free) per ml of solution.

Octreotide Mayne is available in the following pack sizes: Octreotida Mayne solution for injection 50 micrograms/1 ml (packs of 5, or 30 vials) Octreotida Mayne solution for injection 100 micrograms/1 ml (packs of 5, or 30 vials) Octreotida Mayne solution for injection 500 micrograms/1 ml (packs of 5, or 30 vials) Octreotida Mayne solution for injection 200 micrograms/ ml (packs of 1 or 10 multidose vials)

The vials may be overwrapped with a protective plastic to minimise the risk of spillage if the vials break; these vials are referred to as ONCO-TAIN.

Marketing authorisation holder and manufacturer: Mayne Pharma Plc Queensway Royal Leamington Spa Warwickshire CV31 3RW United Kingdom

This leaflet was last approved in June 2007


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Cyclafem 7/7/7


Generic Name: ethinyl estradiol and norethindrone (ETH in il ess tra DYE ole and nor ETH in drone)
Brand Names: Aranelle, Balziva, Brevicon, Briellyn, Cyclafem 1/35, Cyclafem 7/7/7, Estrostep Fe, Femcon FE, Generess Fe, Gildess FE 1.5/0.03, Gildess FE 1/0.2, Junel 1.5/30, Junel 1/20, Junel Fe 1.5/30, Junel Fe 1/20, Leena, Lo Loestrin Fe, Loestrin 21 1.5/30, Loestrin 21 1/20, Loestrin 24 Fe, Loestrin Fe 1.5/30, Loestrin Fe 1/20, Microgestin 1.5/30, Microgestin 1/20, Microgestin FE 1.5/30, Microgestin FE 1/20, Modicon, Necon 0.5/35, Necon 1/35, Necon 10/11, Necon 7/7/7, Norinyl 1+35, Nortrel 0.5/35, Nortrel 1/35, Nortrel 7/7/7, Ortho-Novum 1/35, Ortho-Novum 7/7/7, Ovcon 35, Ovcon 35 Fe, Ovcon 50, Tilia Fe, Tri-Legest Fe, Tri-Norinyl, Zenchent Fe, Zeosa

What is Cyclafem 7/7/7 (ethinyl estradiol and norethindrone)?

Ethinyl estradiol and norethindrone contains a combination of female hormones that prevent ovulation (the release of an egg from an ovary). This medication also causes changes in your cervical mucus and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.

Ethinyl estradiol and norethindrone are used as contraception to prevent pregnancy. It is also used to treat severe acne.

Ethinyl estradiol and norethindrone may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Cyclafem 7/7/7 (ethinyl estradiol and norethindrone)? Do not use birth control pills if you are pregnant or if you have recently had a baby. Do not use this medication if you have any of the following conditions: a history of stroke or blood clot, circulation problems, a hormone-related cancer such as breast or uterine cancer, abnormal vaginal bleeding, liver disease or liver cancer, or a history of jaundice caused by birth control pills.

You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medication. Follow your doctor's instructions.

Taking hormones can increase your risk of blood clots, stroke, or heart attack, especially if you smoke and are older than 35.

Some drugs can make birth control pills less effective, which may result in pregnancy. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

What should I discuss with my healthcare provider before taking Cyclafem 7/7/7 (ethinyl estradiol and norethindrone)? This medication can cause birth defects. Do not use if you are pregnant. Tell your doctor right away if you become pregnant, or if you miss two menstrual periods in a row. If you have recently had a baby, wait at least 4 weeks before taking birth control pills (6 weeks if you are breast-feeding). You should not take birth control pills if you have:

coronary artery disease, a severe or uncontrolled heart valve disorder, untreated or uncontrolled high blood pressure;

a history of a stroke, blood clot, or circulation problems;

a hormone-related cancer such as breast or uterine cancer;

unusual vaginal bleeding that has not been checked by a doctor;

liver disease or liver cancer;

severe migraine headaches; or

a history of jaundice caused by pregnancy or birth control pills.

To make sure you can safely take this medication, tell your doctor if you have any of these other conditions:

high blood pressure or a history of heart disease;

high cholesterol, gallbladder disease, or diabetes;

migraine headaches or a history of depression; or

a history of breast cancer or an abnormal mammogram.

The hormones in birth control pills can pass into breast milk and may harm a nursing baby. This medication may also slow breast milk production. Do not use if you are breast-feeding a baby. How should I take Cyclafem 7/7/7 (ethinyl estradiol and norethindrone)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Take your first pill on the first day of your period or on the first Sunday after your period begins (follow your doctor's instructions).

You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medication. Follow your doctor's instructions.

The 28-day birth control pack contains seven "reminder" pills to keep you on your regular cycle. Your period will usually begin while you are using these reminder pills.

You may have breakthrough bleeding, especially during the first 3 months. Tell your doctor if this bleeding continues or is very heavy.

Take one pill every day, no more than 24 hours apart. When the pills run out, start a new pack the following day. You may get pregnant if you do not use this medication regularly. Get your prescription refilled before you run out of pills completely.

The chewable tablet may be chewed or swallowed whole. If chewed, drink a full glass of water just after you swallow the pill.

If you need surgery or medical tests or if you will be on bed rest, you may need to stop using this medication for a short time. Any doctor or surgeon who treats you should know that you are using birth control pills.

Your doctor will need to check your progress on a regular basis. Do not miss any scheduled appointments.

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

Missing a pill increases your risk of becoming pregnant. If you miss one "active" pill, take two pills on the day that you remember. Then take one pill per day for the rest of the pack.

If you miss two "active" pills in a row in week one or two, take two pills per day for two days in a row. Then take one pill per day for the rest of the pack. Use back-up birth control for at least 7 days following the missed pills.

If you miss two "active" pills in a row in week three, or if you miss three pills in a row during any of the first 3 weeks, throw out the rest of the pack and start a new one the same day if you are a Day 1 starter. If you are a Sunday starter, keep taking a pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new one that day.

If you miss two or more pills, you may not have a period during the month. If you miss a period for two months in a row, call your doctor because you might be pregnant.

If you miss any reminder pills, throw them away and keep taking one pill per day until the pack is empty. You do not need back-up birth control if you miss a reminder pill.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include nausea, vomiting, and vaginal bleeding. What should I avoid while taking Cyclafem 7/7/7 (ethinyl estradiol and norethindrone)? Do not smoke while using birth control pills, especially if you are older than 35. Smoking can increase your risk of blood clots, stroke, or heart attack caused by birth control pills.

Birth control pills will not protect you from sexually transmitted diseases--including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.

Cyclafem 7/7/7 (ethinyl estradiol and norethindrone) 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 this medication and call your doctor at once if you have any of these serious side effects:

sudden numbness or weakness, especially on one side of the body;

sudden severe headache, confusion, problems with vision, speech, or balance;

sudden cough, wheezing, rapid breathing, coughing up blood;

pain, swelling, warmth, or redness in one or both legs;

chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

a change in the pattern or severity of migraine headaches;

pain in your upper stomach, jaundice (yellowing of the skin or eyes);

a lump in your breast;

swelling in your hands, ankles, or feet; or

symptoms of depression (sleep problems, weakness, mood changes).

Less serious side effects may include:

mild nausea or vomiting, appetite or weight changes;

breast swelling or tenderness;

headache, nervousness, dizziness;

problems with contact lenses;

freckles or darkening of facial skin, loss of scalp hair; or

vaginal itching or discharge.

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 Cyclafem 7/7/7 (ethinyl estradiol and norethindrone)?

Some drugs can make ethinyl estradiol and norethindrone less effective, which may result in pregnancy. Before using ethinyl estradiol and norethindrone, tell your doctor if you are using any of the following drugs:

acetaminophen (Tylenol) or ascorbic acid (vitamin C);

bosentan (Tracleer);

prednisolone (Orapred);

St. John's wort;

theophylline (Elixophyllin, Theo-24, Uniphyl);

an antibiotic;

HIV or AIDS medications;

phenobarbital (Solfoton) and other barbiturates; or

seizure medication.

This list is not complete and other drugs may interact with birth control pills. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Cyclafem 7/7/7 resources Cyclafem 7/7/7 Side Effects (in more detail) Cyclafem 7/7/7 Use in Pregnancy & Breastfeeding Cyclafem 7/7/7 Drug Interactions 0 Reviews for Cyclafem 7/7/7 - Add your own review/rating Aranelle Prescribing Information (FDA) Balziva Prescribing Information (FDA) Brevicon Prescribing Information (FDA) Briellyn Prescribing Information (FDA) Cyclafem 1/35 Prescribing Information (FDA) Cyclafem 7/7/7 Prescribing Information (FDA) Estrostep Fe Prescribing Information (FDA) Femcon FE Prescribing Information (FDA) Femcon Fe Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer) Femhrt Consumer Overview Femhrt Prescribing Information (FDA) Femhrt MedFacts Consumer Leaflet (Wolters Kluwer) Jevantique Prescribing Information (FDA) Jinteli Prescribing Information (FDA) Leena Prescribing Information (FDA) Lo Loestrin Fe MedFacts Consumer Leaflet (Wolters Kluwer) Lo Loestrin Fe Consumer Overview Lo Loestrin Fe Advanced Consumer (Micromedex) - Includes Dosage Information Lo Loestrin Fe Prescribing Information (FDA) Loestrin 24 FE Prescribing Information (FDA) Loestrin 24 Fe Consumer Overview Loestrin Fe 1/20 MedFacts Consumer Leaflet (Wolters Kluwer) Ovcon 35 MedFacts Consumer Leaflet (Wolters Kluwer) Tilia FE Prescribing Information (FDA) Tri-Norinyl Prescribing Information (FDA) Zenchent FE Prescribing Information (FDA) Zeosa Prescribing Information (FDA) Compare Cyclafem 7/7/7 with other medications Abnormal Uterine Bleeding Acne Birth Control Endometriosis Gonadotropin Inhibition Menstrual Disorders Polycystic Ovary Syndrome Where can I get more information? Your pharmacist can provide more information about ethinyl estradiol and norethindrone.

See also: Cyclafem 7/7/7 side effects (in more detail)


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Loestrin 24 Fe


Generic Name: ethinyl estradiol and norethindrone (ETH in il ess tra DYE ole and nor ETH in drone)
Brand Names: Aranelle, Balziva, Brevicon, Briellyn, Cyclafem 1/35, Cyclafem 7/7/7, Estrostep Fe, Femcon FE, Generess Fe, Gildess FE 1.5/0.03, Gildess FE 1/0.2, Junel 1.5/30, Junel 1/20, Junel Fe 1.5/30, Junel Fe 1/20, Leena, Lo Loestrin Fe, Loestrin 21 1.5/30, Loestrin 21 1/20, Loestrin 24 Fe, Loestrin Fe 1.5/30, Loestrin Fe 1/20, Microgestin 1.5/30, Microgestin 1/20, Microgestin FE 1.5/30, Microgestin FE 1/20, Modicon, Necon 0.5/35, Necon 1/35, Necon 10/11, Necon 7/7/7, Norinyl 1+35, Nortrel 0.5/35, Nortrel 1/35, Nortrel 7/7/7, Ortho-Novum 1/35, Ortho-Novum 7/7/7, Ovcon 35, Ovcon 35 Fe, Ovcon 50, Tilia Fe, Tri-Legest Fe, Tri-Norinyl, Zenchent Fe, Zeosa

What is ethinyl estradiol and norethindrone?

Ethinyl estradiol and norethindrone contains a combination of female hormones that prevent ovulation (the release of an egg from an ovary). This medication also causes changes in your cervical mucus and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.

Ethinyl estradiol and norethindrone are used as contraception to prevent pregnancy. It is also used to treat severe acne.

Ethinyl estradiol and norethindrone may also be used for purposes not listed in this medication guide.

What is the most important information I should know about ethinyl estradiol and norethindrone? Do not use birth control pills if you are pregnant or if you have recently had a baby. Do not use this medication if you have any of the following conditions: a history of stroke or blood clot, circulation problems, a hormone-related cancer such as breast or uterine cancer, abnormal vaginal bleeding, liver disease or liver cancer, or a history of jaundice caused by birth control pills.

You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medication. Follow your doctor's instructions.

Taking hormones can increase your risk of blood clots, stroke, or heart attack, especially if you smoke and are older than 35.

Some drugs can make birth control pills less effective, which may result in pregnancy. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

What should I discuss with my healthcare provider before taking ethinyl estradiol and norethindrone? This medication can cause birth defects. Do not use if you are pregnant. Tell your doctor right away if you become pregnant, or if you miss two menstrual periods in a row. If you have recently had a baby, wait at least 4 weeks before taking birth control pills (6 weeks if you are breast-feeding). You should not take birth control pills if you have:

coronary artery disease, a severe or uncontrolled heart valve disorder, untreated or uncontrolled high blood pressure;

a history of a stroke, blood clot, or circulation problems;

a hormone-related cancer such as breast or uterine cancer;

unusual vaginal bleeding that has not been checked by a doctor;

liver disease or liver cancer;

severe migraine headaches; or

a history of jaundice caused by pregnancy or birth control pills.

To make sure you can safely take this medication, tell your doctor if you have any of these other conditions:

high blood pressure or a history of heart disease;

high cholesterol, gallbladder disease, or diabetes;

migraine headaches or a history of depression; or

a history of breast cancer or an abnormal mammogram.

The hormones in birth control pills can pass into breast milk and may harm a nursing baby. This medication may also slow breast milk production. Do not use if you are breast-feeding a baby. How should I take ethinyl estradiol and norethindrone?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Take your first pill on the first day of your period or on the first Sunday after your period begins (follow your doctor's instructions).

You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medication. Follow your doctor's instructions.

The 28-day birth control pack contains seven "reminder" pills to keep you on your regular cycle. Your period will usually begin while you are using these reminder pills.

You may have breakthrough bleeding, especially during the first 3 months. Tell your doctor if this bleeding continues or is very heavy.

Take one pill every day, no more than 24 hours apart. When the pills run out, start a new pack the following day. You may get pregnant if you do not use this medication regularly. Get your prescription refilled before you run out of pills completely.

The chewable tablet may be chewed or swallowed whole. If chewed, drink a full glass of water just after you swallow the pill.

If you need surgery or medical tests or if you will be on bed rest, you may need to stop using this medication for a short time. Any doctor or surgeon who treats you should know that you are using birth control pills.

Your doctor will need to check your progress on a regular basis. Do not miss any scheduled appointments.

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

Missing a pill increases your risk of becoming pregnant. If you miss one "active" pill, take two pills on the day that you remember. Then take one pill per day for the rest of the pack.

If you miss two "active" pills in a row in week one or two, take two pills per day for two days in a row. Then take one pill per day for the rest of the pack. Use back-up birth control for at least 7 days following the missed pills.

If you miss two "active" pills in a row in week three, or if you miss three pills in a row during any of the first 3 weeks, throw out the rest of the pack and start a new one the same day if you are a Day 1 starter. If you are a Sunday starter, keep taking a pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new one that day.

If you miss two or more pills, you may not have a period during the month. If you miss a period for two months in a row, call your doctor because you might be pregnant.

If you miss any reminder pills, throw them away and keep taking one pill per day until the pack is empty. You do not need back-up birth control if you miss a reminder pill.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include nausea, vomiting, and vaginal bleeding. What should I avoid while taking ethinyl estradiol and norethindrone? Do not smoke while using birth control pills, especially if you are older than 35. Smoking can increase your risk of blood clots, stroke, or heart attack caused by birth control pills.

Birth control pills will not protect you from sexually transmitted diseases--including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.

Ethinyl estradiol and norethindrone 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 this medication and call your doctor at once if you have any of these serious side effects:

sudden numbness or weakness, especially on one side of the body;

sudden severe headache, confusion, problems with vision, speech, or balance;

sudden cough, wheezing, rapid breathing, coughing up blood;

pain, swelling, warmth, or redness in one or both legs;

chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

a change in the pattern or severity of migraine headaches;

pain in your upper stomach, jaundice (yellowing of the skin or eyes);

a lump in your breast;

swelling in your hands, ankles, or feet; or

symptoms of depression (sleep problems, weakness, mood changes).

Less serious side effects may include:

mild nausea or vomiting, appetite or weight changes;

breast swelling or tenderness;

headache, nervousness, dizziness;

problems with contact lenses;

freckles or darkening of facial skin, loss of scalp hair; or

vaginal itching or discharge.

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 ethinyl estradiol and norethindrone?

Some drugs can make ethinyl estradiol and norethindrone less effective, which may result in pregnancy. Before using ethinyl estradiol and norethindrone, tell your doctor if you are using any of the following drugs:

acetaminophen (Tylenol) or ascorbic acid (vitamin C);

bosentan (Tracleer);

prednisolone (Orapred);

St. John's wort;

theophylline (Elixophyllin, Theo-24, Uniphyl);

an antibiotic;

HIV or AIDS medications;

phenobarbital (Solfoton) and other barbiturates; or

seizure medication.

This list is not complete and other drugs may interact with birth control pills. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Loestrin 24 Fe resources Loestrin 24 Fe Side Effects (in more detail)Loestrin 24 Fe Use in Pregnancy & BreastfeedingDrug ImagesLoestrin 24 Fe Drug InteractionsLoestrin 24 Fe Support Group426 Reviews for Loestrin 24 Fe - Add your own review/rating Loestrin 24 Fe Consumer Overview Aranelle Prescribing Information (FDA) Balziva Prescribing Information (FDA) Brevicon Prescribing Information (FDA) Briellyn Prescribing Information (FDA) Cyclafem 1/35 Prescribing Information (FDA) Cyclafem 7/7/7 Prescribing Information (FDA) Estrostep Fe Prescribing Information (FDA) Femcon FE Prescribing Information (FDA) Femcon Fe Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer) Femhrt Consumer Overview Femhrt Prescribing Information (FDA) Femhrt MedFacts Consumer Leaflet (Wolters Kluwer) Jevantique Prescribing Information (FDA) Jinteli Prescribing Information (FDA) Leena Prescribing Information (FDA) Lo Loestrin Fe Consumer Overview Lo Loestrin Fe Advanced Consumer (Micromedex) - Includes Dosage Information Lo Loestrin Fe Prescribing Information (FDA) Lo Loestrin Fe MedFacts Consumer Leaflet (Wolters Kluwer) Loestrin 24 FE Prescribing Information (FDA) Loestrin Fe 1/20 MedFacts Consumer Leaflet (Wolters Kluwer) Ovcon 35 MedFacts Consumer Leaflet (Wolters Kluwer) Tilia FE Prescribing Information (FDA) Tri-Norinyl Prescribing Information (FDA) Zenchent FE Prescribing Information (FDA) Zeosa Prescribing Information (FDA) Compare Loestrin 24 Fe with other medications Abnormal Uterine BleedingAcneBirth ControlEndometriosisGonadotropin InhibitionMenstrual DisordersPolycystic Ovary SyndromePostmenopausal SymptomsPrevention of Osteoporosis Where can I get more information? Your pharmacist can provide more information about ethinyl estradiol and norethindrone.

See also: Loestrin 24 Fe side effects (in more detail)


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Gildess FE 1.5/0.03


Generic Name: ethinyl estradiol and norethindrone (ETH in il ess tra DYE ole and nor ETH in drone)
Brand Names: Aranelle, Balziva, Brevicon, Briellyn, Cyclafem 1/35, Cyclafem 7/7/7, Estrostep Fe, Femcon FE, Generess Fe, Gildess FE 1.5/0.03, Gildess FE 1/0.2, Junel 1.5/30, Junel 1/20, Junel Fe 1.5/30, Junel Fe 1/20, Leena, Lo Loestrin Fe, Loestrin 21 1.5/30, Loestrin 21 1/20, Loestrin 24 Fe, Loestrin Fe 1.5/30, Loestrin Fe 1/20, Microgestin 1.5/30, Microgestin 1/20, Microgestin FE 1.5/30, Microgestin FE 1/20, Modicon, Necon 0.5/35, Necon 1/35, Necon 10/11, Necon 7/7/7, Norinyl 1+35, Nortrel 0.5/35, Nortrel 1/35, Nortrel 7/7/7, Ortho-Novum 1/35, Ortho-Novum 7/7/7, Ovcon 35, Ovcon 35 Fe, Ovcon 50, Tilia Fe, Tri-Legest Fe, Tri-Norinyl, Zenchent Fe, Zeosa

What is Gildess FE 1.5/0.03 (ethinyl estradiol and norethindrone)?

Ethinyl estradiol and norethindrone contains a combination of female hormones that prevent ovulation (the release of an egg from an ovary). This medication also causes changes in your cervical mucus and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.

Ethinyl estradiol and norethindrone are used as contraception to prevent pregnancy. It is also used to treat severe acne.

Ethinyl estradiol and norethindrone may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Gildess FE 1.5/0.03 (ethinyl estradiol and norethindrone)? Do not use birth control pills if you are pregnant or if you have recently had a baby. Do not use this medication if you have any of the following conditions: a history of stroke or blood clot, circulation problems, a hormone-related cancer such as breast or uterine cancer, abnormal vaginal bleeding, liver disease or liver cancer, or a history of jaundice caused by birth control pills.

You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medication. Follow your doctor's instructions.

Taking hormones can increase your risk of blood clots, stroke, or heart attack, especially if you smoke and are older than 35.

Some drugs can make birth control pills less effective, which may result in pregnancy. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

What should I discuss with my healthcare provider before taking Gildess FE 1.5/0.03 (ethinyl estradiol and norethindrone)? This medication can cause birth defects. Do not use if you are pregnant. Tell your doctor right away if you become pregnant, or if you miss two menstrual periods in a row. If you have recently had a baby, wait at least 4 weeks before taking birth control pills (6 weeks if you are breast-feeding). You should not take birth control pills if you have:

coronary artery disease, a severe or uncontrolled heart valve disorder, untreated or uncontrolled high blood pressure;

a history of a stroke, blood clot, or circulation problems;

a hormone-related cancer such as breast or uterine cancer;

unusual vaginal bleeding that has not been checked by a doctor;

liver disease or liver cancer;

severe migraine headaches; or

a history of jaundice caused by pregnancy or birth control pills.

To make sure you can safely take this medication, tell your doctor if you have any of these other conditions:

high blood pressure or a history of heart disease;

high cholesterol, gallbladder disease, or diabetes;

migraine headaches or a history of depression; or

a history of breast cancer or an abnormal mammogram.

The hormones in birth control pills can pass into breast milk and may harm a nursing baby. This medication may also slow breast milk production. Do not use if you are breast-feeding a baby. How should I take Gildess FE 1.5/0.03 (ethinyl estradiol and norethindrone)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Take your first pill on the first day of your period or on the first Sunday after your period begins (follow your doctor's instructions).

You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medication. Follow your doctor's instructions.

The 28-day birth control pack contains seven "reminder" pills to keep you on your regular cycle. Your period will usually begin while you are using these reminder pills.

You may have breakthrough bleeding, especially during the first 3 months. Tell your doctor if this bleeding continues or is very heavy.

Take one pill every day, no more than 24 hours apart. When the pills run out, start a new pack the following day. You may get pregnant if you do not use this medication regularly. Get your prescription refilled before you run out of pills completely.

The chewable tablet may be chewed or swallowed whole. If chewed, drink a full glass of water just after you swallow the pill.

If you need surgery or medical tests or if you will be on bed rest, you may need to stop using this medication for a short time. Any doctor or surgeon who treats you should know that you are using birth control pills.

Your doctor will need to check your progress on a regular basis. Do not miss any scheduled appointments.

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

Missing a pill increases your risk of becoming pregnant. If you miss one "active" pill, take two pills on the day that you remember. Then take one pill per day for the rest of the pack.

If you miss two "active" pills in a row in week one or two, take two pills per day for two days in a row. Then take one pill per day for the rest of the pack. Use back-up birth control for at least 7 days following the missed pills.

If you miss two "active" pills in a row in week three, or if you miss three pills in a row during any of the first 3 weeks, throw out the rest of the pack and start a new one the same day if you are a Day 1 starter. If you are a Sunday starter, keep taking a pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new one that day.

If you miss two or more pills, you may not have a period during the month. If you miss a period for two months in a row, call your doctor because you might be pregnant.

If you miss any reminder pills, throw them away and keep taking one pill per day until the pack is empty. You do not need back-up birth control if you miss a reminder pill.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include nausea, vomiting, and vaginal bleeding. What should I avoid while taking Gildess FE 1.5/0.03 (ethinyl estradiol and norethindrone)? Do not smoke while using birth control pills, especially if you are older than 35. Smoking can increase your risk of blood clots, stroke, or heart attack caused by birth control pills.

Birth control pills will not protect you from sexually transmitted diseases--including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.

Gildess FE 1.5/0.03 (ethinyl estradiol and norethindrone) 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 this medication and call your doctor at once if you have any of these serious side effects:

sudden numbness or weakness, especially on one side of the body;

sudden severe headache, confusion, problems with vision, speech, or balance;

sudden cough, wheezing, rapid breathing, coughing up blood;

pain, swelling, warmth, or redness in one or both legs;

chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

a change in the pattern or severity of migraine headaches;

pain in your upper stomach, jaundice (yellowing of the skin or eyes);

a lump in your breast;

swelling in your hands, ankles, or feet; or

symptoms of depression (sleep problems, weakness, mood changes).

Less serious side effects may include:

mild nausea or vomiting, appetite or weight changes;

breast swelling or tenderness;

headache, nervousness, dizziness;

problems with contact lenses;

freckles or darkening of facial skin, loss of scalp hair; or

vaginal itching or discharge.

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 Gildess FE 1.5/0.03 (ethinyl estradiol and norethindrone)?

Some drugs can make ethinyl estradiol and norethindrone less effective, which may result in pregnancy. Before using ethinyl estradiol and norethindrone, tell your doctor if you are using any of the following drugs:

acetaminophen (Tylenol) or ascorbic acid (vitamin C);

bosentan (Tracleer);

prednisolone (Orapred);

St. John's wort;

theophylline (Elixophyllin, Theo-24, Uniphyl);

an antibiotic;

HIV or AIDS medications;

phenobarbital (Solfoton) and other barbiturates; or

seizure medication.

This list is not complete and other drugs may interact with birth control pills. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Gildess FE 1.5/0.03 resources Gildess FE 1.5/0.03 Side Effects (in more detail) Gildess FE 1.5/0.03 Use in Pregnancy & Breastfeeding Gildess FE 1.5/0.03 Drug Interactions 1 Review for Gildess FE.5/0.03 - Add your own review/rating Aranelle Prescribing Information (FDA) Balziva Prescribing Information (FDA) Brevicon Prescribing Information (FDA) Briellyn Prescribing Information (FDA) Cyclafem 1/35 Prescribing Information (FDA) Cyclafem 7/7/7 Prescribing Information (FDA) Estrostep Fe Prescribing Information (FDA) Femcon FE Prescribing Information (FDA) Femcon Fe Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer) Femhrt Consumer Overview Femhrt Prescribing Information (FDA) Femhrt MedFacts Consumer Leaflet (Wolters Kluwer) Jevantique Prescribing Information (FDA) Jinteli Prescribing Information (FDA) Leena Prescribing Information (FDA) Lo Loestrin Fe MedFacts Consumer Leaflet (Wolters Kluwer) Lo Loestrin Fe Consumer Overview Lo Loestrin Fe Advanced Consumer (Micromedex) - Includes Dosage Information Lo Loestrin Fe Prescribing Information (FDA) Loestrin 24 FE Prescribing Information (FDA) Loestrin 24 Fe Consumer Overview Loestrin Fe 1/20 MedFacts Consumer Leaflet (Wolters Kluwer) Ovcon 35 MedFacts Consumer Leaflet (Wolters Kluwer) Tilia FE Prescribing Information (FDA) Tri-Norinyl Prescribing Information (FDA) Zenchent FE Prescribing Information (FDA) Zeosa Prescribing Information (FDA) Compare Gildess FE 1.5/0.03 with other medications Abnormal Uterine Bleeding Acne Birth Control Endometriosis Gonadotropin Inhibition Menstrual Disorders Polycystic Ovary Syndrome Postmenopausal Symptoms Where can I get more information? Your pharmacist can provide more information about ethinyl estradiol and norethindrone.

See also: Gildess FE.5/0.03 side effects (in more detail)


read more / Download


Zenchent Fe


Generic Name: ethinyl estradiol and norethindrone (ETH in il ess tra DYE ole and nor ETH in drone)
Brand Names: Aranelle, Balziva, Brevicon, Briellyn, Cyclafem 1/35, Cyclafem 7/7/7, Estrostep Fe, Femcon FE, Generess Fe, Gildess FE 1.5/0.03, Gildess FE 1/0.2, Junel 1.5/30, Junel 1/20, Junel Fe 1.5/30, Junel Fe 1/20, Leena, Lo Loestrin Fe, Loestrin 21 1.5/30, Loestrin 21 1/20, Loestrin 24 Fe, Loestrin Fe 1.5/30, Loestrin Fe 1/20, Microgestin 1.5/30, Microgestin 1/20, Microgestin FE 1.5/30, Microgestin FE 1/20, Modicon, Necon 0.5/35, Necon 1/35, Necon 10/11, Necon 7/7/7, Norinyl 1+35, Nortrel 0.5/35, Nortrel 1/35, Nortrel 7/7/7, Ortho-Novum 1/35, Ortho-Novum 7/7/7, Ovcon 35, Ovcon 35 Fe, Ovcon 50, Tilia Fe, Tri-Legest Fe, Tri-Norinyl, Zenchent Fe, Zeosa

What is Zenchent Fe (ethinyl estradiol and norethindrone)?

Ethinyl estradiol and norethindrone contains a combination of female hormones that prevent ovulation (the release of an egg from an ovary). This medication also causes changes in your cervical mucus and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.

Ethinyl estradiol and norethindrone are used as contraception to prevent pregnancy. It is also used to treat severe acne.

Ethinyl estradiol and norethindrone may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Zenchent Fe (ethinyl estradiol and norethindrone)? Do not use birth control pills if you are pregnant or if you have recently had a baby. Do not use this medication if you have any of the following conditions: a history of stroke or blood clot, circulation problems, a hormone-related cancer such as breast or uterine cancer, abnormal vaginal bleeding, liver disease or liver cancer, or a history of jaundice caused by birth control pills.

You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medication. Follow your doctor's instructions.

Taking hormones can increase your risk of blood clots, stroke, or heart attack, especially if you smoke and are older than 35.

Some drugs can make birth control pills less effective, which may result in pregnancy. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

What should I discuss with my healthcare provider before taking Zenchent Fe (ethinyl estradiol and norethindrone)? This medication can cause birth defects. Do not use if you are pregnant. Tell your doctor right away if you become pregnant, or if you miss two menstrual periods in a row. If you have recently had a baby, wait at least 4 weeks before taking birth control pills (6 weeks if you are breast-feeding). You should not take birth control pills if you have:

coronary artery disease, a severe or uncontrolled heart valve disorder, untreated or uncontrolled high blood pressure;

a history of a stroke, blood clot, or circulation problems;

a hormone-related cancer such as breast or uterine cancer;

unusual vaginal bleeding that has not been checked by a doctor;

liver disease or liver cancer;

severe migraine headaches; or

a history of jaundice caused by pregnancy or birth control pills.

To make sure you can safely take this medication, tell your doctor if you have any of these other conditions:

high blood pressure or a history of heart disease;

high cholesterol, gallbladder disease, or diabetes;

migraine headaches or a history of depression; or

a history of breast cancer or an abnormal mammogram.

The hormones in birth control pills can pass into breast milk and may harm a nursing baby. This medication may also slow breast milk production. Do not use if you are breast-feeding a baby. How should I take Zenchent Fe (ethinyl estradiol and norethindrone)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Take your first pill on the first day of your period or on the first Sunday after your period begins (follow your doctor's instructions).

You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medication. Follow your doctor's instructions.

The 28-day birth control pack contains seven "reminder" pills to keep you on your regular cycle. Your period will usually begin while you are using these reminder pills.

You may have breakthrough bleeding, especially during the first 3 months. Tell your doctor if this bleeding continues or is very heavy.

Take one pill every day, no more than 24 hours apart. When the pills run out, start a new pack the following day. You may get pregnant if you do not use this medication regularly. Get your prescription refilled before you run out of pills completely.

The chewable tablet may be chewed or swallowed whole. If chewed, drink a full glass of water just after you swallow the pill.

If you need surgery or medical tests or if you will be on bed rest, you may need to stop using this medication for a short time. Any doctor or surgeon who treats you should know that you are using birth control pills.

Your doctor will need to check your progress on a regular basis. Do not miss any scheduled appointments.

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

Missing a pill increases your risk of becoming pregnant. If you miss one "active" pill, take two pills on the day that you remember. Then take one pill per day for the rest of the pack.

If you miss two "active" pills in a row in week one or two, take two pills per day for two days in a row. Then take one pill per day for the rest of the pack. Use back-up birth control for at least 7 days following the missed pills.

If you miss two "active" pills in a row in week three, or if you miss three pills in a row during any of the first 3 weeks, throw out the rest of the pack and start a new one the same day if you are a Day 1 starter. If you are a Sunday starter, keep taking a pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new one that day.

If you miss two or more pills, you may not have a period during the month. If you miss a period for two months in a row, call your doctor because you might be pregnant.

If you miss any reminder pills, throw them away and keep taking one pill per day until the pack is empty. You do not need back-up birth control if you miss a reminder pill.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include nausea, vomiting, and vaginal bleeding. What should I avoid while taking Zenchent Fe (ethinyl estradiol and norethindrone)? Do not smoke while using birth control pills, especially if you are older than 35. Smoking can increase your risk of blood clots, stroke, or heart attack caused by birth control pills.

Birth control pills will not protect you from sexually transmitted diseases--including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.

Zenchent Fe (ethinyl estradiol and norethindrone) 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 this medication and call your doctor at once if you have any of these serious side effects:

sudden numbness or weakness, especially on one side of the body;

sudden severe headache, confusion, problems with vision, speech, or balance;

sudden cough, wheezing, rapid breathing, coughing up blood;

pain, swelling, warmth, or redness in one or both legs;

chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

a change in the pattern or severity of migraine headaches;

pain in your upper stomach, jaundice (yellowing of the skin or eyes);

a lump in your breast;

swelling in your hands, ankles, or feet; or

symptoms of depression (sleep problems, weakness, mood changes).

Less serious side effects may include:

mild nausea or vomiting, appetite or weight changes;

breast swelling or tenderness;

headache, nervousness, dizziness;

problems with contact lenses;

freckles or darkening of facial skin, loss of scalp hair; or

vaginal itching or discharge.

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 Zenchent Fe (ethinyl estradiol and norethindrone)?

Some drugs can make ethinyl estradiol and norethindrone less effective, which may result in pregnancy. Before using ethinyl estradiol and norethindrone, tell your doctor if you are using any of the following drugs:

acetaminophen (Tylenol) or ascorbic acid (vitamin C);

bosentan (Tracleer);

prednisolone (Orapred);

St. John's wort;

theophylline (Elixophyllin, Theo-24, Uniphyl);

an antibiotic;

HIV or AIDS medications;

phenobarbital (Solfoton) and other barbiturates; or

seizure medication.

This list is not complete and other drugs may interact with birth control pills. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Zenchent Fe resources Zenchent Fe Side Effects (in more detail) Zenchent Fe Use in Pregnancy & Breastfeeding Zenchent Fe Drug Interactions 0 Reviews for Zenchent Fe - Add your own review/rating Aranelle Prescribing Information (FDA) Balziva Prescribing Information (FDA) Brevicon Prescribing Information (FDA) Briellyn Prescribing Information (FDA) Cyclafem 1/35 Prescribing Information (FDA) Cyclafem 7/7/7 Prescribing Information (FDA) Estrostep Fe Prescribing Information (FDA) Femcon FE Prescribing Information (FDA) Femcon Fe Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer) Femhrt Consumer Overview Femhrt Prescribing Information (FDA) Femhrt MedFacts Consumer Leaflet (Wolters Kluwer) Jevantique Prescribing Information (FDA) Jinteli Prescribing Information (FDA) Leena Prescribing Information (FDA) Lo Loestrin Fe MedFacts Consumer Leaflet (Wolters Kluwer) Lo Loestrin Fe Consumer Overview Lo Loestrin Fe Advanced Consumer (Micromedex) - Includes Dosage Information Lo Loestrin Fe Prescribing Information (FDA) Loestrin 24 FE Prescribing Information (FDA) Loestrin 24 Fe Consumer Overview Loestrin Fe 1/20 MedFacts Consumer Leaflet (Wolters Kluwer) Ovcon 35 MedFacts Consumer Leaflet (Wolters Kluwer) Tilia FE Prescribing Information (FDA) Tri-Norinyl Prescribing Information (FDA) Zenchent FE Prescribing Information (FDA) Zeosa Prescribing Information (FDA) Compare Zenchent Fe with other medications Abnormal Uterine Bleeding Acne Birth Control Endometriosis Gonadotropin Inhibition Menstrual Disorders Polycystic Ovary Syndrome Postmenopausal Symptoms Prevention of Osteoporosis Where can I get more information? Your pharmacist can provide more information about ethinyl estradiol and norethindrone.

See also: Zenchent Fe side effects (in more detail)


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Loestrin Fe 1.5/30


Generic Name: ethinyl estradiol and norethindrone (ETH in il ess tra DYE ole and nor ETH in drone)
Brand Names: Aranelle, Balziva, Brevicon, Briellyn, Cyclafem 1/35, Cyclafem 7/7/7, Estrostep Fe, Femcon FE, Generess Fe, Gildess FE 1.5/0.03, Gildess FE 1/0.2, Junel 1.5/30, Junel 1/20, Junel Fe 1.5/30, Junel Fe 1/20, Leena, Lo Loestrin Fe, Loestrin 21 1.5/30, Loestrin 21 1/20, Loestrin 24 Fe, Loestrin Fe 1.5/30, Loestrin Fe 1/20, Microgestin 1.5/30, Microgestin 1/20, Microgestin FE 1.5/30, Microgestin FE 1/20, Modicon, Necon 0.5/35, Necon 1/35, Necon 10/11, Necon 7/7/7, Norinyl 1+35, Nortrel 0.5/35, Nortrel 1/35, Nortrel 7/7/7, Ortho-Novum 1/35, Ortho-Novum 7/7/7, Ovcon 35, Ovcon 35 Fe, Ovcon 50, Tilia Fe, Tri-Legest Fe, Tri-Norinyl, Zenchent Fe, Zeosa

What is Loestrin Fe 1.5/30 (ethinyl estradiol and norethindrone)?

Ethinyl estradiol and norethindrone contains a combination of female hormones that prevent ovulation (the release of an egg from an ovary). This medication also causes changes in your cervical mucus and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.

Ethinyl estradiol and norethindrone are used as contraception to prevent pregnancy. It is also used to treat severe acne.

Ethinyl estradiol and norethindrone may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Loestrin Fe 1.5/30 (ethinyl estradiol and norethindrone)? Do not use birth control pills if you are pregnant or if you have recently had a baby. Do not use this medication if you have any of the following conditions: a history of stroke or blood clot, circulation problems, a hormone-related cancer such as breast or uterine cancer, abnormal vaginal bleeding, liver disease or liver cancer, or a history of jaundice caused by birth control pills.

You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medication. Follow your doctor's instructions.

Taking hormones can increase your risk of blood clots, stroke, or heart attack, especially if you smoke and are older than 35.

Some drugs can make birth control pills less effective, which may result in pregnancy. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

What should I discuss with my healthcare provider before taking Loestrin Fe 1.5/30 (ethinyl estradiol and norethindrone)? This medication can cause birth defects. Do not use if you are pregnant. Tell your doctor right away if you become pregnant, or if you miss two menstrual periods in a row. If you have recently had a baby, wait at least 4 weeks before taking birth control pills (6 weeks if you are breast-feeding). You should not take birth control pills if you have:

coronary artery disease, a severe or uncontrolled heart valve disorder, untreated or uncontrolled high blood pressure;

a history of a stroke, blood clot, or circulation problems;

a hormone-related cancer such as breast or uterine cancer;

unusual vaginal bleeding that has not been checked by a doctor;

liver disease or liver cancer;

severe migraine headaches; or

a history of jaundice caused by pregnancy or birth control pills.

To make sure you can safely take this medication, tell your doctor if you have any of these other conditions:

high blood pressure or a history of heart disease;

high cholesterol, gallbladder disease, or diabetes;

migraine headaches or a history of depression; or

a history of breast cancer or an abnormal mammogram.

The hormones in birth control pills can pass into breast milk and may harm a nursing baby. This medication may also slow breast milk production. Do not use if you are breast-feeding a baby. How should I take Loestrin Fe 1.5/30 (ethinyl estradiol and norethindrone)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Take your first pill on the first day of your period or on the first Sunday after your period begins (follow your doctor's instructions).

You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medication. Follow your doctor's instructions.

The 28-day birth control pack contains seven "reminder" pills to keep you on your regular cycle. Your period will usually begin while you are using these reminder pills.

You may have breakthrough bleeding, especially during the first 3 months. Tell your doctor if this bleeding continues or is very heavy.

Take one pill every day, no more than 24 hours apart. When the pills run out, start a new pack the following day. You may get pregnant if you do not use this medication regularly. Get your prescription refilled before you run out of pills completely.

The chewable tablet may be chewed or swallowed whole. If chewed, drink a full glass of water just after you swallow the pill.

If you need surgery or medical tests or if you will be on bed rest, you may need to stop using this medication for a short time. Any doctor or surgeon who treats you should know that you are using birth control pills.

Your doctor will need to check your progress on a regular basis. Do not miss any scheduled appointments.

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

Missing a pill increases your risk of becoming pregnant. If you miss one "active" pill, take two pills on the day that you remember. Then take one pill per day for the rest of the pack.

If you miss two "active" pills in a row in week one or two, take two pills per day for two days in a row. Then take one pill per day for the rest of the pack. Use back-up birth control for at least 7 days following the missed pills.

If you miss two "active" pills in a row in week three, or if you miss three pills in a row during any of the first 3 weeks, throw out the rest of the pack and start a new one the same day if you are a Day 1 starter. If you are a Sunday starter, keep taking a pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new one that day.

If you miss two or more pills, you may not have a period during the month. If you miss a period for two months in a row, call your doctor because you might be pregnant.

If you miss any reminder pills, throw them away and keep taking one pill per day until the pack is empty. You do not need back-up birth control if you miss a reminder pill.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include nausea, vomiting, and vaginal bleeding. What should I avoid while taking Loestrin Fe 1.5/30 (ethinyl estradiol and norethindrone)? Do not smoke while using birth control pills, especially if you are older than 35. Smoking can increase your risk of blood clots, stroke, or heart attack caused by birth control pills.

Birth control pills will not protect you from sexually transmitted diseases--including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.

Loestrin Fe 1.5/30 (ethinyl estradiol and norethindrone) 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 this medication and call your doctor at once if you have any of these serious side effects:

sudden numbness or weakness, especially on one side of the body;

sudden severe headache, confusion, problems with vision, speech, or balance;

sudden cough, wheezing, rapid breathing, coughing up blood;

pain, swelling, warmth, or redness in one or both legs;

chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

a change in the pattern or severity of migraine headaches;

pain in your upper stomach, jaundice (yellowing of the skin or eyes);

a lump in your breast;

swelling in your hands, ankles, or feet; or

symptoms of depression (sleep problems, weakness, mood changes).

Less serious side effects may include:

mild nausea or vomiting, appetite or weight changes;

breast swelling or tenderness;

headache, nervousness, dizziness;

problems with contact lenses;

freckles or darkening of facial skin, loss of scalp hair; or

vaginal itching or discharge.

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 Loestrin Fe 1.5/30 (ethinyl estradiol and norethindrone)?

Some drugs can make ethinyl estradiol and norethindrone less effective, which may result in pregnancy. Before using ethinyl estradiol and norethindrone, tell your doctor if you are using any of the following drugs:

acetaminophen (Tylenol) or ascorbic acid (vitamin C);

bosentan (Tracleer);

prednisolone (Orapred);

St. John's wort;

theophylline (Elixophyllin, Theo-24, Uniphyl);

an antibiotic;

HIV or AIDS medications;

phenobarbital (Solfoton) and other barbiturates; or

seizure medication.

This list is not complete and other drugs may interact with birth control pills. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Loestrin Fe 1.5/30 resources Loestrin Fe 1.5/30 Side Effects (in more detail) Loestrin Fe 1.5/30 Use in Pregnancy & Breastfeeding Loestrin Fe 1.5/30 Drug Interactions Loestrin Fe 1.5/30 Support Group 0 Reviews for Loestrin Fe.5/30 - Add your own review/rating Aranelle Prescribing Information (FDA) Balziva Prescribing Information (FDA) Brevicon Prescribing Information (FDA) Briellyn Prescribing Information (FDA) Cyclafem 1/35 Prescribing Information (FDA) Cyclafem 7/7/7 Prescribing Information (FDA) Estrostep Fe Prescribing Information (FDA) Femcon FE Prescribing Information (FDA) Femcon Fe Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer) Femhrt Consumer Overview Femhrt Prescribing Information (FDA) Femhrt MedFacts Consumer Leaflet (Wolters Kluwer) Jevantique Prescribing Information (FDA) Jinteli Prescribing Information (FDA) Leena Prescribing Information (FDA) Lo Loestrin Fe MedFacts Consumer Leaflet (Wolters Kluwer) Lo Loestrin Fe Consumer Overview Lo Loestrin Fe Advanced Consumer (Micromedex) - Includes Dosage Information Lo Loestrin Fe Prescribing Information (FDA) Loestrin 24 FE Prescribing Information (FDA) Loestrin 24 Fe Consumer Overview Loestrin Fe 1/20 MedFacts Consumer Leaflet (Wolters Kluwer) Ovcon 35 MedFacts Consumer Leaflet (Wolters Kluwer) Tilia FE Prescribing Information (FDA) Tri-Norinyl Prescribing Information (FDA) Zenchent FE Prescribing Information (FDA) Zeosa Prescribing Information (FDA) Compare Loestrin Fe 1.5/30 with other medications Abnormal Uterine Bleeding Acne Birth Control Endometriosis Gonadotropin Inhibition Menstrual Disorders Polycystic Ovary Syndrome Postmenopausal Symptoms Prevention of Osteoporosis Where can I get more information? Your pharmacist can provide more information about ethinyl estradiol and norethindrone.

See also: Loestrin Fe.5/30 side effects (in more detail)


read more / Download


Microgestin FE 1.5/30


Generic Name: ethinyl estradiol and norethindrone (ETH in il ess tra DYE ole and nor ETH in drone)
Brand Names: Aranelle, Balziva, Brevicon, Briellyn, Cyclafem 1/35, Cyclafem 7/7/7, Estrostep Fe, Femcon FE, Generess Fe, Gildess FE 1.5/0.03, Gildess FE 1/0.2, Junel 1.5/30, Junel 1/20, Junel Fe 1.5/30, Junel Fe 1/20, Leena, Lo Loestrin Fe, Loestrin 21 1.5/30, Loestrin 21 1/20, Loestrin 24 Fe, Loestrin Fe 1.5/30, Loestrin Fe 1/20, Microgestin 1.5/30, Microgestin 1/20, Microgestin FE 1.5/30, Microgestin FE 1/20, Modicon, Necon 0.5/35, Necon 1/35, Necon 10/11, Necon 7/7/7, Norinyl 1+35, Nortrel 0.5/35, Nortrel 1/35, Nortrel 7/7/7, Ortho-Novum 1/35, Ortho-Novum 7/7/7, Ovcon 35, Ovcon 35 Fe, Ovcon 50, Tilia Fe, Tri-Legest Fe, Tri-Norinyl, Zenchent Fe, Zeosa

What is Microgestin FE 1.5/30 (ethinyl estradiol and norethindrone)?

Ethinyl estradiol and norethindrone contains a combination of female hormones that prevent ovulation (the release of an egg from an ovary). This medication also causes changes in your cervical mucus and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.

Ethinyl estradiol and norethindrone are used as contraception to prevent pregnancy. It is also used to treat severe acne.

Ethinyl estradiol and norethindrone may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Microgestin FE 1.5/30 (ethinyl estradiol and norethindrone)? Do not use birth control pills if you are pregnant or if you have recently had a baby. Do not use this medication if you have any of the following conditions: a history of stroke or blood clot, circulation problems, a hormone-related cancer such as breast or uterine cancer, abnormal vaginal bleeding, liver disease or liver cancer, or a history of jaundice caused by birth control pills.

You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medication. Follow your doctor's instructions.

Taking hormones can increase your risk of blood clots, stroke, or heart attack, especially if you smoke and are older than 35.

Some drugs can make birth control pills less effective, which may result in pregnancy. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

What should I discuss with my healthcare provider before taking Microgestin FE 1.5/30 (ethinyl estradiol and norethindrone)? This medication can cause birth defects. Do not use if you are pregnant. Tell your doctor right away if you become pregnant, or if you miss two menstrual periods in a row. If you have recently had a baby, wait at least 4 weeks before taking birth control pills (6 weeks if you are breast-feeding). You should not take birth control pills if you have:

coronary artery disease, a severe or uncontrolled heart valve disorder, untreated or uncontrolled high blood pressure;

a history of a stroke, blood clot, or circulation problems;

a hormone-related cancer such as breast or uterine cancer;

unusual vaginal bleeding that has not been checked by a doctor;

liver disease or liver cancer;

severe migraine headaches; or

a history of jaundice caused by pregnancy or birth control pills.

To make sure you can safely take this medication, tell your doctor if you have any of these other conditions:

high blood pressure or a history of heart disease;

high cholesterol, gallbladder disease, or diabetes;

migraine headaches or a history of depression; or

a history of breast cancer or an abnormal mammogram.

The hormones in birth control pills can pass into breast milk and may harm a nursing baby. This medication may also slow breast milk production. Do not use if you are breast-feeding a baby. How should I take Microgestin FE 1.5/30 (ethinyl estradiol and norethindrone)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Take your first pill on the first day of your period or on the first Sunday after your period begins (follow your doctor's instructions).

You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medication. Follow your doctor's instructions.

The 28-day birth control pack contains seven "reminder" pills to keep you on your regular cycle. Your period will usually begin while you are using these reminder pills.

You may have breakthrough bleeding, especially during the first 3 months. Tell your doctor if this bleeding continues or is very heavy.

Take one pill every day, no more than 24 hours apart. When the pills run out, start a new pack the following day. You may get pregnant if you do not use this medication regularly. Get your prescription refilled before you run out of pills completely.

The chewable tablet may be chewed or swallowed whole. If chewed, drink a full glass of water just after you swallow the pill.

If you need surgery or medical tests or if you will be on bed rest, you may need to stop using this medication for a short time. Any doctor or surgeon who treats you should know that you are using birth control pills.

Your doctor will need to check your progress on a regular basis. Do not miss any scheduled appointments.

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

Missing a pill increases your risk of becoming pregnant. If you miss one "active" pill, take two pills on the day that you remember. Then take one pill per day for the rest of the pack.

If you miss two "active" pills in a row in week one or two, take two pills per day for two days in a row. Then take one pill per day for the rest of the pack. Use back-up birth control for at least 7 days following the missed pills.

If you miss two "active" pills in a row in week three, or if you miss three pills in a row during any of the first 3 weeks, throw out the rest of the pack and start a new one the same day if you are a Day 1 starter. If you are a Sunday starter, keep taking a pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new one that day.

If you miss two or more pills, you may not have a period during the month. If you miss a period for two months in a row, call your doctor because you might be pregnant.

If you miss any reminder pills, throw them away and keep taking one pill per day until the pack is empty. You do not need back-up birth control if you miss a reminder pill.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include nausea, vomiting, and vaginal bleeding. What should I avoid while taking Microgestin FE 1.5/30 (ethinyl estradiol and norethindrone)? Do not smoke while using birth control pills, especially if you are older than 35. Smoking can increase your risk of blood clots, stroke, or heart attack caused by birth control pills.

Birth control pills will not protect you from sexually transmitted diseases--including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.

Microgestin FE 1.5/30 (ethinyl estradiol and norethindrone) 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 this medication and call your doctor at once if you have any of these serious side effects:

sudden numbness or weakness, especially on one side of the body;

sudden severe headache, confusion, problems with vision, speech, or balance;

sudden cough, wheezing, rapid breathing, coughing up blood;

pain, swelling, warmth, or redness in one or both legs;

chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

a change in the pattern or severity of migraine headaches;

pain in your upper stomach, jaundice (yellowing of the skin or eyes);

a lump in your breast;

swelling in your hands, ankles, or feet; or

symptoms of depression (sleep problems, weakness, mood changes).

Less serious side effects may include:

mild nausea or vomiting, appetite or weight changes;

breast swelling or tenderness;

headache, nervousness, dizziness;

problems with contact lenses;

freckles or darkening of facial skin, loss of scalp hair; or

vaginal itching or discharge.

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 Microgestin FE 1.5/30 (ethinyl estradiol and norethindrone)?

Some drugs can make ethinyl estradiol and norethindrone less effective, which may result in pregnancy. Before using ethinyl estradiol and norethindrone, tell your doctor if you are using any of the following drugs:

acetaminophen (Tylenol) or ascorbic acid (vitamin C);

bosentan (Tracleer);

prednisolone (Orapred);

St. John's wort;

theophylline (Elixophyllin, Theo-24, Uniphyl);

an antibiotic;

HIV or AIDS medications;

phenobarbital (Solfoton) and other barbiturates; or

seizure medication.

This list is not complete and other drugs may interact with birth control pills. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Microgestin FE 1.5/30 resources Microgestin FE 1.5/30 Side Effects (in more detail) Microgestin FE 1.5/30 Use in Pregnancy & Breastfeeding Drug Images Microgestin FE 1.5/30 Drug Interactions Microgestin FE 1.5/30 Support Group 3 Reviews for Microgestin FE.5/30 - Add your own review/rating Aranelle Prescribing Information (FDA) Balziva Prescribing Information (FDA) Brevicon Prescribing Information (FDA) Briellyn Prescribing Information (FDA) Cyclafem 1/35 Prescribing Information (FDA) Cyclafem 7/7/7 Prescribing Information (FDA) Estrostep Fe Prescribing Information (FDA) Femcon FE Prescribing Information (FDA) Femcon Fe Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer) Femhrt Consumer Overview Femhrt Prescribing Information (FDA) Femhrt MedFacts Consumer Leaflet (Wolters Kluwer) Jevantique Prescribing Information (FDA) Jinteli Prescribing Information (FDA) Leena Prescribing Information (FDA) Lo Loestrin Fe MedFacts Consumer Leaflet (Wolters Kluwer) Lo Loestrin Fe Consumer Overview Lo Loestrin Fe Advanced Consumer (Micromedex) - Includes Dosage Information Lo Loestrin Fe Prescribing Information (FDA) Loestrin 24 FE Prescribing Information (FDA) Loestrin 24 Fe Consumer Overview Loestrin Fe 1/20 MedFacts Consumer Leaflet (Wolters Kluwer) Ovcon 35 MedFacts Consumer Leaflet (Wolters Kluwer) Tilia FE Prescribing Information (FDA) Tri-Norinyl Prescribing Information (FDA) Zenchent FE Prescribing Information (FDA) Zeosa Prescribing Information (FDA) Compare Microgestin FE 1.5/30 with other medications Abnormal Uterine Bleeding Acne Birth Control Endometriosis Gonadotropin Inhibition Menstrual Disorders Polycystic Ovary Syndrome Postmenopausal Symptoms Prevention of Osteoporosis Where can I get more information? Your pharmacist can provide more information about ethinyl estradiol and norethindrone.

See also: Microgestin FE.5/30 side effects (in more detail)


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Nortrel 0.5/35


Generic Name: ethinyl estradiol and norethindrone (ETH in il ess tra DYE ole and nor ETH in drone)
Brand Names: Aranelle, Balziva, Brevicon, Briellyn, Cyclafem 1/35, Cyclafem 7/7/7, Estrostep Fe, Femcon FE, Generess Fe, Gildess FE 1.5/0.03, Gildess FE 1/0.2, Junel 1.5/30, Junel 1/20, Junel Fe 1.5/30, Junel Fe 1/20, Leena, Lo Loestrin Fe, Loestrin 21 1.5/30, Loestrin 21 1/20, Loestrin 24 Fe, Loestrin Fe 1.5/30, Loestrin Fe 1/20, Microgestin 1.5/30, Microgestin 1/20, Microgestin FE 1.5/30, Microgestin FE 1/20, Modicon, Necon 0.5/35, Necon 1/35, Necon 10/11, Necon 7/7/7, Norinyl 1+35, Nortrel 0.5/35, Nortrel 1/35, Nortrel 7/7/7, Ortho-Novum 1/35, Ortho-Novum 7/7/7, Ovcon 35, Ovcon 35 Fe, Ovcon 50, Tilia Fe, Tri-Legest Fe, Tri-Norinyl, Zenchent Fe, Zeosa

What is Nortrel 0.5/35 (ethinyl estradiol and norethindrone)?

Ethinyl estradiol and norethindrone contains a combination of female hormones that prevent ovulation (the release of an egg from an ovary). This medication also causes changes in your cervical mucus and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.

Ethinyl estradiol and norethindrone are used as contraception to prevent pregnancy. It is also used to treat severe acne.

Ethinyl estradiol and norethindrone may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Nortrel 0.5/35 (ethinyl estradiol and norethindrone)? Do not use birth control pills if you are pregnant or if you have recently had a baby. Do not use this medication if you have any of the following conditions: a history of stroke or blood clot, circulation problems, a hormone-related cancer such as breast or uterine cancer, abnormal vaginal bleeding, liver disease or liver cancer, or a history of jaundice caused by birth control pills.

You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medication. Follow your doctor's instructions.

Taking hormones can increase your risk of blood clots, stroke, or heart attack, especially if you smoke and are older than 35.

Some drugs can make birth control pills less effective, which may result in pregnancy. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

What should I discuss with my healthcare provider before taking Nortrel 0.5/35 (ethinyl estradiol and norethindrone)? This medication can cause birth defects. Do not use if you are pregnant. Tell your doctor right away if you become pregnant, or if you miss two menstrual periods in a row. If you have recently had a baby, wait at least 4 weeks before taking birth control pills (6 weeks if you are breast-feeding). You should not take birth control pills if you have:

coronary artery disease, a severe or uncontrolled heart valve disorder, untreated or uncontrolled high blood pressure;

a history of a stroke, blood clot, or circulation problems;

a hormone-related cancer such as breast or uterine cancer;

unusual vaginal bleeding that has not been checked by a doctor;

liver disease or liver cancer;

severe migraine headaches; or

a history of jaundice caused by pregnancy or birth control pills.

To make sure you can safely take this medication, tell your doctor if you have any of these other conditions:

high blood pressure or a history of heart disease;

high cholesterol, gallbladder disease, or diabetes;

migraine headaches or a history of depression; or

a history of breast cancer or an abnormal mammogram.

The hormones in birth control pills can pass into breast milk and may harm a nursing baby. This medication may also slow breast milk production. Do not use if you are breast-feeding a baby. How should I take Nortrel 0.5/35 (ethinyl estradiol and norethindrone)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Take your first pill on the first day of your period or on the first Sunday after your period begins (follow your doctor's instructions).

You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medication. Follow your doctor's instructions.

The 28-day birth control pack contains seven "reminder" pills to keep you on your regular cycle. Your period will usually begin while you are using these reminder pills.

You may have breakthrough bleeding, especially during the first 3 months. Tell your doctor if this bleeding continues or is very heavy.

Take one pill every day, no more than 24 hours apart. When the pills run out, start a new pack the following day. You may get pregnant if you do not use this medication regularly. Get your prescription refilled before you run out of pills completely.

The chewable tablet may be chewed or swallowed whole. If chewed, drink a full glass of water just after you swallow the pill.

If you need surgery or medical tests or if you will be on bed rest, you may need to stop using this medication for a short time. Any doctor or surgeon who treats you should know that you are using birth control pills.

Your doctor will need to check your progress on a regular basis. Do not miss any scheduled appointments.

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

Missing a pill increases your risk of becoming pregnant. If you miss one "active" pill, take two pills on the day that you remember. Then take one pill per day for the rest of the pack.

If you miss two "active" pills in a row in week one or two, take two pills per day for two days in a row. Then take one pill per day for the rest of the pack. Use back-up birth control for at least 7 days following the missed pills.

If you miss two "active" pills in a row in week three, or if you miss three pills in a row during any of the first 3 weeks, throw out the rest of the pack and start a new one the same day if you are a Day 1 starter. If you are a Sunday starter, keep taking a pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new one that day.

If you miss two or more pills, you may not have a period during the month. If you miss a period for two months in a row, call your doctor because you might be pregnant.

If you miss any reminder pills, throw them away and keep taking one pill per day until the pack is empty. You do not need back-up birth control if you miss a reminder pill.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include nausea, vomiting, and vaginal bleeding. What should I avoid while taking Nortrel 0.5/35 (ethinyl estradiol and norethindrone)? Do not smoke while using birth control pills, especially if you are older than 35. Smoking can increase your risk of blood clots, stroke, or heart attack caused by birth control pills.

Birth control pills will not protect you from sexually transmitted diseases--including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.

Nortrel 0.5/35 (ethinyl estradiol and norethindrone) 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 this medication and call your doctor at once if you have any of these serious side effects:

sudden numbness or weakness, especially on one side of the body;

sudden severe headache, confusion, problems with vision, speech, or balance;

sudden cough, wheezing, rapid breathing, coughing up blood;

pain, swelling, warmth, or redness in one or both legs;

chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

a change in the pattern or severity of migraine headaches;

pain in your upper stomach, jaundice (yellowing of the skin or eyes);

a lump in your breast;

swelling in your hands, ankles, or feet; or

symptoms of depression (sleep problems, weakness, mood changes).

Less serious side effects may include:

mild nausea or vomiting, appetite or weight changes;

breast swelling or tenderness;

headache, nervousness, dizziness;

problems with contact lenses;

freckles or darkening of facial skin, loss of scalp hair; or

vaginal itching or discharge.

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 Nortrel 0.5/35 (ethinyl estradiol and norethindrone)?

Some drugs can make ethinyl estradiol and norethindrone less effective, which may result in pregnancy. Before using ethinyl estradiol and norethindrone, tell your doctor if you are using any of the following drugs:

acetaminophen (Tylenol) or ascorbic acid (vitamin C);

bosentan (Tracleer);

prednisolone (Orapred);

St. John's wort;

theophylline (Elixophyllin, Theo-24, Uniphyl);

an antibiotic;

HIV or AIDS medications;

phenobarbital (Solfoton) and other barbiturates; or

seizure medication.

This list is not complete and other drugs may interact with birth control pills. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Nortrel 0.5/35 resources Nortrel 0.5/35 Side Effects (in more detail) Nortrel 0.5/35 Use in Pregnancy & Breastfeeding Drug Images Nortrel 0.5/35 Drug Interactions Nortrel 0.5/35 Support Group 1 Review for Nortrel 0.5/35 - Add your own review/rating Aranelle Prescribing Information (FDA) Balziva Prescribing Information (FDA) Brevicon Prescribing Information (FDA) Briellyn Prescribing Information (FDA) Cyclafem 1/35 Prescribing Information (FDA) Cyclafem 7/7/7 Prescribing Information (FDA) Estrostep Fe Prescribing Information (FDA) Femcon FE Prescribing Information (FDA) Femcon Fe Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer) Femhrt Consumer Overview Femhrt Prescribing Information (FDA) Femhrt MedFacts Consumer Leaflet (Wolters Kluwer) Jevantique Prescribing Information (FDA) Jinteli Prescribing Information (FDA) Leena Prescribing Information (FDA) Lo Loestrin Fe MedFacts Consumer Leaflet (Wolters Kluwer) Lo Loestrin Fe Consumer Overview Lo Loestrin Fe Advanced Consumer (Micromedex) - Includes Dosage Information Lo Loestrin Fe Prescribing Information (FDA) Loestrin 24 FE Prescribing Information (FDA) Loestrin 24 Fe Consumer Overview Loestrin Fe 1/20 MedFacts Consumer Leaflet (Wolters Kluwer) Ovcon 35 MedFacts Consumer Leaflet (Wolters Kluwer) Tilia FE Prescribing Information (FDA) Tri-Norinyl Prescribing Information (FDA) Zenchent FE Prescribing Information (FDA) Zeosa Prescribing Information (FDA) Compare Nortrel 0.5/35 with other medications Abnormal Uterine Bleeding Acne Birth Control Endometriosis Gonadotropin Inhibition Menstrual Disorders Polycystic Ovary Syndrome Postmenopausal Symptoms Prevention of Osteoporosis Where can I get more information? Your pharmacist can provide more information about ethinyl estradiol and norethindrone.

See also: Nortrel 0.5/35 side effects (in more detail)


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Sotalol


Pronunciation: SOE-ta-lol
Generic Name: Sotalol
Brand Name: Betapace

Because Sotalol may sometimes cause an abnormal or irregular heartbeat, patients who begin taking or restart Sotalol should be observed in a hospital or similar setting in which heart and kidney function monitoring may be performed for at least 3 days after starting Sotalol. Close monitoring of your heart or kidney function may also be needed if your dose is changed. Do not change from one brand or generic version of Sotalol to another without consulting your doctor or pharmacist. Sotalol is labeled specifically for ventricular arrhythmias.


Sotalol is used for:

Treating certain types of irregular heartbeat (ventricular arrhythmias).

Sotalol is an antiarrhythmic medicine. It works by helping the heart beat regularly for a longer period of time.

Do NOT use Sotalol if: you are allergic to any ingredient in Sotalol you have certain types of irregular heartbeat (eg, long QT syndrome, prolonged QT interval), shock caused by serious heart problems, uncontrolled heart failure, low blood potassium or magnesium levels, or certain lung or breathing problems (eg, asthma, chronic bronchitis, emphysema) you have a very slow heartbeat or certain types of irregular heartbeat (sick sinus syndrome, second- or third-degree heart block) and you do not have a permanent pacemaker you are taking certain antiarrhythmics (eg, amiodarone, disopyramide, dofetilide, procainamide, quinidine), bepridil, cisapride, mibefradil, nilotinib, tetrabenazine, a theophylline (eg, aminophylline), a tricyclic antidepressant (eg, amitriptyline), or vardenafil

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

Before using Sotalol:

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

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have breathing or lung problems (eg, chronic obstructive pulmonary disorder [COPD]); an overactive thyroid; kidney problems; diabetes; blood flow problems; a tumor on your adrenal gland; loss of appetite; increased thirst; or severe or persistent diarrhea, sweating, or vomiting if you have a history of other heart problems (eg, heart failure, slow or irregular heartbeat, a recent heart attack), blood electrolyte problems (eg, low blood potassium or magnesium levels), problems with the acid or base levels in your body, or episodes of low blood sugar if you are on dialysis or you are scheduled for surgery

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

Indomethacin because it may decrease Sotalol's effectiveness Calcium channel blockers (eg, diltiazem, verapamil), clonidine, digoxin, diuretics (eg, furosemide, hydrochlorothiazide), guanethidine, mibefradil, or reserpine because the risk of side effects, such as low blood pressure or heart problems, may be increased Antiarrhythmics (eg, dronedarone, propafenone), arsenic, astemizole, bepridil, chloroquine, cisapride, dolasetron, domperidone, droperidol, fingolimod, fluconazole, halofantrine, haloperidol, iloperidone, ketanserin, macrolides and ketolides (eg, erythromycin), maprotiline, mefloquine, methadone, nilotinib, oseltamivir, paliperidone, pentamidine, phenothiazines (eg, chlorpromazine, thioridazine), pimozide, quinolones (eg, ciprofloxacin), romidepsin, saquinavir, terfenadine, tetrabenazine, tricyclic antidepressants (eg, amitriptyline), tyrosine kinase inhibitors (eg, dasatinib), vardenafil, or ziprasidone because the risk of abnormal heart rhythms may be increased Epinephrine, insulin, lidocaine, meglitinide antidiabetics (eg, nateglinide), or quinazolines (eg, prazosin) because the risk of their side effects may be increased by Sotalol Beta-agonists (eg, albuterol) or theophyllines (eg, aminophylline) because their effectiveness may be decreased by Sotalol

This may not be a complete list of all interactions that may occur. Ask your health care provider if Sotalol 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 Sotalol:

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

Take Sotalol by mouth with or without food. Try to take it the same way (either with food or without food) each time you take your dose. Check with your doctor or pharmacist if you have questions about taking Sotalol with food. Do not take an antacid that has aluminum or magnesium in it within 2 hours before or after you take Sotalol. Sotalol works best if it is taken at the same time each day. Taking Sotalol at the same time each day will also help you remember to take it. Continue to use Sotalol even if you feel well. Do not miss any doses. If you miss a dose of Sotalol, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

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

Important safety information: Sotalol may cause dizziness or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Sotalol with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. Sotalol may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects. Do NOT take more than the recommended dose or change your dose without checking with your doctor. Tell your doctor or dentist that you take Sotalol before you receive any medical or dental care, emergency care, or surgery. Do not suddenly stop taking Sotalol. Sharp chest pain, irregular heartbeat, and, sometimes, heart attack may occur if you suddenly stop Sotalol. The risk may be greater if you have certain types of heart disease. Heart disease is common and you may not know you have it. Your doctor should slowly lower your dose over several weeks if you need to stop taking it. Limit physical activity while you are lowering your dose. If new or worsened chest pain or other heart problems occur, contact your doctor right away. You may need to start taking Sotalol again. Diabetes patients - Sotalol may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine. Diabetes patients - Sotalol may hide signs of low blood sugar, such as rapid heartbeat. Be sure to watch for other signs of low blood sugar. Low blood sugar may make you anxious, sweaty, weak, dizzy, drowsy, or faint. It may also make your vision change; give you a headache, chills, or tremors; or make you more hungry. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine. If you have a history of any severe allergic reaction, talk with your doctor. You may be at risk of an even more severe allergic reaction if you come into contact with the substance that caused your allergy. Some medicines used to treat severe allergies may also not work as well while you are taking Sotalol. Sotalol may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Sotalol. Lab tests, including heart and kidney function, and blood pressure monitoring, may be performed while you take Sotalol. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Sotalol while you are pregnant. Sotalol is found in breast milk. Do not breast-feed while taking Sotalol. Possible side effects of Sotalol:

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:

Dizziness; headache; lightheadedness; mild diarrhea or nausea; tiredness; trouble sleeping.

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); abnormally fast, slow, or irregular heartbeat; changes in vision; chest pain; decreased appetite; excessive thirst; fainting; numbness of an arm or leg; severe or persistent tiredness; severe or persistent nausea, vomiting, or diarrhea; severe stomach pain; shortness of breath; sudden leg pain; sudden, severe headache, vomiting, or dizziness; unusual sweating.

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

See also: Sotalol side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include difficulty breathing; dizziness; fainting; fatigue; severe weakness; slow heartbeat.

Proper storage of Sotalol:

Store Sotalol 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 Sotalol out of the reach of children and away from pets.

General information: If you have any questions about Sotalol, please talk with your doctor, pharmacist, or other health care provider. Sotalol 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 Sotalol. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Sotalol resources Sotalol Side Effects (in more detail) Sotalol Use in Pregnancy & Breastfeeding Drug Images Sotalol Drug Interactions Sotalol Support Group 9 Reviews for Sotalol - Add your own review/rating Compare Sotalol with other medications Atrial Fibrillation Atrial Flutter Ventricular Arrhythmia
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Infergen


Pronunciation: IN-ter-FEER-on AL-fa-kon-1
Generic Name: Interferon Alfacon-1
Brand Name: Infergen

Infergen may cause or aggravate fatal or life-threatening autoimmune (eg, lupus), neuropsychiatric (eg, depression), ischemic (eg, heart problems), or infectious disorders. Contact your health care provider if persistent or worsening symptoms of these conditions occur.


Infergen is used for:

Treating long-term hepatitis C virus infection in patients 18 years of age or older. It may also be used for other conditions as determined by your doctor.

Infergen is an interferon. Exactly how interferon alfacon-1 works against the hepatitis C virus is not known. It may directly kill the virus, prevent the virus from reproducing, or alter the body's natural defense against the virus.

Do NOT use Infergen if: you are allergic to any ingredient in Infergen or products taken from Escherichia coli you are pregnant, planning to become pregnant, or are breast-feeding you have autoimmune hepatitis (inflammation of the liver) or severe or worsening liver problems

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

Before using Infergen:

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

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have diabetes, high blood triglycerides, high blood pressure, difficulty sleeping, heart problems (eg, irregular heartbeat, heart muscle problems), liver problems, thyroid problems, eye problems, lung or breathing problems (eg, pulmonary hypertension, chronic obstructive pulmonary disease [COPD]), pneumonia, cancer, bowel problems (eg, colitis), hepatitis B, HIV, kidney problems, or you have never been treated for hepatitis C before if you have a weakened immune system, have received a transplant, or you are taking medicines that weaken the immune system (eg, tacrolimus) if you have a history of low blood cell counts, autoimmune disorders (eg, rheumatoid arthritis, psoriasis, lupus), bleeding problems, blood clots, heart attack, pancreas problems (eg, pancreatitis), mental or mood disorders (eg, anxiety, depression), or a history of suicidal thoughts or behavior if you have a history of alcoholism or substance abuse

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

Telbivudine because the risk of nerve problems (peripheral neuropathy) may be increased

Ask your health care provider if Infergen 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 Infergen:

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

Infergen comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Infergen refilled. If you will be using Infergen at home, a health care provider will teach you how to use it. Be sure you understand how to use Infergen. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions. Do not shake the vial before using. Infergen may be allowed to reach room temperature before it is injected. Do not use Infergen if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged. Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal. If you miss a dose of Infergen, contact your doctor right away. Do not use 2 doses at once.

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

Important safety information: Infergen may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Infergen with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Infergen; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness. Flu-like symptoms (eg, headache, tiredness, fever, rigors, muscle aches, increased sweating, joint pain) are very common with Infergen. While fever may be related to flu-like symptoms, other causes of persistent fever should not be ruled out. Contact your health care provider if fever recurs or does not go away. Infergen may raise your blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away. Patients who take Infergen may be at increased risk of new or worsening mental or mood changes or suicidal thoughts or actions. Watch all patients who take Infergen closely. Contact the doctor at once if new, worsened, or sudden symptoms such as depressed mood; anxious, restless, or irritable behavior; panic attacks; or any unusual change in mood or behavior occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur. Vision exams are recommended before starting Infergen and during therapy, especially in patients with diabetes or high blood pressure. Stop using Infergen and contact your health care provider at once if vision problems (eg, blurred or double vision) occur. Do not change from one brand or generic version of Infergen to another without consulting your pharmacist or doctor. Products manufactured by different companies may not be equally effective. Do not share razors or toothbrushes with other people. Infergen does not prevent the spread of hepatitis C. If you have questions about how to prevent the spread of hepatitis C, ask your doctor or pharmacist. Tell your doctor or dentist that you take Infergen before you receive any medical or dental care, emergency care, or surgery. You should receive an eye exam before using Infergen. If you have an eye disease or are at risk of eye disease (eg, diabetes), you should have periodic eye exams while using Infergen. Men and women should use effective forms of birth control while taking Infergen. Lab tests, including liver and kidney function, serum albumin, complete blood cell counts, blood cholesterol, and eye exams, may be performed while you use Infergen. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments. Use Infergen with caution in the ELDERLY; they may be more sensitive to its effects. Infergen should not be used in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed. PREGNANCY and BREAST-FEEDING: Do not use Infergen if you are pregnant. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. It is not known if Infergen is found in breast milk. Do not breast-feed while taking Infergen. Possible side effects of Infergen:

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:

Diarrhea; dizziness; flu-like symptoms (eg, chills; headache; mild, temporary fever); hair thinning; increased sweating; joint or muscle aches; loss of appetite; mild bruising, itching, lump, redness, or swelling at the injection site; nausea; stomach upset; tiredness; weight loss.

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; unusual hoarseness); abnormal thinking; black, tarry, or bloody stools or diarrhea; chest, jaw, or left arm pain; confusion; dark urine; decreased or increased urination; fainting; fast or irregular heartbeat; high or persistent fever, chills, or sore throat; loss of coordination; new or worsening mental or mood changes (eg, depression, irritability, nervousness, anxiety, agitation; aggressive behavior); new or worsening vision problems or loss of vision; numbness of an arm or leg; one-sided weakness; pain or burning while urinating; persistent feeling of hot or cold; severe or persistent dizziness or headache; severe stomach or lower back pain; shortness of breath; slurred speech; sudden, severe vomiting; swelling of the stomach; symptoms of high blood sugar (eg, increased thirst or urination, unusual drowsiness, flushing, fruit-like breath odor); thoughts or behaviors of killing or hurting yourself or others; unusual bleeding or bruising; unusual tiredness or weakness; unusual weight changes; yellowing of skin or eyes.

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

See also: Infergen side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include chills; fever; loss of appetite; muscle pain.

Proper storage of Infergen:

Store Infergen in refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Avoid vigorous shaking and exposure to direct sunlight. Use only 1 dose per vial. Do not use solution from the same vial again. Throw away any unused portion. Keep Infergen, as well as syringes and needles, out of the reach of children and away from pets.

General information: If you have any questions about Infergen, please talk with your doctor, pharmacist, or other health care provider. Infergen 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 Infergen. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Infergen resources Infergen Side Effects (in more detail) Infergen Use in Pregnancy & Breastfeeding Infergen Drug Interactions Infergen Support Group 0 Reviews for Infergen - Add your own review/rating Infergen Prescribing Information (FDA) Infergen Concise Consumer Information (Cerner Multum) Infergen Advanced Consumer (Micromedex) - Includes Dosage Information Interferon Alfacon-1 Professional Patient Advice (Wolters Kluwer) Compare Infergen with other medications Hepatitis C
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