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Drug Information: Estrogen and Progestin (Oral Contraceptives)

IMPORTANT WARNING:

Why is this medication prescribed?

Oral contraceptives (birth-control pills) are used to prevent pregnancy. Estrogen and progestin are two female sex hormones. Combinations of estrogen and progestin work by preventing ovulation (the release of eggs from the ovaries).They also change the lining of the uterus (womb) to prevent pregnancy from developing and change the mucus at the cervix (opening of the uterus) to prevent sperm (male reproductive cells) from entering.. Oral contraceptives are a very effective method of birth control, but they do not prevent the spread of human immunodeficiency virus [HIV, the virus that causes acquired immunodeficiency syndrome (AIDS)] and other sexually transmitted diseases.

Some brands of oral contraceptives are also used to treat acne in certain patients. Oral contraceptives work to treat acne by decreasing the amounts of certain natural substances that can cause acne.

How should this medicine be used?

Oral contraceptives come in packets of 21, 28, or 91 tablets to take by mouth once a day, every day or almost every day of a regular cycle. To avoid upset stomach, take oral contraceptives with food or milk. To help you remember to take your oral contraceptive regularly, take it at the same time every day (e.g., after dinner or at bedtime)... Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take your oral contraceptive exactly as directed. Do not take more or less of it, take it more often, or take it for a longer time than prescribed by your doctor.

Oral contraceptives come in many different brands. Different brands of oral contraceptives contain slightly different medications or doses, are taken in slightly different ways, and have different risks and benefits. Be sure that you know which brand of oral contraceptives you are using and exactly how you should use it. Ask your doctor or pharmacist for a copy of the manufacturer's information for the patient and read it carefully.

If you have a 21-tablet packet, take one tablet daily for 21 days and then none for seven days. Then start a new packet.

If you have a 28-tablet packet, take one tablet daily for 28 days. The last seven tablets are a different color. These tablets are not birth-control pills; they contain iron (ferrous fumarate) or an inactive ingredient. You should take one tablet daily continuously for 28 days in the order specified in your packet, starting a new packet the day after taking your 28th tablet.

If you have a 91-day tablet packet, take one tablet daily for 91days. Your packet will contain three trays of tablets. Start with the first tablet on the first tray and continue taking one tablet every day in the order specified on the packet until you have taken all of the tablets on all of the trays. The last seven tablets are a different color. These tablets are not birth-control pills; they contain an inactive ingredient. Start your new packet the day after you take your 91st tablet.

Your doctor will tell you when you should start taking your oral contraceptive. Oral contraceptives are usually started on the first or fifth day of your menstrual period or on the first Sunday after or on which bleeding begins. Your doctor will also tell you whether you need to use another method of birth control during the first seven days that you take your oral contraceptive and will help you choose a method. Follow these directions carefully.

Your menstrual period will probably begin while you are taking the inactive tablets or during the week that you do not take your oral contraceptive and may continue through that week. Be sure to start taking your new packet on schedule even if you are still bleeding.

You may need to use a backup method of birth control if you vomit or have diarrhea while you are taking an oral contraceptive. Talk to your doctor about this before you begin to take your oral contraceptive so that you can prepare a backup method of birth control in case it is needed. If you vomit or have diarrhea while you are taking an oral contraceptive, call your doctor to find out how long you should use the backup method.

If you have recently given birth, wait until 4 weeks after giving birth to begin taking oral contraceptives.

Oral contraceptives will work to prevent pregnancy or treat acne only as long as they are taken regularly. Continue to take oral contraceptives every day even if you are spotting or bleeding, have an upset stomach, or do not think that you are likely to become pregnant. Do not stop taking oral contraceptives without talking to your doctor.

Other uses for this medicine

Oral contraceptives are also sometimes used to treat heavy or irregular menstruation and endometriosis [a condition in which the type of tissue that lines the uterus (womb) grows in other areas of the body and causes pain, heavy or irregular menstruation (periods), and other symptoms].Talk to your doctor about the risks of using this medication for your condition.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow?

Before taking oral contraceptives,

• tell your doctor and pharmacist if you are allergic to estrogen, progestin, or any other medications.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, and nutritional supplements you are taking. Be sure to mention any of the following: acetaminophen (APAP, Tylenol); antibiotics such as ampicillin (Principen),clarithromycin (Biaxin),erythromycin (E.E.S., E-Mycin, Erythrocin),isoniazid (INH, Nydrazid), metronidazole (Flagyl), rifabutin (Mycobutin), rifampin (Rifadin, Rimactane), tetracycline (Sumycin), and troleandomycin (TAO); ; anticoagulants ('blood thinners') such as warfarin (Coumadin); antifungals such as griseofulvin (Fulvicin, Grifulvin, Grisactin), itraconazole (Sporanox) and ketoconazole (Nizoral); atorvastatin (Lipitor); clofibrate (Atromid-S); cyclosporine (Neoral, Sandimmune); danazol (Danocrine); delavirdine (Rescriptor);diltiazem (Cardizem, Dilacor, Tiazac);fluoxetine (Prozac, Sarafem); HIV protease inhibitors such as indinavir (Crixivan) and ritonavir (Norvir); medications for seizures such as carbamazepine (Tegretol), felbamate (Felbatol), oxcarbazepine (Trileptal), phenobarbital (Luminal, Solfoton), phenytoin (Dilantin), primidone (Mysoline), and topiramate (Topamax); modafinil (Provigil); morphine (Kadian, MS Contin, MSIR, others); nefazodone; oral steroids such as dexamethasone (Decadron, Dexone), methylprednisolone (Medrol), prednisone (Deltasone), and prednisolone (Prelone); temazepam (Restoril); theophylline (Theobid, Theo-Dur);thyroid medication such as levothyroxine (Levothroid, Levoxyl, Synthroid); verapamil (Calan, Covera, Isoptin, Verelan);vitamin C; and zafirlukast (Accolate) . Before taking Yasmin, tell your doctor and pharmacist if you are taking angiotensin-converting enzyme (ACE) inhibitors such as benazepril (Lotensin), enalapril (Vasotec), and lisinopril (Prinivil, Zestril); angiotensin II antagonists such as irbesartan (Avapro), losartan (Cozaar), and valsartan (Diovan); aspirin and other nonsteroidal anti-inflammatory medications (NSAIDs) such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn); diuretics ('water pills') such as amiloride (Midamor), spironolactone (Aldactone), and triamterene (Dyrenium); or heparin. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor what herbal products you are taking, especially St. John's wort.
• tell your doctor if you have ever had yellowing of the skin or eyes during pregnancy or while you were using another type of hormonal contraceptive (birth control pills, patches, rings, implants or injections) and if you have recently had surgery or have been unable to move around for any reason. Also tell your doctor if you have or have ever had problems with your breasts such as lumps, an abnormal mammogram (breast x-ray), or fibrocystic breast disease (swollen, tender breasts and/or breast lumps that are not cancer); high blood pressure; high blood cholesterol and fats; diabetes ; asthma; stroke or mini stroke; blood clots in your legs, lungs, or eyes; thrombophilia (a condition in which the blood clots easily); toxemia (high blood pressure during pregnancy); heart attack; chest pain; coronary artery disease (clogged blood vessels leading to the heart); seizures; migraine headaches; depression; liver, heart, gallbladder, or kidney disease; adrenal insufficiency (for Yasmin); jaundice (yellowing of the skin or eyes); unexplained vaginal bleeding; and excessive weight gain and fluid retention (bloating) during the menstrual cycle.
• do not take oral contraceptives if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking oral contraceptives, call your doctor immediately.
• if you miss periods while you are taking oral contraceptives, you may be pregnant. If you are using a 91 tablet packet and you miss one period, call your doctor . If you are using another type of packet according to the directions and you miss one period you may continue to take your tablets. However, if you have not taken your tablets as directed and you miss one period or if you have taken your tablets as directed and you miss two periods, call your doctor and use another method of birth control until you have a pregnancy test.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking oral contraceptives.
• tell your doctor and pharmacist if you wear contact lenses. If you notice changes in vision or ability to wear your lenses while taking hormone replacement therapy, see an eye doctor.

What special dietary instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do if I forget a dose?

If you miss doses of your oral contraceptive, you may not be protected from pregnancy.. You may need to use a backup method of birth control for 7 days or until the end of the cycle. Every brand of oral contraceptives comes with specific directions to follow if you miss a dose. Carefully read the directions in the manufacturer's information for the patient that came with your oral contraceptive. If you have any questions, call your doctor or pharmacist. Continue to take your tablets as scheduled and use a backup method of birth control until your questions are answered. .

What side effects can this medication cause?

Oral contraceptives may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• upset stomach
• vomiting
• stomach cramps or bloating
• diarrhea
• constipation
• gingivitis (swelling of the gum tissue)
• increased or decreased appetite
• weight gain or weight loss
• brown or black skin patches
• acne
• hair growth in unusual places
• bleeding or spotting between menstrual periods
• changes in menstrual flow
• painful or missed periods
• breast tenderness, enlargement, or discharge
• difficulty wearing contact lenses
• swelling, redness, irritation, burning, or itching of the vagina
• white vaginal discharge

Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them, call your doctor immediately:

• severe headache
• severe vomiting
• speech problems
• dizziness or faintness
• weakness or numbness of an arm or leg
• crushing chest pain or chest heaviness
• coughing up blood
• shortness of breath
• pain, warmth, or heaviness in the back of the lower leg
• partial or complete loss of vision
• double vision
• bulging eyes
• severe stomach pain
• yellowing of the skin or eyes
• loss of appetite
• extreme tiredness, weakness, or lack of energy
• fever
• dark-colored urine
• light-colored stool
• swelling of the hands, feet, ankles or lower legs
• depression, especially if you also have trouble sleeping, tiredness, loss of energy, or other mood changes
• unusual bleeding
• rash

Oral contraceptives may increase the chance that you will develop liver tumors. These tumors are not a form of cancer, but they can break and cause serious bleeding inside the body. Oral contraceptives may also increase the chance that you will develop breast or liver cancer, or have a heart attack, a stroke, or a serious blood clot. Talk to your doctor about the risks of using oral contraceptives.

Oral contraceptives may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

What storage conditions are needed for this medicine?

Keep this medication in the packet it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include:

• upset stomach
• vaginal bleeding

What other information should I know?

Keep all appointments with your doctor and the laboratory. You should have a complete physical examination every year, including blood pressure measurements, breast and pelvic exams, and a Pap test. Follow your doctor's directions for examining your breasts; report any lumps immediately.

Before you have any laboratory tests, tell the laboratory personnel that you take oral contraceptives..

If you wish to stop taking oral contraceptives and become pregnant, your doctor may tell you to use another method of birth control until you begin to menstruate regularly again. It may take a long time for you to become pregnant after you stop taking oral contraceptives, especially if you have never had a baby or if you had irregular, infrequent, or complete absence of menstrual periods before taking oral contraceptives. Questions should be discussed with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

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