Desogestrel/
ethinyl estradiol

Generic Name: desogestrel/ethinyl estradiol (DES-oh-JES-trel/ETH-i-nil ES-tra-DYE-ol)
Brand Name: Examples include Desogen and Mircette

Desogestrel/ethinyl estradiol is used for:

Preventing pregnancy. It may also be used for other conditions as determined by your doctor.

Desogestrel/ethinyl estradiol is an estrogen/progestin combination. It works by preventing the release of eggs from the ovaries. It also changes the cervical mucosa to prevent the sperm from reaching the egg and changes the lining of the uterus to prevent a fertilized egg from implanting in the uterus.

Do NOT use desogestrel/ethinyl estradiol if:

• you are allergic to any ingredient in desogestrel/ethinyl estradiol
• you are pregnant or think you may be pregnant
• you have blood clots (eg, in the legs, lungs, eyes) or a history of blood clots or blood clotting problems
• you have chest pain caused by angina or a history of heart or brain blood vessel problems, heart attack, or stroke
• you have known or suspected breast cancer or cancer of the lining of the uterus, cervix, or vagina
• you have a history of breast cancer
• you have abnormal vaginal bleeding of an unknown cause
• you have certain heart valve problems, diabetes that affects circulation, uncontrolled high blood pressure, liver disease, or liver tumor or cancer, or a history of yellowing of the eyes or skin during pregnancy or previous birth control use
• you have certain types of headaches or migraines with aura
• you have had surgery and are or will be confined to a bed or a chair for an extended period of time

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

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Before using desogestrel/ethinyl estradiol:

Some medical conditions may interact with desogestrel/ethinyl estradiol. Tell your health care provider if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have a history of porphyria, diabetes or high blood sugar, gallbladder problems, heart problems (eg, angina), high blood pressure, high cholesterol or triglycerides, high blood calcium levels, kidney or liver problems, mental or mood problems (eg, depression), migraines or headaches, pancreas problems, or seizures
• if a family member has had breast cancer or if you have a history of lumps in the breast, fibrocystic disease of the breast, an abnormal breast x-ray or mammogram, endometriosis or endometrial cancer, uterine fibroids, or irregular or scanty menstrual periods
• if you are having surgery or will be confined to a bed or a chair for a long period of time
• if you smoke, are very overweight, or have fluid retention or swelling problems

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

• Tranexamic acid because the risk of blood clots may be increased
• Aprepitant, armodafinil, azole antifungals (eg, itraconazole), barbiturates (eg, phenobarbital), bosentan, carbamazepine, clobazam, colesevelam, efavirenz, felbamate, griseofulvin, hydantoins (eg, phenytoin), mifepristone, modafinil, nevirapine, oxcarbazepine, penicillins (eg, amoxicillin), phenylbutazone, protease inhibitors (eg, boceprevir, ritonavir), rifamycins (eg, rifampin), rufinamide, St. John's wort, tetracyclines (eg, doxycycline), topiramate, and troglitazone because they may decrease the effectiveness of desogestrel/ethinyl estradiol, resulting in pregnancy or breakthrough bleeding
• Theophyllines (eg, aminophylline), tizanidine, and troleandomycin because the risk of their side effects may be increased by desogestrel/ethinyl estradiol
• Lamotrigine or valproic acid because their effectiveness may be decreased by desogestrel/ethinyl estradiol

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

Use desogestrel/ethinyl estradiol as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with desogestrel/ethinyl estradiol. Talk to your pharmacist if you have questions about this information.
• Take desogestrel/ethinyl estradiol by mouth with or without food.
• If you are also taking colesevelam, take it at least 4 hours before taking desogestrel/ethinyl estradiol.
• Talk with your doctor about how you should start to take your first pack of desogestrel/ethinyl estradiol. If you begin to take desogestrel/ethinyl estradiol during the first 24 hours of your period, you do not need to use an extra form of birth control. If you begin to take desogestrel/ethinyl estradiol on the Sunday after your period starts, you will need to use an extra form of birth control (eg, condoms) for 7 days after you start taking desogestrel/ethinyl estradiol.
• To achieve maximum effectiveness of desogestrel/ethinyl estradiol, it must be taken every day (every 24 hours) and at the same time each day.
• For desogestrel/ethinyl estradiol to be effective, it must be taken every day. Do not skip doses even if you do not have sex very often. Do not skip pills if you are spotting, bleeding, or nauseated. If you have these side effects and they do not go away, check with your doctor.
• Be sure to have an extra full pack of this medication available at all times.
• If you miss 1 dose of desogestrel/ethinyl estradiol, take it as soon as you remember. Take your next dose at the regular time. This means you may take 2 doses on the same day. You do not need to use a backup method of birth control if you only miss 1 pill. If you miss more than 1 active dose of desogestrel/ethinyl estradiol, read the extra patient information leaflet that comes with desogestrel/ethinyl estradiol or contact you doctor for instructions. You must use a backup method of birth control if you miss more than 1 active dose of desogestrel/ethinyl estradiol. If you are not sure about how to handle missed doses, use an extra form of birth control (eg, condoms) and talk with your doctor.

Ask your health care provider any questions you may have about how to use desogestrel/ethinyl estradiol.

Important safety information:

• If you miss 2 periods in a row, or if you miss 1 period when you have not taken your pills correctly, contact your doctor right away to determine if you are pregnant.
• Desogestrel/ethinyl estradiol may cause dark skin patches on your face. Exposure to the sun may make these patches darker. If patches develop, use a sunscreen or protective clothing when exposed to the sun, sunlamps, or tanning booths.
• Tell your doctor or dentist that you take desogestrel/ethinyl estradiol before you receive any medical or dental care, emergency care, or surgery. If you will be having surgery or will be confined to a chair or bed for a long period of time (eg, a long plane flight), notify your doctor 3 to 4 weeks beforehand. You may need to stop taking desogestrel/ethinyl estradiol or take other special precautions for a period of time.
• You should usually not take desogestrel/ethinyl estradiol within 4 weeks after giving birth or after a second-trimester abortion. Talk with your doctor about how to start taking desogestrel/ethinyl estradiol in these instances.
• Bleeding or spotting may occur while taking desogestrel/ethinyl estradiol, especially during the first few months. Do not stop taking desogestrel/ethinyl estradiol if this occurs. If bleeding or spotting is persistent, or if it occurs after menstrual cycles that were previously regular, contact your doctor.
• Desogestrel/ethinyl estradiol may increase the risk of stroke, heart attack, blood clots, high blood pressure, or similar problems. The risk may be greater if you smoke.
• The effectiveness of desogestrel/ethinyl estradiol may be decreased by certain medicines (eg, antibiotics, medicines for seizures, St. John's wort) or conditions (eg, vomiting or diarrhea). This could cause breakthrough bleeding or increase the risk of an unplanned pregnancy if you have sex. To prevent pregnancy, use an additional form of birth control (eg, condoms). Talk with your doctor or pharmacist for more information.
• If you wear contact lenses and you develop problems with them, contact your doctor.
• Desogestrel/ethinyl estradiol does not stop the spread of HIV or other sexually transmitted diseases (STDs) to others through blood or sexual contact. Use barrier methods of birth control (eg, condoms) if you have HIV infection or an STD.
• Diabetes patients - Desogestrel/ethinyl estradiol may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
• Desogestrel/ethinyl estradiol may interfere with certain lab tests. Be sure your doctor and lab personnel know you are using desogestrel/ethinyl estradiol.
• Lab tests, including breast exams, Pap tests, physicals, and blood pressure, may be performed while you use desogestrel/ethinyl estradiol. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Examine your breasts monthly as directed by your doctor. Report any lumps right away.
• Desogestrel/ethinyl estradiol should not be used in CHILDREN who have not had their first menstrual period; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Do not use desogestrel/ethinyl estradiol if you are pregnant. If you think you may be pregnant, contact your doctor right away. Desogestrel/ethinyl estradiol is found in breast milk. Do not breast-feed while you are taking desogestrel/ethinyl estradiol.

Possible side effects of desogestrel/ethinyl estradiol:

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

Breast tenderness or enlargement; changes in appetite; changes in weight; dizziness; headache; loss of scalp hair; nausea; nervousness; stomach cramps or bloating; vaginal spotting or breakthrough bleeding; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody diarrhea; breast lumps, pain, or discharge; bulging eyes; calf or leg pain, swelling, redness, or tenderness; changes in vision (eg, double vision, vision loss); chest pain; coughing up blood; decreased urination; fainting; frequent or painful urination; migraines; missed menstrual period; mood or mental changes (eg, depression); persistent or recurrent abnormal vaginal bleeding; severe pain or tenderness in the stomach area; severe, persistent, or recurring headache or dizziness; shortness of breath; swelling of fingers or ankles; symptoms of heart attack (eg, chest, jaw, or arm pain; sudden severe nausea or vomiting; shortness of breath; sudden unusual sweating); symptoms of liver problems (eg, dark urine, fever, loss of appetite, pale stools, unusual tiredness, yellowing of the skin or eyes); symptoms of stroke (eg, one-sided weakness, slurred speech, confusion); vaginal discharge, itching, or odor; unusual tiredness or weakness.

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

If OVERDOSE is suspected:

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

Store desogestrel/ethinyl estradiol at room temperature, below 86 degrees F (30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep desogestrel/ethinyl estradiol out of the reach of children and away from pets.

General information:

• If you have any questions about desogestrel/ethinyl estradiol, please talk with your doctor, pharmacist, or other health care provider.
• Desogestrel/ethinyl estradiol 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 should not be used to decide whether or not to take desogestrel/ethinyl estradiol or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about desogestrel/ethinyl estradiol. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to desogestrel/ethinyl estradiol. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using desogestrel/ethinyl estradiol.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.