Ethinyl estradiol and desogestrel

Ethinyl estradiol and desogestrel is a combination birth control pill that contains female hormones to stop ovulation (the release of an egg from an ovary). Ethinyl estradiol and desogestrel also changes 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 desogestrel is used to prevent pregnancy. There are many brands of this medicine available. Not all brands are listed in this leaflet.

Ethinyl estradiol and desogestrel may also be used for other reasons not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

You will take your first pill on the first day of your period or on the first Sunday after your period starts. You may need to use back-up birth control, like condoms or a spermicide, when you first begin this medicine. Follow your doctor's instructions.

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

Some birth control packs have seven "reminder" pills to help you stay on your regular cycle. Your period will usually start while you are using these reminder pills.

You may experience breakthrough bleeding. Tell your doctor if it continues or is very heavy.

Use a back-up birth control if you are sick with severe vomiting or diarrhea.

Any doctor or surgeon who treats you should know that you are using birth control pills.

While taking birth control pills, you will need to see your doctor regularly.

Store at room temperature away from moisture and heat.

Do not take birth control pills if you are pregnant or if you have recently had a baby.

You should not use birth control pills if you have: heart problems, circulation problems, undiagnosed vaginal bleeding, liver problems, severe migraine headaches, if you also take certain hepatitis C medication, if you will have major surgery, if you smoke and are over 35, or if you have ever had a heart attack, a stroke, a blood clot, jaundice caused by pregnancy or birth control pills, or cancer of the breast, uterus/cervix, or vagina.

Taking birth control pills can raise your risk of blood clots, stroke, or heart attack. This risk is higher if you have high blood pressure, diabetes, high cholesterol, or if you are overweight. Your risk of stroke or blood clot is greatest during your first year of using birth control pills. The risk is also high if you restart birth control pills after being off them for 4 weeks or longer.

Smoking can increase your risk of blood clots, stroke, or heart attack from birth control pills, especially if you are over 35.

Do not use if you are pregnant. Stop using ethinyl estradiol and desogestrel and inform your doctor immediately if you become pregnant, or if you miss two menstrual periods in a row. If you have recently given birth, wait at least 4 weeks before starting birth control pills.

You should not take birth control pills if you have:

• untreated or uncontrolled high blood pressure, or heart disease (chest pain, coronary artery disease, history of heart attack, stroke, circulation problems, or blood clot) or a higher risk of blood clots due to a heart issue or a hereditary blood disorder;
• a history of hormone-related cancer, or cancer of the breast, uterus/cervix, or vagina;
• unusual vaginal bleeding that has not been evaluated by a doctor;
• liver disease or liver cancer, if you are taking any hepatitis C medication that contains ombitasvir/paritaprevir/ritonavir with or without dasabuvir or if you have a history of jaundice due to pregnancy or birth control pills; or
• severe migraine headaches (with aura, numbness, weakness, or vision changes), especially if you are over 35 or if you smoke and are over 35.

Tell your doctor if you have ever had:

• heart disease, high blood pressure, varicose veins, a tendency to have blood clots, high cholesterol or triglycerides, or if you are overweight;
• depression, migraine headaches, diabetes, or gallbladder disease;
• liver or kidney disease; or
• irregular menstrual cycles, fibrocystic breast disease, lumps, nodules, or an abnormal mammogram.

Ask a doctor if it is safe to breastfeed while using this medicine.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Birth control pills may cause serious side effects. Stop using birth control pills and call your doctor right away if you have:

• signs of a stroke--sudden numbness or weakness, severe headache, slurred speech, problems with vision or balance;
• signs of a blood clot in the lung--chest pain, sudden cough or shortness of breath, dizziness, coughing up blood;
• signs of a blood clot deep in the body--pain, swelling, or warmth in one leg;
• heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
• liver problems--swelling around your midsection, right-sided upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• increased blood pressure--severe headache, blurred vision, pounding in your neck or ears;
• depression--mood changes, feelings of low self-worth, loss of interest in things you once enjoyed, new sleep problems, thoughts about hurting yourself;
• swelling in your hands, ankles, or feet, or a breast lump; or
• changes in the pattern or severity of migraine headaches.

Common side effects of ethinyl estradiol and desogestrel may include:

• weight gain, nausea, vomiting, breast tenderness, or breakthrough bleeding;
• acne, darkening of facial skin; or
• problems with contact lenses.

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.

Usual Adult Dose for Contraception:

0.15 mg desogestrel/0.03 mg ethinyl estradiol tablet regimen:-Days 1 to 21: 1 tablet orally once a day-Days 22 to 28: 1 inert tablet orally once a dayBiphasic regimen:-Days 1 to 21: 0.15 mg desogestrel/0.02 mg ethinyl estradiol tablet orally once a day-Days 22 to 23: 1 inert tablet orally once a day-Days 24 to 28: 0.01 mg ethinyl estradiol tablet orally once a dayTriphasic regimen:-Days 1 to 7: 0.1 mg desogestrel/0.025 mg ethinyl estradiol tablet orally once a day-Days 8 to 14: 0.125 mg desogestrel/0.025 mg ethinyl estradiol tablet orally once a day-Days 15 to 21: 0.15 mg desogestrel/0.025 mg ethinyl estradiol tablet orally once a day-Days 22 to 28: 1 inert tablet orally once a dayComments:-This drug should be taken at the same time each day.-Patients may begin on the first day of the menstrual period or on the first Sunday after the onset of the menstrual period.-Additional forms of contraception should be used if patients begin on Sunday.Use: Prevention of pregnancy

Usual Pediatric Dose for Contraception:

Postpubertal adolescents:0.15 mg desogestrel/0.03 mg ethinyl estradiol tablet regimen:-Days 1 to 21: 1 tablet orally once a day-Days 22 to 28: 1 inert tablet orally once a dayBiphasic regimen:-Days 1 to 21: 0.15 mg desogestrel/0.02 mg ethinyl estradiol tablet orally once a day-Days 22 to 23: 1 inert tablet orally once a day-Days 24 to 28: 0.01 mg ethinyl estradiol tablet orally once a dayTriphasic regimen:-Days 1 to 7: 0.1 mg desogestrel/0.025 mg ethinyl estradiol tablet orally once a day-Days 8 to 14: 0.125 mg desogestrel/0.025 mg ethinyl estradiol tablet orally once a day-Days 15 to 21: 0.15 mg desogestrel/0.025 mg ethinyl estradiol tablet orally once a day-Days 22 to 28: 1 inert tablet orally once a dayComments:-This drug should be taken at the same time each day.-Patients may begin on the first day of the menstrual period or on the first Sunday after the onset of the menstrual period.-Additional forms of contraception should be used if patients begin on Sunday.Use: Prevention of pregnancy

Follow the instructions on your prescription label and read all medication guides or instruction sheets. Missing a pill increases your risk of becoming pregnant.

If you miss 1 active pill, take two pills on the day you remember. Then take one pill each day for the rest of the pack.

If you miss 2 active pills in a row in Week 1 or 2, take two pills each day for two days in a row. Then take one pill each day for the rest of the pack. Use back-up birth control for at least 7 days after missing the pills.

If you miss 2 active pills in a row in Week 3, throw away the rest of the pack and start a new pack the same day if you are a Day 1 starter. If you are a Sunday starter, continue taking a pill every day until Sunday. On Sunday, throw away the rest of the pack and start a new pack that day.

If you miss 3 active pills in a row in Week 1, 2, or 3, throw away the rest of the pack and start a new pack on the same day if you are a Day 1 starter. If you are a Sunday starter, continue taking a pill every day until Sunday. On Sunday, throw away the rest of the pack and start a new pack that day.

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

If you miss a reminder pill, throw it away and keep taking one reminder pill each day until the pack is empty.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include nausea, vomiting, and vaginal bleeding.

Do not smoke while taking birth control pills, especially if you are older than 35 years of age.

Using birth control pills will not prevent your disease from spreading. Ask your doctor how to prevent HIV transmission during sex.

Tell your doctor about all your other medicines, especially:

• phenylbutazone;
• griseofulvin;
• bosentan;
• rifampin;
• St. John's wort;
• glecaprevir/pibrentasvir; or
• anticonvulsants (antiepileptics) such as phenobarbital, phenytoin, carbamazepine, oxcarbazepine, lamotrigine, topiramate, or felbamate.

This list is not complete. Other drugs may affect ethinyl estradiol and desogestrel, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.