Ethinyl estradiol and desogestrel

Generic name: Ethinyl Estradiol And Desogestrel
Dosage form: oral tablet (0.15 mg-0.03 mg; biphasic; triphasic 25 mcg)
Drug class: Contraceptives

Usage of Ethinyl estradiol and desogestrel

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

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

Ethinyl estradiol and desogestrel side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult 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 at once 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.

Before taking Ethinyl estradiol and desogestrel

Taking birth control pills can increase your risk of blood clots, stroke, or heart attack. You are even more at risk if you have high blood pressure, diabetes, high cholesterol, or if you are overweight. Your risk of stroke or blood clot is highest during your first year of taking birth control pills. Your risk is also high when you restart birth control pills after not taking them for 4 weeks or longer.

Smoking can increase your risk of blood clots, stroke, or heart attack caused by birth control pills, especially if you are older than 35.

Do not use if you are pregnant. Stop using ethinyl estradiol and desogestrel and 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.

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 an increased risk of having blood clots due to a heart problem 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 checked by a doctor;

liver disease or liver cancer, if you take any hepatitis C medication containing ombitasvir/paritaprevir/ritonavir with or without dasabuvir or if you have a history of jaundice caused by pregnancy or birth control pills; or

severe migraine headaches (with aura, numbness, weakness, or vision changes), especially if you are older than 35 or if you smoke and are over 35 years old.

Tell your doctor if you have ever had:

heart disease, high blood pressure, varicose veins, if you are prone to having blood clots, high cholesterol or triglycerides, or if you are overweight;

depression, migraine headaches, diabetes, 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.

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How to use Ethinyl estradiol and desogestrel

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

Warnings

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.

What other drugs will affect Ethinyl estradiol and desogestrel

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.

Disclaimer

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