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What is ethinyl estradiol-etonogestrel?

Ethinyl estradiol and etonogestrel is 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 etonogestrel is used as contraception to prevent pregnancy.

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

Precautions

Instructions

Side Effects

Interactions

Precautions

This medication can cause birth defects. Do not use if you are pregnant. Tell your doctor right away if you become pregnant.

Do not use this medication if you are allergic to ethinyl estradiol or etonogestrel, or if you have:

• a history of stroke or blood clot;
• circulation problems (especially if caused by diabetes);
• a hormone-related cancer such as breast or uterine cancer;
• abnormal vaginal bleeding;
• liver disease or liver cancer;
• severe high blood pressure;
• severe migraine headaches;
• a heart valve disorder; or
• a history of jaundice caused by birth control pills.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely take ethinyl estradiol and etonogestrel.

• high blood pressure, heart disease, congestive heart failure, angina (chest pain), or a history of heart attack;
• high cholesterol or triglycerides;
• kidney disease;
• a history of depression;
• gallbladder disease;
• diabetes;
• seizures or epilepsy;
• a history of irregular menstrual cycles, toxic shock syndrome, or easy vaginal irritation;
• prolapsed (dropped) uterus, bladder, or rectum;
• a history of fibrocystic breast disease, lumps, nodules, or an abnormal mammogram;
• severe constipation; or
• migraine headaches.

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.

Do not smoke while using this medication, especially if you are older than 35. Smoking can increase your risk of blood clots, stroke, or heart attack caused by birth control pills.

Ethinyl estradiol and etonogestrel 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.

While using the ethinyl estradiol and etonogestrel vaginal ring, do not use a diaphragm as back-up birth control. The vaginal ring may interfere with the correct placement and position of the diaphragm

Vaginal lubricants, spermicides, and yeast infection treatments should not affect the vaginal ring. However, talk to your doctor before using other vaginal products while using the ethinyl estradiol and etonogestrel vaginal ring.

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Instructions

Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include nausea, vomiting, or vaginal bleeding.

If the ring ever falls out during the 3-week wearing time, rinse it with warm water and reinsert it. If it slides down into the lower part of the vagina, use a finger to push it in farther. If the ring is lost, a new vaginal ring should be inserted as soon as possible and the schedule continued without change. Do not leave a ring out for longer than 3 hours.

During week 1 or 2 of wearing time: If a ring has been out of the vagina for more than 3 hours, you may not be protected from pregnancy. You must use a back-up birth control until the new or replaced ring has been in place for 7 days in a row.

During week 3 of wearing time: If a ring has been out of the vagina for more than 3 hours, you may either insert a new ring and start a new 3-week cycle, or you may wait 7 days (and have a menstrual period) before you insert a new ring. You must use back-up birth control until the new or replaced ring has been in place for 7 days in a row.

Avoid leaving the vaginal ring in place for longer than 3 weeks. Call your doctor if you get off the proper schedule for use and non-use of the vaginal ring. Do not wear more than one ring at a time.

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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 headache, confusion, pain behind the eyes, problems with vision, speech, or balance;
• 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;
• nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• swelling in your hands, ankles, or feet;
• a breast lump; or
• symptoms of depression (sleep problems, weakness, mood changes).

Less serious side effects may include:

• mild nausea, vomiting, bloating, stomach cramps;
• breast pain, tenderness, or swelling;
• freckles or darkening of facial skin;
• increased hair growth, loss of scalp hair;
• changes in weight or appetite;
• problems with contact lenses;
• vaginal itching or discharge;
• changes in your menstrual periods, decreased sex drive; or
• headache, nervousness, dizziness, tired feeling.

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. You may report side effects to FDA at 1-800-FDA-1088.

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Interactions

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

• acetaminophen (Tylenol) or ascorbic acid (vitamin C);
• griseofulvin (Grisactin, Grifulvin V, Fulvicin PG);
• rifampin (Rifadin);
• phenylbutazone (Azolid, Butazolidin);
• modafinil (Provigil);
• St. John's wort;
• seizure medicines such as phenytoin (Dilantin), carbamazepine (Tegretol), felbamate (Felbatol), oxcarbazepine (Trileptal), topiramate (Topamax), or primidone (Mysoline);
• a barbiturate such as amobarbital (Amytal), butabarbital (Butisol), mephobarbital (Mebaral), secobarbital (Seconal), or phenobarbital (Luminal, Solfoton); or
• HIV medicines such as amprenavir (Agenerase), atazanavir (Reyataz), tipranavir (Aptivus), indinavir (Crixivan), saquinavir (Invirase), lopinavir/ritonavir (Kaletra), fosamprenavir (Lexiva), ritonavir (Norvir), or nelfinavir (Viracept).

This list is not complete and there may be other drugs that can interact with ethinyl estradiol and etonogestrel. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

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