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What is ethinyl estradiol-norelgestromin?

Ethinyl estradiol and norelgestromin contains 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 norelgestromin are used as contraception to prevent pregnancy.

Ethinyl estradiol and norelgestromin 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, or if you miss two menstrual periods in a row. If you have recently had a baby, wait at least 4 weeks before using this medication (6 weeks if you are breast-feeding).

Do not use this medication if you have:

• a history of a 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.

Before using this medication, tell your doctor if you have any of the following conditions. You may need a dose adjustment or special tests to safely use this medication.

• high blood pressure, heart disease, congestive heart failure, angina (chest pain), or a history of heart attack;
• high cholesterol or if you are overweight;
• kidney disease;
• a history of depression;
• gallbladder disease;
• diabetes;
• seizures or epilepsy; or
• a history of fibrocystic breast disease, lumps, nodules, or an abnormal mammogram.

The hormones in this medication 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.

Your risk of serious blood clot may be higher with the use of birth control skin patches than with the use of birth control pills.

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

This medication 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.

Avoid using creams, lotions, powders, or other medications on the skin where you apply the patch, or it may not stick to your skin.

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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, and vaginal bleeding.

Apply a skin patch as soon as you remember. If it is almost time to apply your next patch, skip the missed dose and apply a patch on the next regularly scheduled day of the week. Do not use extra patches to make up the missed dose.

Missing a dose increases your risk of becoming pregnant. Follow the weekly patch schedule closely.

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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 the patches 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;
• stomach pain, loss of appetite, dark urine, 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:

• 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. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

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Interactions

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

• acetaminophen (Tylenol) or ascorbic acid (vitamin C);
• phenylbutazone (Azolid, Butazolidin);
• prednisolone (Orapred);
• theophylline (Respbid, Theo-Dur);
• cyclosporine (Neoral, Sandimmune, Gengraf);
• St. John's wort;
• an antibiotic such as amoxicillin (Augmentin), ampicillin (Omnipen), doxycycline (Doryx, Vibramycin), tetracycline (Sumycin, Achromycin, Robitet), and others;
• seizure medicines such as phenytoin (Dilantin), carbamazepine (Tegretol), topiramate (Topamax), and others;
• a barbiturate such as phenobarbital (Solfoton), and others; or
• any medication to treat HIV or AIDS.

This list is not complete and there may be other drugs that can interact with ethinyl estradiol and norelgestromin. 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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