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What is the most important information I should know about ethinyl estradiol and norelgestromin?

Ethinyl estradiol and norelgestromin does not protect you from sexually transmitted diseases--including HIV and AIDS.

Avoid smoking. It greatly increases the risk of a heart attack, stroke or blood clot formation while using hormonal birth control.

Do not use this medication if you are pregnant.

What is ethinyl estradiol and norelgestromin?

Ethinyl estradiol is a form of estrogen and norelgestromin is a form of progesterone. These are both female hormones involved in conception. The ethinyl estradiol and norelgestromin topical patch releases estrogen and progesterone that are absorbed directly through the skin.

Ethinyl estradiol and norelgestromin is used to prevent pregnancy.

Ethinyl estradiol and norelgestromin may also be used for purposes other than those listed in this medication guide.

What should I discuss with my healthcare provider before using ethinyl estradiol and norelgestromin?

Ethinyl estradiol and norelgestromin may be less effective in women weighing more than 198 lbs. (90 kg). Do not use ethinyl estradiol and norelgestromin without first talking to your doctor if you weigh more than 198 lbs. (90 kg).

Do not use ethinyl estradiol and norelgestromin without first talking to your doctor if you have or have had:

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blood clots in your legs (thrombosis), lungs (pulmonary embolism), or eyes;

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chest pain (angina pectoris), heart attack, severe high blood pressure, or disease of the heart valves with complications;

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stroke;

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diabetes with complications of the kidneys, nerves or blood vessels;

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yellowing of the whites of the eyes or skin (jaundice) during pregnancy or with prior use of hormonal birth control;

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liver tumors or liver disease;

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headaches with neurological symptoms;

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any type of breast, uterine, cervix, vaginal or other hormone-dependent cancer;

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unexplained vaginal bleeding;

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need an extended period of bed rest due to surgery or illness; or

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heavy smoking (15 or more cigarettes per day) and over age 35.

Using ethinyl estradiol and norelgestromin may be dangerous in some cases if you have any of the conditions listed above.

Before using ethinyl estradiol and norelgestromin, tell your doctor if you have a family history of breast cancer; breast nodules; fibrocystic disease; abnormal breast x-ray; or abnormal mammogram; diabetes; high cholesterol; high blood pressure; heart disease; liver disease; kidney disease; gallbladder disease; migraines or other headaches; epilepsy; a history of depression; a history of scanty or irregular menstrual periods; smoke cigarettes; or need an extended period of bed rest due to surgery or illness.

Ethinyl estradiol and norelgestromin is in the FDA pregnancy category X.

This means that ethinyl estradiol and norelgestromin is known to cause birth defects in an unborn baby.Do not use ethinyl estradiol and norelgestromin if you are pregnant.

Ethinyl estradiol and norelgestromin may decrease milk flow and have other effects on milk composition. Do not use ethinyl estradiol and norelgestromin without first talking to your doctor if you are breast-feeding a baby.

How should I use ethinyl estradiol and norelgestromin?

Use ethinyl estradiol and norelgestromin exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

This birth control method uses a 28 day (four week) cycle. One topical patch is applied and kept in place for one week. A new topical patch is applied each week for three weeks in a row (21 total days). You should not apply a patch during the fourth week (a one-week break). During the one-week break, you should have your menstrual period. Every new patch should be applied on the same day of the week, this will be your 'Patch Change Day'.

Follow your healthcare provider's instructions regarding when to start using ethinyl estradiol and norelgestromin and whether back-up contraception is needed temporarily.

Clean and dry the area of skin where the patch will be applied. The patch can be placed on the buttock, abdomen, upper outer arm, or upper torso in a place where it won't be rubbed by tight clothing. Never put the patch on the breasts. To avoid skin irritation, apply each new patch to a different place on the skin.

Do not apply the patches to skin that is red, irritated or cut. Do not use creams, oils, powder, or makeup on the skin where you will put a patch or near a patch your are wearing. It may cause the patch to become loose.

If a patch causes irritation, it can be removed and a new patch may be applied to a new location until the next 'Patch Change Day'. Only one patch should be worn at a time.

If a patch has become loose or fallen off for less than one day, try to reapply it or apply a new patch immediately.

Do not use the patch if it is no longer sticky, if it is stuck to itself, another surface, or other material, or if it has previously become loose or fallen off. No tapes or wraps should be used to keep the patch in place. No back-up contraception is needed. Your 'Patch Change Day' stays the same.

If the patch has fallen off for more than one day or if you are not sure for how long it has been off, you may become pregnant. Start a new four week cycle immediately by putting on a new patch. You now have a new 'Day 1' and a new 'Patch Change Day'. You must use another method of birth control such as a condom, spermicide, or a diaphragm for the first week of your new cycle.

Single replacement patches are available through your pharmacist.

Store the topical patches in their protective pouches at room temperature away from moisture and heat. Do not store in the refrigerator or freezer.

What should I avoid while using ethinyl estradiol and norelgestromin?

Ethinyl estradiol and norelgestromin does not protect you from sexually transmitted diseases--including HIV and AIDS.

Avoid smoking. It greatly increases the risk of a heart attack, stroke or blood clot formation while using hormonal birth control.

What are the possible side effects of ethinyl estradiol and norelgestromin?

If you experience any of the following serious side effects, stop using ethinyl estradiol and norelgestromin and seek emergency medical attention or contact your doctor immediately:

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an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);

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sharp chest pain, coughing blood or sudden shortness of breath (possible blood clot in the lung);

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pain in the calf (possible blood clot in the leg);

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crushing chest pain or heaviness in the chest (possible heart attack);

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sudden severe headache or vomiting, dizziness, faintness or problems with vision or speech, weakness or numbness in an arm or leg (possible stroke);

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yellowing of the skin or whites of the eyes (jaundice), especially with fever, tiredness, loss of appetite, dark colored urine, or light colored bowel movements (possible liver problems);

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sudden partial or complete loss of vision (possible clot in the eye);

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severe pain, swelling, or tenderness in the abdomen (gallbladder or liver problems);

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irregular vaginal bleeding or spotting that happens in more than 1 menstrual cycle or lasts for more than a few days;

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swelling (edema) of the fingers or ankles; or

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severe problems with difficulty sleeping, weakness, lack of energy, fatigue, or a change in mood (possible severe depression).

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new or changing breast lumps

Other, less serious side effects may be more likely to occur. Continue to use ethinyl estradiol and norelgestromin and talk to your doctor if you experience

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headache or dizziness;

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changes in menstrual cycle or breast tenderness;

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changes in weight or appetite;

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water retention;

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intolerance to contact lenses;

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changes in skin color; or

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changes in blood sugar.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect ethinyl estradiol and norelgestromin?

Many other drugs may interact with ethinyl estradiol and norelgestromin. Some interactions (e.g. with certain antibiotics, protease inhibitors, seizure medications, St. John's wort, and other medications) may result in decreased effectiveness of ethinyl estradiol and norelgestromin and therefore increase the risk of unintended pregnancy. Talk to your doctor or pharmacist before taking any other prescription or over-the-counter medications, including vitamins and minerals and herbal products, while taking an oral contraceptive.

What does my medication look like?

Ethinyl estradiol and norelgestromin is available with a prescription under the brand name Ortho Evra. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

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Ortho Evra-ethinyl estradiol and norelgestromin (0.75 mg/6 mg) beige topical patch.

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