Norelgestromin and Ethinyl Estradiol, Transdermal

What are other names for this medicine?

Type of medicine: contraceptive (birth control)

Generic and brand names: norelgestromin and ethinyl estradiol, transdermal; Ortho Evra

What is this medicine used for?

This medicine is a patch applied to the skin to prevent pregnancy. It is a combination of a progestin and estrogen, two female hormones. The hormones are slowly released and absorbed into the body.

What should my health care provider know before I take this medicine?

You should not use this product if you have:

• an allergy to any hormones
• blood clots in your legs, lungs, or eyes (now or in the past)
• diabetes
• disease of the heart valves
• gallbladder or kidney disease
• headaches along with symptoms such as vomiting, double vision, unsteadiness, weakness, or personality changes
• had a heart attack or stroke
• high blood pressure or high cholesterol
• had breast cancer or cancer of the lining of the uterus, cervix, or vagina
• liver disease
• a long period of bed rest after major surgery or broken bone in a cast
• unexplained vaginal bleeding
• yellowing of the eyes or skin (jaundice) during pregnancy or during past use of birth control pills.

Females of childbearing age: DO NOT use this product if you are pregnant, think you may be pregnant, or are breast-feeding because it can harm the baby.

How do I use it?

The patch is a weekly form of birth control. You will change your patch once a week for 3 weeks in a row. You will not wear a patch during the fourth week.

Apply the patch on the same day of the week each week. This is your "patch change day". For example, if the first patch is applied on Monday, apply future patches on Monday of each of the 3 weeks in a cycle. Wear only 1 patch at a time.

After 1 week without a patch (week 4), you start a new 4-week cycle by applying a new patch. Never go for more than 7 days without a patch or you will not be protected from getting pregnant.

You can decide with your health care provider when to start wearing the patch -- either on the first day of your period, or on the first Sunday after your period starts.

If you are starting on the first day of your period, you must apply the first patch during the first 24 hours of your menstrual period. If you start after day 1 of your menstrual period, you need to use another kind of birth control, such as condoms or a diaphragm, for the first 7 days that you wear the patch.

For a Sunday start, apply the first patch on the first Sunday after your period starts. Use another kind of birth control such as condoms or a diaphragm for the first 7 days that you wear the patch.

You can wear your patch on the buttocks, abdomen, upper body (front or back, except the breasts), or upper outer arm. Do not apply the patch on skin that is red, irritated, or cut. Do not apply the patch to your breasts. You can wear it in a different place each week to avoid irritation. Do not wear it under tight clothing.

Do not put make-up, creams, lotions, powders, or other products on the skin where you wear a patch.

If a patch comes off, try to put it back on the same spot, or replace it with a new patch right away. No back-up birth control is needed. Your patch change day will stay the same.

Do not reapply a patch if:

• It is no longer sticky.
• It has becomes stuck to itself or another surface.
• It has another material stuck to it.
• It has become loose or fallen off more than once.

If you cannot reapply the same patch, apply a new patch right away. Do not use tape, bandages, or wraps to hold a patch in place.

If the patch comes off and stays off for more than 24 hours, or you are not sure how long the patch has been off, you may not be protected against pregnancy. You must start a new patch cycle by applying a new patch. This will be a new day 1 and a new patch change day. You must use a back-up method of birth control for the first week of the new cycle.

Check with your health care provider if you:

• forget to change a patch
• wish to change your patch change day
• are switching from birth control pills
• are using the patch after childbirth
• are using the patch after an abortion or miscarriage
• are having bleeding or spotting between periods
• have problems with skin irritation
• miss a menstrual period.

What should I watch out for?

Smoking while you take this medicine increases your risk of side effects. The risk increases with age and the number of cigarettes smoked a day. Talk to your health care provider about ways to quit smoking.

If you need emergency care, surgery, or dental work, tell the health care provider or dentist you are using birth control hormones. You may have a greater risk of blood clots.

If you need any lab tests, tell your health care provider you are using the patch. Birth control hormones may change some blood test results.

This product does not protect against HIV infection (AIDS) or other sexually transmitted diseases.

If you wear contact lenses your vision might change. You may not be able to wear contact lenses. Talk to your health care provider about this.

What are the side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your health care provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your health care provider right away. If you are unable to reach your health care provider right away, get emergency medical care or call 911 for help):

• allergic reaction (hives, itching, rash, tightness in your chest, trouble breathing)
• sharp chest pain, coughing blood, or sudden shortness of breath
• sudden severe headache or vomiting, dizziness or fainting, problems with vision or speech, weakness, or numbness in an arm or leg
• sudden partial or complete loss of vision.

Serious (report these to your health care provider right away):

• yellowing of the skin or whites of the eyes (jaundice), especially with fever, tiredness, loss of appetite, dark urine, or light-colored bowel movements
• pain in the calf
• severe pain, swelling, or tenderness in the abdomen
• breast lumps or tenderness
• irregular vaginal bleeding or spotting that happens in more than 1 menstrual cycle or lasts for more than a few days
• swelling of your hands or ankles
• trouble sleeping, weakness, lack of energy, fatigue, or depression.

Other: Vaginal or urinary infection, vaginal discharge, weight gain, headache, nausea.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these medicines together might cause harmful side effects. Talk to your health care provider if you are taking:

• acetaminophen (Tylenol)
• antibiotics such as griseofulvin (Fulvicin, Grisactin, Gris-Peg), penicillin, ampicillin (Omnipen, Totacillin, Polycillin, Principen, Unasyn), amoxicillin (Amoxil, Trimox, Wymox, Augmentin), cloxacillin (Cloxapen), dicloxacillin (Dynapen, Dycill, Pathocil), oxacillin (Bactocill), penicillin VK (Beepen-VK, Pen-Vee K, Veetids), demeclocycline (Declomycin), doxycycline (Vibramycin, Vibra-Tabs, Doryx, Doxychel), minocycline (Minocin, Vectrin), oxytetracycline (Terramycin), and tetracycline (Achromycin V, Sumycin, Panmycin, Tetracyn)
• antifungal agents such as itraconazole (Sporanox) and ketoconazole (Nizoral)
• anticonvulsants such as carbamazepine (Tegretol), felbamate (Felbatol), oxcarbazepine (Trileptal), phenytoin (Dilantin), topiramate (Topamax), ethotoin (Peganone), fosphenytoin (Cerebyx), and mephenytoin (Mesantoin)
• ascorbic acid (vitamin C)
• atorvastatin (Lipitor)
• barbiturates such as phenobarbital, amobarbital (Amytal), butabarbital (Butisol), pentobarbital (Nembutal), and secobarbital (Seconal)
• benzodiazepines such as alprazolam (Xanax), clorazepate (Tranxene, Gen-Xene), chlordiazepoxide (Librium. Libritabs), diazepam (Valium), lorazepam (Ativan), oxazepam (Serax), temazepam (Restoril), and triazolam (Halcion)
• beta blockers such as atenolol (Tenormin), acebutolol (Sectral), esmolol (Brevibloc), carteolol (Cartrol), betaxolol (Kerlone), bisoprolol (Zebeta), metoprolol (Lopressor, Toprol XL), nadolol (Corgard), propranolol (Inderal), timolol (Blocadren), and sotalol (Betapace)
• blood thinners such as warfarin (Coumadin)
• caffeine
• chloramphenicol (Chloromycetin)
• clofibrate (Atromid-S)
• corticosteroids such as betamethasone (Celestone), cortisone (Cortone), dexamethasone (Hexadrol, (Decadron), hydrocortisone (Hydrocortone, Cortef) , methylprednisolone (Medrol), prednisone (Meticorten, Deltasone, Orasone), and prednisolone (Delta-Cortef, Prelone)
• cyclosporine (Sandimmune, Neoral, SangCya)
• isoniazid (Nydrazid, Laniazid)
• medicines to treat HIV such as amprenavir (Agenerase), indinavir (Crixivan), nelfinavir (Viracept), and ritonavir (Norvir, Kaletra)
• morphine
• neomycin (Mycifradin, Neo-fradin, Neo-Tabs)
• nitrofurantoin (Furadantin, Macrobid, Macrodantin)
• phenylbutazone (Butazolidin)
• primidone (Mysoline)
• rifampin (Rifadin, Rimactane) or rifabutin (Mycobutin)
• salicylic acid
• St. John's wort
• sulfonamides such as sulfadiazine, sulfamethoxazole (Gantanol), sulfamethizole (Thiosulfil Forte), and sulfasalazine (Azulfidine)
• theophylline (an ingredient in many asthma medicines)
• triamcinolone (Aristocort, Kenacort)
• tricyclic antidepressants such as amitriptyline (Elavil), nortriptyline (Aventyl, Pamelor), imipramine (Tofranil), and doxepin (Sinequan)
• vitamins.

Keep a list of all your medicines (prescription, nonprescription, supplements, natural remedies, vitamins) with you. Be sure that you tell all health care providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Do not place in refrigerator or freezer. Keep the patches tightly sealed until ready to use. Protect them from heat, high humidity, and bright light.

This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your health care provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.