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Contraceptive patch

General Information and Indications:

Norelgestromin and ethinyl estradiol transdermal system (patch) is used to prevent pregnancy. Norelgestromin is a progestin and ethinyl estradiol is an estrogen. Estrogen and progestin are two female sex hormones. Norelgestromin and ethinyl estradiol contraceptive patch works by preventing the release of eggs from the ovaries (ovulation) and changing the cervical mucus and the lining of the uterus. The contraceptive patch is a very effective method of birth control, but it does not prevent the spread of AIDS and other sexually transmitted diseases.

Information For Users:

Norelgestromin and ethinyl estradiol transdermal system comes as a patch to apply to the skin. One patch is applied once a week for 3 weeks, followed by a patch-free week. Follow the directions on your prescription label, ask your doctor or pharmacist If you have any questions. Use the contraceptive patch exactly as directed.

If you are using the contraceptive patch for the first time, wait for the first day of your menstrual period to apply the first patch. You may choose to start applying the patch on the first Sunday after your period begins. If you begin applying the patch after Day 1 of the menstrual cycle, you must use a backup method of birth control (such as a condom and/or a spermicide) for the first 7 days of the first cycle.

A new patch should always be applied on the same day of the week (the Patch Change Day). Apply a new patch once a week for 3 weeks. During Week 4, do not apply a patch, and expect to begin your menstrual period. On the day after Week 4 ends, apply a new patch to start a new 4-week cycle. You should not go more than 7 days without a patch.

Apply the contraceptive patch to a clean, dry, intact, healthy area of skin on the buttock, abdomen, upper outer arm, or upper torso, in a place where it will not be rubbed by tight clothing. Do not place the contraceptive patch on the breasts or on skin that is red, irritated, or cut. Do not apply makeup, creams, lotions, powders, or other topical products to the skin area where the contraceptive patch is placed. Each new patch should be applied to a new spot on the skin to help avoid irritation.

To apply the contraceptive patch, follow these steps:

o Open the foil pouch by tearing it along the edge.
o Peel apart the foil pouch and open it flat.
o Use your fingernail to lift one corner of the patch and peel the patch with the plastic liner off the foil liner. Sometimes patches can stick to the inside of the pouch; be careful not to remove the clear liner as you remove the patch.
o Peel away half of the clear protective liner. Avoid touching the sticky surface of the patch.
o Apply the sticky surface of the patch to the skin and remove the other half of the plastic liner. Press down firmly on the patch with the palm of your hand for 10 seconds, making sure that the edges stick well.

Check your patch every day to make sure it is sticking. If the patch becomes partially or completely detached for less than one day, try to reapply it in the same place or replace it with a new patch immediately. Your Patch Change Day will stay the same. If the patch has become partially or completely detached for more than one day, you may not be protected from pregnancy. You must start a new cycle by applying a new patch immediately; the day that you apply the new patch becomes your new Patch Change Day. Use backup birth control for the first week of the new cycle.
Other uses for this medicine

special precautions:

o Inform your doctor or pharmacist if you have allergy to estrogens, progestins, or any other medications.
o Inform your doctor and pharmacist what prescription and nonprescription medications, vitamins, and nutritional supplements you are taking. Be sure to mention any of the following: acetaminophen (APAP, Tylenol); antibiotics; anticoagulants ('blood thinners') such as warfarin (Coumadin); atorvastatin (Lipitor); clofibrate (Atromid-S); cyclosporine (Neoral, Sandimmune); griseofulvin (Fulvicin, Grifulvin, Grisactin); HIV protease inhibitors such as indinavir (Crixivan) and ritonavir (Norvir); medications for seizures such as carbamazepine (Tegretol), phenobarbital (Luminal, Solfoton), phenytoin (Dilantin), and topiramate (Topamax); morphine (Kadian, MS Contin, MSIR, others); oral steroids such as dexamethasone (Decadron, Dexone), methylprednisolone (Medrol), prednisone (Deltasone), and prednisolone (Prelone); phenylbutazone; rifabutin (Mycobutin); rifampin (Rifadin, Rimactane); temazepam (Restoril); theophylline (Theobid, Theo-Dur); and thyroid medication such as levothyroxine (Levothroid, Levoxyl, Synthroid). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
o Inform your doctor what herbal products you are taking, especially products containing St. John's wort.
o inform your doctor if you are breast-feeding breast lumps or cancer; endometrial cancer; high blood pressure; high blood cholesterol and fats; diabetes (high blood sugar); asthma; stroke; blood clots; toxemia (high blood pressure during pregnancy); heart attack; epilepsy (seizures); migraine headaches; depression; liver, heart, gallbladder, or kidney disease; jaundice (yellowing of the skin or eyes, jaundice); vaginal bleeding between menstrual periods; and excessive weight gain and fluid retention (bloating) during the menstrual cycle.
o Inform your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using norelgestromin and ethinyl estradiol contraceptive patch, call your doctor without delay.
o if you are having surgery, including dental surgery, tell the doctor or dentist that you are using norelgestromin and ethinyl estradiol contraceptive patch.
o Inform your doctor if you wear contact lenses. If you notice changes in vision or ability to wear your lenses while using norelgestromin and ethinyl estradiol contraceptive patch, see an eye doctor.

If you forget to change your patch at the start of any patch cycle (Week 1, Day 1), you may not be protected from pregnancy. Apply the first patch of the new cycle as soon as you remember. There is now a new Patch Change Day and a new Day 1. Use a backup method of birth control for one week.

If you forget to change your patch in the middle of the patch cycle (Week 2 or Week 3) for 1 or 2 days, apply a new patch immediately and apply the next patch on your usual Patch Change Day. If you forget to change your patch in the middle of the cycle for more than 2 days, you may not be protected from pregnancy. Stop the current cycle and start a new cycle immediately by applying a new patch. There is now a new Patch Change Day and a new Day 1. Use a backup method of birth control for 1 week.

If you forget to remove your patch at the end of the patch cycle (Week 4), take it off as soon as you remember. Start the next cycle on the usual Patch Change Day, the day after Day 28.

If you forget to apply a new patch at the beginning of the new cycle (i.e. there are more than 7 patch-free days), you may not be protected from pregnancy. Use a backup method of birth control for 1 week.

Possible Adverse Effects:

Norelgestromin and ethinyl estradiol contraceptive patch may cause adverse effects. Inform your doctor if any of the following symptoms are severe or do not go away:

o reaction at the application site
o upset stomach
o vomiting
o stomach cramps or bloating
o diarrhea
o constipation
o gingivitis (swelling of the gum tissue)
o weight gain or weight loss
o brown or black skin patches
o acne
o swelling of the hands, feet, or lower legs (fluid retention)
o hair growth in unusual places
o bleeding or spotting between menstrual periods
o changes in menstrual flow
o painful or missed periods
o breast tenderness, enlargement, or discharge
o difficulty wearing contact lenses

Some adverse effects could be serious. The following symptoms are uncommon, but if you experience any of them, call your doctor without delay:

o severe headache
o shortness of breath
o severe vomiting
o partial or complete loss of vision
o double vision (diplopia)
o speech problems
o dizziness or faintness
o weakness or numbness of an arm or leg
o crushing chest pain or chest heaviness
o coughing up blood
o calf pain
o severe stomach pain
o yellowing of the skin or eyes, jaundice
o severe depression
o unusual bleeding
o loss of appetite (anorexia)
o extreme tiredness, weakness, or lack of energy
o fever
o dark-colored urine
o light-colored stool
o rash

Norelgestromin and ethinyl estradiol contraceptive patch may increase the risk of developing endometrial and breast cancer, gallbladder disease, liver tumors, heart attack, stroke, and blood clots. Talk to your doctor about the risks of using this medication.

Brand Name(s):

o Ortho Evra®

Other Name(s):

o Contraceptive patch