Ortho Evra Patch

NORELGESTROMIN / ETHINYL ESTRADIOL Trans dermal System

What is Ortho Evra Patch ?

Ortho Evra Patch is a weekly hormonal birth control patch that is as effective as the Pill but even simpler. It is worn on the skin to prevent pregnancy . It adheres well to the skin even during swimming, bathing and exercising. It is very thin, beige, smooth patch measures 1 3/4 inches on each of its four sides.

What is it used for ?
The Ortho Evra birth control patch is a highly effective ( 99%) , weekly hormonal birth control patch that is worn on the skin to prevent pregnancy. It is worn for one week and replaced on the same day of the week for three consecutive weeks, with the fourth week "patch-free." It prevents pregnancy the same way as birth control pills by preventing ovulation, which means that the ovary does not release an egg to be fertilized. It also causes changes to the cervical mucus, which makes it more difficult for sperm to enter the uterus.

Common Brand Name(S):
Ortho Evra

How is it used?
Ortho Evra uses a 28-day, or four-week cycle. You should apply a new patch on the same day of the week for three consecutive weeks, for a total of 21 days. You should not apply a patch during the fourth week. Your menstrual period should start during this "patch-free" week. Every new patch should be applied on the same day of each week. You should wear only one birth control patch at a time.On the day after week four ends, you should begin a new four-week cycle by applying a new birth control patch.

Do not apply the patch to the breast(s), the area around the breast(s); to red, cut, or irritated skin; or over other topical products (e.g., make-up, creams, lotions, powders).

If the medication patch accidentally comes off, is removed, or if it becomes detached, apply a new patch. If it is detached or comes off for longer than 24 hours, or if you are not sure how long the patch has been detached or removed, use additional forms of birth control (e.g., condoms, spermicide) for at least 7 days and continue with the same cycle. After removing each patch, fold the patch in half so it sticks to itself and discard it in a trash container. Do not discard or flush the patches down a toilet.

If you weigh more than 198 pounds (90 kg), this patch may not work as well for you. Make sure your doctor knows your current weight and ask about which form of birth control is best for you. If any of this information is unclear, consult the Patient Information Leaflet or your doctor or pharmacist.

What are the side effects ?
Most side effects of the contraceptive patch are not serious and those that are, occur infrequently. Serious risks, which can be life threatening, include blood clots, stroke or heart attacks and are increased if you smoke cigarettes. Some women should not use the contraceptive patch, including women who have blood clots, certain cancers, a history of heart attack or stroke, as well as those who are or may be pregnant.

What precautions should you keep in mind while taking Ortho Evra Patch ?
You should not use Ortho Evra if you have any of the following conditions:

•  A history of heart attack or stroke

•  Blood clots in the legs (thrombophlebitis), lungs (pulmonary embolism), or eyes

•  A history of blood clots in the deep veins of your legs

•  Chest pain (angina pectoris)

•  Known or suspected breast cancer or cancer of the lining of the uterus, cervix, or vagina

•  Unexplained vaginal bleeding until your healthcare professional reaches a diagnosis

•  Hepatitis or yellowing of the whites of your eyes or of the skin (jaundice) during pregnancy or during previous use of hormonal contraceptives such as ORTHO EVRA, NORPLANT, or the birth control pill

•  Liver tumor (benign or cancerous)

•  Known or suspected pregnancy

•  Severe high blood pressure

•  Diabetes with complications of the kidneys, eyes, nerves or blood vessels

•  Headaches with neurological symptoms

•  Use of oral contraceptives, birth control pills

•  Disease of heart valves with complications

•  Need for a prolonged period of bed rest following major surgery

•  An allergic reaction to any of the components of ORTHO EVRA

You should not use Ortho Evra if you are pregnant or think you may become pregnant.

How does Ortho Evra Patch interact with other Drugs?
As with all prescription products, you should notify your doctor of any other medications you are taking. Ortho Evra patch, interacts with some drugs:

•  Some drugs decrease the effectiveness of Ortho Evra : These include rifampin, drugs for epilepsy such as barbiturates (for example, phenobarbital), anticonvulsants such as topiramate (TOPAMAX®), carbamazepine (Tegretol® manufactured by Novartis Pharmaceuticals is one brand of this drug), phenytoin (Dilantin® manufactured by Parke-Davis is one brand of this drug), certain drugs used in the treatment of HIV or AIDS, and possibly some antibiotics.

•  Pregnancies and breakthrough bleeding have been reported by users of combination birth control pills who also use some form of St. John's Wort.

What to do if you forget to change the patch?
•  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. You should apply the first patch of your new cycle as soon as you remember. You must use back-up contraception, such as condoms, spermicide, or diaphragm, for the first week of the new cycle.

•  In the middle of the patch cycle (Week Two/Day 8 or Week Three/Day 15) ,for one or two days (up to 48 hours) : You should apply a new patch immediately. The next patch should be applied on the usual "Patch Change Day." No back-up contraception is needed.

•  For more than two days (48 hours or more), you may not be protected from pregnancy. You should stop the current contraceptive cycle and start a new four-week cycle immediately by putting on a new patch. There is now a new "Patch Change Day" and a new "Day 1." You must use back-up contraception for one week.

•  At the end of the patch cycle (Week Four/Day 22) , Week Four (Day 22): If you forget to remove your patch, you should take it off as soon as you remember. The next cycle should be started on the usual "Patch Change Day," which is the day after Day 28. No back-up contraception is needed.

•  There should not be more than a seven-day patch-free interval between cycles: If there are more than seven patch-free days, and back-up contraception, such as condoms, spermicide, or diaphragm, must be used for seven days. If coital exposure has occurred during such an extended patch-free interval, the possibility of fertilization should be considered.

How should you store Ortho Evra Patch?
Ortho Evra birth control patches should be stored in their protective pouches. It should be applied immediately to skin upon removal from the protective pouch. It should be stored at room temperature, (25°C or 77°F), with short variations in other temperatures permitted (to 15-30°C, 59-86°F). Do not store in the refrigerator or freezer.

Warning:
Smoking cigarettes while using Ortho Evra Patch increases your chance of having heart problems. Do not smoke while using Ortho Evra Patch. The risk of heart problems increases with age (in women greater than 35 years of age) and with frequent smoking (15 cigarettes per day or greater).

Consult your doctor or pharmacist. Use of Ortho Evra Patch does not protect you or your partner against sexually transmitted diseases (e.g., HIV, gonorrhea).

Notes:
Do not share this medication patch with others. Keep all appointments with your doctor and when having laboratory tests performed. You should have a complete physical exam including blood pressure, breast exams, pelvic exams, and PAP smears at least once a year.