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Ortho Evra Patches

Chemical Name : Norelgestromin/Ethinyl Estradiol

Ortho Evra Patches Information : Ortho Evra (NORELGESTROMIN / ETHINYL ESTRADIOL) is now available for prescription from your doctor. Ortho Evra (NORELGESTROMIN / ETHINYL ESTRADIOL) is a once-a-week birth control option that's as effective as the Pill. Ortho Evra (NORELGESTROMIN / ETHINYL ESTRADIOL) is the first weekly, non-invasive form of reversible contraception that's 99 percent effective when used correctly. Just change your Ortho Evra (NORELGESTROMIN / ETHINYL ESTRADIOL) patch once a week for three consecutive weeks. You do not need to apply a Ortho Evra (NORELGESTROMIN / ETHINYL ESTRADIOL) patch during the fourth week. You can decide with your doctor or healthcare professional when to start wearing Ortho Evra (NORELGESTROMIN / ETHINYL ESTRADIOL) -- either on the first day of your period, or on the first Sunday after your period starts. You should change your contraceptive Ortho Evra (NORELGESTROMIN / ETHINYL ESTRADIOL) patch on the same day each week. The time of day that you change Ortho Evra (NORELGESTROMIN / ETHINYL ESTRADIOL) does not matter. When you are ready to apply a new contraceptive Ortho Evra (NORELGESTROMIN / ETHINYL ESTRADIOL) patch, first choose where you want to wear Ortho Evra (NORELGESTROMIN / ETHINYL ESTRADIOL). Then carefully apply the Ortho Evra (NORELGESTROMIN / ETHINYL ESTRADIOL) patch to clean, dry skin, following the instructions of your doctor or pharmacist. If a Ortho Evra (NORELGESTROMIN / ETHINYL ESTRADIOL) patch seems loose or has been off or partially off for less than 24 hours, you should try to reapply Ortho Evra (NORELGESTROMIN / ETHINYL ESTRADIOL) or apply a new Ortho Evra (NORELGESTROMIN / ETHINYL ESTRADIOL) patch immediately. No back-up contraception is needed and the "Patch Change Day" will remain the same. You can swim, exercise, bathe, shower, and wear the Ortho Evra (NORELGESTROMIN / ETHINYL ESTRADIOL) patch in warm, humid conditions. And because Ortho Evra (NORELGESTROMIN / ETHINYL ESTRADIOL) is so thin, you can easily wear Ortho Evra (NORELGESTROMIN / ETHINYL ESTRADIOL) patch under your clothes. Ortho Evra (NORELGESTROMIN / ETHINYL ESTRADIOL) is indicated for the prevention of pregnancy. Ortho Evra (NORELGESTROMIN / ETHINYL ESTRADIOL) is not for everyone. Women should speak with their doctor or pharmacist about which birth control method is right for them. The contraceptive Ortho Evra (NORELGESTROMIN / ETHINYL ESTRADIOL) patch contains hormones similar to those in birth control pills.

Ortho Evra Patches Side Effects : Please ask your pharmacist for a more detailed list of Ortho Evra side effects. Ortho Evra birth control patch does not protect against HIV infection (AIDS) and other sexually transmitted diseases. ORTHO EVRA® should not be used in women who currently have the following conditions otherwise they might result in Ortho Evra side effects:
• Thrombophlebitis, thromboembolic disorders
A past history of deep vein thrombophlebitis or thromboembolic disorders
• Cerebrovascular or coronary artery disease (current or past history)
• Valvular heart disease with complications
• Severe hypertension103
• Diabetes with vascular involvement
• Headaches with focal neurological symptoms
• Major surgery with prolonged immobilization
• Known or suspected carcinoma of the breast or personal history of breast cancer
• Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia
• Undiagnosed abnormal genital bleeding
• Cholestatic jaundice of pregnancy or jaundice with prior hormonal contraceptive use
• Acute or chronic hepatocellular disease with abnormal liver function
• Hepatic adenomas or carcinomas • Known or suspected pregnancy
• Hypersensitivity to any component of this product

The Ortho Evra birth control patch delivers hormones directly through your skin and into your bloodstream. This may help eliminate some of the disadvantages associated with other birth control methods. To achieve maximum contraceptive effectiveness, Ortho Evra birth control patches must be used exactly as directed. Transdermal Contraceptive System Overview This system uses a 28-day (four-week) cycle. A new patch is applied each week for three weeks (21 total days). Week Four is patch-free. Withdrawal bleeding is expected during this time. Every new patch should be applied on the same day of the week. This day is known as the “Patch Change Day.” For example, if the first patch is applied on a Monday, all subsequent patches should be applied on a Monday. Only one ORTHO EVRA patch should be worn at a time. On the day after Week Four ends a new four-week cycle is started by applying a new ORTHO EVRA patch. Under no circumstances should there be more than a seven-day patch-free interval between dosing cycles. If the woman is starting ORTHO EVRA for the first time, she should wait until the day she begins her menstrual period. Either a First Day start or Sunday start may be chosen (see below). The day she applies her first patch will be Day 1. Her “Patch Change Day” will be on this day every week. • for First Day Start: the patient should apply her first patch during the first 24 hours of her menstrual period. If therapy starts after Day 1 of the menstrual cycle, a non-hormonal back-up contraceptive (such as a condoms, spermicide, or diaphragm) should be used concurrently for the first 7 consecutive days of the first treatment cycle. OR • for Sunday Start: the woman should apply her first patch on the first Sunday after her menstrual period starts. She must use back-up contraception for the first week of her first cycle. If the menstrual period begins on a Sunday, the first patch should be applied on that day, and no back-up contraception is needed. Where to apply the patch. The patch should be applied to clean, dry, intact healthy skin on the buttock, abdomen, upper outer arm or upper torso, in a place where it won’t be rubbed by tight clothing. ORTHO EVRA should not be placed on skin that is red, irritated or cut, nor should it be placed on the breasts. To prevent interference with the adhesive properties of ORTHO EVRA®, no make-up, creams, lotions, powders or other topical products should be applied to the skin area where the ORTHO EVRA® patch is or will be placed. Application of the ORTHO EVRA patch The foil pouch is opened by tearing it along the edge using the fingers. The foil pouch should be peeled apart and open flat. A corner of the patch is grasped firmly and it is gently removed from the foil pouch. The woman should be instructed to use her fingernail, to lift one corner of the patch and peel the patch and the plastic liner off the foil liner. Sometimes patches can stick to the inside of the pouch – the woman should be careful not to accidentally remove the clear liner as she removes the patch. Half of the clear protective liner is to be peeled away. (The woman should avoid touching the sticky surface of the patch). The sticky surface of the patch is applied to the skin and the other half of the liner is removed. The woman should press down firmly on the patch with the palm of her hand for 10 seconds, making sure that the edges stick well. She should check her patch every day to make sure it is sticking. The patch is worn for seven days (one week). On the “Patch Change Day”, Day 8, the used patch is removed and a new one is applied immediately. The used patch still contains some active hormones – it should be carefully folded in half so that it sticks to itself before safely disposing of it in the trash. Used patches should not be flushed down the toilet. A new patch is applied for Week Two (on Day 8) and again for Week Three (on Day 15), on the usual “Patch Change Day”. Patch changes may occur at any time on the Change Day. Each new ORTHO EVRA® patch should be applied to a new spot on the skin to help avoid irritation, although they may be kept within the same anatomic area. Week Four is patch-free (Day 22 through Day 28), thus completing the four-week contraceptive cycle. Bleeding is expected to begin during this time. The next four-week cycle is started by applying a new patch on the usual “Patch Change Day,” the day after Day 28, no matter when the menstrual period begins or ends. Under no circumstances should there be more than a seven-day patch-free interval between patch cycles. If the ORTHO EVRA patch becomes partially or completely detached and remains detached, insufficient drug delivery occurs. If a patch is partially or completely detached: • for less than one day (up to 24 hours), the woman should try to reapply it to the same place or replace it with a new patch immediately. No back-up contraception is needed. The woman’s “Patch Change Day” will remain the same. • for more than one day (24 hours or more) OR if the woman is not sure how long the patch has been detached, SHE MAY NOT BE PROTECTED FROM PREGNANCY. She should stop the current contraceptive cycle and start a new cycle immediately by applying a new patch. There is now a new “Day 1” and a new “Patch Change Day.” Back-up contraception, such as condoms, spermicide, or diaphragm, must be used for the first week of the new cycle. A patch should not be re-applied if it is no longer sticky, if it has become stuck to itself or another surface, if it has other material stuck to it or if it has previously become loose or fallen off. If a patch cannot be re-applied, a new patch should be applied immediately. Supplemental adhesives or wraps should not be used to hold the ORTHO EVRA® patch in place. If the woman forgets to change her patch… • at the start of any patch cycle (Week One /Day 1): SHE MAY NOT BE PROTECTED FROM PREGNANCY. She should apply the first patch of her new cycle as soon as she remembers. There is now a new “Patch Change Day” and a new “Day 1.” The woman 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), she should apply a new patch immediately. The next patch should be applied on the usual “Patch Change Day.” No back-up contraception is needed. (See Figures 3 and 4 in the Clinical Pharmacology section.) - for more than two days (48 hours or more), SHE MAY NOT BE PROTECTED FROM PREGNANCY. She 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.” The woman must use back-up contraception for one week. • at the end of the patch cycle (Week Four/Day 22), Week Four (Day 22): If the woman forgets to remove her patch, she should take it off as soon as she remembers. 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. Under no circumstances should there be more than a seven-day patch-free interval between cycles. If there are more than seven patch-free days, THE WOMAN MAY NOT BE PROTECTED FROM PREGNANCY and back-up contraception, such as condoms, spermicide, or diaphragm, must be used for seven days. As with combined oral contraceptives, the risk of ovulation increases with each day beyond the recommended drug-free period. If coital exposure has occurred during such an extended patch-free interval, the possibility of fertilization should be considered. Change Day Adjustment If the woman wishes to change her Patch Change Day she should complete her current cycle, removing the third ORTHO EVRA patch on the correct day. During the patch-free week, she may select an earlier Patch Day Change by applying a new ORTHO EVRA patch on the desired day. In no case should there be more than 7 consecutive patch-free days. Switching from an Oral Contraceptive Treatment with ORTHO EVRA should begin on the first day of withdrawal bleeding. If there is no withdrawal bleeding within 5 days of the last active (hormone-containing) tablet, pregnancy must be ruled out. If therapy starts later than the first day of withdrawal bleeding, a non-hormonal contraceptive should be used concurrently for 7 days. If more than 7 days elapse after taking the last active oral contraceptive tablet, the possibility of ovulation and conception should be considered. Use after Childbirth Women who elect not to breast-feed should start contraceptive therapy with ORTHO EVRA no sooner than 4 weeks after childbirth. If a woman begins using ORTHO EVRA postpartum, and has not yet had a period, the possibility of ovulation and conception occurring prior to use of ORTHO EVRA should be considered, and she should be instructed to use an additional method of contraception, such as condoms, spermicide, or diaphragm, for the first seven days. (See Precautions: Nursing Mothers, and Warnings: Thromboembolic and Other Vascular Problems.) Use after Abortion or Miscarriage106 After an abortion or miscarriage that occurs in the first trimester, ORTHO EVRA may be started immediately. An additional method of contraception is not needed if ORTHO EVRA is started immediately. If use of ORTHO EVRA is not started within 5 days following a first trimester abortion, the woman should follow the instructions for a woman starting ORTHO EVRA for the first time. In the meantime she should be advised to use a non-hormonal contraceptive method. Ovulation may occur within 10 days of an abortion or miscarriage. ORTHO EVRA should be started no earlier than 4 weeks after a second trimester abortion or miscarriage. When ORTHO EVRA is used postpartum or postabortion, the increased risk of thromboembolic disease must be considered.

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