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Ortho Evra

Generic Name: 

Norelgestromin, ethinyl estradiol

Brand Names: 

Ortho Evra

Ortho Evra Description: 

Marketed by Ortho-McNeil-Janssen Pharmaceuticals, Ortho Evra is a combination transdermal contraceptive patch. The active ingredients, synthetic estrogen and progestin, are slowly released for absorption through the skin and used in the body to prevent pregnancy as effectively as a contraceptive pill. Because of its transdermal nature, the Ortho Evra patch contains elevated levels of estrogen when compared to typical birth control pills. This increases risks for certain side effects when compared to the pill. Side effects range from mild to severe, including venous thromboembolic events (blood clots) in the legs or lungs of its users. The patch is manufactured in a single design with no variations in size or dosage.

Ortho Evra Uses: 

Ortho Evra is prescribed for the prevention of pregnancy and as an alternative to contraceptive pills.

Possible alternative uses of Ortho Evra include the treatment of acne, premenstrual dysphoric disorder (PMDD), and irregular menstrual cycles. Using Ortho Evra as treatment for such conditions has not been thoroughly tested and little or no studies have been performed.

Ortho Evra, like other contraceptive pills, does not protect the user or her sexual partner against HIV or other sexually transmitted diseases (STDs).

Ortho Evra Interactions: 

Adverse reactions have been reported with the use of combination hormonal contraceptives as well as drug interactions with anti-HIV protease inhibitors, herbal products, and co-administered drugs that can increase or change plasma hormone levels.

Interactions may occur with many other drugs, so check with your doctor before taking acetaminophen, antibiotics, anticonvulsants, aspirin, atorvastatin, barbiturates, clofibrate, cyclosporine, diabetes medications, folic acid, morphine, phenylbutazone, prednisolone, St. John’s wort, temazepam, theophylline, and Vitamin C.

Ortho Evra Dosage Information: 

Typical Dosage Recommendation:

Ortho Evra is a transdermal patch that is applied directly to the skin on areas where it will not be rubbed off by clothing, including the buttock, upper torso (except the breasts), abdomen, or upper outer arm. Consecutive applications of the patch should include the alternation of these four locations on the body as a means of reducing or avoiding possible skin irritations.

Ortho Evra is used in a 4-week cycle consisting of 3 weeks of continuous use followed by one week of the absence of the patch. For first time users, the patch should be applied on the day that the menstrual period begins. The changing of the patch throughout the first 3 weeks of its use should be performed on the same day every week. This means that a new patch should be applied immediately following the removal of the old, except on the start of the fourth week, which is the patch-free week.

Users should not exceed 7 days of patch-free use during the fourth week, or risk the possibility of pregnancy on the next cycle.

Missing a Dose:

If the patch becomes loose or falls off for less than one day, try to re-stick it, or apply a new patch immediately. If you suspect the patch has been missing for more than one day, there is a chance you could become pregnant, so use a backup form of birth control.

Overdosing:

There is little risk of overdosing associated with Ortho Evra, since the patch releases such a small amount of hormones at a slow rate. If you suspect an overdose, seek medical help. Symptoms of overdose include nausea, vomiting, and vaginal bleeding.

Ortho Evra FDA Approval: 

November 20, 2001

Ortho Evra Recall/Black Box Warning Information: 

There is a Black Box warning on Ortho Evra concerning the risk of cardiovascular side effects associated with cigarette smoking and using the patch. The risk increases with age and with heavy smoking (15 or more cigarettes per day), and women over the age of 35 are particularly at risk. Patients are strongly advised not to smoke while using Ortho Evra to avoid the formation of deadly blood clots which develop in the legs and could travel to the lungs.

On November 10, 2005, The FDA updated the Ortho Evra labeling in November of 2005 to warn women that they are exposed to higher levels of estrogen than from taking normal birth control pills. The patch delivers about 60 percent more estrogen than the pill at peak absorption times, an increase that further heightens the risk of blood clots.

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