Ortho Evra (Norelgestromin, Ethinyl Estradiol)

Ortho Evra Review

Ortho Evra is a contraceptive (birth control) skin patch used to prevent pregnancy. It is a combination hormonal contraceptive because it contains two hormones, estrogen and progestin. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

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Ortho Evra Drug Class and Mechanism

Like all combined hormonal contraceptives, Ortho Evra / Evra works primarily by preventing ovulation. A secondary mechanism of action is inhibition of sperm penetration by changes in the cervical mucus. Hormonal contraceptives also have effects on the endometrium that theoretically could affect implantation, however no scientific evidence indicates that prevention of implantation actually results from their use. The 20 cm? Ortho Evra contraceptive patch contains 750 µg ethinyl estradiol (an estrogen) and 6000 µg norelgestromin (a progestin). The 20 cm? Evra contraceptive patch contains 600 µg ethinyl estradiol and 6000 µg norelgestromin.[3] The Ortho Evra contraceptive patch and the Evra contraceptive patch are both intended to gradually release into the systemic circulation approximately 20 µg/day of ethinyl estradiol and 150 µg/day of norelgestromin.

Ortho Evra Uses

ORTHO EVRA® is indicated for the prevention of pregnancy in women who elect to use a transdermal patch as a method of contraception. The pharmacokinetic profile for the ORTHO EVRA® transdermal patch is different from that of an oral contraceptive. Healthcare professionals should balance the higher estrogen exposure and the possible increased risk of venous thromboembolism with ORTHO EVRA®against the chance of pregnancy if a contraceptive pill is not taken daily. . Like oral contraceptives, ORTHO EVRA® is highly effective if used as recommended in this label. In 3 large clinical trials in North America, Europe and South Africa, 3,330 women (ages 18-45) completed 22,155 cycles of ORTHO EVRA® use, pregnancy rates were approximately 1 per 100 women-years of ORTHO EVRA® use. The racial distribution was 91% Caucasian, 4.9% Black, 1.6% Asian, and 2.4% Other. With respect to weight, 5 of the 15 pregnancies reported with ORTHO EVRA® use were among women with a baseline body weight ? 198 lbs. (90kg), which constituted < 3% of the study population. The greater proportion of pregnancies among women at or above 198 lbs. was statistically significant and suggests that ORTHO EVRA® may be less effective in these women. Health Care Professionals who consider ORTHO EVRA® for women at or above 198 lbs. should discuss the patient's individual needs in choosing the most appropriate contraceptive option.

Ortho Evra Side Effects

In three large clinical trials involving a total of 3,330 women using the Ortho Evra / Evra patch for up to one year, 12% of users discontinued the patch because of adverse events. The most frequent adverse events leading to patch discontinuation were: nausea and/or vomiting (2.4%), application site reaction (1.9%), breast discomfort, engorgement or pain (1.9%), headache (1.1%), and emotional lability (1.0%). The most frequent adverse events reported while using the Ortho Evra / Evra patch were: breast discomfort, engorgement or pain (22%), headache (21%), application site reaction (17%), nausea (17%), upper respiratory tract infection (10%), menstrual cramps (10%), and abdominal pain (9%). Breakthrough bleeding and/or spotting while using the Ortho Evra / Evra patch was reported by: 18% in cycle 1, 12% in cycle 3, 8% in cycle 6 and cycle 13. Breakthrough bleeding (requiring more than one pad or tampon per day) was reported by: 4% in cycle 1, 3% in cycle 3 and cycle 6, and 1% in cycle 13. Additional side effect information is provided in the Ortho Evra label information and the Evra SPC and PIL

Ortho Evra Pregnancy

Ortho Evra Overdose

Serious ill effects have not been reported following accidental ingestion of large doses of hormonal contraceptives. Overdosage may cause nausea and vomiting, and withdrawal bleeding may occur in females. Given the nature and design of the ORTHO EVRA® patch, it is unlikely that overdosage will occur. Serious ill effects have not been reported following acute ingestion of large doses of oral contraceptives by young children. In case of suspected overdose, all ORTHO EVRA® patches should be removed and symptomatic treatment given.

Ortho Evra More Information

Your health care professional will take a medical and family history before prescribing Ortho Evra and will examine you. You should be reexamined at least once a year. Be sure to inform your health care professional if there is a family history of any of the conditions listed previously in this leaflet. Be sure to keep all appointments with your health care professional, because this is a time to determine if there are early signs of side effects of hormonal contraceptive use. Do not use the drug for any condition other than the one for which it was prescribed. This drug has been prescribed specifically for you; do not give it to others who may want birth control. If you want more information about Ortho Evra, ask your health care professional or pharmacist.