Ortho Evra

[NORELGESTROMIN - ETHINYL ESTRADIOL]

Indications & Dosage
INDICATIONS AND USAGE

ORTHO EVRAŽ is indicated for the prevention of pregnancy.

Like oral contraceptives, ORTHO EVRAŽ 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 EVRAŽ use, pregnancy rates were approximately 1 per 100 women-years of ORTHO EVRAŽ use. The racial distribution was 91% Caucasian, 4.9% Black, 1.6% Asian, and 2.4% Other.

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With respect to weight, 5 of the 15 pregnancies reported with ORTHO EVRAŽ 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 EVRAŽ may be less effective in these women.

Health Care Professionals who consider ORTHO EVRAŽ for women at or above 198 lbs. should discuss the patient’s individual needs in choosing the most appropriate contraceptive option.

Table 2 lists the accidental pregnancy rates for users of various methods of contraception. The efficacy of these contraceptive methods, except sterilization, IUD, and Norplant depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.

Table 2: Percentage of Women Experiencing an Unintended Pregnancy During the First Year of Typical Use and the First Year of Perfect Use of Contraception and the Percentage Continuing Use at the End of the First Year. United States. % of Women Experiencing an Unintended % of Women Pregnancy within the First Year of Use Continuing Use at One Year3

Method Typical Use1 Perfect Use2
(1) (2) (3) (4)
Chance4 85 85
Spermicides5 26 6 40
Periodic abstinence 25 63
Calendar 9
Ovulation Method 3
Sympto-Thermal6 2
Post-Ovulation 1
Cap7
Parous Women 40 26 42
Nulliparous Women 20 9 56
Sponge
Parous Women 40 20 42
Nulliparous Women 20 9 56
Diaphragm7 20 6 56
Withdrawal 19 4
Condom8
Female (Reality) 21 5 56
Male 14 3 61
Pill 5 71
Progestin Only 0.5
Combined 0.1
IUD
Progesterone T 2.0 1.5 81
Copper T380A 0.8 0.6 78
LNg 20 0.1 0.1 81
Depo-Provera 0.3 0.3 70
Norplant and Norplant-2 0.05 0.05 88
Female Sterilization 0.5 0.5 100
Male Sterilization 0.15 0.10 100

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