vyfemla norethindrone and ethinyl estradiol kit
INDICATIONS AND USAGE Oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptives are highly effective. Table 1 lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. TABLE 1 LOWEST EXPECTED AND TYPICAL FAILURE RATES DURING THE FIRST YEAR OF CONTINUOUS USE OF A METHOD % of Women Experiencing an Accidental Pregnancy in the First Year of Continuous Use Reproduced with permission of the Population Council from J. Trussell, et al: Contraceptive failure in the United States: An update. Studies in Family Planning, 21(1), January-February 1990. Method Lowest Expected The authors’ best guess of the percentage of women expected to experience an accidental pregnancy among couples who initiate a method (not necessarily for the first time) and who use it consistently and correctly during the first year if they do not stop for any reason other than pregnancy. Typical This term represents “typical” couples who initiate use of a method (not necessarily for the first time), who experience an accidental pregnancy during the first year if they do not stop use for any reason other than pregnancy. (No contraception) (85) (85) Oral contraceptives combined 0.1 3 Combined typical rate for both combined and progestin only. progestin only 0.5 3 Diaphragm with spermicidal cream or jelly 6 18 Spermicides alone (foam, creams, jellies and vaginal suppositories) 3 21 Vaginal sponge nulliparous 6 18 multiparous 9 28 IUD 0.8 to 2.0 3 Combined typical rate for both medicated and nonmedicated IUD. Condom without spermicides 2 12 Periodic abstinence (all methods) 1 to 9 20 Injectable progestogen 0.3 to 0.4 0.3 to 0.4 Implants 6 capsules 0.04 0.04 2 rods 0.03 0.03 Female sterilization 0.2 0.4 Male sterilization 0.1 0.15
lupin pharmaceuticals, inc.
ROUND ORANGE LU I25
LU I25 ROUND ORANGE
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HOW SUPPLIED Vyfemla (
NORETHINDRONE AND ETHINYL ESTRADIOL tablets USP) is available in blister (NDC 68180-875-71) containing 28 tablets packed in a pouch (NDC 68180-875-71). Such three pouches are packaged in a carton (NDC 68180-875-73). Each of the 21 light peach colored, round, flat face beveled edged tablets debossed with "LU" on one side and "I25" on the other side containing 0.4 mg norethindrone and 0.035 mg ethinyl estradiol. Each of the 7 white to off-white, round, biconvex tablets debossed with "LU" on one side and "U22" on other side containing inert ingredients. Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F). [See USP Controlled Room Temperature]. References are available upon request. Distributed by: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States Manufactured by: Lupin Limited Pithampur (M.P.) - 454 775 INDIA Revised: December 18, 2021
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