Ország: Egyesült Államok
Nyelv: angol
Forrás: NLM (National Library of Medicine)
LEVONORGESTREL (UNII: 5W7SIA7YZW) (LEVONORGESTREL - UNII:5W7SIA7YZW), ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U)
Sandoz Inc
LEVONORGESTREL
LEVONORGESTREL 0.15 mg
PRESCRIPTION DRUG
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 and the IUD, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. TABLE 1: PERCENTAGE OF WOMEN EXPERIENCING AN UNINTENDED PREGNANCY DURING THE FIRST YEAR OF USE OF A CONTRACEPTIVE METHOD Method Perfect Use Typical Use Levonorgestrel implants 0.05 0.05 Male sterilization 0.1 0.15 Female sterilization 0.5 0.5 Depo-Provera® (injectable progestogen) 0.3 0.3 Oral contraceptives 5 Combined 0.1 NA Progestin only 0.5 NA IUD Progesterone 1.5 2 Copper T 380A 0.6 0.8 Condom (male) without spermicide 3 14 (Female) without spermicide 5 21 Cervical cap Nulliparous women 9 20 Par
AltaveraTM tablets (levonorgestrel and ethinyl estradiol, USP) are available as follows: Each blister card contains 21 active tablets and 7 inactive tablets. The 21 active tablets are peach, round, film-coated, debossed with SZ on one side and L3 on the other side. The 7 inert tablets are white, round, film-coated, debossed with SZ on one side and J1on the other side. NDC 0781-5583-15, one carton containing 3 individual blister cartons STORAGE Store at 20° to 25° C (68° to 77° F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
ALTAVERA- LEVONORGESTREL AND ETHINYL ESTRADIOL SANDOZ INC ---------- ALTAVERA (LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS, USP) 0.15 MG/0.03 MG RX ONLY PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT AGAINST HIV INFECTION (AIDS) AND OTHER SEXUALLY TRANSMITTED DISEASES. DESCRIPTION 21 peach Altavera tablets, each containing 0.15 mg of levonorgestrel, (d(-)-13 beta-ethyl-17-alpha- ethinyl-17-beta-hydroxygon-4-en-3-one), a totally synthetic progestogen, and 0.03 mg of ethinyl estradiol, (19-nor-17α-pregna-1,3,5(10)-trien-20-yne-3,17-diol), and 7 white inert tablets. The inactive ingredients present in the active tablet are: lactose anhydrous, iron oxide black, iron oxide red, iron oxide yellow, magnesium stearate, polyethylene glycol, polyvinyl alcohol-part hydrolyzed, povidone, talc, titanium dioxide. The inactive ingredients present in the inert/placebo tablet are: lactose anhydrous, magnesium stearate, polyethylene glycol, polyvinyl alcohol-part hydrolyzed, povidone, talc, titanium dioxide. TM TM CLINICAL PHARMACOLOGY Combination oral contraceptives act by suppression of gonadotropins. Although the primary mechanism of this action is inhibition of ovulation, other alterations include changes in the cervical mucus (which increase the difficulty of sperm entry into the uterus) and the endometrium (which reduce the likelihood of implantation). 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 and the IUD, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. TABLE 1: PERCENTAGE OF WOMEN EXPERIENCING AN UNINTENDED PREGNANCY DURING THE FIRST YEAR OF USE OF A CONTRACEPTIVE METHOD METHO Olvassa el a teljes dokumentumot