Country: Amerika Syarikat
Bahasa: Inggeris
Sumber: NLM (National Library of Medicine)
ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U), NORETHINDRONE ACETATE (UNII: 9S44LIC7OJ) (NORETHINDRONE - UNII:T18F433X4S)
RPK Pharmaceuticals, Inc.
PRESCRIPTION DRUG
Tarina Fe 1/20 is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table I 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. Adapted from RA Hatcher et al, Reference 7. * 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 other reason. ** 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
Tarina Fe® 1/20 (norethindrone acetate and ethinyl estradiol tablets USP, 1 mg/0.02 mg and ferrous fumarate tablets, 75 mg) are packaged in a carton (NDC 50102-128-03) of three pouches (NDC 50102-128-01); each pouch contains a blister pack of 28 tablets. Each blister pack contains 21 white to off-white, round, flat-faced, unscored tablet debossed with 239 on one side and plain on the other side and 7 brown, round, flat-faced, unscored tablets debossed with 291 on one side and plain on the other side. Each brown tablet contains 75 mg ferrous fumarate. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]
Abbreviated New Drug Application
TARINA FE 1/20 - NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL RPK PHARMACEUTICALS, INC. ---------- TARINA® FE 1/20 (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS, USP AND FERROUS FUMARATE TABLETS) Rx only TARINA FE 1/20 (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS USP, 1 MG/0.02 MG AND FERROUS FUMARATE TABLETS, 75 MG ) Ferrous Fumarate Tablets are not USP for dissolution and assay. PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT AGAINST HIV INFECTION (AIDS) AND OTHER SEXUALLY TRANSMITTED DISEASES. DESCRIPTION Tarina Fe 1/20 tablets are a progestogen-estrogen combination. Tarina Fe 1/20 provide a continuous dosage regimen consisting of 21 oral contraceptive tablets and seven ferrous fumarate tablets. The ferrous fumarate tablets are present to facilitate ease of drug administration via a 28-day regimen, are non-hormonal, and do not serve any therapeutic purpose. Each white to off-white tablet contains norethindrone acetate (19-Norpregn-4-en-20-yn-3-one, 17- (acetyloxy)-, (17α) ), 1 mg; ethinyl estradiol 19-Norpregna-1,3,5(10)-trien-20-yne-3, 17-diol, (17α)- , 0.02 mg. Also contains lactose anhydrous, _dl_-α-tocopherol, compressible sugar, crosscarmellose sodium, lactose monohydrate, magnesium stearate, povidone K-25, sodium lauryl sulphate. The structural formulas are as follows: Each brown tablet contains colloidal silicon dioxide, crosscarmellose sodium, ferrous fumarate, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone K-90. 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). PHARMACOKINETICS The pharmacokinetics of norethindrone acetate and ethinyl estradiol tablets have not been characterized; however, the following pharmacokinetic information regarding n Baca dokumen lengkap