Negara: Amerika Serikat
Bahasa: Inggris
Sumber: NLM (National Library of Medicine)
NORETHINDRONE ACETATE (UNII: 9S44LIC7OJ) (NORETHINDRONE - UNII:T18F433X4S), ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U)
Aurobindo Pharma Limited
NORETHINDRONE ACETATE
NORETHINDRONE ACETATE 1.5 mg
ORAL
PRESCRIPTION DRUG
Aurovela 1.5/30 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. - Oral contraceptives are contraindicated in women who currently have the following conditions: - Thrombophlebitis or thromboembolic disorders - A past history of deep vein thrombophlebitis or thromboembolic disorders - Cerebral vascular or coronary artery disease - Current diagnosis of, or history of, breast cancer, which may be hormone sensitive - Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia - Undiagnosed abnormal genital bleeding - Cholestatic jaundice of pregnancy o
Aurovela® 1.5/30 (norethindrone acetate and ethinyl estradiol tablets USP, 1.5 mg/30 mcg) is white to off-white, round, flat-faced, beveled-edge, uncoated tablets, debossed with ‘S’ on one side and ‘69’ on other side of the tablet. 1 pouch of 21 tablets NDC 65862-935-21 Carton of 3 Pouches NDC 65862-935-74 Carton of 5 Pouches NDC 65862-935-54 Store at 20o to 25o C (68o to 77o F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
AUROVELA 1.5/30 - NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLET AUROBINDO PHARMA LIMITED ---------- AUROVELA 1.5/30 (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS USP) RX ONLY WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs, including Aurovela 1.5/30, are contraindicated in women who are over 35 years of age and smoke (see CONTRAINDICATIONS and WARNINGS). DESCRIPTION Aurovela 1.5/30 is progestogen-estrogen combination. Each white to off-white tablet contains norethindrone acetate USP (17 alpha-ethinyl-19- nortestosterone acetate), 1.5 mg; ethinyl estradiol USP (17 alpha -ethinyl-1,3,5(10)- estratriene-3, 17 beta-diol), 30 mcg. Each white to off-white tablet contains the following inactive ingredients: compressible sugar, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and vitamin E. The structural formulas are as follows: Meets USP Dissolution Test 2. 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 Aurovela 1.5/30 have not been characterized; however, the following pharmacokinetic information regarding norethindrone acetate and ethinyl estradiol is taken from the literature. ABSORPTION Norethindrone acetate appears to be completely and rapidly deacetylated to norethindrone after oral administration, since the disposition of norethindrone acetate is ® indistinguishable from that of orally administered norethindrone (1). Norethindrone acetate and eth Baca dokumen lengkapnya