Země: Spojené státy
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
DESOGESTREL (UNII: 81K9V7M3A3) (DESOGESTREL - UNII:81K9V7M3A3)
Northstar Rx LLC
DESOGESTREL
DESOGESTREL 0.15 mg
PRESCRIPTION DRUG
Abbreviated New Drug Application
DESOGESTREL AND ETHINYL ESTRADIOL- DESOGESTREL AND ETHINYL ESTRADIOL NORTHSTAR RX LLC ---------- DESOGESTREL AND ETHINYL ESTRADIOL TABLETS, USP, 0.15 MG /0.03 MG WARNINGS: CARDIOVASCULAR RISK ASSOCIATED WITH SMOKING Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, combination oral contraceptives, including Desogestrel and Ethinyl Estradiol tablets, should not be used by women who are over 35 years of age and smoke. PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT AGAINST HIV INFECTION (AIDS) AND OTHER SEXUALLY TRANSMITTED DISEASES. DESCRIPTION Desogestrel and ethinyl estradiol tablets USP, provide an oral contraceptive regimen of 21 yellow round tablets each containing 0.15 mg desogestrel (13-ethyl-11-methylene-18,19-dinor-17 alpha-pregn- 4-en- 20-yn-17-ol) and 0.03 mg ethinyl estradiol (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne- 3,17,diol). Each “active” yellow tablet with “S3” debossed on one side contains the following inactive ingredients: lactose monohydrate, pregelatinized corn starch, povidone, stearic acid, vitamin E, HPMC/hypromellose, titanium dioxide, macrogol/polyethylene glycol, D&C Yellow No. 10 Aluminum Lake, FD&C Yellow No. 6 Aluminium Lake, Iron Oxide Yellow, FD&C Red No. 40 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake. Each “inactive” reminder white, biconvex, round tablets debossed with “P” on one side and “N” on the other side, contains the following inactive ingredients: titanium dioxide, polydextrose, hypromellose, triacetin, polyethylene glycol, lactose, magnesium stearate, and pregelatinized corn starch. The 21 yellow tablets meet USP Dissolution Test 2. CLINICAL PHARMACOLOGY PHARMACODYNAMICS Combined oral contraceptives act by suppression of gonadotropins. Although the primary mechanism of this action is inhibition of ovulation, other alterations include cha Přečtěte si celý dokument