Χώρα: Ηνωμένες Πολιτείες
Γλώσσα: Αγγλικά
Πηγή: NLM (National Library of Medicine)
DESOGESTREL (UNII: 81K9V7M3A3) (DESOGESTREL - UNII:81K9V7M3A3), ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U)
RPK Pharmaceuticals, Inc.
PRESCRIPTION DRUG
EMOQUETTE® (desogestrel and ethinyl estradiol tablets USP) tablets are 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 1 lists the typical accidental pregnancy rates for users of combined oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and the Norplant System depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates. In a clinical trial with EMOQUETTE® , 1,195 subjects completed 11,656 cycles and a total of 10 pregnancies were reported. This represents an overall user-efficacy (typical user-efficacy) pregnancy rate of 1.12 per 100 women-years. This rate includes patients who did not take the drug correctly. % of Women Experiencing an Unintended Pregnancy Within the First Year of Use Typical Use1 (2) Perfect Use2 (3) Emerg
EMOQUETTE® (desogestrel and ethinyl estradiol tablets USP) is packaged in cartons of 3 and 6 blister pack tablet dispensers; each blister pack tablet dispenser contains 28 tablets. Each white tablet contains 0.15 mg desogestrel and 0.03 mg ethinyl estradiol. Each light-green tablet contains inert ingredients. The white tablets are round, film-coated, imprinted with “93” on one side and “876” on the other side; the light-green tablets are round, film-coated imprinted with “93” on one side, and “743” on the other side. Blister pack tablet dispenser NDC 0603-7540-01 Boxes of 3 blister pack tablet dispensers NDC 0603-7540-49 Boxes of 6 blister pack tablet dispensers NDC 0603-7540-17
Abbreviated New Drug Application
EMOQUETTE- DESOGESTREL AND ETHINYL ESTRADIOL RPK PHARMACEUTICALS, INC. ---------- EMOQUETTE (DESOGESTREL AND ETHINYL ESTRADIOL TABLETS USP) 0.15 MG AND 0.03 MG RX ONLY WARNING: 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 EMOQUETTE , 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 EMOQUETTE (desogestrel and ethinyl estradiol tablets USP) tablets provide an oral contraceptive regimen of 21 white 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). Inactive ingredients include colloidal silicon dioxide, hypromellose, lactose monohydrate, povidone, polyethylene glycol, pregelatinized starch, stearic acid and vitamin E. Each light-green tablet contains the following inactive ingredients: FD&C Blue No. 2 aluminum lake, hypromellose, iron oxide yellow, lactose monohydrate, magnesium stearate, polyethylene glycol, and pregelatinized starch. ® ® ® ® Emoquette meets 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 changes in the cervical mucus, which increase the difficulty of sperm entry into the uterus, and changes in the endometrium which reduce the likelihood of implantation. Receptor binding studies, as well as studies in animals, have shown that 3-keto-desogestrel, the biologically active metabolite of desogestrel, combines high proges Διαβάστε το πλήρες έγγραφο