Երկիր: Ամերիկայի Միացյալ Նահանգներ
Լեզու: անգլերեն
Աղբյուրը: NLM (National Library of Medicine)
DESOGESTREL (UNII: 81K9V7M3A3) (DESOGESTREL - UNII:81K9V7M3A3), ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U)
RPK Pharmaceuticals, Inc.
PRESCRIPTION DRUG
Azurette (Desogestrel and Ethinyl Estradiol Tablets, USP and Ethinyl Estradiol Tablets, USP) is 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 II 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 these methods can result in lower failure rates. Adapted from Hatcher et al., 1998, Ref#1. 1 Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 2 Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accid
AZURETTE® (Desogestrel and Ethinyl Estradiol Tablets, USP and Ethinyl Estradiol Tablets, USP) contain 21 round dark blue tablets, 2 round white tablets and 5 round green tablets in a blister card (NDC 51862-890-01) within a plastic dispenser. Each dark blue tablet (debossed with "M3" on one side) contains 0.15 mg desogestrel and 0.02 mg ethinyl estradiol. Each white tablet (debossed with "P" on one side and the "N " on the other side) contains inert ingredients.Each green tablet (debossed with "M4" on one side) contains 0.01 mg ethinyl estradiol. AZURETTE Tablets are available in the following configurations: Carton of 1 NDC 51862-890-02 Carton of 3 NDC 51862-890-03 Carton of 6 NDC 51862-890-06 Storage Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Rx Only
Abbreviated New Drug Application
AZURETTE - DESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL RPK PHARMACEUTICALS, INC. ---------- AZURETTE (DESOGESTREL AND ETHINYL ESTRADIOL TABLETS, USP AND ETHINYL ESTRADIOL TABLETS, USP 0.15 MG/0.02 MG AND 0.01 MG) RX ONLY PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT AGAINST HIV INFECTION (AIDS) AND OTHER SEXUALLY TRANSMITTED DISEASES. DESCRIPTION Azurette (Desogestrel and Ethinyl Estradiol tablets, USP and Ethinyl Estradiol tablets, USP) provide an oral contraceptive regimen of 21 dark blue tablets each containing 0.15 mg desogestrel (13-ethyl-11-methylene-18,19-dinor-17 alpha-pregn-4-en-20-yn-17-ol), 0.02 mg ethinyl estradiol (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17-diol), and inactive ingredients which include: titanium dioxide, macrogol/PEG 400 NF, hydroxypropyl-methylcellulose/hypromellose, FD&C Red #40, FD&C Yellow #6, FD&C Blue #1, vitamin E, lactose monohydrate, povidone, stearic acid and pregelatinized starch, followed by 2 white tablets with the following inactive ingredients: titanium dioxide, polydextrose, hypromellose, triacetin, macrogol/polyethylene glycol 8000, lactose, magnesium stearate and pregelatinized corn starch. Azurette also contains 5 green tablets containing 0.01 mg ethinyl estradiol (19-nor-17 alpha-pregna-1,3,5 (10)- trien-20-yne-3,17-diol) and inactive ingredients which include: polyvinyl alcohol, titanium dioxide, talc, macrogol/PEG, lecithin (soya), D&C Yellow No. 10, FD&C Blue No. 1, Iron Oxide Yellow, FD&C Red No. 40, lactose monohydrate, magnesium stearate and pregelatinized starch. The molecular weights for desogestrel and ethinyl estradiol are 310.48 and 296.21 respectively. The structural formulas are as follows: ® The 21 dark blue tablets meet 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 Կարդացեք ամբողջական փաստաթուղթը