Riik: Ameerika Ühendriigid
keel: inglise
Allikas: NLM (National Library of Medicine)
ETHYNODIOL DIACETATE (UNII: 62H10A1236) (ETHYNODIOL - UNII:9E01C36A9S), ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U)
Mylan Pharmaceuticals Inc.
ETHYNODIOL DIACETATE
ETHYNODIOL DIACETATE 1 mg
PRESCRIPTION DRUG
Ethynodiol diacetate and ethinyl estradiol tablets USP, 1 mg/35 mcg 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 combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization and progestogen implants and injections, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. % of women experiencing an unintended pregnancy within the first year of use % of women continuing use at one year ‡ Method (1) Typical use § (2) Perfect use ¶ (3) (4) Chance # 85 85 Spermicides Þ 26 6 40 Periodic abstinence 25 63 Calendar 9 Ovulation method 3 Sympto-thermal ß 2 Post-ovulation 1 Withdrawal 19 4 Cap à Parous women 40 26 42 Nulliparous women 20 9 56 Sponge Parous wo
Each light orange ethynodiol diacetate and ethinyl estradiol tablet USP, 1 mg/35 mcg is round in shape, unscored and debossed with 245 on one side and plain on the other side and contains 1 mg of ethynodiol diacetate and 35 mcg of ethinyl estradiol. Ethynodiol diacetate and ethinyl estradiol tablets USP, 1 mg/35 mcg are packaged in cartons of three (NDC 0378-7307-53) tablet dispensers. Each dispenser contains 21 light orange tablets and 7 green placebo tablets. (Placebo tablets are debossed with 302 on one side and plain on the other side.) Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]
Abbreviated New Drug Application
ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL- ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL MYLAN PHARMACEUTICALS INC. ---------- ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL TABLETS USP, 1 MG/35 MCG RX ONLY ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL TABLETS USP, 1 MG/35 MCG PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT AGAINST HIV INFECTION (AIDS) AND OTHER SEXUALLY TRANSMITTED DISEASES. DESCRIPTION ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL TABLETS USP, 1 MG/35 MCG. Each light orange tablet contains 1 mg of ethynodiol diacetate and 35 mcg of ethinyl estradiol, and the inactive ingredients include lactose monohydrate, povidone K-25, microcrystalline cellulose, polacrilin potassium, magnesium stearate. In addition, the coloring agent is FD&C Yellow No. 6 Aluminum Lake. Each green tablet in the ethynodiol diacetate and ethinyl estradiol tablets USP, 1 mg/35 mcg package is a placebo containing no active ingredients, and the inactive ingredients include lactose monohydrate, polacrilin potassium, magnesium stearate, yellow iron oxide and FD&C Blue No. 1 Aluminum Lake. The chemical name for ethynodiol diacetate is 19-Nor-17α-pregn-4-en-20-yne-3β, 17-diol diacetate, and for ethinyl estradiol it is 19-Nor- 17α-pregna-1,3,5(10)-trien-20-yne-3, 17- diol. The structural formulas are as follows: Therapeutic class: Oral contraceptive. CLINICAL PHARMACOLOGY Combination oral contraceptives act primarily by suppression of gonadotropins. Although the primary mechanism of this action is inhibition of ovulation, other alterations in the genital tract, including changes in the cervical mucus (which increase the difficulty of sperm entry into the uterus) and the endometrium (which may reduce the likelihood of implantation) may also contribute to contraceptive effectiveness. INDICATIONS AND USAGE Ethynodiol diacetate and ethinyl estradiol tablets USP, 1 mg/35 mcg are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effect Lugege kogu dokumenti