Nchi: Marekani
Lugha: Kiingereza
Chanzo: NLM (National Library of Medicine)
ETHYNODIOL DIACETATE (UNII: 62H10A1236) (ETHYNODIOL - UNII:9E01C36A9S)
Actavis Pharma, Inc.
ETHYNODIOL DIACETATE
ETHYNODIOL DIACETATE 1 mg
PRESCRIPTION DRUG
Abbreviated New Drug Application
ZOVIA 1/50E-28- ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL ACTAVIS PHARMA, INC. ---------- _ZOVIA 1/50E-28_ (ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL TABLETS USP) REVISED: MAY 2017 RX ONLY PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT AGAINST HIV INFECTION (AIDS) AND OTHER SEXUALLY TRANSMITTED DISEASES. DESCRIPTION _Zovia 1/50E-28_. Each pink tablet contains 1 mg of ethynodiol diacetate and 50 mcg of ethinyl estradiol, and the inactive ingredients include lactose (anhydrous), magnesium stearate, microcrystalline cellulose, polacrilin potassium, and povidone. In addition, the coloring agents are D&C Red No. 30 Aluminum Lake and D&C Yellow No. 10 Aluminum Lake. Each white tablet in the Zovia 1/50E-28 package is a placebo containing no active ingredients, and the inactive ingredients include lactose (anhydrous), magnesium stearate and microcrystalline cellulose. 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 Zovia 1/50E is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptive products such as Zovia 1/50E, which contain 50 mcg of estrogen, should not be used unless medically indicated. Oral contraceptives are highly effective. Table 1 lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contra Soma hati kamili