ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL kit

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U), ETHYNODIOL DIACETATE (UNII: 62H10A1236) (ETHYNODIOL - UNII:9E01C36A9S)

Disponível em:

Mylan Pharmaceuticals Inc.

DCI (Denominação Comum Internacional):

ETHINYL ESTRADIOL

Composição:

ETHINYL ESTRADIOL 50 ug

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Ethynodiol diacetate and ethinyl estradiol tablets USP, 1 mg/50 mcg are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptive products such as ethynodiol diacetate and ethinyl estradiol tablets, 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 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    C

Resumo do produto:

Each orange ethynodiol diacetate and ethinyl estradiol tablet USP, 1 mg/50 mcg is round in shape, unscored and debossed with 252 on one side of the tablet and plain on the other side and contains 1 mg of ethynodiol diacetate and 50 mcg of ethinyl estradiol. Ethynodiol diacetate and ethinyl estradiol tablets USP, 1 mg/50 mcg are packaged in cartons of three (NDC 0378-7306-53) tablet dispensers. Each dispenser contains 21 orange tablets and 7 green inert tablets. (Inert tablets are debossed with 302 on one side of the tablet and plain on the other side.) Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Status de autorização:

Abbreviated New Drug Application

Características técnicas

ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL- ETHYNODIOL DIACETATE AND
ETHINYL ESTRADIOL
MYLAN PHARMACEUTICALS INC.
----------
RX ONLY
ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL TABLETS USP, 1 MG/50 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/50 mcg.
_Each orange tablet
contains 1 mg of ethynodiol diacetate and 50 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/50 mcg package is an inert tablet 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/50 mcg
are indicated for the
prevention of pregnancy in women who elect to use oral contraceptives
as a method of
contraception. Oral contraceptive products such as ethynodiol
diacetate and ethinyl
estradiol tablets, which contain 50