ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL kit

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Mylan Pharmaceuticals Inc.

INN (International Name):

ETHYNODIOL DIACETATE

Sammensætning:

ETHYNODIOL DIACETATE 1 mg

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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

Produkt oversigt:

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.]

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

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