KELNOR 1/35- ethynodiol diacetate and ethinyl estradiol kit

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

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

Доступна з:

Teva Pharmaceuticals USA, Inc.

ІПН (Міжнародна Ім'я):

ETHYNODIOL DIACETATE

Склад:

ETHYNODIOL DIACETATE 1 mg

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

Kelnor 1/35 (28 Day Regimen) (ethynodiol diacetate and ethinyl estradiol tablets) is 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. TABLE 1: PERCENTAGE OF WOMEN EXPERIENCING AN UNINTENDED PREGNANCY DURING THE FIRST YEAR OF TYPICAL USE AND THE FIRST YEAR OF PERFECT USE OF CONTRACEPTION AND THE PERCENTAGE CONTINUING USE AT THE END OF THE FIRST YEAR. UNITED STATES. % of Women Experiencing an Unintended Pregnancy Within the First Year of Use % of Women Continuing Use at One Year 1 Method (1) Typical Use 2 (2) Perfect Use 3 (3) (4) Chance4

Огляд продуктів:

Kelnor® 1/35 (28 Day Regimen) (ethynodiol diacetate and ethinyl estradiol tablets USP) is packaged in cartons of six blister card dispensers. Each blister card dispenser contains 21 light yellow, round, flat-faced, beveled-edge, unscored tablets, debossed with stylized b on one side and 14 on the other side and 7 white, round, flat-faced, beveled-edge, unscored placebo tablets, debossed with stylized b on one side and 143 on the other side. Each light yellow tablet contains 1 mg of ethynodiol diacetate, USP and 0.035 mg of ethinyl estradiol, USP. Each white tablet contains inert ingredients. Available in cartons of six blisters NDC 0555-9064-58 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Статус Авторизація:

Abbreviated New Drug Application

Характеристики продукта

KELNOR 1/35- ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL
TEVA PHARMACEUTICALS USA, INC.
----------
KELNOR 1/35 (28 DAY REGIMEN)
(ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL TABLETS USP)
PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT
AGAINST HIV
INFECTION (AIDS) AND OTHER SEXUALLY TRANSMITTED DISEASES.
DESCRIPTION
Kelnor
1/35 (28 Day Regimen) (ethynodiol diacetate and ethinyl estradiol
tablets USP):
Each light yellow tablet contains 1 mg of ethynodiol diacetate, USP
and 35 mcg of ethinyl
estradiol, USP. The inactive ingredients include anhydrous lactose,
D&C yellow no. 10
aluminum lake, magnesium stearate, microcrystalline cellulose,
polacrilin potassium, and
povidone. Each white tablet is a placebo containing only inert
ingredients as follows:
anhydrous lactose, hypromellose, magnesium stearate, and
microcrystalline cellulose.
The chemical name for ethynodiol diacetate, USP is
19-nor-17α-pregn-4-en-20-yne-3β,
17-diol diacetate, and for ethinyl estradiol, USP it is
19-nor-17α-pregna-1, 3, 5 (10)-trien-
20-yne-3, 17-diol. The structural formulas are as follows:
Ethynodiol Diacetate, USP
C
H
O M.W. 384.51
Ethinyl Estradiol, USP
®
®
24
32
4
C
H
O M.W. 296.40
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
Kelnor 1/35 (28 Day Regimen) (ethynodiol diacetate and ethinyl
estradiol tablets) is
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 o