ZOVIA 1/35- ethynodiol diacetate and ethinyl estradiol kit

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

Mayne Pharma Inc.

INN (Международно Name):

ETHYNODIOL DIACETATE

Композиция:

ETHYNODIOL DIACETATE 1 mg

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

Zovia 1/35 (28 Day Regimen) (ethynodiol diacetate and ethinyl estradiol tablets USP) 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. % 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¶ 26 6 40 Periodic abstinence 25 63 Calendar 9 Ovulation method 3 Sympto-thermal# 2 Post-ovulation 1 Withdrawal 19 4 CapÞ Parous women 40 26 42 Nulliparous women 20 9 56 Sponge Parous women 40 20 42 Nulliparous w

Каталог на резюме:

Zovia® 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 51862-260-06 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 Оторизация:

Abbreviated New Drug Application

Данни за продукта

ZOVIA 1/35- ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL
MAYNE PHARMA INC.
----------
ZOVIA 1/35E (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
Zovia
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
Zovia 1/35 (28 Day Regimen) (ethynodiol diacetate and ethinyl
estradiol tablets USP) 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
contr