VYFEMLA- norethindrone 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), NORETHINDRONE (UNII: T18F433X4S) (NORETHINDRONE - UNII:T18F433X4S)

Disponível em:

Lupin Pharmaceuticals, Inc.

DCI (Denominação Comum Internacional):

ETHINYL ESTRADIOL

Composição:

ETHINYL ESTRADIOL 0.035 mg

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product 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, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. Reproduced with permission of the Population Council from J. Trussell, et al: Contraceptive failure in the United States: An update. Studies in Family Planning, 21(1), January-February 1990. Oral contraceptives should not be used in women who currently have the following conditions: - Thrombophlebitis or thromboembolic disorders - A past history of deep vein thrombophlebitis or thromboembolic disorders - Cerebrovascular or coronary artery disease - Known or suspected carcinoma of the breast - Carcinoma of th

Resumo do produto:

Vyfemla (norethindrone and ethinyl estradiol tablets USP) is available in wallet (NDC 68180-875-11) containing 28 tablets packed in a pouch (NDC 68180-875-11). Such three pouches are packaged in a carton (NDC 68180-875-13). Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F). [See USP Controlled Room Temperature]. References are available upon request. Distributed by: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States Manufactured by: Lupin Limited Pithampur (M.P.) - 454 775 INDIA May 26, 2017                                                                                                ID#252106

Status de autorização:

Abbreviated New Drug Application

Características técnicas

VYFEMLA - NORETHINDRONE AND ETHINYL ESTRADIOL
LUPIN PHARMACEUTICALS, INC.
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VYFEMLA™
(NORETHINDRONE AND ETHINYL ESTRADIOL TABLETS USP)
0.4 MG/0.035 MG
RX ONLY
28 - DAY REGIMEN
PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT
AGAINST HIV-INFECTION (AIDS) AND
OTHER SEXUALLY TRANSMITTED DISEASES.
DESCRIPTION
Vyfemla™ (norethindrone and ethinyl estradiol tablets USP) provides
a continuous regimen for oral
contraception derived from 21 light peach tablets composed of
norethindrone and ethinyl estradiol to be
followed by 7 white tablets of inert ingredients. The structural
formulas are:
The light peach active Vyfemla (norethindrone and ethinyl estradiol
tablets USP) contains 0.4 mg
norethindrone and 0.035 mg ethinyl estradiol and contain the following
inactive ingredients: FD&C
yellow No. 6 (aluminum lake), lactose anhydrous, lactose monohydrate,
magnesium stearate, povidone,
and sodium starch glycolate. The white tablets in the 28 Day regimen
contains only inert ingredients as
follows croscarmellose sodium, lactose monohydrate, magnesium stearate
and microcrystalline
cellulose.
CLINICAL PHARMACOLOGY
Combination oral contraceptives act by suppression of gonadotropins.
Although the primary mechanism
of this action is inhibition of ovulation, other alterations include
changes in the cervical mucus (which
increase the difficulty of sperm entry into the uterus) and the
endometrium (which reduce the likelihood
of implantation).
INDICATIONS AND USAGE
Oral contraceptives are indicated for the prevention of pregnancy in
women who elect to use this
product 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, depends upon the
reliability with which they are used.
Correct and consistent use of methods can result in lower failure
rates.
TABLE 1 LOWEST EXPECTED AND TYPICAL FAILURE RATES D