BLISOVI FE 1/20- norethindrone acetate and ethinyl estradiol kit

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U), NORETHINDRONE ACETATE (UNII: 9S44LIC7OJ) (NORETHINDRONE - UNII:T18F433X4S)

Предлага се от:

Lupin Pharmaceuticals, Inc.

INN (Международно Name):

ETHINYL ESTRADIOL

Композиция:

ETHINYL ESTRADIOL 0.02 mg

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

Blisovi Fe 1/20 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 I 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. Adapted from RA Hatcher et al, Reference 7. Oral contraceptives are contraindicated in women who currently have the following conditions: - Thrombophlebitis or thromboembolic disorders - A past history of deep vein thrombophlebitis or thromboembolic disorders - Cerebral vascular or coronary artery disease - Current diagnosis of, or history of, breast cancer, which may be hormone sensitive - Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia - Undiagnosed abnormal genital bleeding - Cholestatic jaundice of pregnancy or jaundice with prior pill use - Hepatic adenomas or carcinomas - Are receiving Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations (see WARNINGS, RISK OF LIVER ENZYME ELEVATIONS WITH CONCOMITANT HEPATITIS C TREATMENT ).

Каталог на резюме:

Blisovi  Fe  1/20  ( norethindrone acetate and ethinyl estradiol tablets USP, 1 mg/0.02 mg and ferrous fumarate tablets) are available in a blister (NDC 68180-865-71) containing 28 tablets packed in a pouch (NDC 68180-865-71). Such three pouches are packaged in a carton (NDC 68180-865-73). Each blister contains 28 tablets, as follows: Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature].

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

BLISOVI FE 1/20 - NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
LUPIN PHARMACEUTICALS, INC.
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BLISOVI™ FE 1/20
(NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS USP AND FERROUS
FUMARATE TABLETS*)
1 MG/0.02 MG
*Ferrous fumarate tablets are not USP for dissolution
BLISOVI™ FE 1/20
Each yellow tablet contains 1 mg norethindrone acetate and 20 mcg
ethinyl estradiol.
Each brown tablet contains 75 mg ferrous fumarate.
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR
EVENTS
Cigarette smoking increases the risk of serious cardiovascular events
from
combination oral contraceptive (COC) use. This risk increases with
age, particularly
in women over 35 years of age, and with the number of cigarettes
smoked. For
this reason, COCs, including Blisovi Fe 1/20, are contraindicated in
women who are
over 35 years of age and smoke _(see CONTRAINDICATIONS and WARNINGS)._
DESCRIPTION
Blisovi™ Fe 1/20 is a progestogen-estrogen combination.
Blisovi Fe 1/20 provides a continuous dosage regimen consisting of 21
oral
contraceptive tablets and seven ferrous fumarate tablets. The ferrous
fumarate tablets
are present to facilitate ease of drug administration via a 28-day
regimen, are
nonhormonal, and do not serve any therapeutic purpose.
Each yellow tablet contains norethindrone acetate
(17α-ethinyl-19-nortestosterone
acetate), 1 mg; ethinyl estradiol
(17α-ethinyl-1,3,5(10)-estratriene-3,17β-diol), 20 mcg.
Each yellow tablet contains the following inactive ingredients:
acacia, confectioner's
sugar, corn starch, D&C yellow no. 10 aluminium lake, lactose
monohydrate, magnesium
stearate, and talc.
The structural formulas are as follows:
Each brown placebo tablet contains ferrous fumarate, magnesium
stearate,
microcrystalline cellulose, povidone, sodium starch glycolate,
and sucrose.The ferrous fumarate tablets do not serve any therapeutic
purpose.
*Ferrous fumarate tablets are not USP for dissolution.
CLINICAL PHARMACOLOGY
Combination oral contraceptives act by suppression of gonadotropins.
Although the
primary mechan