BLISOVI 24 FE- norethindrone acetate and ethinyl estradiol kit

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

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

Доступна с:

Lupin Pharmaceuticals, Inc.

ИНН (Международная Имя):

ETHINYL ESTRADIOL

состав:

ETHINYL ESTRADIOL 0.02 mg

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

Blisovi™ 24 Fe is indicated for use by women to prevent pregnancy [see CLINICAL STUDIES (14)]. The efficacy of Blisovi 24 Fe in women with a body mass index (BMI) of > 35 kg/m2 has not been evaluated. Do not prescribe Blisovi 24 Fe to women who are known to have the following conditions: - A high risk of arterial or venous thrombotic diseases. Examples include women who are known to: Smoke, if over age 35 [see BOXED WARNING and WARNINGS AND PRECAUTIONS (5.1)] Have deep vein thrombosis or pulmonary embolism, now or in the past [see WARNINGS AND PRECAUTIONS (5.1)] Have inherited or acquired hypercoagulopathies [see WARNINGS AND PRECAUTIONS (5.1)] Have cerebrovascular disease [see WARNINGS AND PRECAUTIONS (5.1)] Have coronary artery disease [see WARNINGS AND PRECAUTIONS (5.1)] Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see WARNINGS AND PRECAUTIONS (5.1)] Have uncontrolled hyper

Обзор продуктов:

Blisovi 24 Fe is available in a wallet (NDC 68180-864-11) containing 28 tablets packed in a pouch (NDC 68180-864-11). Such three pouches are packaged in a carton (NDC 68180-864-13). Each wallet (28 tablets) contains in the following order:

Статус Авторизация:

Abbreviated New Drug Application

Характеристики продукта

BLISOVI 24 FE - NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
LUPIN PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BLISOVI 24 FE SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR BLISOVI 24 FE.
BLISOVI™ 24 FE [NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS
USP, (1 MG/0.02 MG) AND FERROUS FUMARATE
TABLETS, (75 MG)] FOR ORAL USE
INITIAL U.S. APPROVAL: 1968
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
● BLISOVI 24 FE IS CONTRAINDICATED IN WOMEN OVER 35 YEARS OLD WHO
SMOKE. (4)
● CIGARETTE SMOKING INCREASES THE RISK OF SERIOUS CARDIOVASCULAR
EVENTS FROM COMBINATION ORAL
CONTRACEPTIVES (COC) USE. (4)
RECENT MAJOR CHANGES
Contraindications (4) 08/2017
Warnings (5.3) 08/2017
INDICATIONS AND USAGE
Blisovi 24 Fe is a progestin/estrogen COC indicated for use by women
to prevent pregnancy. (1) The efficacy of Blisovi 24
Fe in women with a body mass index (BMI) of >35 kg/m has not been
evaluated. (1, 8.8)
DOSAGE AND ADMINISTRATION
Take one tablet by mouth at the same time every day for 28 days (2.1)
Take tablets in the order directed on the blister pack (2.1)
Blisovi 24 Fe may be administered without regard to meals (12.3)
DOSAGE FORMS AND STRENGTHS
Blisovi 24 Fe consists of 28 tablets in the following order (3):
24 white tablets (active), each containing 1 mg norethindrone acetate
and 20 mcg ethinyl estradiol
4 brown tablets (non-hormonal placebo), each containing 75 mg ferrous
fumarate. The ferrous fumarate tablets do not
serve any therapeutic purpose.
CONTRAINDICATIONS
A high risk of arterial or venous thrombotic diseases (4)
Liver tumors or liver disease (4)
Undiagnosed abnormal uterine bleeding (4)
Breast cancer or other estrogen- or progestin-sensitive cancer (4)
Pregnancy (4)
Co-administration with Hepatitis C drug combinations containing
ombitasvir/paritaprevir/ritonavir, with or without
dasabuvir (4)
WARNINGS AND PRECAUTIONS
Throm