NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE kit

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

Amneal Pharmaceuticals NY LLC

INN (Међународно име):

NORETHINDRONE ACETATE

Састав:

NORETHINDRONE ACETATE 1 mg

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

Norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets are indicated for use by females of reproductive age to prevent pregnancy [see Clinical Studies (14)] . The efficacy of norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets in women with a body mass index (BMI) of more than 35 kg/m2 has not been evaluated. Norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets are contraindicated in females who are known to have or develop 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 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 th

Резиме производа:

Norethindrone acetate and ethinyl estradiol tablets, USP 1 mg/20 mcg and ferrous fumarate tablets, 75 mg are available in blister cards (dispensers) containing 28 tablets (NDC 60219-1031-6): Cartons of 3 blister cards (dispensers)            NDC 60219-1031-7 Each blister card contains 28 tablets in the following order: Store at 20° to 25° C (68° to 77° F); excursions permitted between 15° to 30° C (59° to 86° F) [see USP Controlled Room Temperature]. Keep this drug and all drugs out of the reach of children.

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS
FUMARATE- NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS
FUMARATE
AMNEAL PHARMACEUTICALS NY LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NORETHINDRONE
ACETATE AND ETHINYL ESTRADIOL TABLETS AND FERROUS FUMARATE TABLETS
SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR NORETHINDRONE
ACETATE AND ETHINYL
ESTRADIOL TABLETS AND FERROUS FUMARATE TABLETS.
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS AND FERROUS
FUMARATE TABLETS,
FOR ORAL USE
INITIAL U.S. APPROVAL: 1968
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
WOMEN OVER 35 YEARS OLD WHO SMOKE SHOULD NOT USE NORETHINDRONE ACETATE
AND
ETHINYL ESTRADIOL TABLETS AND FERROUS FUMARATE TABLETS (4)
CIGARETTE SMOKING INCREASES THE RISK OF SERIOUS CARDIOVASCULAR EVENTS
FROM
COMBINATION ORAL CONTRACEPTIVE (COC) USE (4)
INDICATIONS AND USAGE
Norethindrone acetate and ethinyl estradiol tablets and ferrous
fumarate tablets are a combination of
norethindrone acetate, a progestin, and ethinyl estradiol, an
estrogen, indicated for use by females of
reproductive potential to prevent pregnancy (1)
The efficacy in females of reproductive potential with a body mass
index of more than 35 kg/m has not
been evaluated (1, 8.8)
DOSAGE AND ADMINISTRATION
One tablet daily chewed and swallowed or swallowed whole taken at the
same time of day. Follow with 8
ounces of water (2.1)
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)
Tablets may be administered without regard to meals (12.3)
DOSAGE FORMS AND STRENGTHS
Norethindrone acetate and ethinyl estradiol tablets, USP and ferrous
fumarate tablets consists of 28
tablets in the following order (3):
24 white chewable tablets (active), each containing 1 mg norethindrone
acetate and 20 mcg ethinyl
estradiol
4 brown tablets (non-hormonal pla