ESTROSTEP FE norethindrone acetate and ethinyl estradiol ferrous fumarate

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

NORETHINDRONE ACETATE (UNII: 9S44LIC7OJ) (NORETHINDRONE - UNII:T18F433X4S)

Доступна з:

Warner Chilcott (US), LLC

ІПН (Міжнародна Ім'я):

NORETHINDRONE ACETATE

Склад:

NORETHINDRONE ACETATE 1 mg

Тип рецепту:

PRESCRIPTION DRUG

Статус Авторизація:

New Drug Application

Характеристики продукта

ESTROSTEP FE- NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS
FUMARATE
WARNER CHILCOTT (US), LLC
----------
ESTROSTEP FE
(NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS, USP AND FERROUS
FUMARATE TABLETS*)
*FERROUS FUMARATE TABLETS ARE NOT USP FOR DISSOLUTION AND ASSAY.
ESTROSTEP
FE
(Each white triangular tablet contains 1 mg norethindrone acetate and
20 mcg ethinyl estradiol; each
white square tablet contains 1 mg norethindrone acetate and 30 mcg
ethinyl estradiol; each white round
tablet contains 1 mg norethindrone acetate and 35 mcg ethinyl
estradiol; each brown tablet contains 75
mg ferrous fumarate.)
PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT
AGAINST HIV INFECTION (AIDS) AND
OTHER SEXUALLY TRANSMITTED DISEASES.
DESCRIPTION
ESTROSTEP Fe is a graduated estrophasic oral contraceptive providing
estrogen in a graduated
sequence over a 21-day period with a constant dose of progestogen.
ESTROSTEP Fe provides for 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 non-hormonal, and do not
serve any therapeutic purpose.
Each white triangle-shaped tablet contains 1 mg norethindrone acetate
[(17 alpha)-17-(acetyloxy)-19-
norpregna-4-en-20-yn-3-one] and 20 mcg ethinyl estradiol [(17
alpha)-19-norpregna-1,3,5(10)-trien-20-
yne-3,17-diol]; each white square-shaped tablet contains 1 mg
norethindrone acetate and 30 mcg ethinyl
estradiol; and each white round tablet contains 1 mg norethindrone
acetate and 35 mcg ethinyl estradiol.
Each tablet also contains calcium stearate; lactose; microcrystalline
cellulose; and starch.
The structural formulas are as follows:
Each brown tablet contains microcrystalline cellulose; ferrous
fumarate; magnesium stearate; povidone;
sodium starch glycolate; sucrose with modified dextrins.
Each ESTROSTEP Fe tablet dispenser contains five white triangular
tablets, seven white square tablets,
nine white