TILIA FE norethindrone acetate and ethinyl estradiol ferrous fumarate

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

Watson Pharma, Inc.

INN (Международно Name):

NORETHINDRONE ACETATE

Композиция:

NORETHINDRONE ACETATE 1 mg

Вид предписание :

PRESCRIPTION DRUG

Статус Оторизация:

New Drug Application

Данни за продукта

TILIA FE- NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, AND FERROUS
FUMARATE
WATSON PHARMA, INC.
----------
T ILIA
FE
(NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS,
USP AND FERROUS FUMARATE TABLETS*)
*FERROUS FUMARATE TABLETS ARE NOT USP FOR DISSOLUTION AND ASSAY.
T ILIA
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
T ilia
Fe is a graduated estrophasic oral contraceptive providing estrogen in
a graduated sequence
over a 21-day period with a constant dose of progestogen.
T ilia
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 Tilia
Fe tablet dispenser contains five white triangular tablets, seven
white square tablets, nine
white round tablets, and seven