GILDESS FE 1/20 norethindrone acetate ethinyl estradiol and ferrous fumarate

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

Qualitest Pharmaceuticals

INN (International namn):

NORETHINDRONE ACETATE

Sammansättning:

NORETHINDRONE ACETATE 1 mg

Receptbelagda typ:

PRESCRIPTION DRUG

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

GILDESS FE 1/20- NORETHINDRONE ACETATE, ETHINYL ESTRADIOL AND FERROUS
FUMARATE
PAR PHARMACEUTICAL
----------
GILDESS FE 1/20
(NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS, USP AND
FERROUS FUMARATE TABLETS, USP)
NORETHINDRONE ACETATE (1 MG) AND ETHINYL ESTRADIOL (0.02 MG) TABLETS,
USP AND FERROUS FUMARATE (75 MG) TABLETS, USP
(Each white tablet contains 1 mg norethindrone acetate and 0.02 mg
ethinyl estradiol. Each white-
speckled brown tablet contains 75 mg ferrous fumarate.)
RX ONLY
PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT
AGAINST HIV INFECTION (AIDS) AND
OTHER SEXUALLY TRANSMITTED DISEASES.
DESCRIPTION
Norethindrone acetate and ethinyl estradiol tablets, USP are
progestogen-estrogen combinations.
Norethindrone acetate and ethinyl estradiol, tablets, USP and ferrous
fumarate tablets, USP: Each
provides a continuous dosage regimen consisting of 21 oral
contraceptive tablets and seven ferrous
fumarate tablets, USP. The ferrous fumarate tablets, USP 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 tablet contains norethindrone acetate (17
alpha-ethinyl-19-nortestosterone acetate), 1 mg;
ethinyl estradiol (17 alpha-ethinyl-1,3,5(10)-estratriene-3, 17
beta-diol), 0.02 mg. Also contains
compressible sugar, colloidal silicon dioxide, croscarmellose sodium,
hypromellose 2910 6cP,
lactose monohydrate, magnesium stearate, polyethylene glycol 400,
polyethylene glycol 8000,
pregelatinized starch, sodium lauryl sulfate and Vitamin E.
The structural formulas are as follows:
®
Each white-speckled brown tablet contains ferrous fumarate USP;
magnesium stearate, NF;
microcrystalline cellulose and pregelatinized starch.
CLINICAL PHARMACOLOGY
Combination oral contraceptives act by suppression of gonadotropins.
Although the primary mechanism
of this action is inhibition of ovulation, other alterations include
changes in the cervical mucus (which
increase the difficulty of sperm entry into the uterus) and t