GILDESS 24 FE norethindrone acetate and ethinyl estradiol ferrous fumarate

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

Qualitest Pharmaceuticals

INN (Rahvusvaheline Nimetus):

NORETHINDRONE ACETATE

Koostis:

NORETHINDRONE ACETATE 1 mg

Retsepti tüüp:

PRESCRIPTION DRUG

Volitamisolek:

Abbreviated New Drug Application

Toote omadused

GILDESS 24 FE- NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS
FUMARATE
QUALITEST PHARMACEUTICALS
----------
GILDES S 24 FE
(NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS USP, 1 MG/0.02 MG
AND FERROUS FUMARATE
TABLETS USP)
RX ONLY
PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT
AGAINST HIV INFECTION (AIDS) AND
OTHER SEXUALLY TRANSMITTED DISEASES.
DESCRIPTION
Gildess
24 Fe (norethindrone acetate and ethinyl estradiol tablets USP, 1
mg/0.02 mg and ferrous
fumarate tablets USP) provides a dosage regimen consisting of 24 white
progestogen-estrogen
contraceptive tablets and 4 white-speckled brown ferrous fumarate
(placebo) tablets.
Each white tablet contains 1 mg norethindrone acetate and 0.02 mg
ethinyl estradiol. Each white tablet
also contains the following inactive ingredients: colloidal silicon
dioxide, compressible sugar,
croscarmellose sodium, hypromellose, lactose monohydrate, magnesium
stearate, polyethylene glycol,
pregelatinized starch, sodium lauryl sulfate, and Vitamin E.
Each white-speckled brown tablet contains ferrous fumarate, magnesium
stearate, microcrystalline
cellulose and pregelatinized starch. The ferrous fumarate tablets do
not serve any therapeutic purpose.
The structural formulas for the active hormones are:
Ethinyl Estradiol [19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol,
(17α)-]
®
®
Norethindrone Acetate [19-Norpregn-4-en-20-yn-3-one, 17-(acetyloxy)-,
(17α)-]
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 the
endometrium (which reduce the likelihood
of implantation).
PHARMACOKINETICS
_ABSORPTION_
Norethindrone acetate appears to be completely and rapidly
deacetylated to norethindrone after oral
administration, because the disposition of norethindrone acetate is
indistinguishable from that of orally
administered norethind