MICROGESTIN 24 FE norethindrone acetate and ethinyl estradiol ferrous fumarate

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

Actavis Pharma, Inc.

INN (الاسم الدولي):

NORETHINDRONE ACETATE

تركيب:

NORETHINDRONE ACETATE 1 mg

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الوضع إذن:

New Drug Application

خصائص المنتج

MICROGESTIN 24 FE- NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND
FERROUS FUMARATE
ACTAVIS PHARMA, INC.
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MICROGESTIN 24 FE
MICROGESTIN 24 FE
(norethindrone acetate and ethinyl estradiol tablets, USP and ferrous
fumarate tablets)
Ferrous fumarate tablets are not USP for dissolution and assay.
RX ONLY
PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT
AGAINST HIV INFECTION (AIDS) AND
OTHER SEXUALLY TRANSMITTED DISEASES.
DESCRIPTION
Microgestin 24 Fe provides a dosage regimen consisting of 24 white
progestogen-estrogen
contraceptive tablets and 4 brown ferrous fumarate (placebo) tablets.
Each white tablet contains 1 mg norethindrone acetate and 20 mcg
ethinyl estradiol.
Each white tablet also contains the following inactive ingredients:
acacia, lactose, magnesium stearate,
starch, confectioner’s sugar, and talc.
Each brown tablet contains ferrous fumarate, microcrystalline
cellulose, magnesium stearate, povidone,
sodium starch glycolate, mannitol, sucralose and spearmint flavor. 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
ABS ORPTION
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 norethindrone. Norethindrone acetate and ethinyl
estradiol are rapidly absorbed from
Microgestin24 Fe tablets, with maximum plasma concentrations of
norethind