FEMCON FE norethindrone and ethinyl estradiol ferrous fumarate

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

Warner Chilcott (US), LLC

INN (Algemene Internationale Benaming):

NORETHINDRONE ACETATE

Samenstelling:

NORETHINDRONE ACETATE 0.4 mg

Prescription-type:

PRESCRIPTION DRUG

Autorisatie-status:

New Drug Application

Productkenmerken

FEMCON FE- NORETHINDRONE AND ETHINYL ESTRADIOL, AND FERROUS FUMARATE
WARNER CHILCOTT (US), LLC
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FEMCON FE
(NORETHINDRONE AND ETHINYL ESTRADIOL TABLETS,
CHEWABLE AND FERROUS FUMARATE TABLETS) 0.4 MG / 35 MCG
Ferrous fumarate tablets are not USP for dissolution and assay.
PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT
AGAINST HIV INFECTION (AIDS) AND
OTHER SEXUALLY TRANSMITTED DISEASES.
DESCRIPTION
FEMCON Fe provides a regimen for oral contraception derived from 21
white tablets composed of
norethindrone and ethinyl estradiol followed by 7 brown ferrous
fumarate (placebo) tablets. The
chemical name for norethindrone is
17-hydroxy-19-nor-17α-pregn-4-en-20-yn-3-one and for ethinyl
estradiol the chemical name is
19-nor-17α-pregna-1,3,5(10)-trien-20-yne-3,17-diol. The structural
formulas are:
NORETHINDRONE
ETHINYL ESTRADIOL
The active white FEMCON Fe tablets contain 0.4 mg norethindrone and
0.035 mg ethinyl estradiol, and
the following inactive ingredients: dibasic calcium phosphate,
lactose, magnesium stearate,
maltodextrin, povidone, sodium starch glycolate, spearmint flavor and
sucralose.
The brown tablets contain ferrous fumarate, microcrystalline
cellulose, magnesium stereate, povidone,
sodium starch glycolate, and compressible sugar. The ferrous fumarate
tablets do not serve any
therapeutic purpose.
®
®
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
Ethinyl estradiol and norethindrone are rapidly absorbed with maximum
plasma concentrations occurring
within 2 hours after FEMCON Fe administration (see Table 1).
Norethindrone appears to be completely
absorbed following oral administration; however, it is subject to
first-pass metabolism resulting in an
absolu