MICROGESTIN FE 1/20- norethindrone acetate and ethinyl estradiol and ferrous fumarate
MICROGESTIN 1/20- norethindrone acetate and ethinyl estradiol tablet
MICROGESTIN 1.5/30- norethindrone acetate and ethinyl estradiol tablet
MICROGESTIN FE 1.5/30- norethindrone acetate and ethinyl estradiol and ferrous fumarate
Mayne Pharma Inc.
MICROGESTIN� 1/20
(Each white tablet contains 1 mg norethindrone acetate and 20 mcg ethinyl estradiol.)
MICROGESTIN� 1.5/30
(Each green tablet contains 1.5 mg norethindrone acetate and 30 mcg ethinyl estradiol.)
MICROGESTIN� Fe
(Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets*)
*Ferrous fumarate tablets are not USP for dissolution and assay.
MICROGESTIN� Fe 1/20
(Each white tablet contains 1 mg norethindrone acetate and 20 mcg ethinyl estradiol. Each brown tablet contains 75 mg ferrous fumarate.)
MICROGESTIN� Fe 1.5/30 (Each green tablet contains 1.5 mg norethindrone acetate and 30 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
MICROGESTIN and MICROGESTIN Fe are progestogen-estrogen combinations.
MICROGESTIN Fe 1/20 and 1.5/30: Each provides 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 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), 20 mcg. Also contains acacia, NF; lactose, NF; magnesium stearate, NF; starch, NF; confectioner�s sugar, NF; talc, USP.
Each green tablet contains norethindrone acetate (17 alpha-ethinyl-19-nortestosterone acetate), 1.5 mg; ethinyl estradiol (17 alpha-ethinyl-1,3,5(10)-estratriene-3, 17 beta-diol), 30 mcg. Also contains acacia, NF; lactose, NF; magnesium stearate, NF; starch, NF; confectioner�s sugar, NF; talc, USP; D&C yellow No. 10; FD&C yellow No. 6; FD&C blue No. 1. Each brown tablet contains ferrous fumarate, USP; mannitol, USP; povidone, USP; microcrystalline cellulose, NF; sodium starch glycolate, NF; magnesium stearate, NF; sucralose, NF; spearmint flavor.
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).