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Hailey Fe 1/20
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  • FDA PI

Hailey Fe 1/20

Generic name:norethindrone acetate and ethinyl estradiol and ferrous fumarate
Dosage form: tablets
Drug class:Contraceptives

Medically reviewed by Drugs.com. Last updated on Aug 1, 2021.

Hailey Fe 1/20 Description

Hailey® Fe 1/20 (norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets, USP) is a progestogen-estrogen combination.

Hailey Fe 1/20 (norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets, USP): 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 to off-white tablet contains norethindrone acetate, USP [(19-Norpregn-4-en-20-yn-3-one,17-(acetyloxy)-, (17α)], 1 mg; ethinyl estradiol, USP [19-Norpregna-1,3,5(10)-triene-20-yne-3,17-diol, (17 α)], 20 mcg. Also contains acacia, lactose monohydrate, magnesium stearate, corn starch, sucrose and talc.

The structural formulas are as follows:

Norethindrone Acetate, USP

Ethinyl Estradiol, USP

Each brown to dark brown tablet contains microcrystalline cellulose, ferrous fumarate, magnesium stearate, povidone, sodium starch glycolate, corn starch and talc. The ferrous fumarate tablets do not serve any therapeutic purpose.

Hailey Fe 1/20 - 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

The pharmacokinetics of Hailey Fe 1/20 have not been characterized; however, the following pharmacokinetic information regarding norethindrone acetate and ethinyl estradiol is taken from the literature...