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Minastrin 24 Fe

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Minastrin 24 Fe

MINASTRIN 24 FE
(norethindrone acetate and ethinyl estradiol/ferrous fumarate) Capsules

WARNING

CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS

Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs should not be used by women who are over 35 years of age and smoke [see CONTRAINDICATIONS].

DRUG DESCRIPTION

Minastrin 24 Fe (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules) contain norethindrone acetate, a progestin, and ethinyl estradiol, an estrogen. Minastrin 24 Fe provides an oral contraceptive regimen consisting of 24 yellow active soft gelatin capsules that contain the active ingredients, followed by 4 maroon non-hormonal placebo soft gelatin capsules as specified below:

  • 24 oval, transparent, pale yellow capsules each containing 1 mg norethindrone acetate and 20 mcg ethinyl estradiol.
  • 4 oval, opaque, maroon, capsules each containing 75 mg ferrous fumarate

Each yellow active capsule also contains the following inactive ingredients: sesame oil, linoleoyl polyoxylglycerides, DL-α-tocopherol, dehydrated alcohol, gelatin, sorbitol and glycerin.

Each maroon placebo capsule contains ferrous fumarate, soybean oil, lecithin, yellow beeswax, gelatin, sorbitol, glycerin, FD&C Blue No. 1, FD&C Red No. 40 and titanium dioxide. The ferrous fumarate capsules do not serve any therapeutic purpose.

The chemical name of ethinyl estradiol is [19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-]. The empirical formula of ethinyl estradiol is C20H24O2 and the structural formula is:

Ethinyl estradiol Structural Formula Illustration

 

The chemical name of norethindrone acetate is [19-Norpregn-4-en-20-yn-3-one, 17(acetyloxy)-, (17α)-]. The empirical formula of norethindrone acetate is C22H28O3 and the structural formula is:

Norethindrone acetate Structural Formula Illustration

Last reviewed on RxList: 5/6/2013
This monograph has been modified to include the generic and brand name in many instances.

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