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Generess Fe

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Generess Fe

GENERESS Fe
(norethindrone and ethinyl estradiol chewable tablets and ferrous fumarate chewable tablets)

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

GENERESS Fe provides an oral contraceptive regimen consisting of 24 tablets that contain the active ingredients specified below, followed by four non-hormonal placebo tablets:

24 light green, round tablets each containing 0.8 mg norethindrone and 0.025 mg ethinyl estradiol

4 brown, round tablets each containing 75 mg ferrous fumarate.

Each light green tablet also contains the following inactive ingredients: D&C Yellow No. 10 aluminum lake, FD&C Blue No. 1 aluminum lake, FD&C Yellow No. 6 aluminum lake, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, povidone, sodium starch glycolate, spearmint flavor, sucralose and vitamin E.

Each brown, round tablet contains ferrous fumarate, magnesium stearate, mannitol, microcrystalline cellulose, povidone, sodium starch glycolate, spearmint flavor and sucralose. The ferrous fumarate chewable tablets do not serve any therapeutic purpose. Ferrous fumarate chewable tablets are not USP for dissolution and assay.

The empirical formula of ethinyl estradiol is C20H24O2 and the chemical structure is:

Ethinyl estradiol Structural Formula Illustration

The chemical name of ethinyl estradiol is [19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol,(17α)-]

The empirical formula of norethindrone is C20H26O2 and the chemical structure is:

Norethindrone Structural Formula Illustration

The chemical name of norethindrone is [17-hydroxy-19-nor-17α-pregn-4-en-20-yn-3-one]

Last reviewed on RxList: 7/15/2011
This monograph has been modified to include the generic and brand name in many instances.

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