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LO LOESTRIN FE (norethindrone acetate and ethinyl estradiol, ethinyl estradiol tablets)
(norethindrone acetate and ethinyl estradiol, ethinyl estradiol and ferrous fumarate) 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.]
Lo Loestrin Fe (norethindrone acetate and ethinyl estradiol, ethinyl estradiol tablets) (norethindrone acetate and ethinyl estradiol tablets, ethinyl estradiol tablets and ferrous fumarate tablets) provides an oral contraceptive regimen consisting of 24 blue active tablets and 2 white active tablets that contain the active ingredients specified for each tablet below, followed by 2 non-hormonal placebo tablets:
Each blue tablet also contains the inactive ingredients mannitol, microcrystalline cellulose, FD&C Blue No. 1 Aluminum Lake, sodium starch glycolate, magnesium stearate, povidone, vitamin E and lactose monohydrate.
Each white tablet also contains the inactive ingredients mannitol, microcrystalline cellulose, sodium starch glycolate, magnesium stearate, povidone, vitamin E and lactose monohydrate.
Each brown tablet contains ferrous fumarate, mannitol, povidone, microcrystalline cellulose, sodium starch glycolate, magnesium stearate, sucralose and spearmint flavor. The ferrous fumarate tablets do not serve any therapeutic purpose. Ferrous fumarate tablets are not USP for dissolution and assay.
The empirical formula of ethinyl estradiol is C20H24O2 and the structural formula is:
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The chemical name of ethinyl estradiol is [19-Norpregna-l,3,5(10)-trien-20-yne-3,17-diol, (17α)-].
The empirical formula of norethindrone acetate is C22H28O3 and the structural formula is:
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The chemical name of norethindrone acetate is [19-Norpregn-4-en-20-yn-3-one, 17-(acetyloxy)-, (17α)-].
Last reviewed on RxList: 11/30/2010
This monograph has been modified to include the generic and brand name in many instances.
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