"Today, the U.S. Food and Drug Administration announced it has approved the use of Plan B One-Step (levonorgestrel) as a nonprescription product for all women of child-bearing potential. This action complies with the April 5, 2013 order of the Uni"...
(norethindrone and ethinyl estradiol) Tablets, Chewable and Ferrous Fumarate Tablets 0.4mg/35mcg
Ferrous fumarate tablets are not USP for dissolution and assay.
Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
FEMCON® Fe (norethindrone and ethinyl estradiol tablets) provides a regimen for oral contraception derived from 21 white tablets composed of norethindrone and ethinyl estradiol followed by 7 brown ferrous fumarate (placebo) tablets. The chemical name for norethindrone is 17-hydroxy-19-nor-17a-pregn-4-en-20-yn-3-one and for ethinyl estradiol the chemical name is 19-nor-17a-pregna-1,3,5(10)-trien-20-yne-3,17-diol. The structural formulas are:
The active white FEMCON Fe (norethindrone and ethinyl estradiol tablets) tablets contain 0.4 mg norethindrone and 0.035 mg ethinyl estradiol, and the following inactive ingredients: dibasic calcium phosphate, lactose, magnesium stearate, maltodextrin, povidone, sodium starch glycolate, spearmint flavor and sucralose.
The brown tablets contain ferrous fumarate, microcrystalline cellulose, magnesium stereate, povidone, sodium starch glycolate, and compressible sugar. The ferrous fumarate tablets do not serve any therapeutic purpose.
What are the possible side effects of ethinyl estradiol and norethindrone?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using this medication and call your doctor at once if you have any of these serious side effects:
- sudden numbness or weakness, especially on one side of the body;
- sudden severe headache, confusion, problems with vision, speech, or balance;
- sudden cough, wheezing, rapid breathing, coughing up blood;
- pain, swelling, warmth, or redness in one or both legs;
Last reviewed on RxList: 1/29/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Femcon Fe Information
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