"The U.S. Food and Drug Administration today announced that it has approved an amended application submitted by Teva Women's Health, Inc. to market Plan B One-Step (active ingredient levonorgestrel) for use without a prescription by women 15 years"...
(norethindrone acetate and ethinyl estradiol) Tablets, USP and (ferrous fumarate) Tablets*
*Ferrous fumarate tablets are not USP for dissolution and assay.
ESTROSTEP®Fe (norethindrone acetate and ethinyl estradiol tablets)
(Each white triangular tablet contains 1 mg norethindrone acetate and 20 mcg ethinyl estradiol; each white square tablet contains 1 mg norethindrone acetate and 30 mcg ethinyl estradiol; each white round tablet contains 1 mg norethindrone acetate and 35 mcg ethinyl estradiol; each brown tablet contains 75 mg ferrous fumarate.)
Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
ESTROSTEP® Fe is a graduated estrophasic oral contraceptive providing estrogen in a graduated sequence over a 21-day period with a constant dose of progestogen.
ESTROSTEP Fe (norethindrone acetate and ethinyl estradiol tablets) provides for 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 triangle-shaped tablet contains 1 mg norethindrone acetate [(17 alpha)-17-(acetyloxy)-19-norpregna-4-en-20-yn-3-one] and 20 mcg ethinyl estradiol [(17 alpha)-19-norpregna-1,3,5(10)-trien-20-yne-3,17-diol]; each white square-shaped tablet contains 1 mg norethindrone acetate and 30 mcg ethinyl estradiol; and each white round tablet contains 1 mg norethindrone acetate and 35 mcg ethinyl estradiol. Each tablet also contains calcium stearate; lactose; microcrystalline cellulose; and starch.
The structural formulas are as follows:
Each brown tablet contains microcrystalline cellulose; ferrous fumarate; magnesium stearate; povidone; sodium starch glycolate; sucrose with modified dextrins.
Each ESTROSTEP Fe (norethindrone acetate and ethinyl estradiol tablets) tablet dispenser contains five white triangular tablets, seven white square tablets, nine white round tablets, and seven brown tablets. These tablets are to be taken in the following order: one triangular tablet each day for five days, then one square tablet each day for seven days, followed by one round tablet each day for nine days, and then one brown tablet each day for seven days.
What are the possible side effects of birth control pills?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using birth control pills and call your doctor at once if you have a serious side effect such as:
- sudden numbness or weakness, especially on one side of the body;
- sudden and severe headache, confusion, problems with vision, speech, or balance;
- chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
- sudden cough, wheezing, rapid...
What are the precautions when taking norethindrone acetate and ethinyl estradiol tablets (Estrostep Fe)?
See also Warning section.
Before using this medication, tell your doctor or pharmacist if you are allergic to ethinyl estradiol, norethindrone, or ferrous fumarate; or to other estrogens, progestins, or iron products; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood clots (for example, in the legs, eyes, lungs), blood clotting disorders (such as protein C or protein S deficiency), high blood pressure, abnormal breast exam, cancer (especially endometrial or breast cancer), high cholesterol or triglyceride (blood fat) levels, depression,...
Last reviewed on RxList: 4/28/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Estrostep Fe Information
Estrostep Fe - User Reviews
Estrostep Fe User Reviews
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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