"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"...
(norgestimate and ethinyl estradiol) Tablets
Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
Sprintec™ (norgestimate and ethinyl estradiol tablets) Tablets are a combination oral contraceptive containing the progestational compound norgestimate and the estrogenic compound ethinyl estradiol.
Each blue tablet contains 0.250 mg of the progestational compound norgestimate (18, 19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acety-loxy)-13-ethyl-, oxime, (17α)-(+)-) and 0.035 mg of the estrogenic compound, ethinyl estradiol (19-nor-17α-pregna, 1,3,5(10)-trien-20-yne-3, 17-diol), and the inactive ingredients include anhydrous lactose, FD&C blue no. 2 aluminum lake, lactose monohydrate, magnesium stearate, and pregelatinized starch.
Each white tablet contains only inert ingredients as follows: anhydrous lactose, hydroxypropyl methylcellulose 2208, magnesium stearate, and microcrystalline cellulose.
The structural formula is as follows:
What are the possible side effects of ethinyl estradiol and norgestimate?
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 taking this medicine 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 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;
- chest pain or...
Last reviewed on RxList: 12/10/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Sprintec Information
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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