"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"...
(90 mcg levonorgestrel and 20 mcg ethinyl estradiol) Tablets
Patients should be counseled that oral contraceptives do not protect against transmission of HIV (AIDS) and other sexually transmitted diseases (STDs) such as chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis.
Twenty-eight (28) yellow tablets each containing 90 mcg of levonorgestrel (17α)-(–)13-ethyl-17hydroxy-18, 19-dinorpregn-4-en-20-yn-3-one, a totally synthetic progestogen, and 20 mcg of ethinyl estradiol, (17α)-19-norpregna-1,3,5(10)-trien-20-yne-3,17-diol. The inactive ingredients present are microcrystalline cellulose, lactose monohydrate, magnesium stearate, polacrilin potassium, hypromellose, titanium dioxide, polyethylene glycol 400, iron oxide, polyethylene glycol 1450, montanic ester wax.
What are the possible side effects of ethinyl estradiol and levonorgestrel?
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,...
What are the precautions when taking levonorgestrel and ethinyl estradol tablets (Lybrel)?
See also Warning section.
Before using this medication, tell your doctor or pharmacist if you are allergic to ethinyl estradiol or levonorgestrel; or to other estrogens or progestins; 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.
This medication should not be used if you have certain medical conditions. Before using this product, consult your doctor or pharmacist if you have: history of stroke or other blood clots (e.g., in the legs, eyes, lungs), blood clotting disorders (such as protein C or protein S deficiency), severe high blood pressure, abnormal breast exam, cancer (especially endometrial and breast cancer), diabetes that has caused...
Last reviewed on RxList: 12/5/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Lybrel Information
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