"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"...
(levonorgestrel) Tablets, 0.75 mg
Available without a prescription for consumers 18 and older. Rx only for women age 17 and younger
For women age 17 and younger, Plan B® (levonorgestrel) is a prescription-only emergency contraceptive. Plan B® is intended to prevent pregnancy after known or suspected contraceptive failure or unprotected intercourse. Emergency contraceptive pills (like all oral contraceptives) do not protect against infection with HIV (the virus that causes AIDS) and other sexually transmitted diseases.
- Patient Information:
Details with Side Effects
Emergency contraceptive tablet. Each Plan B® (levonorgestrel) tablet contains 0.75 mg of a single active steroid ingredient, levonorgestrel [18,19-Dinorpregn-4-en-20-yn-3-one-13-ethyl-17-hydroxy-, (17α)- (-)-], a totally synthetic progestogen. The inactive ingredients present are colloidal silicon dioxide, potato starch, gelatin, magnesium stearate, talc, corn starch, and lactose monohydrate. Levonorgestrel has a molecular weight of 312.45, and the following structural and molecular formulas:
What are the possible side effects of levonorgestrel emergency contraceptive (Next Choice, Plan B, Plan B One-Step)?
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.
Call your doctor at once if you have severe pain in your lower stomach or side. This could be a sign of a tubal pregnancy (a pregnancy that implants in the fallopian tube instead of the uterus). A tubal pregnancy is a medical emergency.
Less serious side effects may include:
- nausea, diarrhea, or stomach pain;
- dizziness, tired...
What are the precautions when taking levonorgestrel (Plan B)?
Before using this medication, tell your doctor or pharmacist if you are allergic to it; or to other progestins (e.g., norethindrone); 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: unexplained vaginal bleeding, current or suspected pregnancy.
Before using this product, tell your doctor your medical history, especially of: diabetes, migraine headaches.
This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such...
Last reviewed on RxList: 5/24/2007
This monograph has been modified to include the generic and brand name in many instances.
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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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