"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"...
- Patient Information:
Details with Side Effects
Next Choice™ is a progestin-only emergency contraceptive indicated for prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure. To obtain optimal efficacy, the first tablet should be taken as soon as possible within 72 hours of intercourse. The second tablet should be taken 12 hours later.
Next Choice™ is available only by prescription for women younger than age 17 years, and available over the counter for women 17 years and older.
Next Choice™ is not indicated for routine use as a contraceptive.
DOSAGE AND ADMINISTRATION
Take one levonorgestrel tablet orally as soon as possible within 72 hours after unprotected intercourse or a known or suspected contraceptive failure. Efficacy is better if the tablet is taken as soon as possible after unprotected intercourse. The second tablet should be taken 12 hours after the first dose. Next Choice™ can be used at any time during the menstrual cycle.
If vomiting occurs within two hours of taking either dose of medication, consideration should be given to repeating the dose.
Dosage Forms and Strengths
Each Next Choice™ tablet is supplied as a peach, round, bevel edged, flat faced tablet containing 0.75 mg of levonorgestrel and is embossed with "475" on one side and "WATSON" on the other side.
Next Choice™ (levonorgestrel) tablets, 0.75 mg, are available for a single course of treatment in PVC/aluminum foil blister packages of two tablets each. Each tablet is peach, round, bevel edged, and flat faced and embossed with "475" on one side and "WATSON" on the other side.
Available as: Unit-of-use NDC 52544-275-36
Store Next Choice™ tablets at 20° to 25°C (68° to 77°F) [see USP controlled room temperature].
Manufactured by: Watson Laboratories, Inc. Corona, CA 92880 USA. Distributed by: Watson Pharma, Inc. Corona, CA 92880 USA. Phone: 1-866-9WATSON (1-866-992-8766) www.mynextchoice.com. Issued: August 2009
Last reviewed on RxList: 7/19/2011
This monograph has been modified to include the generic and brand name in many instances.
Additional Next Choice 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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