"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"...
For women age 17 and younger, Plan B® (levonorgestrel) is a prescription-only emergency contraceptive that can be used to prevent 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 must be taken 12 hours later.
DOSAGE AND ADMINISTRATION
One tablet of Plan B® (levonorgestrel) should be taken orally as soon as possible within 72 hours after unprotected intercourse. The second tablet should be taken 12 hours after the first dose. Efficacy is better if Plan B® (levonorgestrel) is taken as directed as soon as possible after unprotected intercourse. Plan B® (levonorgestrel) can be used at any time during the menstrual cycle.
The user should be instructed that if she vomits within one hour of taking either dose of medication she should contact her health care professional to discuss whether to repeat that dose.
Plan B® (levonorgestrel) tablets, 0.75 mg are available for a single course of treatment in PVC/aluminum foil blister packages of two tablets each. The tablet is white, round, and marked: INOR.
Unit-of-use NDC 51285-038-93
Store Plan B® (levonorgestrel) tablets at controlled room temperature, 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP].
Mfg. by Gedeon Richter, Ltd., Budapest, Hungary
for Duramed Pharmaceuticals, Inc.
Subsidiary of Barr Pharmaceuticals, Inc.
Pomona, NY 10970
Phone: 1-800-330-1271 Web site: www.go2planb.com
Revised August 2006
BR- 038 / 21000382503
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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