Plan B One-Step
"The U.S. Food and Drug Administration on Wednesday approved a request by Danco Laboratories to expand authorized use of its abortion pill Mifeprex (mifepristone), formerly known as RU-486, to 70 days of gestation from 49 days.
Plan B One-Step
Plan B® One-Step 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 tablet should be taken as soon as possible within 72 hours of intercourse.
Plan B One-Step is available only by prescription for women younger than age 17 years, and available over the counter for women 17 years and older.
Plan B One-Step is not indicated for routine use as a contraceptive.
DOSAGE AND ADMINISTRATION
Take Plan B One-Step 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. Plan B One-Step can be used at any time during the menstrual cycle.
If vomiting occurs within two hours of taking the tablet, consideration should be given to repeating the dose.
Dosage Forms And Strengths
The Plan B One-Step tablet is supplied as an almost white, round tablet containing 1.5 mg of levonorgestrel and is marked G00 on one side.
Storage And Handling
The Plan B One-Step (levonorgestrel) tablet 1.5 mg is available in a PVC/aluminum foil blister package. The tablet is almost white, round, and marked G00 on one side.
NDC 51285-088-88 (1 tablet unit of use package)
Store Plan B One-Step at 20°to 25°C (68°to 77°F) [see USP Controlled Room Temperature].
Mfg. by Gedeon Richter, Ltd., Budapest, Hungary for Duramed Pharmaceuticals, Inc., Subsidiary of Barr Pharmaceuticals, Inc., Pomona, New York 10970. Phone: 1-800-330-1271. Website: www.PlanBOneStep.com. Revised: July 2009.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 7/30/2009
Additional Plan B One-Step Information
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