HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use Plan B One-Step safely and effectively. See full prescribing information for Plan B One-Step.
Plan B One-Step (levonorgestrel) tablet, 1.5 mg, for oral use
Initial U.S. Approval: 1982
INDICATIONS AND USAGE
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. 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 intended for routine use as a contraceptive. (1)
DOSAGE AND ADMINISTRATION
One tablet taken orally as soon as possible within 72 hours after unprotected intercourse. Efficacy is better if the tablet is taken as soon as possible after unprotected intercourse. (2)
DOSAGE FORMS AND STRENGTHS
1.5 mg tablet (3)
Known or suspected pregnancy (4)
WARNINGS AND PRECAUTIONS
Ectopic pregnancy: Women who become pregnant or complain of lower abdominal pain after taking Plan B One- Step should be evaluated for ectopic pregnancy. (5.1)
Plan B One-Step is not effective in terminating an existing pregnancy. (5.2)
Effect on menses: Plan B One-Step may alter the next expected menses. If menses is delayed beyond 1 week, pregnancy should be considered. (5.3)
STI/HIV: Plan B One-Step does not protect against STI/HIV. (5.4)
The most common adverse reactions (≥10%) in clinical trials included heavier menstrual bleeding (31%), nausea (14%), lower abdominal pain (13%), fatigue (13%), headache (10%), and dizziness (10%). (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Barr Laboratories at 1-800-330-1271 or FDA at 1-800-FDA-1088 or MedWatch: The FDA Safety Information and Adverse Event Reporting Program
Drugs or herbal products that induce certain enzymes, such as CYP3A4, may decrease the effectiveness of progestin-only pills. (7)
USE IN SPECIFIC POPULATIONS
Nursing Mothers: Small amounts of progestin pass into the breast milk of nursing women taking progestin-only pills for long-term contraception, resulting in detectable steroid levels in infant plasma. (8.3)
Plan B One-Step is not intended for use in premenarcheal (8.4) or postmenopausal females (8.5).
See 17 for PATIENT COUNSELING INFORMATION.