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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)
-----------CONTRAINDICATIONS-----------------
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)
----------------ADVERSE REACTIONS--------------
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 www.fda.gov/medwatch.
----------------DRUG INTERACTIONS--------------
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.
Revised 7/2009
FULL PRESCRIBING INFORMATION:
CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Ectopic Pregnancy
5.2 Existing Pregnancy
5.3 Effect on Menses
5.4 STI/HIV
5.5 Physical Examination and Follow-up
5.6 Fertility Following Discontinuation
6 ADVERSE REACTIONS
6.1 Clinical Trial Experience
6.2 Postmarketing Experience
7 DRUG INTERACTIONS
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Race
8.7 Hepatic Impairment
8.8 Renal Impairment
9 DRUG ABUSE AND DEPENDENCE
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment
of Fertility
14 CLINICAL STUDIES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING NFORMATION
17.1 Information for Patients
*Sections or subsections omitted from the full prescribing
information are not listed