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HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use Plan B
safely and effectively. See full prescribing information for Plan B.
Plan B (levonorgestrel) tablets, 0.75mg, for oral use
Initial U.S. Approval: 1982
----------------------------INDICATIONS AND USAGE---------------------------
Plan B is a progestin-only emergency contraceptive, indicated for prevention
of pregnancy following unprotected intercourse or a known or suspected
contraceptive failure. Plan B 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 is not intended for routine use as a contraceptive. (1)
----------------------DOSAGE AND ADMINISTRATION-----------------------
The first tablet is 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 is taken as soon as possible after
unprotected intercourse. (2)
---------------------DOSAGE FORMS AND STRENGTHS----------------------
A total of two 0.75 mg tablets taken 12 hours apart as a single course of
treatment (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 should be evaluated for ectopic
pregnancy. (5.1)
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
• Plan B is not effective in terminating an existing pregnancy. (5.2)
• Effect on menses: Plan B may alter the next expected menses. If menses
is delayed beyond 1 week, pregnancy should be considered. (5.3)
• STI/HIV: Plan B does not protect against STI/HIV. (5.4)
------------------------------ADVERSE REACTIONS-------------------------------
The most common adverse reactions (≥ 10%) in the clinical trial included
menstrual changes (26%), nausea (23%), abdominal pain (18%), fatigue
(17%), headache (17%), dizziness (11%), and breast tenderness (11%). (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 is not intended for use in premenarcheal (8.4) or postmenopausal
females (8.5).
• Clinical trials demonstrated a higher pregnancy rate in the Chinese
population. (8.6)
See 17 for PATIENT COUNSELING INFORMATION
Revised: 7/2009
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 INFORMATION
17.1 Information for Patients
*Sections or subsections omitted from the full prescribing information are not
listed.