Ask for Plan B One-Step™ at the pharmacy.

Plan B One-Step (levonorgestrel) tablet. 1.5 mg
Brief Summary (Sec Package Brochure Far Full Prescribing Information)
Rx only for women younger than age 17 years
For women younger than age 17 years. Plan B! One-Step is a prescription-only emergency contraccptivc. Plan B': One-Step is indicated to prevent
prcgnancy after known or suspectcd contraccptivc failure or unprotected intercourse. To obtain optimal cflficacy, the tablet should be taken as soon as possible within 72 hours of intercourse. It is not indicated for routine use as a contracept ve.
CONTRAINDICATIONS
Plan B" One-Step is contraindieated for use in the case of known or suspected pregnancy.
WARNINGS AND PRECAUTIONS
Ectopic Pregnancy
Ectopic pregnancies account for approximately 2% of all reported pregnancies. Up to .0% of pregnancies reported in clinical studies of routine use of progestin-only contraceptives are ectopic. A history of ectopic pregnancy is not a contraindication to use of this emergency contraceptive method. Healthcare providers, however, should consider the possibility of an ectopic prcgnancy ir women who become pregnant or complain of lower abdominal pain after taking Plan H' One-Step. A tollow-up physical or pelvic examination is recommended if there is any doubt concerning the general health or prcgnancy status of any woman after taking Plan 131 One-Step. Existing Pregnancy
Plan B* One-Step is not effective in terminating an existing pregnancy. Effects on Menses
Some women may experience spotting a tew clays alter taking Plan b* Une-Stcp. Mcnstiual bleeding patterns arc often irregular among women using prog-estin-onlv oral contraceptives and women using levonorgestrel for postcoital and emergency contraception. If there is a delay in the onset of expected menses be yond l week, consider the possibility of pregnancy. ST I/HIV
Plan B* One-Step docs not protcct against HIV infection (AIDS) or other sexually transmitted infections (STls). Physical Examination and Follow-up
A physical examination is not required p-ior to prescribing Plan B* One Step. A follow-up physical or pelvic examination is recommended if there is any doubt concerning the general health or pregnancy status of any woman after taking Plan B'"' One-Step. Fertility Following Discontinuation
A rapid return of fertility is likely following treatment with Plan B' One-Step for emergency contraception; therefore, routine contraception should be continued or initiated as soon as possible following use of Plan B* One-Step to ensure ongoing prevention of pregnancy. ADVERSE REACTIONS Clinical Trials Experience
The most common adverse events (>10%) in the clinical trial for women receiving Plan B* One-Slep included heavier menstrual bleeding (30.9%), nausea (13.7%), lower abdominal pain (13.3%), fatigue (13.3%), and headache (10.3%). Table 1 lists those adverse everts that were reported in > 4% of Plan B* One-Slep users.
Table 1. Adverse Events in > 4% of Women, by % Frequency
size. it is not always possible to reliably estimate their frequency or establish a causal relationship tc drug exposure.
Gastrointestinal Disorders: Abdominal Pain, Nausea, Vomiting General Disorders and Administration Site Conditions: Fatigue Nervous System Disorders: Dizziness, Headache
Rcpixxiuctivc System and Breast Disorders: Dysmenorrhea, Irregular Mcn-stniation. Oligomenorrhea. Pelvic Pain DRUG INTERACTIONS
Drugs or herbal products thul induce enzymes, including CYP3A4, that metabolize progestins may decrease the plasma concentrations of progestins, and may decrease the effectiveness of progestin-only pills. USE IN SPECIFIC POPULATIONS Pregnancy
Many studies have found no harmful effects on fetal development associated with long-term use of contraccptivc doses of oral progestins. The few studies of infant growth and development that have been conducted with progestin-only pills have not demonstrated significant adverse effects. Nursing Mother*
In general, no adverse effects of progestin-only pills have been found on breastfeeding performance or on the health, growth, or development of the infant. However, isolated post-marketing cases of decreased milk production have been reported. Small amounts of progestins pass into the breast milk of nursing mothers taking progestin-only pills for long-term contraception, resulting in detectable steroid levels in infant plasma. Pediatric Use
Safety and efficacy of progestin-only pills for long-term contraception have been established in women of reproductive age. Safety and efficacy are expected to be the same for postpubertal adolescents less than I / years and for users 17 years and older. Use of Plan B* One-Step emergency contraception before mcnarche is not indicated. Geriatric Use
This product is not intended for use in postmenopausal womer. Race
No formal studies have evaluated the effect of race. However, clinical trials demonstrated a higher pregnancy rate in Chinese women with both Plan B" and the Yu/pc regimen (another form of emergency contraception). There was a non-statistically significant increased rate of prcgnancy among Chinese women in the Plan B5 One-Step trial. The reason for this apparent increase in the pregnancy rate with emergency contraceptives in Chinese women is unknown.
DRUG ABUSE AND DEPENDENCE
Levonorgestrel is not a controlled substance. There is no information about dependence associated with the use of Plan B* One-Step. OVERDOSAGE
There are no data on overdosage of Plan B* One-Step, although the common
adverse event of nausea and associated vomiting may be anticipated.
Mfg. by Gedeon Ricliter, Ltd.. Budapest, Hungary
for Duramed Pharmaceuticals. Inc.
Subsidiary of Barr Pharmaceuticals, Inc.
Pomona, New York