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Plan B One-Step (Levonorgestrel) - Warnings and Precautions

 
 



WARNINGS AND PRECAUTIONS

Ectopic Pregnancy

Ectopic pregnancies account for approximately 2% of all reported pregnancies. Up to 10% 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 pregnancy in women who become pregnant or complain of lower abdominal pain after taking 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.

Existing Pregnancy

Plan B One-Step is not effective in terminating an existing pregnancy.

Effects on Menses

Some women may experience spotting a few days after taking Plan B One-Step. Menstrual bleeding patterns are often irregular among women using progestin-only oral contraceptives and women using levonorgestrel for postcoital and emergency contraception.

If there is a delay in the onset of expected menses beyond 1 week, consider the possibility of pregnancy.

STI/HIV

Plan B One-Step does not protect against HIV infection (AIDS) or other sexually transmitted infections (STIs).

Physical Examination and Follow-up

A physical examination is not required prior 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.

USE IN SPECIFIC POPULATIONS

Pregnancy

Many studies have found no harmful effects on fetal development associated with long-term use of contraceptive 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 Mothers

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 17 years and for users 17 years and older. Use of Plan B  One-Step emergency contraception before menarche is not indicated.

Geriatric Use

This product is not intended for use in postmenopausal women.

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 Yuzpe regimen (another form of emergency contraception). There was a non-statistically significant increased rate of pregnancy among Chinese women in the Plan B One-Step trial. The reason for this apparent increase in the pregnancy rate with emergency contraceptives in Chinese women is unknown.

Hepatic Impairment

No formal studies were conducted to evaluate the effect of hepatic disease on the disposition of Plan B One-Step.

Renal Impairment

No formal studies were conducted to evaluate the effect of renal disease on the disposition of Plan B One-Step.

Page last updated: 2013-11-21

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