Plan B® - The Morning After Pill

You have a second chance when things don't go as planned

	Plan B® - The Morning After Pill
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Plan B® is an emergency contraceptive that can still prevent a pregnancy after contraceptive failure or unprotected sex. Plan B® should be taken within 3 days or 72 hours of unprotected sex and can reduce the risk of pregnancy by 89%. But the sooner you take it the more effective it will be.

PRESCRIBING INFORMATION
Plan B (Levonorgestrel) tablets, 0.75 mg Rx

Only Plan B is intended to prevent pregnancy after known or suspected contraceptive failure or unprotected intercourse. Emergency contraceptive pills (like all oral contraceptives) do not protect against infection with HIV and other sexually transmitted diseases.

DESCRIPTION
Emergency contraceptive tablet. Each Plan B tablet contains 0.75 mg of a single active steroid ingredient, levonorgestrel, a totally synthetic progestogen. The inactive ingredients present are colloidal silicon dioxide, potato starch, gelatin, magnesium stearate, talc, corn starch, and lactose monohydrate.

CLINICAL PHARMACOLOGY

Emergency contraceptives are not effective if the woman is already pregnant. Plan B is believed to act as an emergency contraceptive principally by preventing ovulation or fertilization by altering tubal transport of sperm and/or ova. In addition, it may inhibit implantation by altering the endometrium. It is not effective once the process of implantation has begun. This product is not intended for use in geriatric age 65 years or older populations. Plan B reduced the expected number of pregnancies by 89%. Emergency contraceptives are not as effective as routine contraception since their failure rate, while low based on a single use, would accumulate over time with repeated use. Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.

CONTRAINDICATIONS
Progestin-only contraceptive pills (POPs) are used as a routine method of birth control over longer periods of time, and are contraindicated in some conditions. It is not known whether these same conditions apply to the Plan B regimen consisting of the emergency use of two progestin pills. POPs however, are not recommended for use in the following conditions: • Known or suspected pregnancy • Hypersensitivity to any component of the product • Undiagnosed abnormal genital bleeding.

WARNINGS
Plan B is not recommended for routine use as a contraceptive. Plan B is not effective in terminating an existing pregnancy. Effects on Menses Menstrual bleeding patterns are often irregular among women using progestin-only oral contraceptives and in clinical studies of levonorgestrel for postcoital and emergency contraceptive use. Some women may experience spotting a few days after taking Plan B. At the time of expected menses, approximately 75% of women using Plan B had vaginal bleeding similar to their normal menses, 12-13% bled more than usual, and 12% bled less than usual. The majority of women (87%) had their next menstrual period at the expected time or within ± 7 days, while 13% had a delay of more than 7 days beyond the anticipated onset of menses. If there is a delay in the onset of menses beyond 1 week, the possibility of pregnancy should be considered. Ectopic Pregnancy Ectopic pregnancies account for approximately 2% of reported pregnancies (19.7 per 1000 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 need not be considered a contraindication to use of this emergency contraceptive method. Health providers, however, should be alert to the possibility of an ectopic pregnancy in women who become pregnant or complain of lower abdominal pain after taking Plan B.

PRECAUTIONS
Pregnancy Many studies have found no effects on fetal development associated with long-term use of contraceptive doses of oral progestins (POPs). The few studies of infant growth and development that have been conducted with POPs have not demonstrated significant adverse effects. Physical Examination and Follow-up A physical examination is not required prior to prescribing Plan B. A follow-up physical or pelvic examination, however, is recommended if there is any doubt concerning the general health or pregnancy status of any woman after taking Plan B.

STD/HIV
Plan B, like progestin-only contraceptives, does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

ADVERSE REACTIONS
The most common adverse events in the clinical trial for women receiving Plan B included nausea, abdominal pain, fatigue, headache, and menstrual changes.

DRUG ABUSE AND DEPENDENCE
There is no information about dependence associated with the use of Plan B. OVERDOSAGE
There are no data on overdosage of Plan B, although the common adverse event of nausea and its associated vomiting may be anticipated.

DOSAGE AND ADMINISTRATION
One tablet of Plan B should be taken orally 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 directed as soon as possible after unprotected intercourse. Plan B can be used at any time during the menstrual cycle. The user should be instructed that if she vomits within one hour of taking either dose of medication she should contact her healthcare professional to discuss whether to repeat that dose.

HOW SUPPLIED
Plan B (Levonorgestrel) tablets, 0.75 mg are available for a single course of treatment in PVC/aluminum foil