Plan B One-step

What is Plan B One-step?

• Plan B One-Step is a progestin-only emergency contraceptive used for prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure.

What are the uses of this medicine?

• 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.
• To obtain optimal efficacy, the tablet should be taken as soon as possible within 72 hours of intercourse.
• 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.

Limitation of use: Plan B One-Step is not indicated for routine use as a contraceptive.

How does this medicine work?

• Emergency contraceptive pills are not effective if a woman is already pregnant.
• Plan B One-Step 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.

Who Should Not Use this medicine ?

This medicine cannot be used in patients:

• in the case of known or suspected pregnancy

What drug interactions can this medicine cause?

Drugs or herbal products that induce certain enzymes, such as CYP3A4, may decrease the effectiveness of progestin-only pills. Some drugs or herbal products that may decrease the effectiveness of progestin-only pills include:

• barbiturates
• bosentan
• carbamazepine
• felbamate
• griseofulvin
• oxcarbazepine
• phenytoin
• rifampin
• St. John’s wort
• topiramate

Is this medicine FDA approved?

• FDA approved this drug in the year of 2013 for emergency contraceptive without a prescription for women 15 years of age and older.

How should this medicine be used?

Recommended Dosage:

• 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.
• Plan B One-Step can be used at any time during the menstrual cycle.
• If vomiting occurs within two hours of taking the tablet, consideration should be given to repeating the dose.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As 1.5 mg tablet

This medicine is available in fallowing brand namesː

• Plan B One-Step

What side effects can this medication cause?

The most common side effects of this medicine include:

• menstrual bleeding
• nausea
• lower abdominal pain
• fatigue
• headache
• dizziness

What special precautions should I follow?

• Up to 10% of pregnancies reported in clinical studies of routine use of progestin-only contraceptives are ectopic. Women who become pregnant or complain of lower abdominal pain after taking Plan B One- Step should be evaluated for ectopic pregnancy.
• Plan B One-Step is not effective in terminating an existing pregnancy.
• 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.
• Plan B One-Step does not protect against HIV infection (AIDS) or other sexually transmitted infections (STIs).
• 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.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• There are no data on overdosage of Plan B One-Step, although the common adverse event of nausea and associated vomiting.

Can this medicine be used in pregnancy?

• Many studies have found no harmful effects on fetal development associated with long-term use of contraceptive doses of oral progestins.

Can this medicine be used in children?

• 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.

What are the active and inactive ingredients in this medicine?

Active ingredients:

• LEVONORGESTREL

Inactive ingredients:

• SILICON DIOXIDE
• STARCH, CORN
• LACTOSE MONOHYDRATE
• MAGNESIUM STEARATE
• STARCH, POTATO
• TALC

Who manufactures and distributes this medicine?

• Packager: Rebel Distributors Corp

What should I know about storage and disposal of this medication?

• Store Plan B One-Step at 20º to 25ºC (68º to 77ºF).

• Dailymed label info on Plan B One-step
• FDA Plan B One-step