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Description
Emergency contraceptive tablet. Each Plan B table 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.
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Geriatric
This product is not intended for use in geriatric (age 65
years or older) populations and pharmacokinetic data are not available
for this population.
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Pediatric
This product is not intended for use in pediatric (premenarcheal)
populations and pharmacokinetic data are not available for
this population.
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Race
No formal studies have evaluated the effect of race.
However, cllinical trials demonstrated a higher pregnancy rate
in the Chinese population with both Plan B and the Yuzpe
(another form of emergency contraception). The reason for this
apparent increase in the pregnancy rate of emergency rate of
emergency contraceptives in Chinese women is unkown.
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Drug-Drug Interactions
No formal studies of drug-drug interactions were
conducted.
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Indications & Usage
Plan B is an emergency contraceptive that can be used to
prevent pregnancy following unprotected intercourse or a known
or suspected contraceptive failure. To obtain optimal
efficacy, the first tablet should be taken as soon as possible
within 72 hours of intercourse. The second tablet must be
taken 12 hours later.
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Clinical Studies
A double-blind, controlled clinical trial in 1,955
evaluable women compared the efficacy and safety of Plan B
(one 0.75 mg tablet of levonorgestrel taken within 72 hours of
intercourse, and two tablets taken 12 hours later) to the
Yuzpe regimen (two tablets of 0.25 mg levonorgestrel and 0.05
mg ethinyl estradiol, taken within 72 hours of intercourse,
and two tablets taken 12 hours later). Plan B was at least as
effective as the Yuzpe regimen in preventing pregnancy. After
a single act of intercourse, the expected pregnancy rate of 8%
(with no contraception) was reduced to approximately 1% with
Plan B. Thus, 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 (see
Warnings).
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Contraindicatons
Progestin-only contraceptive pills (POPs) are used as a
routine method of birth control over longer periods of time,
and are contraindicated in some conditons. 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
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Warnings
Plan B is not recommended for routine use as a
contraceptive.
Plan B is not effective in terminating an existing pregnancy.
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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
with POPs have not demonstrated significant adverse effects.
STD/HIV:
Plan B, like progestin-only contraceptives, does not protect
against HIV infection (AIDS) and other sexually transmitted
diseases.
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.
Carbohydrate Metabolism: The effects of Plan B on
carbohydrate metabolism are unknown. Some users of progestin-only
oral contraceptives (POP's) may experience slight
deterioration in glucose tolerance, with increases in plasma
insulin; however, women with diabetes mellitus who use POP's
do not generally experience changes in their insulin
requirements. Nonetheless, diabetic women should be monitored
while taking Plan B.
Drug Interactions: Theoretically, the effectiveness of
low-dose Progestin-only pills is reduced by hepatic
enzyme-inducing drugs such as the anticonvulsants phenytoin,
carbamazepine, and barbiturates, and the antituberculosis drug
riframpin. No significant interaction has been found with
broad-spectrum antibiotics. It is not known whether the
efficacy of Plan B would be affected by these or any other
medication.
Nursing Mothers: Small amounts of progestin pass into
the breast milk in women taking progestin-only pills for
long-term contraceptive resulting in steroid levels in infant
plasma of 1 to 6% of the levels of maternal plasma. However no
adverse effects due to progestin-only pills have been found on
breastfeeding performance, either in the quality or quantity
of the milk, or on the heath, growth or development of the
infant.
Pediatric Use: Safety and efficacy of pregestin-only
pills have been established in women of reproductive age for
long-term contraception. Safety and efficacy are expected to
be the same for postpubertal adolescents under the age of 16
and for users 16 years and older. Use for Plan B emergency
contraception before menarche is not indicated.
Fertility Following Discontinuation: The limited
available data indicate a rapid return of normal ovulation and
fertility following discontinuation of progestin-only pills
for emergency contraception and long-term contraception.
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Adverse Reactions
The most common adverse events in the clinical trial for
women receiving Plan B included nausea (23%), abdominal pain
918%), fatigue (17%), headache (17%), and menstrual
changes.
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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 health care professional to discuss whether
to repeat that dose.
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How Supplied
Plan B (Levonorgestrel) Tablets, 0.75 mg are available for
a single course of treatment in PVC/aluminum foil blister
packages of two tablets each. The tablet is white, round and
marked: INOR.
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