Plan B^® (levonorgestrel) tablets, 0.75 mg

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 (the virus that causes AIDS) and other sexually transmitted diseases.

-----------------------------------------------------------------------

DESCRIPTION

Emergency contraceptive tablet. Each Plan B^®™ 100 mg tablet contains 0.75 mg of a single active steroid ingredient, levonorgestrel [18,19-Dinorpregn-4-en-20-yn-3-one-13-ethyl-17-hydroxy-, (17a)-(-)-], a totally synthetic progestogen. The inactive ingredients present are colloidal silicon dioxide, potato starch, gelatin, magnesium stearate, talc, corn starch, and lactose monohydrate. Levonorgestrel has a molecular weight of 312.45, and the following structural and molecular formulas:

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.

Drug-Drug Interactions

No formal studies of drug-drug interactions were conducted.

Buy Plan B (Levonorgestrel) Now !

INDICATIONS & USAGE

Indication

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.

-----------------------------------------------------------------------

Clinical Studies

A double-blind, controlled clinical trial in 1955 evaluable women compared the efficacy and safety of Plan B^®™ (one 0.75 mg tablet of levonorgestrel taken within 72 hours of intercourse, and one tablet 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). See Table 2 below.

-----------------------------------------------------------------------

Table 2
Percentage of Women Experiencing an Unintended Pregnancy During the First Year of Typical Use and the First Year of Perfect Use of Contraception, and the Percentage Continuing Use at the End of the first Year- United States

-----------------------------------------------------------------------

Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.

Buy Plan B (Levonorgestrel) Now !

Lactational Amenorrhea Method: LAM is a highly effective temporary method of contraception

1.  Among typical couples who initiate use of a method (not necessarily for the first time) who experience an accidental pregnancy during the first year if they do not stop use for any other reason.
2.  Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly) the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason.
3.  Among couples attempting to avoid pregnancy, the percentage (column 4) who continue to use a method for 1 year.
4.  The percent becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within 1 year among women now relying on reversible methods of contraception if they abandoned contraception altogether.
5.  Foams, creams, gels, vaginal suppositories, and vaginal film.
6.  Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phase.
7.  With spermicidal cream or jelly.
8.  Without spermicides.
9.  However, to maintain an effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency or duration of breast feeds is reduced, bottle feeds are introduced, or the baby reaches 6 months of age.

Source: Trussell J. Contraceptive efficacy. In Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Guest F, Kowal D. Contraceptive Technology; Seventeenth Revised Edition. New York, NY: Irvington Publishers, 1998

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

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.

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 (POPs) may experience slight deterioration in glucose tolerance, with increases in plasma insulin; however, women with diabetes mellitus who use POPs 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 rifampin. 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 medications.

Nursing Mothers

Small amounts of progestin pass into the breast milk in women taking progestin-only pills for long-term contraception resulting in steroid levels in infant plasma of 1-6% 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 health, growth or development of the infant.

Pediatric Use

Safety and efficacy of progestin-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 of Plan B^®™ emergency contraception before menarche is not indicated.

Buy Plan B (Levonorgestrel) Now !

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.

ADVERSE REACTIONS

The most common adverse events in the clinical trial for women receiving Plan B^®™ included nausea (23%), abdominal pain (18%), fatigue (17%), headache (17%), and menstrual changes. The table below shows those adverse events that occurred in ³ 5% of Plan B^®™ users.

Table 3
Adverse Events in Less Than or Equal to 5% of Women, by % Frequency

Plan B^®™ demonstrated a superior safety profile over the Yuzpe regimen for the following adverse events: