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Emergency contraceptive

Levonorgestrel

International Name
- Emergency contraceptive
Manufacturer
- Rx
Contains
- Levonorgestrel
Packing
- 1 Tablet
Strength
- 1.5mg
Form
- Tablet

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Pill 72 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.

Emergency contraceptives are not effective if the woman is already pregnant. Pill 72 is believed to act as an emergency contraceptive principally by preventing ovulation or fertilization (by altering tubal transport or 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.

INDICATIONS
Pill 72 is an emergency contraceptive that can be used to prevent pregnancy following unprotected intercourse or a known or suspected contraceptive failure.

DOSAGE AND ADMINISTRATION
One tablet of Pill 72 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 Pill 72 is taken as directed as soon as possible after unprotected intercourse. Pill 72 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 doctor to discuss whether to repeat that dose.

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 Pill 72 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 AND PRECAUTIONS
Warnings
Pill 72 is not recommended for routine use as a contraceptive.
Pill 72 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 Pill 72. At the time of expected menses, approximately 75% of women using Pill 72 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. Doctor, however, should be alert to the possibility of an ectopic pregnancy in women who become pregnant or complain of lower abdominal pain after taking Pill 72.

Precautions

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 Pill 72 would be affected by these or any other medications.

Pregnancy
Many studies have found no effects on fetal development associated with long-term use of contraceptive doses of oral progestins (POPs).

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 Pill 72 emergency contraception before menarche is not indicated.

In the elderly
This product is not intended for use in geriatric (age 65 years or older) populations and pharmacokinetic data are not available for this population.

Pediatric
This product is not intended for use in pediatric (premenarchal) populations, and pharmacokinetic data are not available for this population.

STD/HIV
Pill 72, like progestin-only contraceptives, does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Carbohydrate Metabolism
The effects of Pill 72 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 Pill 72.

Hepatic Insufficiency and Renal Insufficiency
No formal studies have evaluated the effect of hepatic insufficiency or renal insufficiency on the disposition of emergency contraceptive tablets.

Physical Examination and Follow-up
A physical examination is not required prior to prescribing Pill 72. 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 Pill 72.

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.

SIDE EFFECTS
The most common adverse events in the clinical trial for women receiving Pill 72 included nausea (23%), abdominal pain (18%), fatigue (17%), headache (17%), and menstrual changes.
Pill 72 demonstrated a superior safety profile over the Yuzpe regimen for the following adverse events:
Nausea: Occurred in 23% of women taking Pill 72 (compared to 50% with Yuzpe)
Vomiting: Occurred in 6% of women taking Pill 72 (compared to 19% with Yuzpe)

DRUG ABUSE AND DEPENDENCE
There is no information about dependence associated with the use of Pill 72.

OVERDOSAGE
There are no data on overdosage of Pill 72, although the common adverse event of nausea and its associated vomiting may be anticipated.

PRESENTATION
Pill 72 Blister pack of 2 tablets
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