LEVONORGESTREL tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

LEVONORGESTREL (UNII: 5W7SIA7YZW) (LEVONORGESTREL - UNII:5W7SIA7YZW)

Available from:

Lotus Pharmaceutical Co., Ltd. Nantou Plant

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Levonorgestrel tablets are 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 first tablet should be taken as soon as possible within 72 hours of intercourse. The second tablet should be taken 12 hours later. Levonorgestrel tablets are available only by prescription for women younger than age 17 years, and available over the counter for women 17 years and older. Levonorgestrel tablets are not indicated for routine use as a contraceptive. Levonorgestrel tablets are contraindicated for use in the case of known or suspected pregnancy. Many studies have found no harmful effects on fetal development associated with long-term use of contraceptive doses of oral progestins. The few studies of infant growth and development that have been conducted with progestin-only pills have not demonstrated significant adverse effects. In general, no adverse effects of progestin-only pills ha

Product summary:

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 a white, round tablet, debossed with "LP" on one side and "54" on the other side. Available as: Unit-of-Use NDC 40051-054-22 Store Levonorgestrel tablets 20° to 25° C (68° to 77°F); excursions permitted between 15°to 30 °C (59° to 86°F) [see USP Controlled Room Temperature ].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LEVONORGESTREL- LEVONORGESTREL TABLET
LOTUS PHARMACEUTICAL CO., LTD. NANTOU PLANT
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LEVONORGESTREL SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR LEVONORGESTREL
LEVONORGESTREL TABLETS, FOR ORAL USE.
INITIAL U.S. APPROVAL:1982
INDICATIONS AND USAGE
Levonorgestrel tablets are a progestin-only emergency contraceptive,
indicated for prevention of pregnancy following
unprotected intercourse or a known or suspected contraceptive failure.
Levonorgestrel tablets are available only by
prescription for women younger than age 17 years, and available over
the counter for women 17 years and older.
Levonorgestrel tablets are not intended for routine use as a
contraceptive. ( 1 )
DOSAGE AND ADMINISTRATION
The first tablet is taken orally as soon as possible within 72 hours
after unprotected intercourse. The second tablet should
be taken 12 hours after the first dose. Efficacy is better if
Levonorgestrel tablets are taken as soon as possible after
unprotected intercourse. ( 2 )
DOSAGE FORMS AND STRENGTHS
A total of two 0.75 mg tablets taken 12 hours apart as a single course
of treatment ( 3 )
CONTRAINDICATIONS
Known or suspected pregnancy. ( 4 )
WARNINGS AND PRECAUTIONS
Ectopic Pregnancy: Women who become pregnant or complain of lower
abdominal pain after taking Levonorgestrel
tablets should be evaluated for ectopic pregnancy. ( 5.1 )
Levonorgestrel tablets are not effective in terminating an existing
pregnancy. ( 5.2 )
Effect on menses: Levonorgestrel tablets may alter the next expected
menses. If menses is delayed beyond 1 week,
pregnancy should be considered. ( 5.3 )
STI/HIV: Levonorgestrel tablets do not protect against STI/HIV. ( 5.4
)
ADVERSE REACTIONS
The most common adverse reactions (≥ 10%) in the clinical trial
included menstrual changes (26%), nausea (23%),
abdominal pain (18%), fatigue (17%), headache (17%), dizziness (11%)
and breast tenderness (11%). ( 6.1 )
TO REPORT SUSPECTED ADVERSE RE