LEVONORGESTREL tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Novel Laboratories, Inc.

INN (International Name):

LEVONORGESTREL

Composition:

LEVONORGESTREL 1.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Levonorgestrel Tablet, 1.5 mg 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. Levonorgestrel Tablet is available only by prescription for women younger than age 17 years, and available over the counter for women 17 years and older. Levonorgestrel Tablet is not indicated for routine use as a contraceptive. Levonorgestrel Tablet is 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 have been found on breastfeeding performance or on the hea

Product summary:

Levonorgestrel Tablet, 1.5 mg is available in a PVC/aluminum foil blister package. The tablet is a white to off-white, round, flat, debossed with “NL 620” on one side and plain on the other side containing 1.5 mg of levonorgestrel. NDC 40032-620-30 (1 tablet unit of use package) Store Levonorgestrel Tablet at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LEVONORGESTREL - LEVONORGESTREL TABLET
NOVEL LABORATORIES, INC.
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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 (LEVONORGESTREL) TABLET FOR ORAL USE.
INITIAL U.S. APPROVAL: 1982
INDICATIONS AND USAGE
Levonorgestrel Tablet is a progestin-only emergency contraceptive
indicated for prevention of pregnancy following
unprotected intercourse or a known or suspected contraceptive failure.
Levonorgestrel Tablet is available only by
prescription for women younger than age 17 years, and available over
the counter for women 17 years and older.
Levonorgestrel Tablet is not intended for routine use as a
contraceptive. (1)
DOSAGE AND ADMINISTRATION
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. (2)
DOSAGE FORMS AND STRENGTHS
1.5 mg tablet (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
Tablet should be evaluated for ectopic pregnancy. (5.1)
Levonorgestrel Tablet is not effective in terminating an existing
pregnancy. (5.2)
Effect on menses: Levonorgestrel Tablet may alter the next expected
menses. If menses is delayed beyond 1 week,
pregnancy should be considered. (5.3)
STI/HIV: Levonorgestrel Tablet does not protect against STI/HIV. (5.4)
ADVERSE REACTIONS
The most common adverse reactions (≥10%) in clinical trials included
heavier menstrual bleeding (31%), nausea (14%),
lower abdominal pain (13%), fatigue (13%), headache (10%), and
dizziness (10%). (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT AT OR FDA AT
1-800-FDA-1088 OR
_WWW.FDA.GOV/MEDWATCH._
DRUG INTERACTIONS
Drugs or herbal products that induce certain enzymes, such as CYP3A4,
may decrease the effectiveness of proges