LEVETIRACETAM tablet, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

LEVETIRACETAM (UNII: 44YRR34555) (LEVETIRACETAM - UNII:44YRR34555)

Available from:

LUPIN LIMITED

INN (International Name):

LEVETIRACETAM

Composition:

LEVETIRACETAM 500 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Levetiracetam extended-release tablet USP is indicated as adjunctive therapy in the treatment of partial onset seizures in patients 12 years of age and older with epilepsy. None Extended-release levetiracetam tablets levels may decrease during pregnancy [see WARNINGS AND PRECAUTIONS (5.8)]. Pregnancy Category C There are no adequate and well-controlled studies in pregnant women. In animal studies, levetiracetam produced evidence of developmental toxicity, including teratogenic effects, at doses similar to or greater than human therapeutic doses. Extended-release levetiracetam tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Oral administration of levetiracetam to female rats throughout pregnancy and lactation led to increased incidences of minor fetal skeletal abnormalities and retarded offspring growth pre- and/or postnatally at doses >350 mg/kg/day (equivalent to the maximum recommended human dose of 3000 mg [MRHD] on a mg/m2 basis) and with i

Product summary:

Levetiracetam Extended-release Tablets USP, 500 mg are white to off white, oblong-shaped, biconvex, film coated tablets, imprinted 'L008' (in black ink) on one side and plain on the other side. They are supplied in white HDPE bottles containing 60 tablets (NDC 68180-117-07) and white HDPE bottles containing 500 tablets (NDC 68180-117-02). Levetiracetam Extended-release Tablets USP, 750 mg are white to off white, oblong-shaped, biconvex, film coated tablets, imprinted 'L009' (in black ink) on one side and plain on the other side. They are supplied in white HDPE bottles containing 60 tablets (NDC 68180-118-07) and white HDPE bottles containing 500 tablets (NDC 68180-118-02). Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Pharmacist: Dispense in a tight, light-resistant container with a child-resistant closure.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LEVETIRACETAM- LEVETIRACETAM TABLET, EXTENDED RELEASE
LUPIN LIMITED
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LEVETIRACETAM EXTENDED-RELEASE TABLETS USP
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
LEVETIRACETAM EXTENDED-RELEASE TABLETS USP.
LEVETIRACETAM EXTENDED-RELEASE TABLETS USP, FOR ORAL USE
INITIAL U.S. APPROVAL: 1999
RECENT MAJOR CHANGES
Indications and Usage (1) 08/2014
Warnings and Precautions (5.1, 5.3, 5.7) 03/2015
INDICATIONS AND USAGE
Levetiracetam extended-release tablets USP is indicated for adjunctive
therapy in the treatment of partial onset seizures in
patients 12 years of age and older with epilepsy (1)
DOSAGE AND ADMINISTRATION
Initiate treatment with a dose of 1000 mg once daily; increase by 1000
mg every 2 weeks to a maximum recommended
dose of 3000 mg once daily (2)
See full prescribing information for use in patients with impaired
renal function (2.1)
DOSAGE FORMS AND STRENGTHS
500 mg white, film-coated extended-release tablet(3)
750 mg white, film-coated extended-release tablet(3)
CONTRAINDICATIONS
None (4 )
WARNINGS AND PRECAUTIONS
Behavioral abnormalities including psychotic symptoms, suicidal
ideation, irritability, and aggressive behavior have
been observed; monitor patients for psychiatric signs and symptoms
(5.1 )
Suicidal Behavior and Ideation: Monitor patients for new or worsening
depression, suicidal thoughts/behavior, and/or
unusual changes in mood or behavior (5.2)
Monitor for somnolence and fatigue and advise patients not to drive or
operate machinery until they have gained
sufficient experience on extended-release levetiracetam tablets (5.3)
Withdrawal Seizures: Extended-release levetiracetam tablets must be
gradually withdrawn (5.6)
ADVERSE REACTIONS
Most common adverse reactions (incidence ≥5% more than placebo)
include: somnolence and irritability (6.1 )
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT LUPIN PHARMACEUTICALS,
INC. AT 1-800-399-2561 OR FDA
AT 1-800-FDA-1088 OR _WWW.FDA.