البلد: الولايات المتحدة
اللغة: الإنجليزية
المصدر: NLM (National Library of Medicine)
LEVETIRACETAM (UNII: 44YRR34555) (LEVETIRACETAM - UNII:44YRR34555)
LUPIN LIMITED
LEVETIRACETAM
LEVETIRACETAM 500 mg
ORAL
PRESCRIPTION DRUG
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
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.
Abbreviated New Drug Application
LEVETIRACETAM- LEVETIRACETAM TABLET, EXTENDED RELEASE LUPIN LIMITED ---------- 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. اقرأ الوثيقة كاملة