Country: Amerika Syarikat
Bahasa: Inggeris
Sumber: NLM (National Library of Medicine)
LEVETIRACETAM (UNII: 44YRR34555) (LEVETIRACETAM - UNII:44YRR34555)
Nexus Pharmaceuticals Inc
LEVETIRACETAM
LEVETIRACETAM 100 mg in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
LEVETIRACETAM injection is an alternative for adult patients (16 years and older) when oral administration is temporarily not feasible. LEVETIRACETAM is indicated as adjunctive therapy in the treatment of partial onset seizures in adults with epilepsy. LEVETIRACETAM is indicated as adjunctive therapy in the treatment of myoclonic seizures in adults with juvenile myoclonic epilepsy. None 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 the
LEVETIRACETAM (500 mg/5 mL injection is a clear, colorless, sterile solution. It is supplied in single-use 5 mL vials, available in cartons of 10 vials (NDC 14789-400-05). Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
LEVETIRACETAM- LEVETIRACETAM INJECTION, SOLUTION NEXUS PHARMACEUTICALS INC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE LEVETIRACETAM SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LEVETIRACETAM. LEVETIRACETAM INJECTION FOR INTRAVENOUS USE. INITIAL U.S. APPROVAL : 1999 RECENT MAJOR CHANGES Indications and Usage, Myoclonic Seizures In Patients With Juvenile Myoclonic Epilepsy (1.2) [09/2007] Dosage and Administration, (2.2) [05/2008] Warnings and Precautions, (5.1, 5.3) [05/2008] INDICATIONS AND USAGE LEVETIRACETAM injection is an antiepileptic drug indicated for adjunct therapy in adults (≥16 years of age) with the following seizure types when oral administration of LEVETIRACETAM is temporarily not feasible: Partial Onset Seizures (1.1) Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy (1.2) DOSAGE AND ADMINISTRATION LEVETIRACETAM injection should be diluted in 100 mL of a compatible diluent and administered intravenously as a 15- minute infusion (2.1). INITIAL EXPOSURE TO LEVETIRACETAM (2.2): PARTIAL ONSET SEIZURES: 1000 mg/day, given as twice-daily dosing (500 mg twice daily), increased as needed and as tolerated in increments of 1000 mg/day additional every 2 weeks to a maximum recommended daily dose of 3000 mg. MYOCLONIC SEIZURES IN PATIENTS WITH JUVENILE MYOCLONIC EPILEPSY: 1000 mg/day, given as twice-daily dosing (500 mg twice daily), increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been adequately studied. REPLACEMENT THERAPY (2.3): When switching from oral LEVETIRACETAM, the initial total daily intravenous dosage of LEVETIRACETAM should be equivalent to the total daily dosage and frequency of oral LEVETIRACETAM. At the end of the intravenous treatment period, the patient may be switched to equivalent daily dosage and frequency of the intravenous administration. See full prescribing information for dosing instructions ( Baca dokumen lengkap