Երկիր: Ամերիկայի Միացյալ Նահանգներ
Լեզու: անգլերեն
Աղբյուրը: NLM (National Library of Medicine)
LEVETIRACETAM (UNII: 44YRR34555) (LEVETIRACETAM - UNII:44YRR34555)
XGen Pharmaceuticals DJB, Inc.
LEVETIRACETAM
LEVETIRACETAM 500 mg in 5 mL
INTRAVENOUS
PRESCRIPTION DRUG
Levetiracetam is indicated for the treatment of partial-onset seizures in patients 1 month of age and older. Levetiracetam is indicated as adjunctive therapy for the treatment of myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy. Levetirecetam is indicated as adjunctive therapy for the treatment of primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy. Levetiracetam injection is for intravenous use only as an alternative for patients when oral administration is temporarily not feasible. Levetiracetam Injection is contraindicted in patients with a hypersensitivity to levetiracetam. Reactions have included anaphylaxis and angioedema. [see Warnings and Precautions (5.3) ]. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), including Levetiracetam injection, during pregnancy. Encourage women who are taking Levetiraceta
Levetiracetam 500 mg/5 mL injection is a clear, colorless, sterile solution. It is supplied in single-dose 5 mL vials, available in cartons of 10 vials (NDC 39822-4000-1). Store at 20º -25º C (68 º – 77 º F); excursions permitted between 15º–30ºC (59º–86ºF) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
LEVETIRACETAM- LEVETIRACETAM INJECTION, SOLUTION, CONCENTRATE XGEN PHARMACEUTICALS DJB, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE LEVETIRACETAM INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LEVETIRACETAM INJECTION. LEVETIRACETAM INJECTION, SOLUTION, CONCENTRATE FOR INTRAVENOUS USE. INITIAL U.S. APPROVAL: 1999 RECENT MAJOR CHANGES Indications and Usage ( 1.1) (10/2019) Dosage and Administration ( 2.1, 2.8) (10/2019) INDICATIONS AND USAGE Levetiracetam is indicated for the treatment of partial-onset seizures in patients 1 month of age and older ( 1.1) Levetiracetam is indicated for adjunctive therapy for the treatment of: Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy ( 1.2) Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy ( 1.3) Levetiracetam injection is for intravenous use only as an alternative for patients when oral administration is temporarily not feasible. ( 1.4) DOSAGE AND ADMINISTRATION Levetiracetam injection is for intravenous use only ( 2.1) Partial-Onset Seizures 1 Month to < 6 Months: 7 mg/kg twice daily; increase by 7 mg/kg twice daily every 2 weeks to recommended dose of 21 mg/kg twice daily ( 2.1) 6 Months to < 4 Years: 10 mg/kg twice daily; increase by 10 mg/kg twice daily every 2 weeks to recommended dose of 25 mg/kg twice daily ( 2.1) 4 Years to < 16 Years: 10 mg/kg twice daily; increase by 10 mg/kg twice daily every 2 weeks to recommended dose of 30 mg/kg twice daily ( 2.1) Adults 16 Years and Older: 500 mg twice daily; increase by 500 mg twice daily every 2 weeks to a recommended dose of 1500 mg twice daily ( 2.1) Myoclonic Seizures in Adults and Pediatric Patients 12 Years and Older 500 mg twice daily; increase by 500 mg twice daily every 2 weeks to recommended dose of 1500mg twice daily ( 2.2) Primary Generalized Tonic-Clonic Seizures 6 Years to < 16 Years: 10 mg/kg twice daily; in Կարդացեք ամբողջական փաստաթուղթը