LEVETIRACETAM injection, solution, concentrate

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

XGen Pharmaceuticals DJB, Inc.

INN (Internationale Bezeichnung):

LEVETIRACETAM

Zusammensetzung:

LEVETIRACETAM 500 mg in 5 mL

Verabreichungsweg:

INTRAVENOUS

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

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

Produktbesonderheiten:

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].

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

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