LEVETIRACETAM injection, solution

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Nexus Pharmaceuticals Inc

INN (Internationale Bezeichnung):

LEVETIRACETAM

Zusammensetzung:

LEVETIRACETAM 100 mg in 1 mL

Verabreichungsweg:

INTRAVENOUS

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

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

Produktbesonderheiten:

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].

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

LEVETIRACETAM- LEVETIRACETAM INJECTION, SOLUTION
NEXUS PHARMACEUTICALS INC
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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 (