LEVETIRACETAM- levetiracetam solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Par Pharmaceutical

INN (International Name):

LEVETIRACETAM

Composition:

LEVETIRACETAM 100 mg in 1 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Levetiracetam oral solution, USP is indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 1 month of age and older with epilepsy. Levetiracetam oral solution, USP is indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy. Levetiracetam oral solution, USP is indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy. None. Levetiracetam blood levels may decrease during pregnancy [see Warnings and Precautions (5.9) ]. Pregnancy Category C There are no adequate and 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. Levetiracetam should be used during pregnancy only if the potential benefit just

Product summary:

Levetiracetam oral solution, USP 100 mg/mL is a clear, colorless to light yellow, grape-flavored liquid. It is supplied in 16 fl. oz. (473 mL) bottles (NDC 0603-1384-58). Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with a child-resistant closure.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

These highlights do not include all the information needed
to use LEVETIRACETAM ORAL SOLUTION safely and
effectively. See full prescribing information for LEVETIRACETAM
ORAL SOLUTION.
LEVETIRACETAM oral solution Initial U.S.
Approval: 1999

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LEVETIRACETAM-
levetiracetam solution  Par
Pharmaceutical
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MEDICATION GUIDE
LEVETIRACETAM ORAL
SOLUTION, USP(lee" va tye ra'se tam)100 mg/mLRx Only 
Read this Medication Guide before you start taking
levetiracetam oral solution and each time you get a refill. There
may be new information. This information does not take the place
of talking to your healthcare provider about your medical
condition or treatment.
What is the most important information
I should know about levetiracetam oral
solution?
Like other antiepileptic drugs,
levetiracetam oral solution may

Read the complete document

Summary of Product characteristics

LEVETIRACETAM- LEVETIRACETAM SOLUTION
PAR PHARMACEUTICAL
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LEVETIRACETAM ORAL SOLUTION SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LEVETIRACETAM
ORAL SOLUTION.
LEVETIRACETAM ORAL SOLUTION
INITIAL U.S. APPROVAL: 1999
RECENT MAJOR CHANGES
Warnings and Precautions, (5.1, 5.3, 5.7, 5.8) 03/2015
INDICATIONS AND USAGE
Levetiracetam oral solution, USP is indicated for adjunctive therapy
in the treatment of:
Partial onset seizures in patients one month of age and older with
epilepsy (1.1)
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)
DOSAGE AND ADMINISTRATION
• Use the oral solution for pediatric patients with body weight ≤
20 kg (2.1)
• For pediatric patients, use weight-based dosing for the oral
solution with a calibrated measuring device (not a household
teaspoon or tablespoon) (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 (2.2)
• 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 (2.2)
• 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 (2.2)
• Adults 16 Years And Older: 500 mg twice daily; increase by 500 mg
twice daily every 2 weeks to a recommended dose
of 1,500 mg twice daily (2.2)
_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 1,500 mg twice daily (2.3)
_Primary Generalized Tonic-Clonic Seizures_
• 6 Years To < 16 Years: 10 mg/kg twice daily, increase in
increments of 10 mg/kg twice daily every 2 w