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Lecetam Oral Solution

Lecetam Oral Solution Dosage/Direction for Use

levetiracetam

Manufacturer:

Unison

Distributor:

F.C.P.

Marketer:

B.Grimm Pharma
Full Prescribing Info
Dosage/Direction for Use
Mode of Administration and Recommended Dose: Oral administration.
Levetiracetam oral solution is the preferred formulation for use in children under the age of 6 years. For children from 6 years of age and above, levetiracetam oral solution should be used for doses under 250 mg, for doses that are not multiple of 250 mg when dosing recommendation is not achievable by taking multiple for tablets and for patients unable to swallow tablets.
Monotherapy: The recommended starting dose is 250 mg twice daily which should be increased to an initial therapeutic dose of 500 mg twice daily after 2 weeks. The dose can be further increased by 250 mg twice daily every two weeks depending upon the clinical response. The maximum dose is 1,500 mg twice daily.
Partial onset seizures: Children and Adolescents 4 to < 16 years: Initial: 10 mg/kg/dose twice daily; increase every 2 weeks by 10 mg/kg/dose to a recommended dose of 30 mg/kg/dose twice daily (maximum daily dose: 3,000 mg/day).
Adolescents ≥ 16 years and Adults: Initial: 500 mg twice daily; increase every 2 weeks by 500 mg/dose to the maximum recommended dose of 1,500 mg twice daily.
Efficacy of doses other than 3,000 mg/day has not been established.
Myoclonic seizures: Children ≥ 12 years, Adolescents, and Adults: Initial: 500 mg twice daily; increase every 2 weeks by 500 mg/dose to the recommended dose of 1,500 mg twice daily.
Efficacy of doses other than 3,000 mg/day has not been established.
Tonic-clonic seizures: Children and Adolescents 6 to < 16 years: Initial: 10 mg/kg/dose twice daily; increase every 2 weeks by 10 mg/kg/dose to a recommended dose of 30 mg/kg/dose twice daily.
Efficacy of doses other than 60 mg/kg/day has not been established.
Adolescents ≥ 16 years and Adults: Initial: 500 mg twice daily; increase every 2 weeks by 500 mg/dose to the recommended dose of 1,500 mg twice daily.
Efficacy of doses other than 1,500 mg twice daily has not been established. (See Tables 1 and 2.)

Click on icon to see table/diagram/image


Click on icon to see table/diagram/image

Dosing adjustment in renal impairment: ClCr > 80 ml/min/1.73 m2: 500-1500 mg every 12 hours.
ClCr 50-79 ml/min/1.73 m2: 500-1000 mg every 12 hours.
ClCr 30-49 ml/min/1.73 m2: 250-750 mg every 12 hours.
ClCr < 30 ml/min/1.73 m2: 250-500 mg every 12 hours.
End-stage renal disease requiring hemodialysis: 500-1000 mg every 24 hours; supplemental dose of 250 to 500 mg is recommended posthemodialysis.
Dosing adjustment in hepatic impairment: Mild to moderate impairment: No dosage adjustment necessary.
Severe impairment: Reduce maintenance dose by 50% in patients who also have ClCr < 60 ml/min/1.73 m2.
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