Kepreptol Dosage/Direction for Use

The film-coated tablets must be taken orally, swallowed with a sufficient quantity of water and may be taken with or without food. The daily dose is administered in 2 equally divided doses. Levetiracetam treatment can be started by oral administration. In case that the route of administration is changed from intravenous to oral or inversely, it can be directly administered without dose titration, but total daily dose and dose frequency should be kept.
Monotherapy: Adults and Adolescents (16 years and older): 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 500 mg a day [250 mg, twice daily] every 2 weeks depending upon the clinical response. The maximum dose is 3000 mg [1500 mg twice daily].
Add-on Therapy: Partial seizures: Adults (≥18 year) and Adolescents (12-17 years) of ≥50 kg: The initial therapeutic dose is 500 mg, twice daily. Depending upon the clinical response and tolerance, the daily dose can be increased up to 3000 mg/day. Dose changes can be made in 1000 mg/day increments or decrements every 2-4 weeks.
Adolescents (12-17 years) and Children (4-11 years) of <50 kg: Initial therapeutic dose is 10 mg/kg twice daily.
Depending upon the clinical response and tolerability, the dose can be increased up to 60 mg/kg/day [30 mg/kg twice daily]. Dose changes should not exceed increments or decrements of 10 mg/kg twice daily every 2 weeks. The lowest effective dose should be used, Dosage in children ≥50 kg is the same as in adults. (See Table 1.)

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Myoclonic Seizures In Pediatric Patients (12 Years of age and older): Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg BID). Dosage should be 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 studied.
Primary generalized tonic-clonic seizures (12 Years of age and older): Adults (≥18 years) and adolescents (12-17 years) weighing more than 50 kg or more: Treatment should be initiated with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg BID). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg [1,500 mg, BID]. The effectiveness of doses lower than 3000 mg/day has not been studied.
Adolescents (12-17 years) of <50 kg: Treatment should be initiated with a daily dose of 20 mg/kg, given as twice-daily dosing (10 mg/kg, BID). Additional dosing increments may be given at 20 mg/kg/day (10 mg/kg, BID) additional every 2 weeks to a maximum recommended daily dose of 60 mg/kg [30 mg/kg, BID]. The effectiveness of doses lower than 60 mg/day has not been studied.
Patients with Impaired Renal Function: Levetiracetam dosing must be individualized according to the patient's renal function status. Recommended doses and adjustment for dose for adults are shown in the following table. To use this dosing table, an estimate of the patient's creatinine clearance (CLcr) in mL/min is needed. CLcr in mL/min may be estimated from serum creatinine (mg/dL) determination using the following formula. (See Equation 1 and Table 2.)

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The CLcr in mL/min/1.73 m² may be estimated from serum creatinine (mg/dL) determination, for young adolescents, children and infants, using the following formula: See Equation 2.

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Ks = 0.45 in Term infants to 1 year old; ks = 0.55 in Children to less than 13 years and in adolescent female; ks = 0.7 in adolescent male. (See Table 3.)

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Patients with Hepatic Impairment: No dose adjustment is needed in patients with mild to moderate hepatic impairment. In patients with severe hepatic impairment, the CrCl may underestimate the renal insufficiency. Therefore, a 50% reduction of the daily maintenance dose is recommended when the CrCl is <60 mL/min/1.73 m².
Children: The safety and efficacy of oral Levetiracetam product has not been thoroughly assessed in infants aged less than 1 year. The tablet formulation is not adapted for use in children under the age of 4 years and a Levetiracetam oral solution is used in infants older than 1 month of age. Because safety and efficacy of Levetiracetam injection in children below 16 years of age, it is not recommended.
Elderly (from 65 years old): Adjustment of the dose is recommended in the elderly patients with compromised renal function.