Active Ingredient and Strength	LEVETIRACETAM - 100 MG/ML
Dosage Form	SOLUTION
Manufacturer and Country	REMEDICA LTD - CYPRUS
Registration Number	SIN16254P
Licence Holder	INTEGA PTE LTD
Forensic Classification	PRESCRIPTION ONLY MEDICINES
Anatomical Therapeutic Chemical (ATC) code	N03AX14

Indications

inTiracetam is indicated as monotherapy in the treatment of partial onset seizures with or without secondary generalisation in adults and adolescents from 16 years of age with newly diagnosed epilepsy.

inTiracetam is indicated as adjunctive therapy in the treatment of:

partial onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy.
myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy.
primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with Idiopathic Generalised Epilepsy.

Dosage and Administration

Levetiracetam therapy can be initiated with either intravenous or oral administration. Conversion to or from oral to intravenous administration can be done directly without titration. The total daily dose and frequency of administration should be maintained.

The oral solution may be diluted in a glass of water and may be taken with or without food. After oral administration the bitter taste of levetiracetam may be experienced. The daily dose is administered in two equally divided doses.

Route of Administration

For oral use.

Adults

Monotherapy

Adults and adolescents from 16 years of age

The recommended starting dose is 250 mg twice daily which should be increased to an initial therapeutic dose of 500 mg twice daily after two weeks. The dose can be further increased by 250 mg twice daily every two weeks depending upon the clinical response. The maximum dose is 1500 mg twice daily.

Add-on therapy

Adults (≥18 years) and adolescents (12 to 17 years) weighing 50 kg or more

The initial therapeutic dose is 500 mg twice daily. This dose can be started on the first day of treatment.

Depending upon the clinical response and tolerability, the daily dose can be increased up to 1500 mg twice daily. Dose changes can be made in 500 mg twice daily increases or decreases every two to four weeks.

Children

Levetiracetam oral solution is the preferred formulation for use in children under the age of 6 years, in children weighing less than 25 kg, for patients unable to swallow tablets or for the administration of doses below 250 mg.

Monotherapy

The safety and efficacy of levetiracetam in children and adolescents below 16 years as monotherapy treatment have not been established.

There are no data available.

Add-on therapy

Add-on therapy for children (4 to 11 years) and adolescents (12 to 17 years) weighing less than 50 kg

Levetiracetam oral solution is the preferred formulation for use in children under the age of 6 years.

For children 6 years and above, levetiracetam oral solution should be used for doses under 250 mg, for doses not multiple of 250 mg when dosing recommendation is not achievable by taking multiple tablets and for patients unable to swallow tablets.

The initial therapeutic dose is 10 mg/kg twice daily.

Depending upon the clinical response and tolerability, the dose can be increased up to 30mg/kg twice daily. Dose changes should not exceed increases or decreases of 10 mg/kg twice daily every two weeks.

The lowest effective dose should be used.

Dose in children 50 kg or greater is the same as in adults.

Dose recommendations for children and adolescents:

Intiracetam Oral Solution Dosage Table 1

Infants and children less than 4 years

There are insufficient data to recommend the use of levetiracetam in children under 4 years of age.

Elderly

Adjustment of the dose is recommended in elderly patients with compromised renal function.

Renal impairment

The daily dose must be individualised according to renal function (see Section Warnings and Precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

For adult patients, refer to the following table and adjust the dose as indicated. To use this dosing table, an estimate of the patient's creatinine clearance (CL_cr) in ml/min is needed.

The CL_cr in ml/min may be estimated from serum creatinine (mg/dl) determination, for adults and adolescents weighting 50 kg or more, using the following formula:

Intiracetam Oral Solution Dosage Formula 1

Then CL_cr is adjusted for body surface area (BSA) as follows:

Intiracetam Oral Solution Dosage Formula 2

Dosing adjustment for adult and adolescent patients weighing more than 50kg with impaired renal function

Intiracetam Oral Solution Dosage Table 2

For children with renal impairment, levetiracetam dose needs to be adjusted based on the renal function as levetiracetam clearance is related to renal function. This recommendation is based on a study in adult renally impaired patients.

Hepatic impairment

No dose adjustment is needed in patients with mild to moderate hepatic impairment. In patients with severe hepatic impairment, the creatinine clearance may underestimate the renal insufficiency.

Therefore a 50% reduction of the daily maintenance dose is recommended when the creatinine clearance is < 60 ml/min/1.73m².

Contraindications

Levetiracetam is contraindicated in:

Hypersensitivity to the active substance or other pyrrolidone derivatives or to any of the excipients.