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National Drug Formulary

LEVETROY CONCENTRATE FOR SOLUTION FOR INFUSION 100MG/ ML [SIN17546P]

Active ingredients: LEVETROY CONCENTRATE FOR SOLUTION FOR INFUSION 100MG/ ML

View product's general information
Last updated 21 July 2026

Product Info

LEVETROY CONCENTRATE FOR SOLUTION FOR INFUSION 100MG/ ML

[SIN17546P]

Product information

Active Ingredient and Strength

LEVETIRACETAM - 100 MG/ML

Dosage Form

INJECTION, SOLUTION, CONCENTRATE

Manufacturer and Country

TROIKAA PHARMACEUTICALS LIMITED - INDIA

Registration Number

SIN17546P

Licence Holder

SIXMURS SINGAPORE PTE. LTD.

Forensic Classification

PRESCRIPTION ONLY MEDICINES

Anatomical Therapeutic Chemical (ATC) code

N03AX14

Prescription-only Medicines with Exemptions for Supply without Prescription

NA

Indication

INDICATION:
Levetroy is indicated as monotherapy in the treatment of partial onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy.
Levetroy is indicated as adjunctive therapy:

  • in the treatment of partial onset seizures with or without secondary generalisation in adults and children from 4 years of age with epilepsy.

  • in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy.

  • in the treatment of primary generalised tonic-clonic seizures in adults and children from 12 years of age with Idiopathic Generalised Epilepsy.

Levetiracetam concentrate is an alternative for patients (adults and children from 4 years of age) when oral administration is temporarily not feasible.

Dosing

RECOMMENDED DOSAGE:
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
The physician should prescribe the most appropriate pharmaceutical form, presentation and strength according to age, weight and dose. The safety and efficacy of levetiracetam concentrate for solution for infusion in infants and children less than 4 years have not been established.
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
The initial therapeutic dose is 10 mg/kg twice daily. Depending upon the clinical response and tolerability, the dose can be increased up to 30 mg/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 for all indications. Dose in children 50 kg or greater is the same as in adults.

Dose recommendations for children and adolescents:

Levetroy 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.
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 (CLcr) in ml/min is needed.
The CLcr in ml/min may be estimated from serum creatinine (mg/dl) determination, for adults and adolescents weighing 50 kg or more, using the following formula:

Levetroy Dosage Formula 1



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

Levetroy Dosage Formula 2



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

Levetroy 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

CONTRAINDICATIONS:
Levetiracetam is contraindicated in:

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