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AG-Cetam

Generic:

Levetiracetam
 

Therapeutic Class:

Anti Epileptics

 

Composition:

  • Each AG-Cetam tablet contains 250 mg or 500 mg of levetiracetam.
  • AG-Cetam solution contains 100 mg of levetiracetam per mL.
  • AG-Cetam Inj contains 500 mg of levetiracetam per 5 ml.
 

Description:

AG-Cetam (Levetiracetam) is an anti-epileptic drug (anticonvulsant) often used in conjunction with other drugs to treat types of seizures in people with epilepsy.

 

Indications:

Partial Onset Seizures

Indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 1 month of age and older with epilepsy.

Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy

Indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy.

Primary Generalized Tonic-Clonic Seizures

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.

Dosage:

Dosing For Partial Onset Seizures

Adults 16 Years and Older:

Initiate treatment with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. There is no evidence that doses greater than 3000 mg/day confer additional benefit.

Pediatric Patients:

One month to < 6 months: Initiate treatment with a daily dose of 14 mg/kg in 2 divided doses (7 mg/kg twice daily). Increase the daily dose every 2 weeks by increments of 14 mg/kg to the recommended daily dose of 42 mg/kg (21 mg/kg twice daily).

6 months to < 4 years: Initiate treatment with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). Increase the daily dose in 2 weeks by an increment of 20 mg/kg to the recommended daily dose of 50 mg/kg (25 mg/kg twice daily). If a patient cannot tolerate a daily dose of 50 mg/kg, the daily dose may be reduced.

4 years to < 16 years: Initiate treatment with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). Increase the daily dose every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced.

Pediatric patients weighing 20 to 40 kg: Initiate treatment with a daily dose of 500 mg given as twice daily dosing (250 mg twice daily). Increase the daily dose every 2 weeks by increments of 500 mg to a maximum recommended daily dose of 1500 mg (750 mg twice daily).

Pediatric patients weighing more than 40 kg: Initiate treatment with a daily dose of 1000 mg/day given as twice daily dosing (500 mg twice daily). Increase the daily dose every 2 weeks by increments of 1000 mg/day to a maximum recommended daily dose of 3000 mg (1500 mg twice daily).

Weight-Based Dosing Calculation for Oral Solution in Pediatric Patients

The following calculation should be used to determine the appropriate daily dose of oral solution for pediatric patients:

Total daily dose (mL/day) = Daily dose (mg/kg/day) x patient weight (kg) / 100 mg/mL

Dosing for Myoclonic Seizures in Patients 12 Years of Age and Older with Juvenile Myoclonic Epilepsy
Initiate treatment with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Increase the dosage 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.

Dosing for Primary Generalized Tonic-Clonic Seizures

Adults 16 Years and Older:

Initiate treatment with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Increase dosage 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 adequately studied.

Pediatric Patients ages 6 to < 16 years

Initiate treatment with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). Increase the daily dose every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). The effectiveness of doses lower than 60 mg/kg/day has not been adequately studied.

Patients with body weight ≤ 20 kg: Prescribe oral solution.

Patients with body weight above 20 kg: Prescribe tablets or oral solution.

Presentations:

  • AG-Cetam Tab 250 mg & 500 mg are available in blister the packs of 10’s.
  • AG-Cetam Sol 100 mg/ml is available in a bottle of 60 ml.
  • AG-Cetam Inj 500 mg/5ml is available in the pack of 1’s.