1.2. Pediatrics

Gabapentin is FDA-approved for use as adjunctive therapy for partial seizures with or without generalization in pediatric epileptic patients 12 years of age and older, as well as adjunctive therapy for partial seizures in pediatric patients 3 years to 12 years of age1-5. Gabapentin extended-release formulations are not approved for use in pediatric patients as safety and efficacy in this patient population have not been established1-4, 6, 7. Maximum recommended pediatric gabapentin dosages are summarized in Table 25. The maximum time interval between gabapentin doses should not exceed 12 hours. Patient profiles containing gabapentin doses greater than maximum recommendations will be reviewed.

Table 2: Maximum Recommended Pediatric Gabapentin Dosages

Treatment Indication Drug Name Dosage Form/Strength Maximum Recommended Dosage
Partial seizures with/without secondary generalized tonic-clonic seizures gabapentin (Neurontin®, generics) 100 mg, 300 mg, 400 mg immediate-release (IR) capsules
600 mg, 800 mg IR tablet
250 mg/5 mL, 300 mg/ 6 mL oral solution
  • 12 years and older: 2400 mg/day (in three divided doses*)
  • 5-11 years of age: 35 mg/kg/day (in 3 divided doses+)
  • 3-4 years of age:  40 mg/kg/day (in 3 divided doses+)

Legend:

  • +Doses up to 50 mg/kg/day have been well tolerated in an extended clinical trial.
  • *Doses of 3600 mg/day have also been well tolerated in small numbers of patients for abbreviated treatment durations.