1.2. Pediatrics

Neurontin and generic gabapentin immediate-release dosing 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 11 years of age^1-3. Gabapentin extended-release formulations are not approved for use in pediatric patients as safety and efficacy in this patient population have not been established.4,5 Maximum recommended pediatric gabapentin dosages are summarized in Table 2. The maximum time interval between Neurontin and generic gabapentin immediate-release dosing should not exceed 12 hours. Patient profiles containing gabapentin doses greater than maximum recommendations will be reviewed.

Drug Name	Dosage Form/Strength	Treatment Indication	Maximum Recommended Dosage
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	Partial seizures with/without secondary generalized tonic-clonic seizures	12 years and older: 2400 mg/day (in three divided doses*) 5-11 years of age: 35 mg/kg/day (in three divided doses+) 3-4 years of age:  40 mg/kg/day (in three divided doses+)

Legend:

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