Gabapentin

Gabapentin capsules, USP are indicated for:

• Management of postherpetic neuralgia in adults
• Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy

• Postherpetic Neuralgia (2.1)
  • Dose can be titrated up as needed to a dose of 1800 mg/day
  • Day 1: Single 300 mg dose
  • Day 2: 600 mg/day (i.e., 300 mg two times a day)
  • Day 3: 900 mg/day (i.e., 300 mg three times a day)

• Epilepsy with Partial Onset Seizures (2.2)
  • Patients 12 years of age and older: starting dose is 300 mg three times daily; may be titrated up to 600 mg three times daily
  • Patients 3 to 11 years of age: starting dose range is 10 to 15 mg/kg/day, given in three divided doses; recommended dose in patients 3 to 4 years of age is 40 mg/kg/day, given in three divided doses; the recommended dose in patients 5 to 11 years of age is 25 to 35 mg/kg/day, given in three divided doses. The recommended dose is reached by upward titration over a period of approximately 3 days
• Dose should be adjusted in patients with reduced renal function (2.3, 2.4)

• 100 mg: Hard gelatin capsules with white opaque body with white opaque cap, imprinted with "AHD" on cap and "100" on body in black ink and filled with white to off-white powder.
• 300 mg: Hard gelatin capsules with yellow opaque body with caramel opaque cap, imprinted with "AHD" on cap and "300" on body in black ink and filled with white to off-white powder.
• 400 mg: Hard gelatin capsules with orange opaque body with caramel opaque cap, imprinted with "AHD" on cap and "400" on body in black ink and filled with white to off-white powder.

• Pregnancy: Based on animal data, may cause fetal harm (8.1)

• Drug Reaction with Eosinophilia and Systemic Symptoms (Multiorgan hypersensitivity): Discontinue if alternative etiology is not established (5.1)
• Anaphylaxis and Angioedema: Discontinue and evaluate patient immediately (5.2)
• Driving Impairment; Somnolence/Sedation and Dizziness: Warn patients not to drive until they have gained sufficient experience to assess whether their ability to drive or operate heavy machinery will be impaired (5.3,5.4)
• Increased seizure frequency may occur in patients with seizure disorders if Gabapentin is abruptly discontinued (5.5)
• Suicidal Behavior and Ideation: Monitor for suicidal thoughts/behavior (5.6)
• Respiratory Depression: May occur with gabapentin when used with concomitant central nervous system (CNS) depressants, including opioids, or in the setting of underlying respiratory impairment. Monitor patients and adjust dosage as appropriate (5.7)
• Neuropsychiatric Adverse Reactions in Children 3 to 12 Years of Age: Monitor for such events (5.8)