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Gabapal
  • Professionals
  • FDA PI

Gabapal

Generic name: gabapentin, lidocaine hydrochloride
Dosage form: kit

Gabapentin capsules are indicated for:

  • Postherpetic neuralgia in adults (1)
  • 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 (1)
  • Postherpetic Neuralgia (2.1)
  • Dose can be titrated up as needed to a dose of 1,800 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)
  • Capsules: 100 mg, 300 mg, and 400 mg (3)
  • Tablets (functional scored): 600 mg, and 800 mg (3)
  • Known hypersensitivity to gabapentin or its ingredients (4)
  • 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...