Gabapentin
Gabapentin Prescribing Information
Gabapentin is 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
- 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
- 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
- 100 mg: White hard gelatin capsules imprinted “216” on body with blue ink.
- 300 mg: Yellow hard gelatin capsules imprinted “215” on body with blue ink.
- 400 mg: Orange hard gelatin capsules imprinted “214” on body with blue ink.
Pregnancy: Based on animal data, may cause fetal harm (8.1)
Gabapentin is contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients.
• Drug Reaction with Eosinophilia and Systemic Symptoms (Multiorgan hypersensitivity): Discontinue if alternative etiology is not established
• Anaphylaxis and Angioedema: Discontinue and evaluate patient immediately
• 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
• Increased seizure frequency may occur in patients with seizure disorders if gabapentin is abruptly discontinued
• Suicidal Behavior and Ideation: Monitor for suicidal thoughts/behavior
• 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
• Neuropsychiatric Adverse Reactions in Children 3 to 12 Years of Age: Monitor for such events