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NEURONTIN® (gabapentin) Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use NEURONTIN safely and effectively. See full prescribing information for NEURONTIN.

NEURONTIN® (gabapentin) capsules, for oral use
NEURONTIN® (gabapentin) tablets, for oral use
NEURONTIN® (gabapentin) oral solution
Initial U.S. Approval: 1993

RECENT MAJOR CHANGES

Warnings and Precautions, Respiratory Depression (5.7)04/2020

INDICATIONS AND USAGE

NEURONTIN is 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)

DOSAGE AND ADMINISTRATION

  • 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)

DOSAGE FORMS AND STRENGTHS

  • Capsules: 100 mg, 300 mg, and 400 mg (3)
  • Tablets: 600 mg, and 800 mg (3)
  • Oral Solution: 250 mg/5mL (3)

CONTRAINDICATIONS

Known hypersensitivity to gabapentin or its ingredients (4)

WARNINGS AND PRECAUTIONS

  • 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 NEURONTIN is abruptly discontinued (5.5)
  • Suicidal Behavior and Ideation: Monitor for suicidal thoughts/behavior (5.6)
  • Respiratory depression: May occur with NEURONTIN when used with concomitant central nervous system (CNS) depressants 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)

ADVERSE REACTIONS

Most common adverse reactions (incidence ≥8% and at least twice that for placebo) were:

  • Postherpetic neuralgia: Dizziness, somnolence, and peripheral edema (6.1)
  • Epilepsy in patients >12 years of age: Somnolence, dizziness, ataxia, fatigue, and nystagmus (6.1)
  • Epilepsy in patients 3 to 12 years of age: Viral infection, fever, nausea and/or vomiting, somnolence, and hostility (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer, Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

  • Concentrations increased by morphine; may need dose adjustment (5.4, 7.2)

USE IN SPECIFIC POPULATIONS

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

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

Revised: 4/2020

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