Gabapentin - Drug Monograph

Comprehensive information about Gabapentin including mechanism, indications, dosing, and safety information.

Introduction

Gabapentin is a widely prescribed anticonvulsant medication originally developed as a structural analog of gamma-aminobutyric acid (GABA). First approved by the FDA in 1993 for epilepsy, it has since gained multiple approved indications and extensive off-label use. Despite its structural similarity to GABA, gabapentin does not act directly on GABA receptors but exerts its effects through a unique mechanism involving voltage-gated calcium channels.

Mechanism of Action

Gabapentin's primary mechanism of action involves binding to the α2δ subunit of voltage-gated calcium channels in the central nervous system. This binding reduces calcium influx at nerve terminals, which subsequently decreases the release of excitatory neurotransmitters such as glutamate, norepinephrine, and substance P. Unlike traditional antiepileptic drugs, gabapentin does not enhance GABAergic inhibition directly, nor does it affect sodium channels. Its action results in reduced neuronal excitability and dampened pain signal transmission, making it effective for both seizure control and neuropathic pain management.

Indications

FDA-approved indications:
  • Partial-onset seizures with and without secondary generalization (as adjunctive therapy in patients ≥3 years)
  • Postherpetic neuralgia (in adults)
  • Neuropathic pain associated with diabetic neuropathy
Common off-label uses:
  • Fibromyalgia
  • Bipolar disorder maintenance
  • Restless legs syndrome
  • Migraine prophylaxis
  • Anxiety disorders
  • Alcohol withdrawal syndrome
  • Various chronic pain syndromes

Dosage and Administration

Adults:
  • Epilepsy: Initial dose 300 mg three times daily; may titrate up to 1800-3600 mg/day in divided doses
  • Neuropathic pain: Initial dose 300 mg once daily on day 1, 300 mg twice daily on day 2, then 300 mg three times daily on day 3; may titrate up to 1800-3600 mg/day
Renal impairment dosing:
  • CrCl ≥60 mL/min: 300-1200 mg three times daily
  • CrCl 30-59 mL/min: 200-700 mg twice daily
  • CrCl 15-29 mL/min: 200-700 mg once daily
  • CrCl <15 mL/min: 100-300 mg once daily
Administration:
  • Take with or without food
  • Do not crush or chew extended-release formulations
  • For patients requiring dose reduction or discontinuation, taper gradually over at least one week

Pharmacokinetics

Absorption: Bioavailability is approximately 60% at lower doses (300 mg) but decreases with increasing doses due to saturable absorption. Food has minimal effect on absorption. Distribution: Volume of distribution is 0.6-0.8 L/kg. Protein binding is negligible (<3%). Crosses blood-brain barrier and placenta. Metabolism: Not significantly metabolized in humans; no hepatic cytochrome P450 involvement. Elimination: Excreted unchanged primarily renally. Elimination half-life is 5-7 hours in patients with normal renal function. Dialyzable.

Contraindications

  • Hypersensitivity to gabapentin or any component of the formulation
  • Concomitant use with other gabapentin products due to potential additive effects

Warnings and Precautions

Boxed Warning:
  • Antiepileptic drugs increase the risk of suicidal thoughts or behavior
Additional warnings:
  • CNS depression: May impair mental and/or physical abilities
  • Respiratory depression: Risk increased with concomitant opioid use
  • Withdrawal symptoms: Abrupt discontinuation may precipitate seizures
  • Tumorigenic potential: Pancreatic acinar cell tumors observed in rodent studies
  • Drug reaction with eosinophilia and systemic symptoms (DRESS)
  • Anaphylaxis and angioedema
  • Driving impairment: Patients should not drive until they understand how gabapentin affects them

Drug Interactions

Major interactions:
  • Opioids: Increased risk of respiratory depression and CNS depression
  • Alcohol: Enhanced CNS depressant effects
  • Antacids: Reduced gabapentin absorption (administer gabapentin至少 2 hours after antacids)
  • Hydrocodone: Increased hydrocodone concentrations
Moderate interactions:
  • Other CNS depressants (benzodiazepines, barbiturates, sedatives)
  • Morphine: Increased gabapentin concentrations

Adverse Effects

Common (≥5%):
  • Dizziness (28%)
  • Somnolence (21%)
  • Peripheral edema (8%)
  • Fatigue (11%)
  • Ataxia (8%)
  • Nystagmus (8%)
Serious:
  • Suicidal ideation and behavior
  • Respiratory depression
  • Severe dermatologic reactions (Stevens-Johnson syndrome, DRESS)
  • Rhabdomyolysis
  • Clinical worsening of seizures with abrupt withdrawal
  • Angioedema

Monitoring Parameters

  • Seizure frequency and characteristics (for epilepsy indication)
  • Pain assessment and functional status (for pain indications)
  • Mental status changes, depression, or suicidal ideation
  • Signs of CNS depression
  • Renal function (at baseline and periodically)
  • Weight gain and peripheral edema
  • Signs of hypersensitivity reactions
  • Respiratory status, especially with concomitant opioid use

Patient Education

  • Take medication exactly as prescribed; do not stop abruptly
  • Avoid alcohol and other CNS depressants
  • Be aware of potential dizziness and drowsiness; use caution when driving or operating machinery
  • Report any mood changes, depression, or suicidal thoughts immediately
  • Notify healthcare provider if pregnancy is planned or suspected
  • Inform all healthcare providers about gabapentin use
  • Keep medication out of reach of children
  • Report any signs of allergic reaction (rash, swelling, difficulty breathing)
  • Be aware that gabapentin may cause weight gain and peripheral edema

References

1. FDA Prescribing Information: Neurontin (gabapentin). 2017. 2. Backonja M, et al. Gabapentin for the symptomatic treatment of painful neuropathy in patients with diabetes mellitus. JAMA. 1998;280(21):1831-1836. 3. Rowbotham M, et al. Gabapentin for the treatment of postherpetic neuralgia. JAMA. 1998;280(21):1837-1842. 4. Johannessen Landmark C, et al. Pharmacological management of epilepsy: recent advances and future prospects. Drugs. 2015;75(4):339-355. 5. Bockbrader HN, et al. Clinical pharmacokinetics of gabapentin. Drugs Today. 1995;31(9):613-619. 6. Goodman CW, Brett AS. Gabapentin and Pregabalin for Pain - Is Increased Prescribing a Cause for Concern? N Engl J Med. 2017;377(5):411-419. 7. UpToDate: Gabapentin drug information. Accessed 2023. 8. Clinical Pharmacology [database online]. Tampa, FL: Elsevier; 2023.

Medical Disclaimer

The information provided in this article is for educational purposes only and is not intended as a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website.

The content on MedQuizzify is designed to support, not replace, the relationship that exists between a patient and their healthcare provider. If you have a medical emergency, please call your doctor or emergency services immediately.

How to Cite This Article

admin. Gabapentin - Drug Monograph. MedQuizzify [Internet]. 2025 Sep 08 [cited 2025 Sep 09]. Available from: http://medquizzify.pharmacologymentor.com/blog/drug-monograph-gabapentin

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