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Criteria for Outpatient Use Guidelines

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Gabapentin (Neurontin®)

[Developed, June 2006; Revised, August 2006; April 2010]

Information on indications for use or diagnosis is assumed to be unavailable. All criteria may be applied retrospectively; prospective application is indicated with [*].

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1.* Dosage

Adults
Gabapentin is FDA-approved for use in adults with postherpetic neuralgia and as adjunctive therapy for managing partial seizures with or without generalization in epileptic patients. Maximum recommended adult dosages are summarized in Table 1. The maximum time interval between gabapentin doses should not exceed 12 hours. Patient profiles containing doses that exceed the maximum recommended dose will be reviewed.

Table 1
Maximum Recommended Adult Gabapentin Dosages

Disease State

Maximum Dosage

Epilepsy

2400 mg/day (in three divided doses)*

Postherpetic neuralgia

1800 mg/day (in three divided doses)+

*Doses of 3600 mg/day have also been well tolerated in small numbers of patients for abbreviated treatment durations.
+Doses up to 3600 mg/day have been administered with therapeutic effect; however, additional benefit with doses greater than 1800 mg/day has not been observed.

While not FDA-approved, gabapentin has also been evaluated in adult clinical trials for use in migraine prophylaxis, neuropathic pain, fibromyalgia, and vasomotor symptoms with favorable results.

Pediatrics
Gabapentin is FDA-approved for use as adjunctive therapy for partial seizures with or without generalization in pediatric epileptic patients 12 years of age and older, as well as adjunctive therapy for partial seizures in pediatric patients 3 years to 12 years of age. Maximum recommended pediatric gabapentin dosages are summarized in Table 2. The maximum time interval between gabapentin doses should not exceed 12 hours. Patient profiles containing gabapentin doses greater than maximum recommendations will be reviewed.

Table 2
Maximum Recommended Pediatric Gabapentin Dosages
Disease State Maximum Dosage

Epilepsy

3-4 years old: 40 mg/kg/day (in 3 divided doses)+
5-12 years of age: 35 mg/kg/day (in 3divided doses)+
> 12 years of age: 2400 mg/day (in 3 divided doses)*

Limited data have also documented gabapentin efficacy in managing pediatric neuropathic pain in doses of 35 mg/kg/day.

Renal Impairment
Gabapentin dosing guidelines for adult and adolescent patients older than 12 years of age with renal impairment are summarized in Table 3. Gabapentin use in pediatric patients younger than 12 years of age with impaired renal function has not been evaluated.

Table 3
Gabapentin Dosage Guidelines in Adults, Adolescents 12 Years of Age and Older with Renal Impairment
Creatinine Clearance (CrCl) Recommended Daily Dose

60 ml/min or greater

900 mg to 3600 mg daily, in three divided doses

30-59 ml/min

400 mg to 1400 mg daily, in two divided doses

15-29 ml/min

200 mg to 700 mg once daily

15 ml/min

100 mg to 300 mg once daily

< 15 ml/min

daily dose decreased in proportion to CrCl (e.g., CrCl = 7.5 ml/min – administer 50% of dose for CrCl of 15 ml/min)

anephric patients

maintenance doses based on CrCl estimates, with supplemental doses of 125 mg to 350 mg administered after every 4 hour hemodialysis session

2. Duration of Therapy

There is no basis for limiting the duration of gabapentin therapy since patients may suffer from epilepsy on a chronic basis, and postherpetic neuralgia management may require weeks to months of therapy.

3.*Drug-Drug Interactions

Patient profiles will be assessed to identify those drug regimens which may result in clinically significant drug-drug interactions. Drug-drug interactions considered clinically relevant for gabapentin are summarized in Table 4. Only those drug-drug interactions identified as clinical significance level 1 or those considered life-threatening which have not yet been classified will be reviewed.

Table 4
Gabapentin Drug-Drug Interactions
INTERACTING DRUG INTERACTION RECOMMENDATION CLINICAL SIGNIFICANCE
antacids decreased gabapentin oral availability by approximately 20% administer gabapentin at least two hours after antacids to avoid bioavailability problems moderate (DrugReax)
2-major (Clinical Pharmacology)
hydrocodone potential for decreased hydrocodone peak concentrations and AUC with concomitant gabapentin-hydrocodone administration in dose-dependent fashion; minor increases in gabapentin AUC observe patients for decreased hydrocodone efficacy or additive drowsiness minor (DrugReax)
3-moderate (Clinical Pharmacology)
morphine concurrent administration may result in increased gabapentin serum levels (gabapentin AUC increased by 44% when morphine 60 mg controlled- release given 2 hours prior to gabapentin 600 mg) monitor patients for increased CNS depression; adjust gabapentin and/or morphine doses as necessary moderate (DrugReax)
3-moderate (Clinical Pharmacology)

References

  1. AHFS Drug Information 2010 [book online]. Jackson, WY: Teton Data Systems, Version 6.7.1, 2009. Based on: McEvoy GK, editor. AHFS drug information 2010. Bethesda (MD): American Society of Health-System Pharmacists; 2010. Stat!Ref Electronic Medical Library.
  2. Drug Facts and Comparisons. Clin-eguide [database online]. St. Louis, MO: Wolters Kluwer Health, Inc; 2010. Available at: http://clineguide.com. Accessed April 13th, 2010.
  3. Clinical Pharmacology [database online]. Tampa, FL: Gold Standard, Inc; 2010. Available at: http://www.clinicalpharmacology.com. Accessed April 13th, 2010.
  4. Gabapentin (Drug Evaluation). In: DRUGDEX® System (electronic version). Thomson Reuters (Healthcare) Inc., Greenwood Village, Colorado, USA. Available at: http://www.thomsonhc.com.libproxy.uthscsa.edu. Accessed April 13th, 2010.
  5. Gabapentin (Neurontin®) package insert. Parke-Davis Division of Pfizer Inc., April 2009.
  6. Bajwa ZH, Warfield CA, Crovo DG. Postherpetic neuralgia. UpToDate
  7. Dubinsky RM, Kabbani H, El-Chami Z, Boutwell C, Ali H. Practice Parameter: Treatment of postherpetic neuralgia: An evidence-based report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology. 2004;63;959-965.
  8. Appleton R, Fichtner K, LaMoreaux L, et al. Gabapentin as add-on therapy in children with refractory partial seizures: a 12-week, multicentre, double-blind, placebo-controlled study. Gabapentin Paediatric Study Group. Epilepsia. 1999;40(8):1147-54.
  9. Appleton R, Fichtner K, LaMoreaux L, et al. Gabapentin as add-on therapy in children with refractory partial seizures: a 24-week, multicentre, open-label study. Dev Med Child Neurol. 2001;43(4):269-73.
  10. Khurana DS, Riviello J, Helmers S, et al. Efficacy of gabapentin therapy in children with refractory partial seizures. J Pediatr. 1996; 128:829-33.
  11. Custer JW, Rau RE, eds. The Harriet Lane handbook. 18th ed. Philadelphia, PA: Elsevier Mosby; 2009.
  12. O'Connor AB, Dworkin RH. Treatment of neuropathic pain: an overview of recent guidelines. Am J Med. 2009;122(10 Suppl):S22-32.
  13. Dworkin RH, O'Connor AB, Backonja M, et al. Pharmacologic management of neuropathic pain: evidence-based recommendations. Pain. 2007;132(3):237-51.
  14. Wiffen PJ, McQuay HJ, Edwards JE, Moore RA. Gabapentin for acute and chronic pain. Cochrane Database Syst Rev. 2005;3:CD005452. DOI: 10.1002/14651858.CD005452.

Prepared by: Drug Information Service, The University of Texas Health Science Center at San Antonio, and the College of Pharmacy, The University of Texas at Austin.