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Clinical data
Trade namesNeurontin, others [1]
License dataUS  DailyMed:  52049, US   FDA: Gabapentin
Pregnancy categoryAU: B1 US: C (Risk not ruled out)
Routes of administrationBy mouth
Drug classGabapentinoid
ATC codeN03AX12 ( WHO )
Legal status
Legal statusAU: S4 (Prescription only) CA : ℞-only UK: POM (Prescription only) US: ℞-only
Pharmacokinetic data
Bioavailability27–60% (inversely proportional to dose; a high fat meal also increases bioavailability) [2] [3]
Protein bindingLess than 3% [2] [3]
MetabolismNot significantly metabolized [2] [3]
Elimination half-life5 to 7 hours [2] [3]
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The maximum recommended human dose (MRHD) of 80 mg on a mg/m 2 basis) throughout organogenesis. until 2003 when it was taken off the market by drug manufacturer Wyeth after its patent expired. Epididymal vacuolation and hypospermia (at 30 mg/kg/day corresponding to plasma exposures approximately 5 to 10 times the average AUC in pediatric patients at the MRHD of 20 mg/day.

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