Neurontin is used alone or in combination with other medications to treat seizures caused by epilepsy in adults and children who are at least 12 years old. Gabapentin has been shown in vitro to interfere with activity of the α2δ subunit of voltage-activated calcium channels, a receptor involved in neuronal synaptogenesis. The responder rate at 600 mg (17%) was also not significantly higher than in the placebo, but the responder rate in the 1,800 mg group (26%) was statistically significantly superior to the placebo rate. Administer Gabapentin three times a day using 300 mg or 400 mg capsules. The recommended maintenance dose of Gabapentin is 300 mg to 600 mg three times a day. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.Pooled analyses of 199 placebo-controlled clinical trials (mono- and adjunctive therapy) of 11 different AEDs showed that patients randomized to one of the AEDs had approximately twice the risk (adjusted Relative Risk 1.8, 95% CI:1.2, 2.7) of suicidal thinking or behavior compared to patients randomized to placebo. Response ratio is distributed within the range -1 to +1. Renal clearance (CLr) and CLr adjusted for body surface area also declined with age; however, the decline in the renal clearance of Gabapentin with age can largely be explained by the decline in renal function Although no formal study has been conducted to compare the pharmacokinetics of Gabapentin in men and women, it appears that the pharmacokinetic parameters for males and females are similar and there are no significant gender differences.Pharmacokinetic differences due to race have not been studied.

In patients with stable renal function, creatinine clearance can be reasonably well estimated using the equation of Cockcroft and Gault:The use of Gabapentin in patients less than 12 years of age with compromised renal function has not been studied.Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and dose should be adjusted based on creatinine clearance values in these patients.Gabapentin capsules should be swallowed whole with water.If the Gabapentin dose is reduced, discontinued, or substituted with an alternative medication, this should be done gradually over a minimum of 1 week (a longer period may be needed at the discretion of the prescriber).Gabapentin is contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients.Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), also known as multiorgan hypersensitivity, has occurred with Gabapentin.
Gabapentin is not appreciably metabolized in humans.Gabapentin elimination half-life is 5 to 7 hours and is unaltered by dose or following multiple dosing. Pharmacokinetic/pharmacodynamic modeling provided confirmatory evidence of efficacy across all doses.
A mean pain score during baseline of at least 4 was required for randomization. The effects on the breastfed infant and on milk production are unknown. Because Gabapentin is primarily renally excreted and there are no important racial differences in creatinine clearance, pharmacokinetic differences due to race are not expected.Gabapentin pharmacokinetics were determined in 48 pediatric subjects between the ages of 1 month and 12 years following a dose of approximately 10 mg/kg. Encourage women who are taking Gabapentin during pregnancy to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry by calling the toll free number 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org/.There are no adequate data on the developmental risks associated with the use of Gabapentin in pregnant women. It is not used for routine pain caused by minor injuries or arthritis. Acute oral overdoses of Gabapentin have been reported.

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