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The incidence of adverse reactions increased slightly with increasing age in patients treated with either gabapentin or placebo. Although this rate exceeds that expected in a healthy population matched for age and sex, it is within the range of estimates for the incidence of sudden unexplained deaths in patients with epilepsy not receiving gabapentin (ranging from 0.0005 for the general population of epileptics to 0.003 for a clinical trial population similar to that in the gabapentin program, to 0.005 for patients with refractory epilepsy). 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. 0000001151 00000 n 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.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).Oral solution: 250 mg per 5 mL (50 mg per mL), clear colorless to slightly yellow solutionGabapentin Oral Solution 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.
The adverse reactions most commonly associated with withdrawal in pediatric patients were emotional lability (1.6%), hostility (1.3%), and hyperkinesia (1.1%).Table 4 lists adverse reactions that occurred in at least 1% of gabapentin-treated patients >12 years of age with epilepsy participating in placebo-controlled trials and were numerically more common in the gabapentin group. There were no statistically significant differences between treatments in either the response ratio or responder rate.Store Gabapentin Oral Solution refrigerated, 2°C to 8°C (36°F to 46°F).Advise the patient to read the FDA-approved patient labeling (Medication Guide).Inform patients that gabapentin is taken orally with or without food. 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 Dosage adjustment in adult patients with compromised renal function is necessary Dosage adjustment in patients undergoing hemodialysis is necessary Gabapentin does not exhibit affinity for benzodiazepine, opiate (mu, delta or kappa), or cannabinoid 1 receptor sites. endstream endobj 86 0 obj <> endobj 87 0 obj <>/ColorSpace<>/Font<>/ProcSet[/PDF/Text/ImageC/ImageI]/Properties<>/ExtGState<>>>/Type/Page>> endobj 88 0 obj <> endobj 89 0 obj <> endobj 90 0 obj [/Indexed 95 0 R 255 99 0 R] endobj 91 0 obj <> endobj 92 0 obj <> endobj 93 0 obj <> endobj 94 0 obj <>stream Responder rate was higher in the gabapentin 1200 mg/day group (16%) than in the placebo group (8%), but the difference was not statistically significant. The lowest effect dose for developmental toxicity in rats is approximately equal to the MRHD on a mg/m When pregnant rabbits were treated with gabapentin during the period of organogenesis, an increase in embryo-fetal mortality was observed at all doses tested (60, 300, or 1500 mg/kg). Figures 1 and 2 show pain intensity scores over time for Studies 1 and 2.Figure 1. 0000001214 00000 n Do not use this medication in pets with liver, lung, or kidney disease or those that are allergic to barbiturates. A small number of postmarketing cases report gabapentin misuse and abuse. Patients should be instructed to discontinue gabapentin and seek immediate medical care should they experience signs or symptoms of anaphylaxis or angioedema.Epilepsy with Partial Onset Seizures (Adjunctive Therapy)Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan HypersensitivityDizziness and Somnolence and Effects on Driving and Operating Heavy MachineryWhat is the most important information I should know about gabapentin?Do not stop taking gabapentin without first talking to your healthcare provider.gabapentin can cause serious side effects including:1. You may report side effects to FDA at 1-800-FDA-1088.Keep gabapentin and all medicines out of the reach of children.General information about the safe and effective use of gabapentinWhat are the ingredients in Gabapentin Oral Solution?We comply with the HONcode standard for trustworthy health information -
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