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One study compared NEURONTIN 1200 mg/dayin three divided doses with placeboResponder rate was 2314/61in the NEURONTIN group and 96/66in the placebo groupthe difference between groups was statistically significantResponse ratio was also better in the NEURONTIN group0.199than in the placebo group0.044a difference that also achieved statistical significance.

Drug Reaction with Eosinophilia and Systemic SymptomsDRESSalso known as multiorgan hypersensitivityhas occurred with NEURONTINSome of these reactions have been fatal or lifethreateningDRESS typicallyalthough not exclusivelypresents with feverrashand/or lymphadenopathyin association with other organ system involvementsuch as hepatitisnephritishematological abnormalitiesmyocarditisor myositis sometimes resembling an acute viral infectionEosinophilia is often presentThis disorder is variable in its expressionand other organ systems not noted here may be involved.

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One study compared NEURONTIN 1200 mg/dayin three divided doses with placeboResponder rate was 2314/61in the NEURONTIN group and 96/66in the placebo groupthe difference between groups was statistically significantResponse ratio was also better in the NEURONTIN group0.199than in the placebo group0.044a difference that also achieved statistical significance.

Both studies demonstrated efficacy compared to placebo at all doses tested.

Analyses were also performed in each study to examine the effect of NEURONTIN on preventing secondarily generalized tonic-clonic seizuresPatients who experienced a secondarily generalized tonic-clonic seizure in either the baseline or in the treatment period in all three placebo-controlled studies were included in these analysesThere were several response ratio comparisons that showed a statistically significant advantage for NEURONTIN compared to placebo and favorable trends for almost all comparisons.

Creatinine clearanceCLCris difficult to measure in outpatientsIn patients with stable renal functioncreatinine clearance can be reasonably well estimated using the equation of Cockcroft and Gault:

There are no adequate and well-controlled studies in pregnant womenIn nonclinical studies in miceratsand rabbitsgabapentin was developmentally toxic when administered to pregnant animals at doses similar to or lower than those used clinicallyNEURONTIN should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

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