NEURONTIN

All pharmacological actions following gabapentin administration are due to the activity of the parent compound; gabapentin is not appreciably metabolized in humans. Oral Bioavailability Gabapentin bioavailability is not dose proportional; i.e., as dose is increased, bioavailability decreases. Bioavailability of gabapentin is approximately 60%, 47%, 34%, 33%, and 27% following 900, 1200, 2400, 3600, and 4800 mg/day given in 3 divided doses, respectively. Food has only a slight effect on the rate ...

14.1 Postherpetic Neuralgia NEURONTIN was evaluated for the management of postherpetic neuralgia (PHN) in two randomized, double-blind, placebo-controlled, multicenter studies. The intent-to-treat (ITT) population consisted of a total of 563 patients with pain for more than 3 months after healing of the herpes zoster skin rash (Table 6). TABLE 6. Controlled PHN Studies: Duration, Dosages, and Number of Patients Study Study Duration Gabapentin (mg/day) Given in 3 divided doses (TID) Target Dose Patients Receiving Gabapentin Patients Receiving Placebo 1 8 weeks 3600 113 116 2 7 weeks 1800, 2400 ...

The following serious adverse reactions are discussed in greater detail in other sections:

• Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity [see Warnings and Precautions (5.1) ]
• Anaphylaxis and Angioedema [see Warnings and Precautions (5.2) ]
• Somnolence/Sedation and Dizziness [see Warnings and Precautions (5.4) ]
• Suicidal Behavior and Ideation [see Warnings and Precautions (5.5) ]
• Increased Risk of Seizures and Other Adverse Reactions with Abrup...

NEURONTIN is contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients. Known hypersensitivity to gabapentin or its ingredients ( 4 )

• Drug Reaction with Eosinophilia and Systemic Symptoms (Multiorgan hypersensitivity): Discontinue if alternative etiology is not established ( 5.1 )
• Anaphylaxis and Angioedema: Discontinue and evaluate patient immediately ( 5.2 )
• Driving Impairment; Somnolence/Sedation and Dizziness: Warn patients not to drive until they have gained sufficient experience to assess whether their ability to drive or operate heavy machinery will be impaired ( 5.3 , 5.4 )
• Suicidal Behavior and Ideation: Monit...

7 DRUG INTERACTIONS Concentrations increased by morphine; may need dose adjustment ( 5.4 , 7.1 ) 7.1 Opioids Respiratory depression and sedation, sometimes resulting in death, have been reported following coadministration of gabapentin with opioids (e.g., morphine, hydrocodone, oxycodone, buprenorphine) [see Warnings and Precautions (5.8) ] . Hydrocodone Coadministration of NEURONTIN with hydrocod...