Indicated for:

• Management of postherpetic neuralgia in adults.

• Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.

The use of NEURONTIN in patients less than 12 years of age with compromised renal function has not been studied.

Safety and effectiveness of NEURONTIN in the management of postherpetic neuralgia in pediatric patients have not been established.

Effectiveness as adjunctive therapy in the treatment of partial seizures in pediatric patients below the age of 3 years has not been established.

Antiepileptic drugs (AEDs), including NEURONTIN, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. 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.

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), also known as multiorgan hypersensitivity, has occurred with NEURONTIN. Some of these reactions have been fatal or life-threatening.

There is evidence from case reports, human studies, and animal studies associating gabapentin with serious, life-threatening, or fatal respiratory depression when co-administered with CNS depressants, including opioids, or in the setting of underlying respiratory impairment. When the decision is made to co prescribe NEURONTIN with another CNS depressant, particularly an opioid, or to prescribe NEURONTIN to patients with underlying respiratory impairment, monitor patients for symptoms of respiratory depression and sedation, and consider initiating NEURONTIN at a low dose. The management of respiratory depression may include close observation, supportive measures, and reduction or withdrawal of CNS depressants (including NEURONTIN).

Antiepileptic drugs should not be abruptly discontinued because of the possibility of increasing seizure frequency. If the NEURONTIN 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).

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.

In clinical studies in adjunctive therapy in epilepsy, new tumors were reported in 10 patients (2 breast, 3 brain, 2 lung 1 adrenal,1 non-Hodgkin’s lymphoma,1 endometrial carcinoma in situ), and pre-existing tumors worsened in 11 patients (9 brain, 1 breast,1 prostate) during or up to 2 years following discontinuation of NEURONTIN.

During the course of premarketing development of NEURONTIN, 8 sudden and unexplained deaths were recorded among a cohort of 2203 epilepsy patients treated (2103 patient-years of exposure) with NEURONTIN.

NEURONTIN can cause anaphylaxis and angioedema after the first dose or at any time during treatment. Signs and symptoms in reported cases have included difficulty breathing, swelling of the lips, throat, and tongue, and hypotension requiring emergency treatment.

Patients should be carefully observed for signs of central nervous system (CNS) depression, such as somnolence and sedation, when NEURONTIN is used with other drugs with sedative properties because of potential synergy. In addition, patients who require concomitant treatment with morphine may experience increases in gabapentin concentrations and may require dose adjustment.

It is recommended that gabapentin be taken at least 2 hours following Maalox administration.

Co-administration of NEURONTIN with hydrocodone decreases hydrocodone exposure.

Because false positive readings were reported with the Ames N-Multistix SG dipstick test for urinary protein when gabapentin was added to other antiepileptic drugs, the more specific sulfosalicylic acid precipitation procedure is recommended to determine the presence of urine protein.

There are no adequate data on the developmental risks associated with the use of NEURONTIN in pregnant women. Animal studies: increased fetal skeletal and visceral abnormalities, and increased embryo-fetal mortality.

Gabapentin is secreted into human milk following oral administration.

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• Monotherapy in treatment of epilepsy. GoToSource

• Diabetic neuropathy, trigeminal neuralgia, HIV-neuropathy, bipolar disorder, essential tremor, migraine prophylaxis, cocaine dependence, fibromyalgia, restless legs syndrome, movement disorders, acute-phase cerebral infarction, HIV-1 encephalitis, parkinson’s disease, alzheimer’s disease, amyotrophic lateral sclerosis, anxiety, social phobias, panic disorder, insomnia, autism spectrum disorders, bipolar and obsessive-compulsive disorder. GoToSource

• Reflex sympathetic dystrophy. GoToSource

• Attention deficit hyperactivity disorder. GoToSource

• Alcohol dependence, elapse-related symptoms of insomnia, dysphoria and craving. GoToSource

• Management of dysautonomia following severe traumatic brain injury. GoToSource

• Interstitial cystitis. GoToSource

• Refractory genitourinary tract pain. GoToSource

• Dementia-associated agitation. GoToSource

• Muscle cramps. GoToSource

• Tinnitus. GoToSource

• Phantom limb pain. GoToSource

• Peripheral neuropathy. GoToSource

• Failed back surgery syndrome. GoToSource

• Post-traumatic stress disorder. GoToSource

• Menopausal hot flashes. GoToSource

• Mood disorders. GoToSource 

• Somatoform pain disorder. GoToSource

• Adjunctive therapy for treatment-resistant depression. GoToSource 

• Guillain-barré syndrome. GoToSource 

• Preemptive use in abdominal hysterectomy. GoToSource 

• Pruritus. GoToSource 

• Chronic pelvic pain. GoToSource 

• Intractable hiccups. GoToSource

Suicidal thoughts or behavior. GoToSource

Abuse and withdrawal symptoms. GoToSource 

Asterixis (movement disorder). GoToSource 

Pancreatic cancer. GoToSource

Cholestasis (flow of bile from the liver is slowed or blocked). GoToSource 

Memory disturbances, electrolyte abnormalities, liver toxicity and thrombocytopenia (low blood platelet level). GoToSource

Anaphylaxis (life-threatening allergic reaction), angioedema (swelling in deep layers of skin), impotence, xerostomia (dry mouth) and diplopia (double vision). GoToSource 

Drug rash with eosinophilia and systemic symptoms. GoToSource 

Rhabdomyolysis (breakdown of skeletal muscle fibers). GoToSource

Chorea (movement disorder). GoToSource 

Respiratory depression. GoToSource

Dizziness, somnolence, peripheral edema, nasopharyngitis (inflammation of nose and pharynx), weight gain, urinary tract infection and constipation. GoToSource

Lawsuits filed for suicide.