Administer NEURONTIN three times a day using 300 mg or 400 mg capsules, or 600 mg or 800 mg tablets. The maximum time between doses should not exceed 12 hours. Neurontin was evaluated for the management of postherpetic neuralgia (PHN) in 2 randomized, double-blind, placebo-controlled, multicenter studies; N=563 patients in the intent-to-treat (ITT) In adults with postherpetic neuralgia, NEURONTIN may be initiated on Day 1 as a single 300 mg dose, on Day 2 as 600 mg/day (300 mg two times a day), and on Day 3 as 900 mg/day (300 mg three times Gabapentin is eliminated from the systemic circulation by renal excretion as unchanged drug. 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. Gabapentin elimination rate constant, plasma clearance, and renal clearance are directly IN TABLETS. GABAPENTIN tablets, for oral use Initial U.S. Ap. ided doses. The recommended dose is reached by upward titration over a period of approxim. three t. Gabapentin can cause serious side effects including: 1. Suicidal Thoughts. Like other antiepileptic drugs, gabapentin may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you: 6.2 Adverse Events Associated With Gabapentin . 7 DRUG INTERACTIONS 8 USE IN SPECIFIC POPULATIONS . 8.1 Pregnancy 8.2 Labor and Delivery . 8.3 Nursing Mothers 8.4 Pediatric Use . 8.5 Geriatric Use 8.6 Renal Impairment . 9 DRUG ABUSE AND DEPENDENCE . 9.1 Controlled Subs tance 9.2 Abuse 9.3 Dependence . 10 OVERDOSAGE . 10.1 Human Overdose Experience NEURONTIN can cause serious side effects including: • Suicidal Thoughts. Like other antiepileptic drugs, NEURONTIN may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you: • During the controlled epilepsy trials in patients older than 12 years of age receiving doses of gabapentin up to 1,800 mg daily, somnolence, dizziness, and ataxia were reported at a greater rate in patients receiving gabapentin compared to placebo: i.e., 19% in drug versus 9% in placebo for somnolence, 17% in drug versus 7% in placebo for Drug Reaction with Eosinophilia and Systemic Symptoms (Multiorgan hypersensitivity): discontinue Gabapentin Oral Solution if an alternative etiology cannot be established (5.1) • Anaphylaxis and Angioedema: discontinue Gabapentin Oral Solution and evaluate patient immediately (5.2) Due to inconsistencies between the drug labels on DailyMed and the pill images provided by RxImage, we no longer display the RxImage pill images associated with drug labels. We anticipate reposting the images once we are able identify and filter out images that do not match the information provided in the drug labels. Gabapentin package insert / prescribing information for healthcare professionals. Includes: indications, dosage, adverse reactions and pharmacology. NEURONTIN (gabapentin) is indicated as adjunctive therapy for the management of patients with epilepsy who are not satisfactorily controlled by conventional therapy. 1.1 Pediatrics Read the Medication Guide before you start taking gabapentin and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment. What is the most important information I should know about gabapentin? Gabapentin oral solution is contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients. 5 WARNINGS AND PRECAUTIONS 5.1 Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), also known as 5.3 Withdrawal of Gabapentin 5.4 . Tumorigenic Potential 5.5 . Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity 5.6. Laboratory Tests 6 ADVERSE REACTIONS . 6.1 Clinical Trials Experience . 6.2 Postmarketing and Other Experience with other Formulations of Gabapentin . 7 DRUG INTERACTIONS . 7.1 Phenytoin indicate that gabapentin may cause significant driving impairment. Prescribers and patients should be aware that patients’ ability to assess their own driving competence, as well as their ability to assess the degree of somnolence caused by NEURONTIN, can be imperfect. The duration of . Gabapentin capsules can cause serious side effects including: 1. Suicidal Thoughts. Like other antiepileptic drugs, gabapentin capsules may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you: Administer gabapentin capsules orally with or without food. Gapapentin capsules should be swallowed whole with water. If the gabapentin capsules 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 caused a marked decrease in neuronal synapse formation in brains of intact mice and abnormal neuronal synapse formation in a mouse model of synaptic repair. 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
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