NEURONTIN. NEURONTIN® (gabapentin) capsules,for oral use NEURONTIN® (gabapentin) tablets,for oral use NEURONTIN® (gabapentin) oral solution Initial U.S.Approval: 1993-----INDICATIONS AND USAGE-----NEURONTINis indicated for: Postherpetic neuralgia in adults (1) In adults with postherpetic neuralgia, gabapentin 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 a day). The dose can subsequently be titrated up as needed for pain relief to a dose of 1800 mg/day (600 mg three times a day). Neurontin® (gabapentin) Capsules, Neurontin (gabapentin) Tablets, and Neurontin (gabapentin) Oral Solution are supplied as imprinted hard shell capsules containing 100 mg, 300 mg, and 400 mg 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 Gabapentin Tablets are indicated for: In adults with postherpetic neuralgia, gabapentin tablets 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 a day). 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. 3 days. The recommended maintenance dose of NEURONTIN in patients 3 to 4 years of age is 40 mg/kg/day, given in three divided doses. The recommended maintenance dose of NEURONTIN in patients 5 to 11 years of age is 25 mg/kg/day to 35 mg/kg/day, given in three divided doses. NEURONTIN may be administered as the oral solution, capsule, or tablet, or NEURONTIN (gabapentin) capsules, tablets, and oral solution are supplied as follows: 100 mg capsules: White hard gelatin capsules printed with "PD" on the body and "Neurontin/100 mg" on the Advise the patient to read the FDA-approved patient labeling (Medication Guide). NEURONTIN may be administered as the oral solution, capsule, or tablet, or using combinations of these formulations. Dosages up to 50 mg/kg/day have been well tolerated in a long-term clinical study. The maximum time interval between doses should not exceed 12 hours. 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 Administer gabapentin capsules orally with or without food. Gabapentin 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). 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 a day). The dose can subsequently be titrated up as needed for pain relief to a dose of 1800 mg/day (600 mg three times a day). Neurontin® (gabapentin) capsules, Neurontin® (gabapentin) tablets, and Neurontin® (gabapentin) oral solution are supplied as imprinted hard shell capsules containing 100 mg, 300 mg, and 400 mg of gabapentin, elliptical film-coated tablets containing 600 mg and 800 mg of gabapentin or an oral solution containing 250 mg/5 mL of gabapentin. Neurontin® (gabapentin) Capsules, Neurontin (gabapentin) Tablets, and Neurontin (gabapentin) Oral Solution are supplied as imprinted hard shell capsules containing 100 mg, 300 mg, and 400 17.5 Drug Reaction With Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity . 17.6 Lack of Interchangeability With Gabapentin 17.7 Dosing Instructions . 17.8 Alcohol * Sections or subsections omitted from the full prescribing information are not listed. 1. Reference ID: 4584082 . This label may not be the latest approved by FDA. Gabapentin is indicated for: In adults with postherpetic neuralgia, gabapentin 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 a day). The use of gabapentin in patients less than 12 years of age with compromised renal function has not been studied. 2.4 consequence of increased gabapentin exposure for a given dose that results from an age-related Dosage in Elderly Because elderly patients are more likely to have decreased renal function, care should be taken in See package insert . T hese highlights do not include all the information needed to use gabapentin capsules safely and. Gabapentin is not a scheduled drug. 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
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