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HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
NEURONTIN safely and effectively. See full prescribing information for
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----------------------------
NEURONTIN is indicated for:
Postherpetic neuralgia in adults (1)
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 (1)
------------------------DOSAGE AND ADMINISTRATION----------------------
Postherpetic Neuralgia (2.1)
o Dose can be titrated up as needed to a dose of 1800 mg/day
o Day 1: Single 300 mg dose
o Day 2: 600 mg/day (i.e., 300 mg two times a day)
o Day 3: 900 mg/day (i.e., 300 mg three times a day)
Epilepsy with Partial Onset Seizures (2.2)
o Patients 12 years of age and older: starting dose is 300 mg three times
daily; may be titrated up to 600 mg three times daily
o Patients 3 to 11 years of age: starting dose range is 10 to 15 mg/kg/day,
given in three divided doses; recommended dose in patients 3 to
4 years of age is 40 mg/kg/day, given in three divided doses; the
recommended dose in patients 5 to 11 years of age is 25 to
35 mg/kg/day, given in three divided doses. The recommended dose is
reached by upward titration over a period of approximately 3 days
Dose should be adjusted in patients with reduced renal function (2.3, 2.4)
---------------------DOSAGE FORMS AND STRENGTHS----------------------
Capsules: 100 mg, 300 mg, and 400 mg (3)
Tablets: 600 mg, and 800 mg (3)
Oral Solution: 250 mg/5mL (3)
------------------------------CONTRAINDICATIONS-------------------------------
Known hypersensitivity to gabapentin or its ingredients (4)
----------------------WARNINGS AND PRECAUTIONS-------------------------
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)
Increased seizure frequency may occur in patients with seizure disorders if
NEURONTIN is abruptly discontinued (5.5)
Suicidal Behavior and Ideation: Monitor for suicidal thoughts/behavior
(5.6)
Neuropsychiatric Adverse Reactions in Children 3 to 12 Years of Age:
Monitor for such events (5.7)
-----------------------------------ADVERSE REACTIONS--------------------------
Most common adverse reactions (incidence ≥8% and at least twice that for
placebo) were:
Postherpetic neuralgia: Dizziness, somnolence, and peripheral edema (6.1)
Epilepsy in patients >12 years of age: Somnolence, dizziness, ataxia,
fatigue, and nystagmus (6.1)
Epilepsy in patients 3 to 12 years of age: Viral infection, fever, nausea
and/or vomiting, somnolence, and hostility (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Pfizer, Inc. at
1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
----------------------------DRUG INTERACTIONS------------------------------
Concentrations increased by morphine; may need dose adjustment (5.4,
7.2)
---------------------------USE IN SPECIFIC POPULATIONS--------------------
Pregnancy: Based on animal data, may cause fetal harm. (8.1)
See 17 for PATIENT COUNSELING INFORMATION and Medication
Guide.
Revised: 10/2017
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Dosage for Postherpetic Neuralgia
2.2 Dosage for Epilepsy with Partial Onset Seizures
2.3 Dosage Adjustment in Patients with Renal Impairment
2.4 Dosage in Elderly
2.5 Administration Information
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Drug Reaction with Eosinophilia and Systemic Symptoms
(DRESS)/Multiorgan Hypersensitivity
5.2 Anaphylaxis and Angioedema
5.3 Effects on Driving and Operating Heavy Machinery
5.4 Somnolence/Sedation and Dizziness
5.5 Withdrawal Precipitated Seizure, Status Epilepticus
5.6 Suicidal Behavior and Ideation
5.7 Neuropsychiatric Adverse Reactions (Pediatric Patients 3 to 12
Years of Age)
5.8 Tumorigenic Potential
5.9 Sudden and Unexplained Death in Patients with Epilepsy
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Postmarketing Experience
7 DRUG INTERACTIONS
7.1 Other Antiepileptic Drugs
7.2 Opioids
7.3 Maalox
®
(aluminum hydroxide, magnesium hydroxide)
7.4 Drug/Laboratory Test Interactions
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Renal Impairment
9 DRUG ABUSE AND DEPENDENCE
9.1 Controlled Substance
9.2 Abuse
9.3 Dependence
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
14.1 Postherpetic Neuralgia
14.2 Epilepsy for Partial Onset Seizures (Adjunctive Therapy)
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
*Sections or subsections omitted from the full prescribing information are not
listed.
FULL PRESCRIBING INFORMATION
Reference ID: 4168942