Gabapentin 100 mg Capsules — Generic For Neurontin — Time Cap Labs

These highlights do not include all the information needed to use

GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES.

GABAPENTIN capsules, for oral use

Initial U.S. Approval: 1993

Recent Major Changes

Warnings and Precautions (5.5, 5.6) 4/2025

Warnings and Precautions, removal-

Sudden and Unexplained Death in Patients with Epilepsy (5.10) 4/2025

Indications And Usage

Gabapentin Capsules are 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)

Dose can be titrated up as needed to a dose of 1800 mg/day

Day 1: Single 300 mg dose

Day 2: 600 mg/day (i.e., 300 mg two times a day)

Day 3: 900 mg/day (i.e., 300 mg three times a day)

Epilepsy with Partial Onset Seizures

(2.2)

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

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)

Contraindications

Known hypersensitivity to gabapentin or its ingredients (

4)

Warnings And Precautions

• (5.5, 5.6) 4/2025 Warnings and Precautions, removal- Sudden and Unexplained Death in Patients with Epilepsy (5.10) 4/2025 INDICATIONS AND USAGE Gabapentin Capsules are 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)
• Dose can be titrated up as needed to a dose of 1800 mg/day
• Day 1: Single 300 mg dose
• Day 2: 600 mg/day (i.e., 300 mg two times a day)
• Day 3: 900 mg/day (i.e., 300 mg three times a day)

• (5.5, 5.6) 4/2025 Warnings and Precautions, removal- Sudden and Unexplained Death in Patients with Epilepsy (5.10) 4/2025 INDICATIONS AND USAGE Gabapentin Capsules are 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)
• Dose can be titrated up as needed to a dose of 1800 mg/day
• Day 1: Single 300 mg dose
• Day 2: 600 mg/day (i.e., 300 mg two times a day)
• Day 3: 900 mg/day (i.e., 300 mg three times a day)

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: Monitor for suicidal thoughts/behavior (

5.5)

Abrupt or rapid discontinuation may increase the risk for seizures. Withdrawal symptoms, or suicidal behavior and ideation have been observed after discontinuation (

5.6)

Respiratory Depression: May occur with gabapentin when used with concomitant central nervous system (CNS) depressants, including opioids, or in the setting of underlying respiratory impairment. Monitor patients and adjust dosage as appropriate (5.8)

Neuropsychiatric Adverse Reactions in Children 3 to 12 Years of Age: Monitor for such events (

5.9)

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 Time-Cap Labs at 1-877-376-4271 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: 8/2025