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GABAPENTIN Capsules, Tablets, Oral Suspension (GREENSTONE LLC)

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GABAPENTIN Capsules, Tablets, Oral Suspension (GREENSTONE LLC) Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...
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1 INDICATIONS AND USAGE

Gabapentin is indicated for:

  • Management of postherpetic neuralgia in adults
  • Adjunctive therapy in the treatment of partial onset seizures, with and without secondary...
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2 DOSAGE AND ADMINISTRATION

2.1 Dosage for Postherpetic Neuralgia

In adults with postherpetic neuralgia, gabapentin may be initiated on Day 1 as a single 300 mg dose...

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3 DOSAGE FORMS AND STRENGTHS

Capsules

  • 100 mg: white hard gelatin capsules printed with "PD" on the body and "Neurontin...
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4 CONTRAINDICATIONS

Gabapentin is contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients.

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5 WARNINGS AND PRECAUTIONS

5.1 Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity

Drug Reaction with Eosinophilia and Systemic...

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6 ADVERSE REACTIONS

The following serious adverse reactions are discussed in greater detail in other sections:

  • Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan...
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7 DRUG INTERACTIONS

7.1 Opioids

Respiratory depression and sedation, sometimes resulting in death, have been reported following coadministration of gabapentin with...

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Pregnancy Exposure Registry

There is...

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9 DRUG ABUSE AND DEPENDENCE

9.1 Controlled Substance

Gabapentin is not a scheduled drug.

9.2 Abuse...

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10 OVERDOSAGE

Signs of acute toxicity in animals included ataxia, labored breathing, ptosis, sedation, hypoactivity, or excitation.

Acute oral overdoses of gabapentin have been reported. Symptoms have included double...

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11 DESCRIPTION

The active ingredient in gabapentin capsules, tablets, and oral solution is gabapentin, which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid.

The molecular formula of gabapentin is C...

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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

The precise mechanisms by which gabapentin produces its analgesic and antiepileptic actions are unknown. Gabapentin...

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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

...

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14 CLINICAL STUDIES

14.1 Postherpetic Neuralgia

Gabapentin was evaluated for the management of postherpetic neuralgia (PHN) in two randomized, double-blind, placebo-...

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16 HOW SUPPLIED/STORAGE AND HANDLING

Gabapentin capsules, tablets, and oral solution are supplied as follows:

100 mg capsules:

 
White...
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17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Administration...

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MEDICATION GUIDE

Gabapentin (GAB-a-PEN-tin)

Capsules, Tablets, and Oral Solution

What is the most important information I should know about gabapentin?

Do not...

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This product's labeling may have been updated. For the most recent prescribing information, please visit www.greenstonellc.com.

...

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