Gabapentin Capsules

CONTRAINDICATIONS

• Gabapentin capsules are contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients. ( 4)

WARNINGS AND PRECAUTIONS

• Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), also known as multiorgan hypersensitivity, has occurred with gabapentin capsules. Some of these reactions have been fatal or life-threatening. ( 5.1)
• Gabapentin capsules can cause anaphylaxis and angioedema after the first dose or at any time during treatment. ( 5.2)
• Patients taking gabapentin capsules should not drive until they have gained sufficient experience to assess whether gabapentin capsules impairs their ability to drive. ( 5.3)
• Somnolence, dizziness and ataxia occur at higher rates with gabapentin compared to placebo in controlled trials. ( 5.4)
• Antiepileptic drugs (AEDs), including gabapentin, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. ( 5.5)
• Antiepileptic drugs should not be abruptly discontinued because of the possibility of increasing seizure frequency. ( 5.6)
• Status epilepticus. ( 5.7)
• There is evidence from case reports, human studies and animal studies associating gabapentin with serious, life-threatening or fatal respiratory depression when coadministered with CNS depressants, including opioids. ( 5.8)
• Gabapentin use in pediatric patients with epilepsy 3 to 12 years of age is associated with the occurrence of CNS related adverse reactions. ( 5.9)
• In an oral carcinogenicity study, gabapentin increased the incidence of pancreatic acinar cell tumors in rats. ( 5.10)

ADVERSE REACTIONS

Postherpetic Neuralgia: The most common adverse reactions associated with the use of gabapentin capsules in adults, not seen at an equivalent frequency among placebo-treated patients, were dizziness, somnolence and peripheral edema. ( 6.1)

Epilepsy (patients > 12 years of age): The most common adverse reactions with gabapentin in combination with other antiepileptic drugs in patients > 12 years of age, not seen at an equivalent frequency among placebo-treated patients, were somnolence, dizziness, ataxia, fatigue and nystagmus. ( 6.1)

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To report SUSPECTED ADVERSE REACTIONS, contact Trifluent Pharma, LLC at 1-888-927-5191 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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Full Safety and Prescribing Information: DailyMed