See Full Prescribing Information

Please see Full Prescribing Information and Important Safety Information on the product itself or by clicking here.

Individual patient results may vary. To report suspected adverse reactions, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also contact Pangea Pharmaceuticals at 855-892-8224 or drugsafety@pangeapharm.com.

Indications & Usage

• Management of postherpetic neuralgia in adults.
• Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years of age and older with epilepsy.

Contraindications

Gabapentin capsules are contraindicated in patients who have demonstrated hypersensitivity to gabapentin or any of its ingredients.

How Supplied

Gabapentin Capsules USP, 200 mg are supplied as size "2" hard gelatin capsules with an orange opaque cap imprinted "G 200" and a white opaque body imprinted "S 09". Bottles contain 60 capsules with a child-resistant closure. NDC 81279-126-60.

Warnings

• Serious hypersensitivity reactions: DRESS/multiorgan hypersensitivity, anaphylaxis, and angioedema have occurred and may be life-threatening or fatal. Discontinue and evaluate immediately if signs or symptoms occur.
• Suicidal behavior and ideation: Antiepileptic drugs, including gabapentin, increase the risk of suicidal thoughts or behavior. Monitor for new or worsening depression, suicidal thoughts or behavior, or unusual changes in mood or behavior.
• Respiratory depression: Serious, life-threatening, or fatal respiratory depression may occur, particularly with opioids or other CNS depressants or in patients with underlying respiratory impairment.
• Discontinuation: Abrupt or rapid discontinuation may increase seizure risk and has been associated with withdrawal symptoms. Gabapentin should generally be tapered over at least one week.

Precautions

• Gabapentin may cause somnolence, dizziness, ataxia, sedation, and impairment of driving or operation of heavy machinery. Patients should assess the effects of gabapentin before performing potentially hazardous activities.
• Monitor for CNS depression when gabapentin is used with opioids or other medications with sedative properties.
• Pediatric patients 3 to 12 years of age may experience neuropsychiatric adverse reactions, including emotional lability, hostility, thought disorder, and hyperkinesia.
• Gabapentin is eliminated by the kidneys. Dosage adjustment is recommended in patients with renal impairment and appropriate dose selection should be considered in elderly patients with reduced renal function.

Adverse Reactions

The most common adverse reactions reported with gabapentin include:

• Postherpetic neuralgia: dizziness, somnolence, and peripheral edema.
• Epilepsy in patients over 12 years of age: somnolence, dizziness, ataxia, fatigue, and nystagmus.
• Epilepsy in pediatric patients 3 to 12 years of age: viral infection, fever, nausea and/or vomiting, somnolence, and hostility.

Abuse and Dependence

Gabapentin misuse and abuse have been reported in the postmarketing setting, most commonly in individuals with a history of polysubstance abuse. Physical dependence may develop with gabapentin use. Withdrawal symptoms have been reported following discontinuation, including seizures, anxiety, insomnia, and nausea. Gabapentin capsules should generally be tapered over at least one week when discontinuing.

Pregnancy Exposure Registry

This registry monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), such as gabapentin, during pregnancy. Women who are taking gabapentin during pregnancy are encouraged to enroll in the North American Antiepileptic Drug (NMED) Pregnancy Registry by calling 1-888-233-2334 or visiting aedpregnancyregistry.org.

Antacid Drug Interaction

The mean bioavailability of gabapentin was reduced by about 20% with concomitant use of an antacid (Maalox) containing magnesium and aluminum hydroxides. It is recommended that gabapentin be taken at least 2 hours following Maalox administration.