Each capsule contains:
Gabapentin 100, 300 or 400 mg
Postherpetic Neuralgia – Gabapentin is indicated for the management of postherpetic neuralgia in adults .
Epilepsy (treatment adjunct) – Gabapentin is indicated as an adjunct to other anticonvulsant medications (in the treatment of partial seizures with or without secondary generalization in adults and adolescents) with epilepsy . Gabapentin is also indicated as adjunctive therapy for the treatment of partial seizures in pediatric patients 3 years of age and older with epilepsy .
Dosage and administration:
Initial: 300mg single dose on Day 1, then 300mg bid (600mg/day) on Day 2, and 300mg tid (900mg/day) on Day 3.
Titrate: May subsequently increase if needed up to 600mg tid (1800mg/day).
Adjuvant Therapy for Partial Onset Seizures with Epilepsy, with and without Secondary Generalization:
Initial: 300mg tid
Maint: 300-600mg tid
Doses up to 2400mg/day (long-term) and 3600mg/day (short-term) have been well tolerated.
Dosing intervals should not exceed 12 hrs
Note: The dosage may be gradually increased based on clinical response.
Note: the maximum time between doses should not exceed twelve hours.
Note: Dose reduction or substitution with an alternative medication should be done gradually over ≥1 week.
Initial: 300mg qd
Titrate: Refer to Adult Dosage
CrCl ≥60mL/min: 1800mg qd
CrCl 30-60mL/min: 600-1800mg qd
CrCl <30mL/min or Hemodialysis: Do not administer
Pregnancy and lactation:
Category C, caution in nursing.
Gabapentin is contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients .
Warning and precautions:
Not interchangeable with other gabapentin products.
Increased risk of suicidal thoughts or behavior.
May have tumorigenic potential.
Drug reaction with eosinophilia and systemic symptoms (DRESS)/multiorgan hypersensitivity reported; evaluate immediately if signs/symptoms are present, and disconctinue therapy if an alternative etiology cannot be established.
Dizziness, somnolence, headache, peripheral edema, diarrhea.
Naproxen may increase absorption.
May reduce levels of hydrocodone.
Hydrocodone and morphine may increase AUC.
Cimetidine may decrease oral clearance and CrCl.
Reduced bioavailability with an antacid containing aluminum hydroxide and magnesium hydroxide; take at least 2 hrs following the antacid.
Packaging and storage :
Store below 30°c. protect from moisture.