Novell Pharma


Averroes Pharma
Concise Prescribing Info
Adjunctive therapy in partial seizures w/ & w/o secondary generalization in adults & childn ≥3 yr. Neuropathic pain which includes diabetic neuropathy, post-herpetic & trigeminal neuralgia in adults ≥18 yr.
Dosage/Direction for Use
Epilepsy Adult & childn >12 yr 900-3,600 mg daily, may be initiated by 300 mg tds on Day 1. Thereafter, increase in 3 equally divided doses up to max of 3,600 mg daily. Childn 3-12 yr 10-15 mg/kg daily in equally divided dose tds, ≥5 yr Effective dose: 25-35 mg/kg daily in equally divided doses tds, 3 to <5 yr 40 mg/kg daily in equally divided doses tds. Neuropathic pain Adult 900 mg daily in 3 equally divided doses. Max: 3,600 mg daily. Hemodialysis Loading dose: 300-400 mg, then 200-300 mg following each 4-hr of hemodialysis.
May be taken with or without food.
Special Precautions
Not for treatment of absence seizures. Early manifestations of hypersensitivity, drug rash w/ eosinophilia & systemic symptoms/multiorgan hypersensitivity. Increased risk of suicidal thoughts or behaviors. Monitor for signs of CNS depression; suicidality, worsening depression &/or unusual behavioral or mood changes. Avoid abrupt discontinuation. Renal impairment or hemodialysis. May impair ability to drive & use machines. Pregnancy & lactation. Childn 3-12 yr.
Adverse Reactions
Somnolence, dizziness, ataxia, fatigue. Confusion, depression, nervousness.
Drug Interactions
Reduced GIT absorption by Al- & Mg-containing antacids. Reduced clearance w/ morphine & cimetidine. Reduced anticonvulsant effectiveness w/ ginkgo, evening primrose & ketorolac. Decreased bioavailability of hydrocodone.
ATC Classification
N03AX12 - gabapentin ; Belongs to the class of other antiepileptics.
Epiven cap 300 mg
3 × 10's
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