EpilepsyAdult & ped patients >12 yr Dosing range: 900-3,600 mg daily. Initially 300 mg tid on Day 1 or titrating dose to 300 mg once daily on Day 1, 300 mg bid on Day 2 & 300 mg tid on Day 3. Thereafter, dose may be increased in 3 equally divided doses. Max: 3,600 mg up to 4,800 mg daily. Max time interval: ≤12 hr. Ped patients 3-12 yr Initially 10-15 mg/kg daily in equally divided doses tid for approx 3 days, ≥5 yr 25-35 mg/kg daily in equally divided doses tid, 3 to <5 yr 40 mg/kg daily in equally divided doses tid. Max dose: 50 mg/kg daily. Max time interval: ≤12 hr. Neuropathic pain Adult Initially 900 mg daily in 3 equally divided doses, increased if necessary. Therapy should be initiated by titrating dose from 300 mg once daily on Day 1, to 300 mg bid on Day 2, then 300 mg tid on Day 3. Max dose: 3,600 mg daily. Renal impairment w/ CrCl ≥80 mL/min 900-3,600 mg daily, 50-79 mL/min 600-1,800 mg daily, 30-49 mL/min 300-900 mg daily, 15-29 mL/min 150 mg (administered as 300 mg every other day) to 600 mg daily, <15 mL/min 150 mg (administered as 300 mg every other day) to 300 mg daily. Patients undergoing hemodialysis Loading dose: 300-400 mg, then 200-300 mg following each 4 hr of hemodialysis.
Severe, life-threatening, systemic hypersensitivity reactions eg, DRESS. Discontinue treatment if signs or symptoms of anaphylaxis (eg, difficulty breathing, swelling lips, throat, tongue & hypotension) occur; alternative etiology for signs & symptoms of hypersensitivity cannot be established. Evaluate patients immediately if signs or symptoms of hypersensitivity eg, fever or lymphadenopathy are present. Monitor for signs & symptoms of abuse or dependence eg, development of tolerance, dose escalation & drug-seeking behavior. Increased occurrence of accidental injury (fall) due to dizziness & somnolence; confusion, loss of consciousness & mental impairment. Not for treatment of absence seizures. Current or history of substance abuse. May cause hematologic disorder. W/drawal symptoms including anxiety, insomnia, nausea, pains, sweating, tremor, headache, depression, feeling abnormal, dizziness & malaise may occur shortly after discontinuation & usually w/in 48 hr. Abrupt w/drawal may precipitate status epilepticus. Gradually reduce dose, discontinue or substitute treatment over min of 1 wk. Evaluate patients for history of drug abuse &/or psychiatric disorder. Observe signs of CNS depression eg, somnolence, sedation & resp depression in patients requiring concomitant treatment w/ CNS depressants including opioids. May impair ability to drive or operate machines. Liver & kidney disease. Women of childbearing potential must use effective contraception during treatment. Pregnancy & lactation. May increase risk of neonatal w/drawal syndrome in newborns exposed in utero to concomitant use w/ opioids. Adolescents <18 yr w/ neuropathic pain; monotherapy in childn <12 yr w/ epilepsy; adjunctive therapy in ped patients <3 yr w/ epilepsy.
Resp depression, sedation & death may occur w/ CNS depressants including opioids. Reduced bioavailability w/ Al- & Mg-containing antacids. False +ve readings w/ Ames N-Multistix SG dipstick test when used concomitantly w/ other anticonvulsant drugs.
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