KEPPRA ORAL SOLUTION Rx
Generic Name and Formulations:
Levetiracetam 100mg/mL; grape flavor; dye-free.
Indications for KEPPRA ORAL SOLUTION:
Adjunct in partial onset seizures in patients ≥1 month old. Adjunct in myoclonic seizures in patients ≥12yrs old with juvenile myoclonic epilepsy. Adjunct in primary generalized tonic-clonic seizures in patients ≥6yrs old with idiopathic generalized epilepsy.
Partial onset: ≥16yrs: Initially 500mg twice daily. May increase at 2-week intervals in increments of 1g/day; max 3g/day. Myoclonic: Initially 500mg twice daily; increase at 2-week intervals in increments of 1g/day to target dose of 3g/day. Tonic-clonic: ≥16yrs: Initially 500mg twice daily; increase at 2-week intervals by 1g/day to target dose of 3g/day. Renal impairment: CrCl 50–80mL/min: 500mg–1g every 12hrs; CrCl 30–50mL/min: 250–750mg every 12hrs; CrCl <30mL/min: 250–500mg every 12hrs; ESRD patients on dialysis: 500mg–1g every 24hrs and a supplement of 250–500mg post-dialysis.
Give in 2 divided doses. Partial onset: 1 month–<6 months: 14mg/kg/day; increase at 2-week intervals by 14mg/kg/day to target dose of 42mg/kg/day. 6 months–<4yrs: 20mg/kg/day; increase at 2-week intervals by 20mg/kg/day to target dose of 50mg/kg/day. 4–<16yrs: 20mg/kg/day; increase at 2-week intervals by 20mg/kg/day to target dose of 60mg/kg/day. May reduce dose if intolerant. Myoclonic: <12yrs: not recommended. Tonic-clonic: <6yrs: not recommended. 6–16yrs: 20mg/kg/day; increase at 2-week intervals by 20mg/kg/day to target dose of 60mg/kg/day.
Renal impairment. Monitor for behavioral abnormalities, psychiatric symptoms, somnolence, and fatigue. Avoid abrupt cessation. Elderly (consider monitoring renal function). Labor & delivery. Pregnancy (Cat.C); monitor carefully esp. during 3rd trimester. Nursing mothers: not recommended.
Somnolence, asthenia, infection, dizziness, neck pain, pharyngitis; behavioral abnormalities (eg, irritability, aggression, anger, depression, anxiety, apathy), psychotic symptoms, coordination difficulties (eg, ataxia, abnormal gait), hematologic abnormalities, dermatological reactions (may be serious [eg, Stevens-Johnson syndrome, toxic epidermal necrolysis]; discontinue if occurs). Children: also fatigue, nasal congestion, accidental injury, hostility, nervousness, decreased appetite; BP increases in children 1 month–4years (monitor). XR: also nausea.
Enroll pregnant patients exposed to levetiracetam in the North American Antiepileptic Drug pregnancy registry (888) 233-2334 or the UCB AED Pregnancy Registry (888) 537-7734.
Tabs 250mg, 500mg, 750mg—120; 1000mg—60; XR—60; Soln—16oz; Single-use vials (5mL)—10