Monograph Details
|
|
Central Nervous System
> Seizure disorders
|
|
KEPPRA ORAL SOLUTION |
| Manufacturer |
|
UCB Inc. |
| Legal Classification |
|
Rx
|
| Generic Name |
|
Levetiracetam 100mg/mL; grape flavor; dye-free. |
| Also |
• KEPPRA
• KEPPRA INJECTION
• KEPPRA XR
|
| Indications |
|
Adjunct in partial onset seizures in patients ≥4yrs 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. |
| Children |
|
Give in 2 divided doses. Partial onset: <4yrs: not recommended. 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. All: if body wt. ≤20kg: use oral soln. |
| Adults |
|
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 12 hours; CrCl 30–50mL/min: 250–750mg every 12 hours; CrCl <30mL/min: 250–500mg every 12 hours; ESRD patients on dialysis: 500mg–1g every 24 hours and a supplement of 250–500mg post-dialysis. |
| Precautions |
|
Renal impairment. Suicidal tendencies (monitor). Avoid abrupt cessation. Elderly (consider monitoring renal function). Labor & delivery. Pregnancy (Cat.C). Nursing mothers: not recommended. |
| Adverse Reactions |
|
Somnolence, asthenia, infection, dizziness, coordination difficulties (eg, ataxia, abnormal gait), mood and behavioral abnormalities (eg, irritability, anger, depression, anxiety, apathy), neck pain, pharyngitis, hematologic abnormalities; rare: psychotic symptoms. Children: also accidental injury, hostility, nervousness. XR: also nausea. |
| Extra Text |
|
Note: Register pregnant patients exposed to levetiracetam by calling (888) 537-7734. |
| How Supplied |
Tabs 250mg, 500mg, 750mg—120
1000mg—60
XR—60
Soln—pt
Single-use vials (5mL)—10 |
| Additional Resources |
|
• Related Prescribing Note |
|
|
|
|
