Monograph Details
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Central Nervous System
> Seizure disorders
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KEPPRA |
| Manufacturer |
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UCB Inc. |
| Legal Classification |
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Rx
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| Generic Name |
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Levetiracetam 250mg, 500mg, 750mg, 1000mg; scored tabs. |
| Also |
• KEPPRA INJECTION
• KEPPRA ORAL SOLUTION
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| Indications |
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Adjunct in partial onset seizures in adults and children ≥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 |
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Give in 2 divided doses. Partial onset: <4yrs: not recommended. 4–15yrs: 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. 6–15yrs: 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 |
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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 |
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Renal impairment. Suicidal tendencies (monitor). Avoid abrupt cessation. Elderly (consider monitoring renal function). Labor & delivery. Pregnancy (Cat.C). Nursing mothers: not recommended. |
| Adverse Reactions |
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Somnolence, asthenia, infection, dizziness, coordination difficulties (eg, ataxia, abnormal gait), mood and behavioral abnormalities (eg, irritability, depression, psychosis, anxiety, apathy), neck pain, pharyngitis, hematologic abnormalities. Also children: accidental injury, hostility, nervousness. |
| Extra Text |
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Note: Register pregnant patients exposed to levetiracetam by calling (888) 537-7734. |
| How Supplied |
Tabs 250mg, 500mg, 750mg—120 1000mg—60 Soln—pt Single-use vials (5mL)—10 |
| Additional Resources |
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• Related Prescribing Note |
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