Keppra Oral Solution

— THERAPEUTIC CATEGORIES —
  • Seizure disorders
PAGE CONTENTS
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Keppra Oral Solution Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Levetiracetam 100mg/mL; grape flavor; dye-free.

    Pharmacological Class

    Antiepileptic.

    See Also

    How Supplied

    Tabs 250mg, 500mg, 750mg—120; 1000mg—60; XR—60; Soln—16oz; Single-use vials (5mL)—10

    Manufacturer

    UCB Inc.

    Mechanism of Action

    The exact mechanism by which levetiracetam exerts its antiepileptic effect is unknown. However, it may be contributed to its interaction with the SV2A protein.

    Keppra Oral Solution Indications

    Indications

    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.

    Keppra Oral Solution Dosage and Administration

    Adult

    Swallow tabs whole. Partial onset: ≥16yrs: initially 500mg twice daily. May increase at 2-week intervals in increments of 1g/day; max 3g/day. Myoclonic: ≥12yrs: 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 on dialysis: 500mg–1g every 24hrs and a supplement of 250–500mg post-dialysis.

    Children

    Swallow tabs whole. Body wt. ≤20kg: use oral soln. Give in 2 divided doses. Partial onset: <1 month: not established. 1 month–<6mos: initially 14mg/kg/day; increase at 2-week intervals by 14mg/kg/day to target dose of 42mg/kg/day. 6mos–<4yrs: initially 20mg/kg/day; increase at 2-week intervals by 20mg/kg/day to target dose of 50mg/kg/day. 4–<16yrs: initially 20mg/kg/day; increase at 2-week intervals by 20mg/kg/day to target dose of 60mg/kg/day; max 3g/day. If using tabs (20–40kg): initially 500mg/day; increase at 2-week intervals by 500mg/day to max 1.5g/day; (≥40kg): initially 1g/day; increase at 2-week intervals by 1g/day to max 3g/day. May reduce dose if intolerant. Myoclonic: <12yrs: not established. Tonic-clonic: <6yrs: not established. 6–<16yrs: initially 20mg/kg/day; increase at 2-week intervals by 20mg/kg/day to target dose of 60mg/kg/day.

    Keppra Oral Solution Contraindications

    Not Applicable

    Keppra Oral Solution Boxed Warnings

    Not Applicable

    Keppra Oral Solution Warnings/Precautions

    Warnings/Precautions

    Monitor for behavioral abnormalities, psychiatric symptoms, emergence or worsening of depression, suicidal ideation, somnolence, fatigue. Hematologic abnormalities: do CBCs in those experiencing significant weakness, pyrexia, recurrent infections, or coagulation disorders. Discontinue if anaphylaxis or angioedema develops. Discontinue at the 1st sign of rash; do not resume if Stevens-Johnson syndrome or toxic epidermal necrolysis is suspected. Evaluate immediately if signs or symptoms of drug reaction with eosinophilia and systemic symptoms (DRESS)/multiorgan hypersensitivity develop; discontinue if alternative etiology cannot be established. Renal impairment. Avoid abrupt cessation. Elderly (consider monitoring renal function). Pregnancy: monitor carefully (esp. during 3rd trimester). Nursing mothers.

    Keppra Oral Solution Pharmacokinetics

    Absorption

    Oral bioavailability: 100%. Rapid absorption with peak plasma concentrations occurring in about an hour.

    Distribution

    Volume of distribution is close to the volume of intracellular and extracellular water. Plasma protein bound: <10%. 

    Metabolism

    Not extensively metabolized. Major metabolic pathway is enzymatic hydrolysis.

    Elimination

    Renal (66%). Plasma half-life: 7±1 hour. Total body clearance: 0.96 mL/min/kg. Renal clearance: 0.6 mL/min/kg.

    Keppra Oral Solution Interactions

    Not Applicable

    Keppra Oral Solution Adverse Reactions

    Adverse Reactions

    Somnolence, asthenia, infection, dizziness; behavioral abnormalities (eg, irritability, aggression, anger, depression, anxiety, apathy), psychotic symptoms, coordination difficulties (eg, ataxia, abnormal gait), hematologic abnormalities, dermatological reactions (may be serious). Children: also fatigue, nasal congestion, decreased appetite; BP increases in children 1 month–4yrs (monitor).

    Keppra Oral Solution Clinical Trials

    See Literature

    Keppra Oral Solution Note

    Notes

    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.

    Keppra Oral Solution Patient Counseling

    See Literature

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