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Keppra Xr Generic Name & Formulations
Legal Class
Rx
General Description
Levetiracetam 500mg, 750mg; ext-rel tabs.
Pharmacological Class
Antiepileptic.
How Supplied
Tabs 250mg, 500mg, 750mg—120; 1000mg—60; XR—60; Soln—16oz; Single-use vials (5mL)—10
Manufacturer
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 Xr Indications
Indications
Partial onset seizures in patients ≥12yrs old.
Keppra Xr Dosage and Administration
Adult
Swallow whole. ≥12yrs (≥50kg): initially 1g once daily; may increase at 2-week intervals in increments of 1g/day; max 3g/day. Renal impairment: CrCl 50–80mL/min: 1–2g every 24hrs; CrCl 30–50mL/min: 500mg–1.5g every 24hrs; CrCl <30mL/min: 500mg–1g every 24hrs; ESRD on dialysis: use immediate-release levetiracetam.
Children
<12yrs: not established.
Keppra Xr Contraindications
Not Applicable
Keppra Xr Boxed Warnings
Not Applicable
Keppra Xr 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. Renal impairment. Avoid abrupt cessation. Elderly (consider monitoring renal function). Pregnancy: monitor carefully (esp. during 3rd trimester). Nursing mothers.
Keppra Xr Pharmacokinetics
Absorption
Peak plasma concentration occurs in about 4 hours. Intake of a high fat, high calorie breakfast before the administration of extended-release levetiracetam tablets resulted in a higher peak concentration, and longer median time to peak.
Distribution
Volume of distribution is close to the volume of intracellular and extracellular water. Plasma protein bound: <10%.
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 Xr Interactions
Not Applicable
Keppra Xr 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 Xr Clinical Trials
See Literature
Keppra Xr 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 Xr Patient Counseling
See Literature
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