Keppra Xr

— THERAPEUTIC CATEGORIES —
  • Seizure disorders

Keppra Xr Generic Name & Formulations

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. 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 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%. 

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 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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