Anticonvulsant, Miscellaneous

Indicated as adjunctive therapy in the treatment of partial onset seizures in adults with epilepsy

C

Should not be administered to patients who have previously exhibited hypersensitivity to levetiracetam or any of the inactive ingredients in the tablets

Associated with the occurrence of central nervous system adverse events; somnolence and fatigue, which were treated by discontinuation, reduction, or hospitalization; coordination difficulty was treated by reduction, and only one patient was hospitalized. Behavioral abnormalities, such as psychosis, hallucinations, psychotic depression and other behavioral symptoms (agitation, hostility, anxiety, apathy, emotional lability, depersonalization, and depression) were treated by reduction of dose and in some cases hospitalization. Levetiracetam should be withdrawn gradually to minimize the potential of increased seizure frequency.

>10%:

Central nervous system: Somnolence (14.8% vs 8.4% with placebo)

Neuromuscular & skeletal: Weakness (14.7% vs 9.1% with placebo)

<10%:

Central nervous system: Psychotic symptoms (0.7%), amnesia (2% vs 1% with placebo), ataxia (3% vs 1% with placebo), depression (4% vs 2% with placebo), dizziness (9% vs 4% with placebo), emotional lability (2%), nervousness (4% vs 2% with placebo), vertigo (3% vs 1% with placebo)

Hematologic: Decreased erythrocyte counts (3.2%), decreased leukocytes (2.4-3.2%)

Neuromuscular & skeletal: Ataxia and other coordination difficulties (3.4% vs 1.6% with placebo), pain (7% vs 6% with placebo)

Ophthalmic: Diplopia (2% vs 1% with placebo)

The precise mechanism by which levetiracetam exerts its antiepileptic effect is unknown and does not appear to derive from any interaction with known mechanisms involved in inhibitory and excitatory neurotransmission

Peak effect: 1 hour

Absorption: Rapid and complete

Protein binding: <10%

Metabolism: Not extensively metabolized; primarily metabolized by enzymatic hydrolysis

Bioavailability: 100%

Half-life: 6-8 hours

Elimination: 66% through renal excretion

Dialyzable: Approximately 50% of pooled levetiracetam is removed during a standard 4-hour hemodialysis

Adults: Initial: 500 mg twice daily; additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg

Dosing adjustment in renal impairment:

Cl_cr >80 mL/min: 500-1500 mg every 12 hours

Cl_cr 50-80 mL/min: 500-1000 mg every 12 hours

Cl_cr 30-50 mL/min: 250-750 mg every 12 hours

Cl_cr <30 mL/min: 250-500 mg every 12 hours

End-stage renal disease patients using dialysis: 500-2000 mg every 24 hours

No information available to require special precautions

No effects or complications reported

Notify your physician and/or pharmacist if you become pregnant during therapy with levetiracetam; be advised that levetiracetam may cause dizziness and somnolence and accordingly, you should not drive or operate machinery or engage in other hazardous activities until sufficient experience has been gained on levetiracetam to gauge whether it adversely affects your performance of these activities

Tablet: 250 mg, 500 mg, 750 mg