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Pronunciation:

(lee va tye RA se tam)

U.S. Brand Names:

Keppra®

Generic Available:

Canadian Brand Names:

Keppra®

Use:

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

Use - Unlabeled/Investigational:

Bipolar disorder; partial onset seizures in children with epilepsy

Pregnancy Risk Factor:

Pregnancy Implications:

Developmental toxicities were observed in animal studies. There are no adequate and well-controlled studies in pregnant women. Two registries are available for women exposed to levetiracetam during pregnancy:

Antiepileptic Drug Pregnancy Registry (888-233-2334 or http://www.mgh.harvard.edu/aed/)

Keppra® pregnancy registry (888-537-7734 or http://www.keppra.com)

Lactation:

Enters breast milk/not recommended

Contraindications:

Hypersensitivity to levetiracetam or any component of the formulation

Warnings/Precautions:

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, anger, aggression, irritability, 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 Levetiracetam should be withdrawn gradually to minimize the potential of increased seizure frequency. There is a potential for dispensing errors between Keppra® and Kaletra™ (lopinavir/ritonavir); use caution when prescribing, dispensing, or administering. Use caution with renal impairment (dosage adjustment may be necessary).

Adverse Reactions:

>10%:

Central nervous system: Somnolence (15%), headache (14%)

Neuromuscular & skeletal: Weakness (15%)

Miscellaneous: Infection (13%)

<10%:

Cardiovascular: Chest pain

Central nervous system: Pain (7%), psychotic symptoms (1%), amnesia (2%), ataxia (3%), depression (4%), dizziness (9%), emotional lability (2%), nervousness (4%), vertigo (3%), agitation, anger, aggression, irritability, hostility (2%), anxiety (2%), apathy, depersonalization, confusion, convulsion, fever, insomnia, thinking abnormal

Dermatologic: Bruising, rash

Gastrointestinal: Anorexia (3%), abdominal pain, constipation, diarrhea, dyspepsia, gastroenteritis, gingivitis, nausea, vomiting, weight gain

Hematologic: Decreased erythrocyte counts (3%), decreased leukocytes (2% to 3%)

Neuromuscular & skeletal: Ataxia and other coordination difficulties (3%), paresthesia (2%), arthralgia, back pain, tremor

Ocular: Diplopia (2%), amblyopia, otitis media

Respiratory: Pharyngitis (6%), rhinitis (4%), cough (2%), sinusitis (2%), bronchitis

Miscellaneous: Flu-like symptoms

Postmarketing and/or case reports: Leukopenia, neutropenia, pancytopenia, thrombocytopenia

Overdosage/Toxicology:

Limited experience. Symptoms would be expected to include drowsiness, somnolence and ataxia. Treatment is symptomatic and supportive. Hemodialysis may be effective.

Drug Interactions:

No interaction was observed in pharmacokinetic trials with other anticonvulsants, including phenytoin, carbamazepine, valproic acid, phenobarbital, lamotrigine, gabapentin, and primidone.

Ethanol/Nutrition/Herb Interactions:

Ethanol: Avoid ethanol (may increase CNS depression).

Food: Food may delay, but does not affect the extent of absorption.

Stability:

Store at 25°C (77°F).

Mechanism of Action:

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

Pharmacodynamics/Kinetics:

Onset of action: Peak effect: 1 hour

Absorption: Rapid and complete

Protein binding: <10%

Metabolism: Not extensive; primarily by enzymatic hydrolysis; forms metabolites (inactive)

Bioavailability: 100%

Half-life elimination: 6-8 hours

Excretion: Urine (66%)

Dialyzable: ~50% of pooled levetiracetam removed during standard 4-hour hemodialysis

Dosage:

Oral:

Children 4-16 years: Partial onset seizures (unlabeled use): 10-20 mg/kg/day in 2 divided doses; may increase weekly by 10-20 mg/kg, up to a maximum of 60 mg/kg

Children 16 years and Adults:

Partial onset seizure: 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

Bipolar disorder (unlabeled use): Initial: 500 mg twice daily; if tolerated, increase to 500 mg twice daily; dose may be increased every 3 days until target dose of 3000 mg/day is reached; maximum: 4000 mg/day

Dosing adjustment in renal impairment:

Clcr >80 mL/minute: 500-1500 mg every 12 hours

Clcr 50-80 mL/minute: 500-1000 mg every 12 hours

Clcr 30-50 mL/minute: 250-750 mg every 12 hours

Clcr<30 mL/minute: 250-500 mg every 12 hours

End-stage renal disease patients using dialysis: 500-1000 mg every 24 hours; a supplemental dose of 250-500 mg following dialysis is recommended

Administration:

Tablets may be crushed and placed in food if unable to swallow whole (bitter taste may be expected).

Dietary Considerations:

May be taken with or without food.

Patient Education:

Take exactly as directed; do not increase dose or frequency or discontinue without consulting prescriber. While using this medication, do not use alcohol and other prescription or OTC medications (especially pain medications, sedatives, antihistamines, or hypnotics) without consulting prescriber. Maintain adequate hydration (2-3 L/day of fluids) unless instructed to restrict fluid intake. You may experience drowsiness, dizziness, or blurred vision (use caution when driving or engaging in tasks requiring alertness until response to drug is known); or nausea, vomiting, loss of appetite, or dry mouth (small, frequent meals, frequent mouth care, chewing gum, or sucking lozenges may help). Wear identification of epileptic status and medications. Report CNS changes, mentation changes, or changes in cognition; muscle cramping, weakness, tremors, changes in gait; persistent GI symptoms (cramping, constipation, vomiting, anorexia); rash or skin irritations; unusual bruising or bleeding (mouth, urine, stool); or worsening of seizure activity or loss of seizure control. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to become pregnant. Breast-feeding is not recommended.

Dental Health: Effects on Dental Treatment:

No significant effects or complications reported

Dental Health: Vasoconstrictor/Local Anesthetic Precautions:

No information available to require special precautions

Mental Health: Effects on Mental Status:

Associated with somnolence and fatigue, psychosis, hallucinations, psychotic depression, and other behavioral symptoms (agitation, anger, aggression, irritability, hostility, anxiety, apathy, emotional lability, depersonalization, and depression)

Mental Health: Effects on Psychiatric Treatment:

May cause leukopenia, neutropenia, pancytopenia, and thrombocytopenia; use caution with clozapine, carbamazepine, and valproic acid

Dosage Forms:

Solution, oral: 100 mg/mL (480 mL) [dye free; grape flavor]

Tablet: 250 mg, 500 mg, 750 mg

International Brand Names:

Keppra® (AT, BE, CA, CH, CZ, DE, DK, ES, FI, FR, GB, IE, IT, NO, PL, PT, SE, SG, TH, ZA)

References

Glauser TA, Pellock JM, Bebin EM, et al, "Efficacy and Safety of Levetiracetam in Children with Partial Seizures: An Open-label Trial,"Epilepsia, 2002, 43(5):518-24.

Hovinga CA, "Levetiracetam: A Novel Antiepileptic Drug,"Pharmacotherapy, 2001, 21(11):1375-88.

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