Drug information of Levetiracetam

Levetiracetam

Drug group: Anticonvulsants

Levetiracetamis ananti-epileptic drug, also called ananticonvulsant. Levetiracetam is used to treat partial onset seizures in adults and children who are at least 1 month old. Levetiracetam is also used to treat tonic-clonic seizures in adults and children who are at least 6 years old, and myoclonic seizures in adults and children who are at least 12 years old.

Mechanism of effect

The precise mechanism(s) by which levetiracetam exerts its antiepileptic effect is unknown. Levetiracetam is thought to stimulate synaptic vesicle protein 2A (SV2A), inhibiting neurotransmitter release.

Pharmacodynamic

Levetiracetam is thought to stimulate synaptic vesicle protein 2A (SV2A), inhibiting neurotransmitter release.

Pharmacokinetics

Rapidly and almost completely absorbed after oral administration (99%).
Peak plasma concentrations occurring in about an hour following oral administration in fasted subjects.
The oral bioavailability of Levetiracetam tablets is 100%. Levetiracetam and its major metabolite are less than 10% bound to plasma proteins.
Levetiracetam is not extensively metabolized in humans. Levetiracetam is eliminated from the systemic circulation by renal excretion as unchanged drug which represents 66% of administered dose. Levetiracetam plasma half-life in adults is 7 ± 1 hour.

Dosage

  • Usual Adult Dose for Seizures (16 years of age and older):

 Initial Dose:

 1000 mg daily by either immediate release oral or intravenous administration, given as 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.

 There is no evidence that doses greater than 3000 mg/day confer additional benefit.

Extended release:

Initial dose: 1000 mg orally once daily This dose may be increased every 2 weeks by 1000 mg/day to a maximum of 3000 mg once daily.

  • Usual Pediatric Dose for Seizures Myoclonic seizures: Oral: (Children 12 years and older): Immediate release: Initial: 500 mg twice daily; may increase every 2 weeks by 500 mg/dose to the recommended dose of 1500 mg twice daily.

Efficacy of doses greater than 3000 mg/day has not been established.

  • Partial onset seizures: Oral: (Children 1 month to less than 6 months old):

Immediate release: 7 mg/kg/dose given twice daily (14 mg/kg/day); may increase every 2 weeks by increments of 14 mg/kg to the recommended daily dose of 42 mg/kg.

-Children 6 months to less than 4 years old: Immediate release: 10 mg/kg given twice daily (20 mg/kg/day); may increase in 2 weeks by an increment of 20 mg/kg to the recommended daily dose of 50 mg/kg (25 mg/kg twice daily).

 The daily dose of 50 mg/kg may be reduced in patients who cannot tolerate this dose.

-Children 4 to less than 16 years: Immediate release: 10 mg/kg/dose given twice daily; may increase every 2 weeks by 10 mg/kg/dose to the recommended dose of 30 mg/kg/dose twice daily (60 mg/kg/daily).

The daily dose of 60 mg/kg may be reduced in patients who cannot tolerate this dose.

 Children 16 years and older: Refer to adult dosing. Maximum dose: 3000 mg/day

  • Tonic-clonic seizures: Oral: Children 6 to less than 16 years: Immediate release: Initial: 10 mg/kg dose given twice daily; may increase every 2 weeks by 10 mg/kg/dose to the recommended dose of 30 mg/kg twice daily.

Efficacy of doses greater than 60 mg/kg/day has not been established. Children 16 years and older: Refer to adult dosing. Maximum dose: 3000 mg/day

Alerts

1-In some patients Levetiracetam causes behavioral abnormalities.
2-Antiepileptic drugs (AEDs), including Levetiracetam, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication.
3-In some patients, Levetiracetam causes somnolence and fatigue.
4-Serious dermatological reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported in both children and adults treated with Levetiracetam.
5-Coordination difficulties were only observed in the adult partial onset seizure studies.

Points of recommendation

1-Antiepileptic drugs, including Levetiracetam, should be withdrawn gradually to minimize the potential of increased seizure frequency.
2-Levetiracetam tablets should be swallowed whole, not chewed or crushed.
3-Levetiracetam is given orally with or without food.

Pregnancy level

C

Related drugs

Piracetam


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