Clinical Pharmacology Details


LEVETIRACETAM


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Indications & Dose:

Monotherapy of focal seizures with or without secondary generalisation



Child 16–17 years: Initially 250 mg once daily for 1 week, then increased to 250 mg twice daily, then increased in steps of 250 mg twice daily (max. per dose 1.5 g twice daily), adjusted according to response, dose to be increased every 2 weeks


Adult: Initially 250 mg once daily for 1–2 weeks, then increased to 250 mg twice daily, then increased in steps of 250 mg twice daily (max. per dose 1.5 g twice daily), adjusted according to response, dose to be increased every 2 weeks


Adjunctive therapy of focal seizures with or without secondary generalisation



Child 1–5 months: Initially 7 mg/kg once daily, then increased in steps of up to 7 mg/kg twice daily (max. per dose 21 mg/kg twice daily), dose to be increased every 2 weeks


Child 6 months–17 years (body-weight up to 50 kg): Initially 10 mg/kg once daily, then increased in steps of up to 10 mg/kg twice daily (max. per dose 30 mg/kg twice daily), dose to be increased every 2 weeks


Child 12–17 years (body-weight 50 kg and above): Initially 250 mg twice daily, then increased in steps of 500 mg twice daily (max. per dose 1.5 g twice daily), dose to be increased every 2–4 weeks Adult: Initially 250 mg twice daily, then increased in steps of 500 mg twice daily (max. per dose 1.5 g twice daily), dose to be increased every 2–4 weeks



Child 4–17 years (body-weight up to 50 kg): Initially 10 mg/kg once daily, then increased in steps of up to 10 mg/kg twice daily (max. per dose 30 mg/kg twice daily), dose to be increased every 2 weeks Child 12–17 years (body-weight 50 kg and above): Initially 250 mg twice daily, then increased in steps of 500 mg twice daily (max. per dose 1.5 g twice daily), dose to be increased every 2 weeks


Adult: Initially 250 mg twice daily, then increased in steps of 500 mg twice daily (max. per dose 1.5 g twice daily), dose to be increased every 2–4 weeks


Adjunctive therapy of myoclonic seizures and tonic-clonic seizures



Child 12–17 years (body-weight up to 50 kg): Initially 10 mg/kg once daily, then increased in steps of up to 10 mg/kg twice daily (max. per dose 30 mg/kg twice daily), dose to be increased every 2 weeks Child 12–17 years (body-weight 50 kg and above): Initially 250 mg twice daily, then increased in steps of 500 mg twice daily (max. per dose 1.5 g twice daily), dose to be increased every 2 weeks Adult: Initially 250 mg twice daily, then increased in steps of 500 mg twice daily (max. per dose 1.5 g twice daily), dose to be increased every 2–4 weeks 

Contraindications:

Side Effects:

CNS: Asthenia, amnesia, anxiety, ataxia, confusion, depression, dizziness, emotional/ability, hostility, insomnia, nervousness, paresthesia, somnolence, tremor, vertigo


CV: Chest pain


EENT: Ambylopia, Diplopia, otitis media


GI: Abdominal pain, constipation, diarrhea, dyspepsia, gastroenteritis, gingivitis, nausea, vomiting, weight gain


HEME: Ecchymosis


MS: Arthralgia, back pain


RESP. Cough, pharyngitis, rhinitis, sinusitis, bronchitis


SKIN: Rash


MISC: Fever, flu syndrome 

Cautions:

Precautions:

Neuropsychiatric conditions (somnolence and fatigue, coordination difficulties, behavioral abnormalities); withdrawal seizures (withdraw slowly to minimize potential); hematologic abnormalities; hepatic abnormalities 

Interaction:

Warnings:

Adverse Effects:

Lactations:

Pregnancy category C; developmental toxicity in animals; excretion into breast milk unknown

Special Precautions:

Counselling:

Side Effects Or Adverse Reactions:

Patient And Carer Advice: