LEVETIRACETAM = LEV oral

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    Last updated: October 2024

     

    Prescription under medical supervision

     

     
    Due to the numerous and potentially severe adverse effects of LEV, patients should be kept under close surveillance.

     

    Therapeutic action

    • Antiseizure (antiepileptic) 

    Indications

    • Epilepsy: generalised tonic-clonic seizures, focal (partial) seizures and absence seizures

    Forms and strengths

    • 250 mg, 500 mg, 750 mg and 1 g tablets
    • 500 mg/5 ml oral solution, to be administered using a measuring device (oral syringe, measuring spoon, or cup with graduations)

    Dosage

    Start with a low dose then increase gradually based on patient's response and tolerance. 

     

    • Child 1 to 5 months: start with 7 mg/kg once daily; increase to 7 mg/kg 2 times daily after 2 weeks, then by increments of 7 mg/kg 2 times daily every 2 weeks if necessary (max. 21 mg/kg 2 times daily).
    • Child 6 months to 17 years (< 50 kg): start with 10 mg/kg once daily; increase to 10 mg/kg 2 times daily after 2 weeks, then by increments of 10 mg/kg 2 times daily every 2 weeks if necessary (max. 30 mg/kg 2 times daily).
    • Child 50 kg and over and adult: start with 250 mg 2 times daily; increase to 500 mg 2 times daily after 2 to 4 weeks, then by increments of 500 mg 2 times daily every 2 to 4 weeks if necessary (max. 1.5 g 2 times daily).

     

    Duration

    • As long as required. Do not stop treatment abruptly, even if changing treatment to another antiseizure medication.

    Contra-indications, adverse effects, precautions

    • Administer with caution to patients with renal impairment (reduce dosage) or heart disorders.
    • May cause:
      • drowsiness (caution when driving/operating machinery), headache, asthenia, dizziness, mood and behavioural disturbances, anxiety, depression, insomnia;
      • haematologic disorders, gastrointestinal disturbances, cough, nasopharyngitis;
      • rarely: QT prolongation, hypersensitivity reactions (including severe cutaneous reactions such as Stevens-Johnson, Lyell and DRESS syndromes). In these cases stop treatment. Early symptoms such as fever, rash, mouth ulcers and bleeding require immediate medical attention. 
      • respiratory depression and coma in the event of overdose.
    • Avoid or monitor the combination with:
      • mefloquine (reduced effect of LEV);
      • drugs that prolong the QT interval (antimalarials, antipsychotics, fluconazole, fluoroquinolones, hydroxyzine, macrolides, ondansetron, etc.);
      • drugs containing alcohol, benzodiazepines, opioid analgesics, antipsychotics, first-generation antihistamines (hydroxyzine, promethazine), antidepressants, other antiseizure medications, etc. (increased sedation).
    • Avoid alcohol during treatment (increased risk of adverse effects).
    • Pregnancy: use the lowest effective dose.

      • Administer folic acid high dose (5 mg daily) during the first trimester. Start as soon as possible, including during the preconception period in case of planned pregnancy.
      • Plasma concentrations may decrease during pregnancy. Monitor clinical response; increase dose if needed then resume the usual dose after delivery. 
    • Breast-feeding: administer with caution (excreted in milk); reduce the dose if increased during pregnancy and monitor the child (risk of drowsiness and poor feeding). 

    Remarks

    • LEV can be used with contraceptive implants and oral contraceptives.

    Storage

     
    –  Below 25 °C