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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.