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Indications & Uses
Leviceta is indicated for:
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
Dosage Adults and adolescents from 16 years of age: The recommended starting dose is 250 mg twice daily, increased to an initial therapeutic dose of 500 mg twice daily after two weeks. The dose can be raised further by 250 mg twice daily every two weeks according to clinical response, up to a maximum of 1500 mg twice daily. Adults (18 years and above) and adolescents (12 to 17 years) weighing 50 kg or more: The initial therapeutic dose is 500 mg twice daily, and this dose can be started from the first day of treatment. Depending on clinical response and tolerability, the daily dose can be increased up to 1,500 mg twice daily. Dose changes should be made in steps of 500 mg twice daily, increasing or decreasing every two to four weeks. Pediatric population: The tablet formulation is not suitable for infants and children under 6 years of age; the oral solution is the preferred formulation for this group. The available tablet strengths are also not appropriate for starting treatment in children weighing less than 25 kg, for patients who cannot swallow tablets, or for giving doses below 250 mg. In all these situations, the oral solution should be used instead. Monotherapy: The safety and efficacy of levetiracetam as monotherapy in children and adolescents below 16 years have not been established. Add on therapy: The oral solution is the preferred formulation for infants and children under 6 years of age. For children aged 6 years and above, the oral solution should be used for doses under 250 mg, for doses that are not exact multiples of 250 mg and so cannot be given accurately with whole tablets, and for patients unable to swallow tablets. The lowest effective dose should always be used. A child or adolescent weighing 25 kg should start at 250 mg twice daily, with a maximum dose of 750 mg twice daily. For children weighing 50 kg or more, dosing follows the same schedule as in adults. Add on therapy for infants aged from 1 month to less than 6 months: The oral solution is the formulation to use in this age group.
Side Effects
Most common adverse reactions (occurring in ≥5% of patients and more often than with placebo) include: In adult patients: sleepiness, weakness, infection, and dizziness. In pediatric patients: fatigue, aggression, stuffy nose, reduced appetite, and irritability.
Cautions & Contraindications
Warnings & Precautions
Renal impairment: The administration of Erata to patients with renal impairment may require dose adjustment. In patients with severely impaired hepatic function, assessment of renal function is recommended before dose selection.Acute kidney injury: The use of Erata has been very rarely associated with acute kidney injury with a time to onset ranging from a few days to several months.Blood cell counts: Rare cases of decreased blood cell counts (neutropenia, agranulocytosis, leucopenia, thrombocytopenia and pancytopenia) have been described in association with Erata administration, generally at the beginning of the treatment. Complete blood cell counts are advised in patients experiencing important weakness, pyrexia, recurrent infections or coagulation disorders.Suicide: Suicide, suicide attempt, suicidal ideation and behaviour have been reported in patients treated with anti-epileptic agents (including Erata). A meta-analysis of randomized placebo-controlled trials of anti-epileptic medicinal products has shown a small increased risk of suicidal thoughts and behaviour. The mechanism of this risk is not known. Therefore patients should be monitored for signs of depression and/or suicidal ideation and behaviours and appropriate treatment should be considered. Patients (and caregivers of patients) should be advised to seek medical advice should signs of depression and/or suicidal ideation or behaviour emerge.Paediatric population: The tablet formulation is not adapted for use in infants and children under the age of 6 years. Available data in children did not suggest an impact on growth and puberty. However, long term effects on learning, intelligence, growth, endocrine function, puberty and childbearing potential in children remain unknown.
Contraindications
Hypersensitivity to levetiracetam, to other pyrrolidone derivatives, or to any of the other ingredients in this medicine is a contraindication to its use.