Eletam 500 mg

Description

Indications

Eletam is used as monotherapy for the treatment of partial-onset seizures, with or without secondary generalization, in adults and adolescents aged 16 years and older who have been newly diagnosed with epilepsy. Additionally, Eletam serves as adjunctive therapy for:

• Partial-onset seizures, with or without secondary generalization, in adults, adolescents, children, and infants from 1 month of age with epilepsy.
• Myoclonic seizures in adults and adolescents aged 12 years and older diagnosed with Juvenile Myoclonic Epilepsy.
• Primary generalized tonic-clonic seizures in adults and adolescents aged 12 years and older with Idiopathic Generalized Epilepsy.

Take this medication as prescribed by a registered physician.

Description The exact mechanism through which Eletam provides its antiepileptic effects remains unknown. It has demonstrated limited activity in submaximal stimulation and threshold tests. However, Eletam has shown protection against secondarily generalized activity from focal seizures induced by pilocarpine and kainic acid—chemoconvulsants that replicate certain features of human complex partial seizures with secondary generalization. Studies on epileptiform activity in the hippocampus indicate that Eletam suppresses burst firing without altering normal neuronal excitability. This suggests that Eletam may selectively inhibit hypersynchronization of epileptiform burst firing and limit the spread of seizure activity.

Dosage

• Adults and adolescents (16 years and older): The recommended starting dose is 250 mg twice daily, increasing to 500 mg twice daily after two weeks. The dosage may be further increased by 250 mg twice daily every two weeks based on clinical response, with a maximum dose of 1500 mg twice daily.
• Adults (18 years and older) and adolescents (12–17 years) weighing 50 kg or more: The initial dose is 500 mg twice daily, which can be administered from the first day of treatment. Depending on response and tolerability, the dose may be increased up to 1500 mg twice daily in increments of 500 mg twice daily every two to four weeks.
• Pediatric Patients:
  • The tablet form is not suitable for children under 6 years old. Instead, an oral solution should be used.
  • The available tablet strengths are not ideal for initial treatment in children weighing less than 25 kg, those unable to swallow tablets, or those requiring doses under 250 mg. In such cases, an oral solution should be used.
  • Monotherapy: Safety and efficacy for monotherapy in children under 16 years have not been established.
  • Adjunctive therapy:
    • Children 6 years and older should use oral solution for doses under 250 mg or if the required dosage is not a multiple of 250 mg.
    • For children weighing 25 kg, the initial dose is 250 mg twice daily, with a maximum of 750 mg twice daily.
    • Children weighing 50 kg or more follow the adult dosage guidelines.
  • Infants (1 to 6 months): Oral solution is the recommended form of administration.

Take this medication as prescribed by a registered physician.

Administration Eletam film-coated tablets should be taken orally with a sufficient amount of liquid. The medication may be taken with or without food and should be administered in two evenly divided doses each day.

Take this medication as prescribed by a registered physician.

Drug Interactions

• Antiepileptic drugs: Clinical studies indicate that Eletam does not affect the serum concentrations of other antiepileptic medications (e.g., phenytoin, carbamazepine, valproic acid, phenobarbital, lamotrigine, gabapentin, primidone), nor do these drugs alter Eletam’s pharmacokinetics.
• Probenecid: This renal tubular secretion blocker inhibits the clearance of Eletam’s primary metabolite but does not impact Eletam itself. The metabolite concentration remains low.
• Methotrexate: Co-administration may reduce methotrexate clearance, potentially leading to toxic levels. Blood levels of methotrexate and Eletam should be closely monitored.
• Laxatives: Macrogol, an osmotic laxative, may reduce Eletam’s effectiveness. It should not be taken one hour before or after Eletam.
• Food and Alcohol: Food does not affect the extent of absorption but may slightly reduce the absorption rate. No data are available regarding interactions with alcohol.

Contraindications Eletam should not be used in individuals with hypersensitivity to levetiracetam, other pyrrolidone derivatives, or any excipients in the formulation.

Side Effects

• Adults: Common side effects include somnolence, weakness, infections, and dizziness.
• Pediatric patients: Common side effects include fatigue, aggression, nasal congestion, decreased appetite, and irritability.

Pregnancy & Lactation Eletam is not recommended during pregnancy or for women of childbearing potential unless deemed clinically necessary. The drug is excreted in breast milk; thus, breastfeeding is not advised. If treatment is essential, the benefits and risks should be carefully evaluated. No impact on fertility was noted in animal studies, but clinical data in humans are limited.

Precautions & Warnings

• Renal impairment: Dose adjustments may be necessary for patients with kidney dysfunction.
• Acute kidney injury: Rarely, Eletam has been associated with acute kidney injury, with onset varying from a few days to several months.
• Blood cell counts: Cases of reduced blood cell counts, including neutropenia, agranulocytosis, leukopenia, thrombocytopenia, and pancytopenia, have been reported, particularly at the beginning of treatment. Regular blood tests are recommended for patients experiencing weakness, fever, recurrent infections, or bleeding disorders.
• Suicidal thoughts and behavior: Patients taking antiepileptic drugs, including Eletam, may have an increased risk of suicidal thoughts or behaviors. Close monitoring for depression and suicidal tendencies is advised. Patients and caregivers should seek medical help if such symptoms arise.
• Pediatric use: The long-term effects of Eletam on growth, puberty, cognitive function, and reproductive potential in children remain unknown.

Use in Special Populations

• Elderly patients (65 years and older): Dose adjustments may be required due to potential renal impairment.
• Renal impairment: Dosages should be individualized based on renal function.
• Hepatic impairment: No dose adjustment is required for mild to moderate hepatic impairment. However, for severe cases, a 50% reduction in daily maintenance dose is recommended when creatinine clearance is below 60 ml/min.

Overdose Effects Symptoms of overdose may include drowsiness, agitation, aggression, reduced consciousness, respiratory depression, and coma. In cases of overdose, gastric lavage or induced vomiting may be necessary. There is no specific antidote for Eletam; treatment should be symptomatic, with hemodialysis as a possible option. The efficiency of dialysis is 60% for Eletam and 74% for its primary metabolite.

Therapeutic Class Adjunctive anti-epileptic drugs

Storage Conditions Store in a cool, dry place at a temperature not exceeding 25°C. Protect from light and moisture.