Eletam 250 mg (Tablet)

Indications

• Monotherapy for partial-onset seizures in adults and adolescents
• Adjunctive therapy for partial-onset seizures in adults, adolescents, children, and infants
• Treatment of myoclonic seizures in adults and adolescents with Juvenile Myoclonic Epilepsy
• Treatment of primary generalized tonic-clonic seizures in adults and adolescents with Idiopathic Generalized Epilepsy

Description

• Mechanism of antiepileptic effect unknown
• Minimal activity in submaximal stimulation and threshold tests
• Protection against secondarily generalized activity from focal seizures
• Inhibition of burst firing without affecting normal neuronal excitability

Dosage

• Recommended starting dose of 250 mg twice daily for adults and adolescents from 16 years of age
• Initial therapeutic dose of 500 mg twice daily after two weeks
• Maximum dose of 1500 mg twice daily
• Different dosage recommendation for pediatric population

Administration

• Oral administration
• To be taken with a sufficient quantity of liquid
• Can be taken with or without food
• Administered in two equally divided doses

Interaction

• No influence on serum concentrations of existing antiepileptic medicinal products
• Inhibition of renal clearance of the primary metabolite by probenecid
• Potential decrease in methotrexate clearance when co-administered with Eletam
• Reports of decreased Eletam efficacy when co-administered with osmotic laxative macrogol

Contraindications

• Hypersensitivity to the active substance or other pyrrolidone derivatives or excipients

Side Effects

• Common adverse reactions include somnolence, asthenia, infection, dizziness

Pregnancy & Lactation

• Not recommended during pregnancy and breastfeeding
• Excreted in human breast milk

Precautions & Warnings

• Dose adjustment may be required for patients with renal impairment
• Rare cases of decreased blood cell counts described at the beginning of treatment
• Risk of suicidal thoughts and behavior
• Tablet formulation not adapted for use in infants and children under 6 years

Use in Special Populations

• Dose adjustment recommended for elderly patients with compromised renal function

Overdose Effects

• Observation of somnolence, agitation, aggression, depressed level of consciousness, respiratory depression, and coma

Therapeutic Class

• Adjunct anti-epileptic drugs

Storage Conditions

• Store at a cool temperature not exceeding 25°C
• Store in a dry place protected from light

Related Brands

• Citazar 500 mg (Tablet) - aci-limited
• Citazar 250 mg (Tablet) - aci-limited