Citazar 250 mg (Tablet)

Indications

• Monotherapy for partial-onset seizures in adults and adolescents
• Adjunctive therapy for partial-onset seizures in adults, adolescents, and children
• Adjunctive therapy for myoclonic seizures in adults and adolescents
• Adjunctive therapy for primary generalized tonic-clonic seizures in adults and adolescents

Description

• Precise mechanism(s) of Citazar's antiepileptic effect is 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 for adults and adolescents from 16 years: 250 mg twice daily
• Initial therapeutic dose for adults (≥18 years) and adolescents (≥50 kg): 500 mg twice daily
• Maximum dose: 1500 mg twice daily
• Different dosage recommendations for pediatric population based on age and weight

Administration

• Flm-coated tablets to be taken orally, with or without food
• Administered in two equally divided doses

Interaction

• No influence on serum concentrations of existing antiepileptic medicinal products
• Probenecid inhibits renal clearance of the primary metabolite
• Concomitant administration with methotrexate decreases methotrexate clearance
• Reports of decreased efficacy when concomitantly administered with osmotic laxative macrogol

Contraindications

• Hypersensitivity to the active substance or other pyrrolidone derivatives

Side Effects

• Common adverse reactions: somnolence, asthenia, infection, dizziness, fatigue, aggression, nasal congestion, decreased appetite, irritability

Pregnancy & Lactation

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

Precautions & Warnings

• Dose adjustment required for patients with renal impairment
• Very rare association with acute kidney injury
• Rare cases of decreased blood cell counts
• Reports of suicidal ideation and behavior
• Not adapted for use in infants and children under the age of 6 years

Use in Special Populations

• Dose adjustment recommended for elderly patients with compromised renal function
• Individualized dosing according to renal and hepatic function

Overdose Effects

• Observation of somnolence, agitation, aggression, depressed level of consciousness, respiratory depression, coma
• No specific antidote for Citazar
• Symptomatic treatment may include haemodialysis

Therapeutic Class

Adjunct anti-epileptic drugs

Storage Conditions

Store at a cool temperature (not exceeding 25°C) and dry place, protected from light

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