Iracet XR 500

Indications

Iracet XR serves as a standalone treatment for partial-onset seizures in adults and adolescents over 16 years old, both with and without secondary generalization, in cases of newly diagnosed epilepsy. Additionally, Iracet XR acts as an adjunctive therapy:

• For partial-onset seizures in adults, adolescents, children, and infants over 1 month old with epilepsy.
• For myoclonic seizures in adults and adolescents over 12 years old diagnosed with Juvenile Myoclonic Epilepsy.
• For primary generalized tonic-clonic seizures in adults and adolescents over 12 years old with Idiopathic Generalised Epilepsy.

Description

Although the exact mechanisms are not fully understood, Iracet XR exhibits antiepileptic effects. It has demonstrated protective activity against secondarily generalized activity from focal seizures induced by certain chemoconvulsants. Studies suggest that Iracet XR selectively prevents hyper synchronization of epileptiform burst firing and propagation of seizure activity.

Dosage

For adults and adolescents over 16 years old, the recommended starting dose is 250 mg twice daily, gradually increasing to an initial therapeutic dose of 500 mg twice daily after two weeks. Dosage adjustments may be made based on clinical response, with a maximum dose of 1500 mg twice daily.

For adults (≥18 years) and adolescents (12 to 17 years) weighing 50 kg or more, the initial therapeutic dose is 500 mg twice daily, with potential dose increases up to 1,500 mg twice daily based on clinical response and tolerability.

Pediatric dosage varies, with oral solution preferred for children under 6 years old. The lowest effective dose should be used, with adjustments made based on weight and clinical response.

Administration

The film-coated tablets should be taken orally, with or without food, and swallowed with a sufficient amount of liquid. The daily dose is divided into two equal administrations.

Interaction

Iracet XR has shown minimal influence on serum concentrations of existing antiepileptic drugs. Careful monitoring is advised when used concomitantly with probenecid, methotrexate, or laxatives.

Contraindications

Hypersensitivity to the active substance or any excipients is a contraindication for Iracet XR.

Side Effects

Common adverse reactions in adult patients include somnolence, asthenia, infection, and dizziness. Pediatric patients may experience fatigue, aggression, nasal congestion, decreased appetite, and irritability.

Pregnancy & Lactation

Levetiracetam is not recommended during pregnancy or breastfeeding unless clinically necessary. It is excreted in human breast milk.

Precautions & Warnings

Special precautions should be taken in patients with renal impairment, acute kidney injury, or compromised blood cell counts. Monitoring for signs of depression and suicidal ideation is essential, particularly in pediatric patients.

Use in Special Populations

Dose adjustments may be required in elderly patients and those with renal or hepatic impairment.

Overdose Effects

Symptoms of overdose may include somnolence, agitation, aggression, and respiratory depression. Treatment is primarily supportive, with hemodialysis being considered in severe cases.

Therapeutic Class

Iracet XR belongs to the category of adjunct anti-epileptic drugs.

Storage Conditions

Store Iracet XR in a cool, dry place, away from light, at temperatures not exceeding 25°C.