Iracet 500

Indications

Iracet serves as a standalone therapy for managing partial-onset seizures, both with and without secondary generalization, in adults and adolescents aged 16 and above who are newly diagnosed with epilepsy. It also acts as an adjunctive therapy:

• For treating partial-onset seizures, with or without secondary generalization, in adults, adolescents, children, and infants as young as 1 month old, who have epilepsy.
• In addressing myoclonic seizures in adults and adolescents aged 12 years and above diagnosed with Juvenile Myoclonic Epilepsy.
• For managing primary generalized tonic-clonic seizures in adults and adolescents aged 12 years and above diagnosed with Idiopathic Generalized Epilepsy.

Description

The precise mechanisms underlying Iracet’s antiepileptic effects remain unknown. While exhibiting minimal activity in certain tests, it has shown protective effects against secondarily generalized activity from focal seizures induced by specific chemoconvulsants. Iracet has demonstrated inhibition of burst firing without affecting normal neuronal excitability, suggesting a potential to prevent hyper synchronization of epileptiform burst firing and propagation of seizure activity.

Dosage

For adults and adolescents aged 16 years and above, the initial recommended dose is 250 mg twice daily, which can be increased to 500 mg twice daily after two weeks. Depending on clinical response, the dose can be further adjusted up to a maximum of 1500 mg twice daily.

For adults (≥18 years) and adolescents (12 to 17 years) weighing 50 kg or more, the starting dose is 500 mg twice daily, with adjustments made based on response and tolerability.

For pediatric use, oral solution is preferred for children under 6 years old. The tablet formulation is not suitable for children under 25 kg or those unable to swallow tablets. Dosing for children weighing 50 kg or more is the same as for adults.

Administration

Tablets should be taken orally with sufficient liquid, with or without food, and divided equally into two daily doses.

Interaction

Pre-marketing data suggest that Iracet has minimal influence on the serum concentrations of existing antiepileptic medications. However, caution is advised when co-administering with certain medications such as methotrexate or laxatives.

Contraindications

Avoid Iracet if there is hypersensitivity to its active substance or other pyrrolidone derivatives.

Side Effects

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

Pregnancy & Lactation

Iracet is not recommended during pregnancy or breastfeeding unless clinically necessary.

Precautions & Warnings

Special precautions are advised for patients with renal impairment, acute kidney injury, or a history of blood cell count abnormalities. Monitoring for signs of depression and/or suicidal ideation is also recommended during treatment.

Use in Special Populations

Dosing adjustments may be necessary for elderly patients and those with renal or hepatic impairment.

Overdose Effects

Symptoms of overdose include somnolence, agitation, aggression, and respiratory depression. Treatment is primarily supportive, with no specific antidote available.

Therapeutic Class

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

Storage Conditions

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