Iracet 250

Indications

Iracet serves as a standalone treatment for partial-onset seizures in adults and adolescents aged 16 and above, with or without secondary generalization, diagnosed with epilepsy. Additionally, it acts as an adjunctive therapy in various seizure types:

• Partial-onset seizures in adults, adolescents, children, and infants aged 1 month and above.
• Myoclonic seizures in adults and adolescents aged 12 and above diagnosed with Juvenile Myoclonic Epilepsy.
• Primary generalized tonic-clonic seizures in adults and adolescents aged 12 and above with Idiopathic Generalized Epilepsy.

Description

While the precise mechanism of Iracet’s antiepileptic effect remains unclear, it has demonstrated minimal activity in various tests. Iracet has shown protection against secondarily generalized activity induced by certain chemoconvulsants, suggesting its potential in preventing hyper synchronization of epileptiform burst firing.

Dosage

For adults and adolescents aged 16 years and above, the recommended starting dose is 250 mg twice daily, which can be increased gradually based on clinical response. The maximum dosage is 1500 mg twice daily. Different dosage recommendations apply for specific age groups and weight categories.

Administration

Iracet tablets should be taken orally with an adequate amount of liquid, regardless of food intake, and divided into two equal doses per day.

Interaction

Pre-marketing studies indicate minimal influence of Iracet on serum concentrations of existing antiepileptic drugs and vice versa. However, caution is advised when co-administering with certain medications like probenecid and methotrexate.

Contraindications

Iracet is contraindicated in individuals with hypersensitivity to its active ingredient or other pyrrolidone derivatives, or any of the excipients used.

Side Effects

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

Pregnancy & Lactation

Use of Iracet during pregnancy and lactation is not recommended unless clinically necessary, as it is excreted in breast milk.

Precautions & Warnings

Special precautions are necessary in patients with renal impairment, acute kidney injury, and regarding blood cell counts. Monitoring for signs of depression and suicidal ideation is crucial during treatment.

Use in Special Populations

Dosage adjustments are recommended for elderly patients and those with renal or hepatic impairment.

Overdose Effects

Symptoms of Iracet overdose include somnolence, agitation, respiratory depression, among others. Treatment of overdose is primarily supportive, with symptomatic management.

Therapeutic Class

Iracet belongs to the therapeutic class of adjunct anti-epileptic drugs.

Storage Conditions

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