Iracet 50 ml Oral Solution

Overview

Iracet Oral Solution contains Levetiracetam 500 mg per 5 ml (100 mg/ml), an antiepileptic drug in liquid form preferred for infants, children under 6 years of age, and patients who cannot swallow tablets. It is indicated as adjunctive therapy for partial-onset seizures (from 1 month of age), myoclonic seizures (from 12 years), and primary generalized tonic-clonic seizures (from 12 years). It is also used as monotherapy for partial-onset seizures in adults and adolescents ≥16 years with newly diagnosed epilepsy. The oral solution allows precise dose measurement in mg/kg to accommodate weight-based dosing in paediatric patients.

Dosage and Administration

Infants 1 month to <6 months (adjunct): Oral solution is the required formulation; dose determined by physician based on weight.

Children 6 years and above (adjunct, 25–50 kg): Starting dose 250 mg (2.5 ml) twice daily, maximum 750 mg (7.5 ml) twice daily. For children ≥50 kg, adult dosing applies.

Adults and adolescents ≥16 years (monotherapy): Starting dose 250 mg (2.5 ml) twice daily for 2 weeks, then increased to 500 mg (5 ml) twice daily. May be increased up to 1500 mg (15 ml) twice daily.

Measure each dose accurately with the measuring device provided. May be taken with or without food. Daily dose divided into two equal doses.

Interaction

No clinically significant pharmacokinetic interactions with common antiepileptics. Probenecid inhibits clearance of the primary metabolite. Concomitant methotrexate may reduce methotrexate clearance — monitor blood levels of both drugs. Avoid osmotic laxatives (macrogol) within one hour before or after dosing.

Contraindications

Hypersensitivity to Levetiracetam, pyrrolidone derivatives, or any excipient in the formulation.

Side Effects

Common effects in children include fatigue, aggression, nasal congestion, decreased appetite, and irritability. Adults may experience somnolence, asthenia, infection, and dizziness. Rare blood dyscrasias and suicidal ideation have been reported with antiepileptic agents.

Pregnancy and Lactation

Not recommended during pregnancy unless clinically necessary. Levetiracetam is excreted in breast milk; breastfeeding is not recommended during treatment.

Precautions and Warnings

Dose adjustment required in renal impairment. In severe hepatic impairment with low creatinine clearance (<60 ml/min), reduce the daily maintenance dose by 50%. Monitor for suicidal ideation, depression, and blood count abnormalities. Use the oral solution for children under 6 years or those unable to swallow tablets.

Storage Conditions

Store at a cool temperature not exceeding 25°C, in a dry place, protected from light. Keep out of the reach of children.

Frequently Asked Questions

Q: Why is the oral solution preferred over tablets for young children?
The Iracet oral solution (100 mg/ml) allows accurate weight-based dosing in milligrams per kilogram body weight, which is essential for infants and young children whose doses differ significantly from adults. Tablet strengths (250 mg, 500 mg) cannot be divided accurately enough for small children, and infants cannot swallow tablets safely. The liquid formulation also allows for flexible dose adjustments as the child grows.

Q: Can the oral solution be mixed with food or juice?
Iracet oral solution can be taken with or without food. While mixing with a small amount of food or liquid may aid palatability, always use the measuring device provided to ensure the prescribed dose is given accurately. Do not dilute in large volumes of liquid, as this makes dose verification difficult. Follow the physician's or pharmacist's instructions for administration.