Iracet 250

Presentation: Each film-coated tablet contains 250 mg of levetiracetam.

Indications: Iracet 250 is indicated as adjunctive therapy in the treatment of:  

• Partial-onset seizures with or without secondary generalization in adults and children from 4 years of age with epilepsy.  
• Myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy.  
• Primary generalized tonic-clonic seizures in adultsand children from 4 years of age with idiopathic generalized epilepsy.  

Dosage and Administration: Iracet 250 tablets are for oral administration and should be swallowed whole with liquid. It can be taken with or without food.

• Adults and Adolescents (16 years and older): The usual starting dose is 500 mg twice daily (1000 mg total daily dose). The dose can be increased every 2 weeks by 500 mg twice daily to a maximum recommended daily dose of 3000 mg.
• Children (4 to 15 years) and Adolescents (weighing less than 50 kg): The starting dose is typically 10 mg/kg twice daily. The dose can be increased every 2 weeks by 10 mg/kg twice daily to a maximum recommended daily dose of 30 mg/kg twice daily.
• Infants and Children (6 months to less than 4 years): An oral solution formulation is generally preferred for this age group.
• Renal Impairment: Dosage adjustments are necessary in adult patients with impaired renal function and should be individualized based on creatinine clearance.
  • Mild (CrCl 50-79 mL/min): 500 mg twice daily.
  • Moderate (CrCl 30-49 mL/min): 250 mg twice daily.
  • Severe (CrCl < 30 mL/min): 250 mg once daily.
  • End-Stage Renal Disease on dialysis: 500 mg once daily after dialysis.
• Hepatic Impairment:No dosage adjustment is required in patients with mild to moderate hepatic impairment. In patients with severe hepatic impairment,creatinine clearance may underestimatethe renal impairment. Therefore, a 50% reduction of the maintenance daily dose is recommended when creatinine clearance is < 60 mL/min.

Side Effects: Common adverse reactions may include somnolence, fatigue, headache, nasopharyngitis, dizziness, and asthenia.

Less common but potentially serious side effects may include behavioral abnormalities (e.g., aggression, agitation, irritability, anxiety, depression, psychotic symptoms), suicidal ideation, Stevens-Johnson syndrome, and toxic epidermal necrolysis.

Precautions: Levetiracetam should be used with caution in patients with pre-existing psychiatric disturbances. Monitor patients for behavioral changes and suicidal ideation. If signs or symptoms of serious skin reactions occur, discontinue Iracet 250 immediately.

Gradual withdrawal of antiepileptic drugs is recommended to minimize the risk of increased seizure frequency.

Inform healthcare professionals regarding pregnancy and breastfeeding status before starting treatment with Iracet 250.

Storage: Store at room temperature (15°C to 30°C), protected from moisture. Keep out of reach of children. Do not use after the expiry date.

Important Note: This information is for general knowledge and informational purposes only, and does not substitute professional medical advice. Always consult your doctor or pharmacist for specific instructions and guidance regarding your medication. They can assess your individual medical condition and provide the most appropriate advice.