Preparation
Oritam 250 mg Tablet: Each tablet contains Levetiracetam USP 250 mg.
Oritam 500 mg Tablet: Each tablet contains Levetiracetam USP 500 mg.
Oritam Syrup: Each 5 ml solution contains Levetiracetam USP 500 mg.
Indication
Oritam is indicated in monotherapy and adjunctive treatment of partial seizures with or without secondary generalization, and for adjunctive therapy of myoclonic seizures and primarily generalized tonic-clonic seizures.
Contraindication
Levetiracetam is contraindicated in patients with known hypersensitivity to the active substance or other pyrrolidone derivatives or to any of the excipients.
Dosage & Administration
The recommended dose of Oritam is as following:
Monotherapy: Adults and adolescents from 16 years of age: Starting dose is 250 mg twice daily which should be increased to an initial therapeutic dose of 500 mg twice daily after two weeks. The dose can be further increased by 250 mg twice daily every two weeks depending upon the clinical response. The maximum dose is 1500 mg twice daily.
Adjunctive therapy: Adults (≥18 years) and adolescents (12 to 17 years) weighing 50 kg or more: The initial therapeutic dose is 500 mg twice daily. This dose can be started on the first day of treatment. Depending upon the clinical response and tolerability, the daily dose can be increased up to 1500 mg twice daily. Children aged 4 to 11 years & adolescents (12 to 17 years) weighing less than 50 kg: The initial therapeutic dose is 10 mg/kg twice daily. Depending upon the clinical response and tolerability, the dose can be increased up to 30 mg/kg twice daily. Dose changes should not exceed increases or decreases of 10 mg/kg twice daily every two weeks. The lowest effective dose should be used.
Use in infants and children less than 4 years: Levetiracetam is not recommended for use in children below 4 years of age due to insufficient data on safety and efficacy.
Dosage in patients with renal impairment: Creatinine clearance - Maximum daily dose 50-80 ml/minute - 2 gm 30-50 ml/minute - 1.5 gm 30 ml/minute - 1 gm
Dosage in patients with hepatic impairment: No dose adjustment is needed in patients with mild to moderate hepatic impairment. In severe hepatic impairment if creatinine clearance is ≤ 70 ml/min, 50% reduction of the daily maintenance dose is recommended.
Side Effect
The common side effects are nausea, vomiting, diarrhea, anorexia, weight changes; drowsiness, asthenia, amnesia, ataxia, seizures, dizziness, headache, tremor, hyperkinesia, insomnia, anxiety, impaired attention, aggression, irritability; thrombocytopenia; myalgia; visual disturbances; pruritus, rash. Pancreatitis, hepatic dysfunction, confusion, psychosis, hallucinations, suicidal ideation, paraesthesia, leucopenia, pancytopenia, and alopecia have also been reported.
Precaution
Levetiracetam should not be withdrawn abruptly. Patients should be monitored for signs of depression and/ or suicidal ideation.
Drug Interaction
No significant interaction with other drugs has been reported with Levetiracetam.
Presentation
Oritam 250 mg Tablet: Each box contains 3 X 10’s tablets in blister pack. Oritam 500 mg Tablet: Each box contains 3 X 10’s tablets in blister pack. Oritam Syrup 100 ml: Each PET bottle contains 100 ml syrup.
Use Children
Levetiracetam is not recommended for use in children below 4 years of age due to insufficient data on safety and efficacy.
Storage
Store in a cool and dry place below 30 °C away from light.
