Levetstad 250

Rx

Indications:

Monotherapy

In the treatment of partial onset seizures with or without secondary generalization in patients from 16 years of age with newly diagnosed epilepsy.

Adjunctive therapy

• In the treatment of partial onset seizures with or without secondary generalization in adults, children from 12 years of age with epilepsy.
• In the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy.
• In the treatment of primary generalized tonic-clonic seizures in adults and children from 12 years of age with idiopathic generalized epilepsy.

Dosage:

Monotherapy

• Patients from 16 years of age: Start with 250 mg twice daily which should be increased to 500 mg twice daily after 2 weeks. The dose can be further increased by 250 mg twice daily every 2 weeks depending upon the clinical response. The maximum dose is 1500 mg twice daily.

Adjunctive therapy

• Adults (≥ 18 years) and adolescents (12 – 17 years) weighing 50 kg or more: The initial therapeutic dose is 500 mg twice daily, the daily dose can be increased up to 1500 mg twice daily. Dose changes can be made in 500 mg twice daily increases every 2 to 4 weeks.
• Elderly (65 years and older) and patients with renal impairment: The daily dose must be individualized according to renal function.
• Clcr > 80 ml/min: 500 – 1500 mg daily, each 12 hours.
• Clcr = 50 – 79 ml/min: 500 – 1000 mg daily, each 12 hours.
• Clcr = 30 – 49 ml/min: 250 – 750 mg daily, each 12 hours.
• Clcr < 30 ml/min: 250 – 500 mg daily, each 12 hours.
• End-stage renal disease – Patients using dialysis: 500 – 1000 mg daily, each 24 hours. Following dialysis, a 250 to 500 mg supplemental dose is recommended.
• Patients with hepatic impairment: No dose adjustment is needed in patients with mild to moderate hepatic impairment. In patients with severe hepatic impairment, the creatinine clearance may underestimate the renal insufficiency. Therefore a 50 % reduction of the daily maintenance dose is recommended when the creatinine clearance is < 70 ml/min/1.73 m².

Usage:

Levetstad 250 must be taken orally, swallowed with a sufficient quantity of water and may be taken with or without food.

Hypersensitivity to levetiracetam, other pyrrolidone derivatives or any of the excipients.

Very common: Nasopharyngitis; Somnolence, headache.

Common: Anorexia; depression, hostility/ aggression, anxiety, insomnia, nervousness/ irritability; convulsion, balance disorder, dizziness, lethargy, tremor; vertigo; cough; abdominal pain, diarrhoea, dyspepsia, vomiting, nausea; rash; asthenia/fatigue.

• Because of the possibility of increased seizure frequency, Levetstad 250 should not be discontinued suddenly. Oral levetiracetam should be withdrawn gradually by reducing the dosage by 1 g daily at 2-week intervals.
• Suicide, suicide attempt, suicide ideas and behavior have been reported in patients treated with antiepileptic agents.
• Levetstad 250 should be used during pregnancy only if the potential benefits justify the potential risk to the fetus. A decision should be made whether to discontinue the drug or discontinue nursing, taking account into the importance of the drug to the mother.
• Caution is recommended in those patients when performing skilled tasks, e.g. driving vehicles or operating machinery. Patients are advised not to drive or use machines until it is established that their ability to perform such activities is not affected.