Levetiracetam Sandoz

Levetiracetam Sandoz

levetiracetam

Manufacturer:

Lek Pharma

Distributor:

Zuellig Pharma

Marketer:

Sandoz
Concise Prescribing Info
Contents
Levetiracetam
Indications/Uses
Monotherapy in the treatment of partial onset seizures w/ or w/o secondary generalisation in adults & adolescents from 16 yr w/ newly diagnosed epilepsy. Adjunctive therapy in the treatment of partial onset seizures in adults & childn from 4 yr w/ epilepsy; myoclonic seizures in adults & adolescents from 12 yr w/ juvenile myoclonic epilepsy; primary generalised tonic-clonic seizures in adults & adolescents from 6 yr w/ idiopathic generalised epilepsy.
Dosage/Direction for Use
Adult & adolescent from 16 yr Monotherapy Initially 250 mg bid, then should be increased to 500 mg bid after 2 wk. Dose can be further increased by 250 mg bid every 2 wk depending upon the clinical response. Max: 1,500 mg bid. Adult (≥18 yr) & adolescents (12-17 yr) weighing ≥50 kg Add-on therapy Initially 500 mg bid & can be increased up to 1,500 mg bid. Dose changes can be made in 500 mg bid increases or decreases every 2-4 wk. Childn (4-11 yr) & adolescents (12-17 yr) weighing <50 kg Add-on therapy Initially 10 mg/kg bid. Dose can be increased up to 30 mg/kg bid depending upon the clinical response & tolerability. Dose changes should not exceed increases or decreases of 10 mg/kg bid every 2 wk, 15 kg 150 mg bid. Max: 450 mg bid, 20 kg 200 mg bid. Max: 600 mg bid, 25 kg 250 mg bid. Max: 750 mg bid, from 50 kg 500 mg bid. Max: 1,500 mg bid (adult dose). Mild renal impairment (CrCl 50-79 mL/min/1.73 m2) 500-1,000 mg bid. Moderate renal impairment (CrCl 30-49 mL/min/1.73 m2) 250-750 mg bid. Severe renal impairment (CrCl <30 mL/min/1.73 m2) 250-500 mg bid. End-stage renal disease patients undergoing dialysis Loading dose: 750 mg on the 1st day of treatment. 500-1,000 mg once daily. Following dialysis, 250-500 mg supplemental dose is recommended. Hepatic impairment (CrCl <60 mL/min/1.73 m2) ½ daily maintenance dose.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity to levetiracetam or other pyrrolidone derivatives.
Special Precautions
W/draw gradually if to be discontinued. Assessment of renal function is recommended in patients w/ severely impaired hepatic function. Perform CBC in patients experiencing important weakness, pyrexia, recurrent infections or coagulation disorders. Monitor for signs of depression &/or suicidal ideation & behaviours. Minor or moderate influence on the ability to drive & use machines. Pregnancy & lactation. Childn <6 yr & infants (w/ epilepsy <1 yr).
Adverse Reactions
Nasopharyngitis; somnolence, headache. 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.
Drug Interactions
Higher clearance w/ enzyme-inducing antiepileptics in childn. Renal clearance of primary metabolite may be inhibit primary metabolite w/ probenecid. May decrease clearance of methotrexate. Decreased efficacy w/ osmotic laxative macrogol. Slightly reduced absorption rate w/ food.
MIMS Class
Anticonvulsants
ATC Classification
N03AX14 - levetiracetam ; Belongs to the class of other antiepileptics.
Presentation/Packing
Form
Levetiracetam Sandoz FC tab 250 mg
Packing/Price
30's
Form
Levetiracetam Sandoz FC tab 500 mg
Packing/Price
60's
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