Epitam 500

Epitam 500

levetiracetam

Manufacturer:

Community Pharm PCL

Distributor:

Community Pharm PCL

Marketer:

Community Pharm PCL
Concise Prescribing Info
Contents
Levetiracetam
Indications/Uses
As monotherapy in partial onset seizures w/ or w/o secondary generalization in adults & adolescents ≥16 yr w/ newly diagnosed epilepsy. As adjunct in partial onset seizures w/ or w/o secondary generalization in adults, adolescents & childn ≥4 yr w/ epilepsy; myoclonic seizures in adults & adolescents ≥12 yr w/ juvenile myoclonic epilepsy; primary generalized tonic-clonic seizures in adults, adolescents & childn ≥6 yr w/ idiopathic generalized epilepsy.
Dosage/Direction for Use
Monotherapy Adult & adolescent ≥16 yr Initially 250 mg bid, increased to 500 mg bid after 2 wk. May further increase by 250 mg bid every 2 wk. Max dose: 1,500 mg bid. Add-on therapy Adult (≥18 yr) & adolescent (12-17 yr) weighing ≥50 kg Initially 500 mg bid on 1st day. May be increased up to 1,500 mg bid in 500-mg increments bid every 2-4 wk. Childn ≥6 yr Initially 10 mg/kg bid. May be increased to 30 mg/kg bid in increments or decrements of 10 mg/kg bid every 2 wk. Childn weighing ≥50 kg Initially 500 mg bid. Max: 1,500 mg bid, 25 kg Initially 250 mg bid. Max: 750 mg bid, 20 kg Initially 200 mg bid. Max: 600 mg bid, 15 kg Initially 150 mg bid. Max: 450 mg bid. Renal impairment in adult & adolescent weighing >50 kg: mild (CrCl 50-79 mL/min) 500-1,000 mg bid, moderate (CrCl 30-48 mL/min) 250-750 mg bid, severe (CrCl <30 mL/min) 250-500 mg bid, ESRD patients undergoing dialysis Loading dose: 750 mg on 1st day of treatment. 500-1,000 mg once daily following dialysis, w/ 250-500 mg supplemental dose. Renal impairment in adult & adolescent weighing <50 kg: mild (CrCl 50-79 mL/min) 10-20 mg/kg bid, moderate (CrCl 30-48 mL/min) 5-15 mg/kg bid, severe (CrCl <30 mL/min) 5-10 mg/kg bid, ESRD patients undergoing dialysis Loading dose: 15 mg/kg on 1st day of treatment. 10-20 mg/kg once daily following dialysis, w/ 5-10 mg/kg supplemental dose. Severe hepatic impairment (CrCl <60 mL/min/1.73 m2 50% reduction of daily maintenance dose.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity to levetiracetam or pyrrolidone derivatives.
Special Precautions
Discontinue treatment or reduce dose if psychosis, paranoia, hallucinations & behavioral symptoms (including aggression, agitation, anger, anxiety, apathy, confusion, depersonalization, depression, emotional lability, hostility, hyperkinesis, irritability, nervousness, neurosis & personality disorder) occur. Avoid abrupt w/drawal. Increased risk of suicidal thoughts/behavior. Decreased RBC & WBC counts, Hb, hematocrit & neutrophils; eosinophilia, agranulocytosis & lymphocytosis. Renal & severe hepatic impairment. Pregnancy & lactation. Tab formulation not for childn <6 yr. Monotherapy in childn & adolescents <16 yr. Elderly w/ compromised renal function.
Adverse Reactions
Loss of appetite, vomiting; infectious disease; decreased bone mineral density, neck pain; asthenia, dizziness, headache; abnormal behavior, irritability; cough, nasopharyngitis; fatigue. SJS, TEN; decreased erythrocyte production & WBC count, raised eosinophil count, neutropenia, pancytopenia, thrombocytopenia; liver failure; anaphylaxis; somnolence; suicidal intent, suicide; angioedema.
Drug Interactions
Doubled steady-state plasma conc of levetiracetam principal inactive metabolite w/ probenecid.
MIMS Class
Anticonvulsants
ATC Classification
N03AX14 - levetiracetam ; Belongs to the class of other antiepileptics.
Presentation/Packing
Form
Epitam 500 FC tab 500 mg
Packing/Price
6 × 10's
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