Levacore

Levacore

levetiracetam

Manufacturer:

Able Medical

Distributor:

Able Medical
Concise Prescribing Info
Contents
Levetiracetam
Indications/Uses
Monotherapy for partial onset seizures w/ or w/o secondary generalisation in adults & adolescents from 16 yr w/ newly diagnosed epilepsy. Adjunctive treatment for treatment of partial onset seizures w/ or w/o secondary generalisation in adults, adolescents & 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 & children from 6 yr w/ idiopathic generalised epilepsy. Alternative for patients when oral administration is temporarily not feasible.
Dosage/Direction for Use
Monotherapy Adult & adolescent from 16 yr Initially 250 mg bid, may be increased to 500 mg bid after 2 wk, then further increased by 250 mg bid every 2 wk depending upon clinical response. Max: 1500 mg bid. Add on therapy Adult 18 yr & adolescent 12-17 yr weighing ≥50 kg Initially 500 mg bid on 1st day of treatment, may 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 & adolescent 12-17 yr weighing≥50 kg Adult dose, <50 kg 10 mg/kg bid, may be increased up to 30 mg/kg bid. Dose changes: Not to exceed increases or decreases of 10 mg/kg bid every 2 wk. Renal impairment Adult & adolescent weighing >50 kg, CrCl ≥80 mL/min/1.73 m2 500-1,500 bid, 50-79 mL/min/1.73 m2 500-1,000 bid, 30-49 mL/min/1.73 m2 250-750 bid, <30 mL/min/1.73 m2 250-500 bid. ESRD patient undergoing dialysis 500-1,000 once daily, following dialysis administer 250-500 mg as supplemental dose. Childn & adolescent weighing <50 kg, CrCl ≥80 mL/min/1.73 m2 10-30 mg/kg bid, 50-79 mL/min/1.73 m2 10-20 mg/kg bid, 30-49 mL/min/1.73 m2 5-15 mg/kg bid, <30 mL/min/1.73 m2 5-10 mg/kg bid. ESRD patient undergoing dialysis 10-20 mg/kg once daily; 15 mg/kg as loading dose on 1st day of treatment, following dialysis administer 5-10 mg/kg as supplemental dose.
Contraindications
Hypersensitivity to levetiracetam or other pyrrolidone derivatives.
Special Precautions
Monitor for signs of depression &/or suicidal ideation & behaviours; developing psychiatric signs suggesting important mood &/or personality changes. Decreased blood cell counts (neutropenia, agranulocytosis, leucopenia, thrombocytopenia & pancytopenia). Worsening of seizure. Patient on controlled Na diet. May affect ability to drive & use machines. Assess renal function in patients w/ severely impaired hepatic function. Liver & renal disease. Acute kidney injury. Women of childbearing potential. Pregnancy. Not recommended during lactation. Childn.
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. SJS, TEN.
Drug Interactions
MIMS Class
Anticonvulsants
ATC Classification
N03AX14 - levetiracetam ; Belongs to the class of other antiepileptics.
Presentation/Packing
Form
Levacore concentrate for soln for infusion 500 mg/5 mL
Packing/Price
5 mL x 1's
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