Keppra

Keppra

levetiracetam

Manufacturer:

GlaxoSmithKline

Distributor:

Zuellig
/
Agencia Lei Va Hong
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 treatment of partial onset seizures w/ or w/o secondary generalisation in adults, adolescents, childn & infants from 1 mth of age (tab & oral soln) or 4 yr (concentrate for soln for infusion) w/ epilepsy; myoclonic seizures in adults & adolescents from 12 yr w/ juvenile myoclonic epilepsy; primary generalised tonic-clonic seizures in adults & adolescents from 12 yr w/ idiopathic generalised epilepsy.
Dosage/Direction for Use
Tab Monotherapy Adult & adolescent (from 16 yr) Starting dose: 250 mg bd, increased to 500 mg bd after 2 wk. Dose can be further increased by 250 mg bd every 2 wk. Max: 1,500 mg bd. Add-on therapy Adult (≥18 yr) & adolescent (12-17 yr) weighing ≥50 kg Initially 500 mg bd, can be increased up to 1,500 mg bd. Dose changes can be made in 500 mg bd increases or decreases every 2-4 wk. Childn ≥50 kg Adult dose. Childn or adolescent weighing 25 kg Starting dose: 250 mg bd. Max: 750 mg bd. Oral soln Preferred for infants & childn <6 yr, childn weighing <25 kg, patients unable to swallow tab, or for administration of doses <250 mg. Add-on therapy Childn ≥50 kg Adult dose. Infant (6-23 mth), childn (2-11 yr), adolescent (12-17 yr) weighing <50 kg Initially 10 mg/kg bd, can be increased up to 30 mg/kg bd. Dose changes should not exceed increases or decreases of 10 mg/kg bd every 2 wk. Infant (1-<6 mth) Initially 7 mg/kg bd, can be increased up to 21 mg/kg bd. Dose changes should not exceed increases or decreases of 7 mg/kg bd every 2 wk. Concentrate for soln for infusion Alternative when oral administration is temporarily not feasible. For IV use only. Recommended dose must be diluted in at least 100 mL of compatible diluent & administered as a 15-min IV infusion. Monotherapy Adult & adolescent (from 16 yr) Starting dose: 250 mg bd, increased to 500 mg bd after 2 wk. Dose can be further increased by 250 mg bd every 2 wk. Max: 1,500 mg bd. Add-on therapy Adult (≥18 yr) & adolescent (12-17 yr) weighing >50 kg Initially 500 mg bd, can be increased up to 1,500 mg bd. Dose changes can be made in 500 mg bd increases or decreases every 2-4 wk. Childn ≥50 kg Adult dose. Childn (4-11 yr) & adolescent (12-17 yr) weighing <50 kg Initially 10 mg/kg bd, can be increased up to 30 mg/kg bd. Dose changes should not exceed increases or decreases of 10 mg/kg bd every 2 wk.
Administration
May be taken with or without food: Tab: Swallow whole, administered in 2 equally divided doses. Oral soln: May be diluted in a glass of water or baby's bottle.
Contraindications
Hypersensitivity to levetiracetam or other pyrrolidone derivatives.
Special Precautions
When discontinuing treatment, w/draw gradually. Very rarely associated w/ acute kidney injury. Rare cases of decreased blood cells (neutropenia, agranulocytosis, leucopenia, thrombocytopenia & pancytopenia) at the beginning of treatment. Monitor for signs of depression &/or suicidal ideation & behaviours. Minor or moderate influence on the ability to drive & use machines. Patients w/ severely impaired hepatic function. Women of childbearing potential. Lowest effective dose is recommended during pregnancy. Breast-feeding is not recommended. Elderly patients (≥65 yr) w/ compromised renal function. Tab Not for use in infants & childn <6 yr; & as initial treatment in childn weighing <25 kg. Oral soln Contains methyl parahydroxybenzoate & propyl parahydroxybenzoate; maltitol liqd. Rare hereditary problems of fructose intolerance. Concentrate for soln for infusion Patients on a controlled Na diet.
Adverse Reactions
Nasopharyngitis, anorexia, depression, hostility/aggression, anxiety, insomnia, nervousness/irritability, somnolence, headache, convulsion, dizziness, tremor, balance disorder, lethargy, vertigo, cough, abdominal pain, diarrhoea, dyspepsia, nausea, vomiting, rash, asthenia/fatigue.
Drug Interactions
Methotrexate, laxatives, macrogol.
MIMS Class
Anticonvulsants
ATC Classification
N03AX14 - levetiracetam ; Belongs to the class of other antiepileptics.
Presentation/Packing
Form
Keppra FC tab 1000 mg
Packing/Price
60's
Form
Keppra FC tab 250 mg
Packing/Price
60's
Form
Keppra FC tab 500 mg
Packing/Price
60's
Form
Keppra conc for soln for infusion 100 mg/mL
Packing/Price
5 mL x 1's
Form
Keppra oral soln 100 mg/mL
Packing/Price
300 mL x 1's
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