Levisat

Levisat

levetiracetam

Manufacturer:

SM Pharmaceuticals

Distributor:

SM Pharmaceuticals
Concise Prescribing Info
Contents
Levetiracetam
Indications/Uses
Monotherapy in treatment of partial onset seizures w/ or w/o secondary generalization in patients from 16 yr w/ newly diagnosed epilepsy. Adjunctive treatment of partial onset seizures w/ or w/o secondary generalisation in adults & childn from 4 yr w/ epilepsy; myoclonic seizures in adults & adolescents from 12 yr w/ juvenile myoclonic epilepsy; primary generalized tonic-clonic seizures in adults & childn from 12 yr w/ idiopathic generalized epilepsy. IV: Alternative when PO is temporarily not feasible.
Dosage/Direction for Use
Monotherapy Adult & adolescent from 16 yr Initially 250 mg bd, may be increased to 500 mg bd after 2 wk then further increased by 250 mg bd every 2 wk. Max: 1,500 mg bd. Add-on therapy Adult ≥18 yr & adolescent 12-17 yr, ≥50 kg Initially 500 mg bd, may 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 4-11 yr & adolescent 12-17 yr, 25-50 kg Initially 10 mg/kg bd, may be increased up to 30 mg/kg bd. Dose changes should not exceed 10 mg/kg bd increases or decreases every 2 wk. Childn ≥50 kg Adult dose.
Administration
May be taken with or without food.
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. Perform CBC count during therapy. Avoid abrupt w/drawal. May affect ability to drive & use machines. Acute kidney injury. Renal & severe hepatic impairment. Women of childbearing potential. Pregnancy. Not recommended during lactation. Elderly ≥65 yr. Monotherapy treatment in childn & adolescents <16 yr. Tab: Not to be used in childn <6 yr. IV: Patients on controlled Na diet.
Adverse Reactions
Nasopharyngitis; somnolence, headache. Anorexia; depression, hostility/aggression, anxiety, insomnia, nervousness/irritability; convulsion, balance disorder, dizziness, lethargy, tremor; vertigo; cough; abdominal pain, diarrhea, dyspepsia, vomiting, nausea; rash; asthenia/fatigue.
Drug Interactions
Decreased MTX clearance. FC tab: Increased clearance w/ enzyme-inducing antiepileptics in childn. Decreased efficacy w/ macrogol. Reduced absorption by food.
MIMS Class
Anticonvulsants
ATC Classification
N03AX14 - levetiracetam ; Belongs to the class of other antiepileptics.
Presentation/Packing
Form
Levisat FC tab 500 mg
Packing/Price
10 × 10's
Form
Levisat infusion conc 500 mg/5 mL
Packing/Price
10 × 1's
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