Ivetra 250/Ivetra 500/Ivetra 1000

Ivetra 250/Ivetra 500/Ivetra 1000

levetiracetam

Manufacturer:

Torrent

Distributor:

Torrent
Concise Prescribing Info
Contents
Levetiracetam
Indications/Uses
Monotherapy of partial onset seizures w/ or w/o secondary generalization in patients from 16 yr w/ newly diagnosed epilepsy. Adjunctive therapy in partial onset seizures w/ or w/o secondary generalization in adults & childn from 1 mth w/ epilepsy; myoclonic seizure 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.
Dosage/Direction for Use
Adult & adolescent >16 yr Monotherapy Initially 250 mg bid, should be increased to 500 mg bid after 2 wk. Can be further increased by 250 mg bid every 2 wk depending on clinical response. Max: 1,500 mg bid. Adult >18 yr & adolescent 12-17 yr weighing ≥50 kg Add-on therapy Initially 500 mg bid, 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. Adolescent 12-17 yr & childn 4-11 yr (<50 kg) Initially 10 mg/kg bid. May be increased up to 30 mg/kg bid depending on clinical response. Dose changes should not exceed increases or decreases of 10 mg/kg bid every 2 wk. Adolescent, childn & infant 6 mth Initially 10 mg/kg bid. Max: 30 mg/kg bid. Weighing from 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, 10 kg Initially 100 mg bid, max: 300 mg bid, 6 kg Initially 60 mg bid, max: 180 mg bid. Adult & adolescent >50 kg, renal impairment CrCl >80 mL/min/1.73 m2 500-1,500 mg bid, 50-79 mL/min/1.73 m2 500-1,000 mg bid, 30-49 mL/min/1.73 m2 250-750 mg bid, <30 mL/min/1.73 m2 250-500 mg bid. End-stage renal disease (ESRD) patient undergoing dialysis 500-1,000 mg once daily. Loading dose: 750 mg on the 1st day of treatment. Supplemental dose: 250-500 mg following dialysis. Adolescent & childn <50 kg, infant 6-23 mth, 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. Loading dose: 15 mg/kg on the 1st day of treatment. Supplemental dose: 5-10 mg/kg following dialysis.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity to levetiracetam or other pyrrolidone derivatives.
Special Precautions
Avoid abrupt withdrawal of therapy. Monitor for signs of depression &/or suicidal ideation/behaviors & renal function in patients w/ severe hepatic impairment.  May affect ability to drive or operate machinery. Pregnancy & lactation. Childn <16 yr (monotherapy). Elderly.
Adverse Reactions
Nasopharyngitis; somnolence. Anorexia; depression, anxiety, insomnia, nervousness/irritability; convulsion, balance disorder, dizziness, lethargy, tremor; vertigo; cough; abdominal pain, diarrhea, dyspepsia, nausea, vomiting; rash; asthenia/fatigue.
MIMS Class
ATC Classification
N03AX14 - levetiracetam ; Belongs to the class of other antiepileptics.
Presentation/Packing
Form
Ivetra 500 FC tab 500 mg
Packing/Price
60's (P2,688/pack)
Form
Ivetra 250 FC tab 250 mg
Packing/Price
60's (P1,362/pack)
Form
Ivetra 1000 FC tab 1000 mg
Packing/Price
60's (P5,196/pack)
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