Ivetra

Ivetra

levetiracetam

Manufacturer:

Torrent

Distributor:

Torrent
Concise Prescribing Info
Contents
Levetiracetam
Indications/Uses
Ivetra 250 FC tab/Ivetra 500 FC tab/Ivetra 1000 FC tab/Ivetra-100 oral soln As monotherapy for partial onset seizures w/ or w/o secondary generalization in patients from 16 yr w/ newly diagnosed epilepsy. As adjunctive therapy for partial onset seizures w/ or w/o secondary generalization in adults & childn from 1 mth 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. Ivetra IV soln for inj As adjunctive therapy for partial onset seizures in adults & childn ≥1 mth w/ epilepsy; myoclonic seizures in adults & adolescents ≥12 yr w/ juvenile myoclonic epilepsy; primary generalized tonic-clonic seizures in adults & childn ≥6 yr w/ idiopathic generalized epilepsy.
Dosage/Direction for Use
Ivetra 250 FC tab/Ivetra 500 FC tab/Ivetra 1000 FC tab/Ivetra-100 oral soln Monotherapy Adult & adolescent from 16 yr Initially 250 mg bid, 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. Add-on therapy Adult (>18 yr) & adolescent (12-17 yr) weighing ≥50 kg Initially 500 mg bid, started on the 1st day of treatment. Can be increased up to 1,500 mg bid depending on clinical response & tolerability. 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. Can be increased up to 30 mg/kg bid depending on clinical response & tolerability. Dose changes should not exceed increases or decreases of 10 mg/kg bid every 2 wk. Adolescent, childn, & infant from 6 mth 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 (2 mL) bid, max: 600 mg (6 mL) bid; 15 kg Initially 150 mg (1.5 mL) bid, max: 450 mg (4.5 mL) bid; 10 kg Initially 100 mg (1 mL) bid, max: 300 mg (3 mL) bid; 6 kg Initially 60 mg (0.6 mL) bid, max: 180 mg (1.8 mL) bid. Infant from 1-< 6 mth Initially 7 mg/kg bid. Can be increased up to 21 mg/kg bid depending on clinical response & tolerability. Dose changes should not exceed increases or decreases of 7 mg/kg bid every 2 wk. 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. 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 Renal impairment 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. Ivetra-100 oral soln Add-on therapy Adolescent (12-17 yr), childn (2-11 yr), & infant (from 6-23 mth) weighing <50 kg Initially 10 mg/kg bid. Can be increased up to 30 mg/kg bid depending on clinical response & tolerability. Dose changes should not exceed increases or decreases of 10 mg/kg bid every 2 wk. Infant <6 mth weighing 7 kg 49 mg (0.5 mL) bid, max: 147 mg (1.5 mL) bid; 5 kg 35 mg (0.35 mL) bid, max: 105 mg (1.05 mL) bid; 4 kg 28 mg (0.3 mL) bid, max: 84 mg (0.85 mL) bid. Ivetra IV soln for inj Partial onset seizures Adult ≥16 yr 1,000 mg/day in 2 divided dosing (500 mg bid). May give additional dosing increments of 1,000 mg/day every 2 wk. Max: 3,000 mg daily. Childn 4-<16 yr 20 mg/kg in 2 divided doses (10 mg/kg bid). Increase every 2 wk by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg bid). May reduce if patient cannot tolerate 60 mg/kg daily dose. Max: 3,000 mg daily. 6 mth-<4 yr 20 mg/kg in 2 divided doses (10 mg/kg bid). Increase every 2 wk by increments of 20 mg/kg to recommended daily dose of 50 mg/kg (25 mg/kg bid). May reduce dose if patient cannot tolerate 50 mg/kg daily. 1 mth-<6 mth 14 mg/kg in 2 divided dose (7 mg/kg bid). Increase every 2 wk by increments of 14 mg/kg to recommended daily dose of 42 mg/kg (21 mg/kg bid). Myoclonic seizures in patient w/ juvenile myoclonic epilepsy 1,000 mg/day in 2 divided doses (500 mg bid). Increase every 2 wk by 1,000 mg/day to recommended daily dose of 3,000 mg daily. Primary generalized tonic-clonic seizures Adult ≥16 yr 1,000 mg/day in 2 divided doses (500 mg bid). Increase every 2 wk by 1,000 mg/day to recommended daily dose of 3,000 mg daily. Childn 6-<16 yr 20 mg/kg in 2 divided dose (10 mg/kg bid). Increase every 2 wk by increments of 20 mg/kg (10 mg/kg bid) to the recommended daily dose of 60 mg/kg (30 mg/kg bid). Adult Renal impairment CrCl >80 mL/min/1.73 m2 500-1,500 mg every 12 hr, 50-80 mL/min/1.73 m2 500-1,000 mg every 12 hr, 30-50 mL/min/1.73 m2 250-750 mg every 12 hr, <30 mL/min/1.73 m2 250-500 mg every 12 hr. ESRD patient undergoing dialysis 500-1,000 mg every 24 hr. Supplemental dose: 250-500 mg following dialysis.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity to levetiracetam or other pyrrolidone derivatives.
Special Precautions
W/draw treatment gradually. Monitor for signs of depression &/or suicidal ideation & behaviors. Assess renal function in patients w/ severe hepatic impairment. Hematologic abnormalities. May affect ability to drive or operate machinery. Pregnancy & lactation. Childn & adolescent <16 yr (monotherapy). Elderly. Ivetra-100 Contains methyl parahydroxybenzoate & propyl parahydroxybenzoate which may cause allergic reactions. Fructose intolerance. Patients undergoing hemodialysis. Moderate & severe renal impairment. Childn <4 yr. Ivetra IV Serious dermatological reactions, including SJS & TEN. Discontinue if signs or symptoms anaphylaxis or angioedema develops. Monitor for signs & symptoms of coordination difficulties. Monitor patients 1 mth-4 yr for increase in diastolic BP. Close monitoring of seizure control during pregnancy.
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. Ivetra-100 Headache. Hostility, agitation. Ivetra IV Serious dermatological reactions, coordination difficulties, hematologic abnormalities, increase in BP.
MIMS Class
Anticonvulsants
ATC Classification
N03AX14 - levetiracetam ; Belongs to the class of other antiepileptics.
Presentation/Packing
Form
Ivetra 1000 FC tab 1000 mg
Packing/Price
60's (P5,196/pack)
Form
Ivetra 250 FC tab 250 mg
Packing/Price
60's (P1,362/pack)
Form
Ivetra 500 FC tab 500 mg
Packing/Price
60's (P2,688/pack)
Form
Ivetra-100 oral soln 100 mg/mL
Packing/Price
(+ 3 mL oral dosing syringe) 200 mL x 1's
Form
Ivetra IV soln for inj 100 mg/mL
Packing/Price
5 mL x 1's (P2,200/box)
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