Great Eastern Drug


Zuellig Pharma
Concise Prescribing Info
Partial onset seizures w/ or w/o secondary generalization in adults & adolescents from 16 yr w/ newly diagnosed epilepsy. Adjunctive therapy in the treatment of partial onset seizures w/ or w/o generalization in adults, adolescents & childn from 4 yr w/ epilepsy; myoclonic seizures in adults & adolescents ≥12 yr w/ juvenile myoclonic epilepsy; primary generalized tonic-clonic seizures in adults, adolescents & childn from 6 yr w/ idiopathic generalized epilepsy.
Dosage/Direction for Use
Administer as 15-min IV infusion. Monotherapy Adult & adolescent from 16 yr Initially 250 mg bid, increased to 500 mg bid after 2 wk. Dose can be further increased by 250 mg bid every 2 wk depending upon clinical response. Max: 1,500 mg bid. Add-on therapy Adult ≥18 yr & adolescent 12-17 yr weighing ≥50 kg Initially 500 mg bid & can be started on 1st day of treatment. May be increased up to 1,500 mg bid. Dose changes can be made in 500 mg bid increased or decreased every 2-4 wk. Add-on therapy Childn 4-11 yr & adolescent 12-17 yr weighing <50 kg Initially 10 mg/kg bid. May be increased up to 30 mg/kg bid. 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. Dosage adjustments: Renal impairment Adult & adolescent weighing <50 kg Mild (50-79 mL/min/1.73 m2): 500-1,000 mg bid, moderate (30-49 mL/min/1.73 m2): 250-750 mg bid, severe (<30 mL/min/1.73 m2): 250-500 mg bid, end-stage renal disease undergoing dialysis: 500-1,000 mg once daily. Childn & adolescent weighing <50 kg Mild (50-79 mL/min/1.73 m2): 10-20 mg/kg bid, moderate (30-49 mL/min/1.73 m2) 5-15 mg/kg bid, severe (<30 mL/min/1.73 m2): 5-10 mg/kg bid, end-stage renal disease undergoing dialysis 10-30 mg/kg once daily.
Special Precautions
Monitor for somnolence & fatigue, coordination difficulties, & behavioral/psychiatric abnormalities. Increased risk of suicidality. Discontinue at the 1st sign of rash suggestive of Stevens-Johnson syndrome or toxic epidermal necrolysis; anaphylaxis or angioedema. W/draw gradually. Perform CBC in patients who experience any signs or symptoms of haematologic abnormalities (eg, severe weakness, pyrexia, recurrent infections, coagulation disorders) during therapy. Monitor ped patients <4 yr for increased diastolic BP during therapy. Closely monitor during pregnancy & throughout postpartum period, especially if dosage is adjusted. Concomitant use w/ alcohol. May affect ability to drive or operate machinery. Liver & renal disease. Pregnancy & lactation. Ped patients <12 yr (management of myoclonic seizures), <6 yr (primary generalized tonic-clonic seizures management), <16 yr.
Adverse Reactions
Somnolence, asthenia, headache, infection, dizziness, pain, pharyngitis, depression, nervousness, rhinitis, anorexia, vertigo, amnesia, anxiety, emotional lability, hostility, paresthesia, increased cough, sinusitis, diplopia; vomiting, nasopharyngitis, fatigue, aggression, upper abdominal pain, nasal congestion, decreased appetite, pharyngolaryngeal pain, abdominal behavior, irritability, diarrhea, lethargy, insomnia, head injury, agitation, constipation, flu, contusion, fall, altered mood, ear pain, conjunctivitis, gastroentritis, joint sprain, arthralgia, neck pain, sedation, labile effect, confusional state, & mood swing.
MIMS Class
ATC Classification
N03AX14 - levetiracetam ; Belongs to the class of other antiepileptics.
Focale Inj 500 mg/5 mL
10 × 1's
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