Focale

Focale

levetiracetam

Manufacturer:

Great Eastern Drug

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Levetiracetam
Indications/Uses
Monotherapy in partial onset seizures w/ or w/o secondary generalization in adults & adolescents ≥16 yr w/ newly diagnosed epilepsy. Adjunctive therapy in partial onset seizures w/ or w/o secondary generalization in adults, adolescents & childn ≥4 yr w/ epilepsy; myoclonic seizures in adults & adolescents ≥12 yr w/ juvenile myoclonic epilepsy; primary generalized tonic-clonic seizures in adults, adolescents & childn ≥6 yr w/ idiopathic generalized epilepsy.
Dosage/Direction for Use
Oral/IV For IV use, administer as 15 min IV infusion. Monotherapy Adult & adolescent ≥16 yr Initially 250 mg bid, may be increased to 500 mg bid after 2 wk. May be further increased by 250 mg bid every 2 wk. Max: 1,500 mg bid. Add on therapy Adult (≥18 yr) & adolescent (12-17 yr) weighing ≥50 kg Initially 500 mg bid. May be increased up to 1,500 mg bid. May increase or decrease 500 mg bid every 2-4 wk. Childn weighing ≥50 kg Same dose as adult. 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. Dose changes should not exceed increments or decrements of 10 mg/kg bid every 2 wk. Dose recommendations (starting dose: 10 mg/kg bid, max dose: 30 mg/kg bid): Childn & adolescent weighing ≥50 kg 500-1,500 mg bid, 25 kg 250-750 mg bid, 20 kg 200-600 mg bid, 15 kg 150-450 mg bid. Switching from or to oral levetiracetam Initial total daily dose of IV should be equiv to daily dose & frequency of oral levetiracetam. May switch back to oral levetiracetam at equiv daily dose & frequency of administered IV after completion of IV treatment. Renal impairment: Adult & adolescent weighing ≥50 kg w/ normal CrCl >80 mL/min/1.73 m2 500-1,500 mg bid, mild CrCl 50-79 mL/min/1.73 m2 500-1,000 mg bid, moderate CrCl 30-49 mL/min/1.73 m2 250-750 mg bid, severe CrCl <30 mL/min/1.73 m2 250-500 mg bid, ESRD undergoing dialysis 750 mg loading dose on 1st day, followed by 500-1,000 mg once daily & recommended 250-500 mg supplemental dose following dialysis. Childn & adolescent weighing <50 kg w/ normal CrCl >80 mL/min/1.73 m2 10-30 mg/kg bid, mild CrCl 50-79 mL/min/1.73 m2 10-20 mg/kg bid, moderate CrCl 30-49 mL/min/1.73 m2 5-15 mg/kg bid, severe CrCl <30 mL/min/1.73 m2 5-10 mg/kg bid, ESRD undergoing dialysis 15 mg/kg loading dose on 1st day, followed by 10-20 mg/kg once daily & recommended 5-10 mg/kg supplemental dose following dialysis. Severe hepatic impairment Reduce 50% of daily maintenance dose when CrCl is <60 mL/min/1.73 m2.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity to levetiracetam or other pyrrolidone derivatives.
Special Precautions
Discontinue therapy at 1st sign of rash; if signs or symptoms of anaphylaxis or angioedema occur. Permanently discontinue therapy if manifestations suggestive of SJS or TEN occur; if alternative etiology cannot be identified. Increased risk of suicidal behavior or ideation. Anxiety, agitation, hostility, hypomania & mania. Hematologic abnormalities (eg, decreased RBC, WBC & neutrophil counts); agranulocytosis, leukopenia, neutropenia, pancytopenia, thrombocytopenia. Avoid abrupt discontinuation; alcohol intake. Monitor patients for adverse neuropsychiatric effects eg, somnolence & fatigue, coordination difficulties & behavioral/psychiatric abnormalities. Perform CBC in patients w/ signs or symptoms of hematologic abnormalities eg, severe weakness, pyrexia, recurrent infections & coagulation disorders during therapy. May impair ability to drive or operate machinery. Liver & renal disease. May gradually decrease plasma levels of levetiracetam in pregnant women (during 3rd trimester). Closely monitor pregnant patients & throughout postpartum period, especially if dose is adjusted during pregnancy. Lactation. Monitor patients <4 yr for increased diastolic BP during therapy. Ped patients <1 mth for management of partial onset seizure; <12 yr for management of myoclonic seizures; <6 yr for management of primary generalized tonic-clonic seizure; <16 yr for NaCl inj. Behavioral abnormalities eg, paranoia, confusional state & increased aggression in ped patients 4-16 yr w/ partial onset seizures. Monotherapy in childn & adolescents <16 yr.
Adverse Reactions
Somnolence, asthenia, headache, infection, dizziness, pain, pharyngitis, depression, nervousness, rhinitis, anorexia, ataxia, 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, gastroenteritis, joint sprain, arthralgia, neck pain, sedation, labile affect, confusional state & mood swing. Nausea.
Drug Interactions
Increased clearance w/ hepatic enzyme-inducing anticonvulsants (eg, carbamazepine) in ped patients.
MIMS Class
Anticonvulsants
ATC Classification
N03AX14 - levetiracetam ; Belongs to the class of other antiepileptics.
Presentation/Packing
Form
Focale FC tab 250 mg
Packing/Price
3 × 10's
Form
Focale FC tab 500 mg
Packing/Price
6 × 10's
Form
Focale inj 500 mg/5 mL
Packing/Price
10 × 1's
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