Focale

Focale

levetiracetam

Manufacturer:

Atlantic Pharma

Distributor:

UNILAB, Inc
Concise Prescribing Info
Contents
Levetiracetam
Indications/Uses
Monotherapy in the treatment of partial onset seizures w/ or w/o secondary generalization in adult & adolescent ≥16 yr. Adjunctive therapy in the treatment of partial onset seizures w/ or w/o secondary generalization in adult, adolescent & childn ≥1 mth w/ epilepsy; myoclonic seizures in adult & adolescent ≥12 yr w/ juvenile myoclonic epilepsy & primary generalized tonic-clonic seizures in adult & childn ≥6 yr w/ idiopathic generalized epilepsy.
Dosage/Direction for Use
Partial onset seizures Adult & adolescent ≥16 yr Initially 250 mg bid, increased to 500 mg bid after 2 wk. May be further increased by 250 mg bid every 2 wk. Max: 1,500 mg bid. Childn 4-<16 yr Initially 10 mg/kg bid. Increase to 20 mg/kg every 2 wk by 20 mg/kg. Myoclonic seizures in childn ≥12 yr w/ juvenile myoclonic epilepsy Initially 500 mg bid, increased by 1,000 mg/day every 2 wk until 3,000 mg/day. Primary generalized tonic-clonic seizures Adult & adolescent ≥16 yr Initially 500 mg bid, increased by 1,000 mg/day every 2 wk until 3,000 mg/day. Childn 6-<16 yr Initially 10 mg/kg bid, increased by 20 mg/kg every 2 wk. Renal impairment in adult & adolescent weighing >50 kg CrCl >80 mL/min 500-1,500 mg every 12 hr, 50-79 mL/min 500-1,000 mg every 12 hr, 30-49 mL/min 250-750 mg every 12 hr, <30 mL/min 250-500 mg every 12 hr, end-stage renal disease undergoing dialysis Loading dose: 750 mg on the 1st day of treatment w/ levetiracetam then 500-1,000 mg. Renal impairment in childn >4 yr & adolescent weighing <50 kg CrCl >80 mL/min 10-30 mg/kg bid, 50-79 mL/min 10-20 mg/kg bid, 30-49 mL/min 5-15 mg/kg bid, <30 mL/min 5-10 mg/kg bid, end-stage renal disease undergoing dialysis Loading dose: 15 mg/kg on the 1st day of treatment w/ levetiracetam then 10-20 mg/kg once daily. Supplemental dose: 5-10 mg/kg following a dialysis.
Administration
May be taken with or without food.
Contraindications
Special Precautions
Behavioral abnormalities. Increase risk of suicidal thoughts or behavior. Somnolence & fatigue. Serious dermatological/hypersensitivity reactions. Coordination difficulties. W/draw gradually to minimize potential increased seizure frequency. Hematologic abnormalities. Monitor for the emergence or worsening of depression, suicidal thoughts of behavior &/or any unusual changes in mood or behavior. Monitor patients 1 mth to <4 yr for increases in diastolic BP. May affect ability to drive or operate machinery. Renal impairment. Pregnancy & lactation. Childn <4 yr & infants.
Adverse Reactions
Infection, viral infection, flu syndrome, otitis media, flu; thrombocytopenia, leukopenia, pancytopenia, pancytopenia w/ bone marrow suppression, neutropenia, agranulocytosis, ecchymosis; hypersensitivity, drug reaction w/ eosinophilia & systemic symptoms (DRESS); anorexia, wt decrease/increase, hyponatremia, dehydration; depression, hostility/aggression, anxiety, insomnia. nervousness/irritability, suicide attempt, suicidal ideation, psychotic disorder, abnormal behavior, hallucination, anger, confusional state, panic attack, affect lability/mood swings, agitation, completed suicide, personality disorder, abnormal thinking, hypersomnia; somnolence, headache, convulsion, balance disorder, dizziness, lethargy, tremor, amnesia, memory impairment, abnormal coordination/ataxia, paresthesia, attention disturbance, choreoathetosis, dyskinesia, hyperkinesia, ataxia, balance disorder, sedation, emotional lability, increased reflex; diplopia, blurred vision, amblyopia, conjunctivitis; vertigo, ear pain; cough, chest pain, bronchitis, pharyngitis, rhinitis, sinusitis, asthma, nasal congestion, pharyngolaryngeal pain, nasopharyngitis; abdominal pain, diarrhea, dyspepsia, vomiting, nausea, pancreatitis, gastroenteritis, gingivitis, tooth disorder, constipation; abnormal LFT, hepatic failure, hepatitis; rash, alopecia, eczema, pruritus, toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, skin discoloration, vesiculobullous rash; muscular weakness, myalgia, back pain, neck pain, arthralgia; UTI, albuminuria, urine abnormality; asthenia/fatigue, fever, pain, face edema,; increased drug level; injury, head injury, contusion, fall, joint sprain.
Drug Interactions
Increases carbamazepine-induced toxicity. Decreases clearance & increases conc of methotrexate. Reduced efficacy w/ osmotic laxative macrogol. OCs (eg, ethinylestradiol & levonorgestrel)
MIMS Class
ATC Classification
N03AX14 - levetiracetam ; Belongs to the class of other antiepileptics.
Presentation/Packing
Form
Focale FC tab 1g
Packing/Price
30's (P2,070/box, P69/film-coated tab)
Form
Focale FC tab 500 mg
Packing/Price
30's (P35/film-coated tab, P1,050/box)
Form
Focale FC tab 250 mg
Packing/Price
30's (P540/box, P18/film-coated tab)
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