Millitam

Millitam

levetiracetam

Manufacturer:

Millimed

Distributor:

Prosp Pharma
Concise Prescribing Info
Contents
Levetiracetam
Indications/Uses
Monotherapy in partial onset seizures w/ or w/o secondary generalization in adults & adolescents from 16 yr w/ newly diagnosed epilepsy. Adjunctive therapy of partial onset seizures in adults & childn ≥4 yr 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
Monotherapy Initially 250 mg bid, increased to 500 mg bid after 2 wk. May be further increased by 250 mg bid every 2 wk depending upon clinical response. Max: 1,500 mg bid. Adjunctive therapy Adult ≥18 yr & adolescent 12-17 yr weighing ≥50 kg Initially 1,000 mg/day & may be started on 1st day of treatment. May be increased up to 3,000 mg/day. Dose changes can be made in 1,000 mg/day increments or decrements every 2-4 wk. Childn 4-11 yr & adolescents 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 10 mg/kg bid increments or decrements every 2-4 wk. Childn & adolescents weighing from 50 kg Initially 500 mg bid. Max dose: 1,500 mg bid, 25 kg Initially 250 mg bid. Max dose: 750 mg bid. Monotherapy or adjunctive therapy Adult & adolescents ≥50 kg w/ impaired renal function: End-stage renal disease patients undergoing dialysis 500-1,000 mg once daily. Loading dose: 750 mg on the 1st day w/ levetiracetam. Following dialysis, a 200-500 mg supplemental dose is recommended, severe <30 mL/min/1.73 m2 250-500 mg bid, moderate 30-49 mL/min/1.73 m2 250-750 mg bid, mild CrCl 50-79 mL/min/1.73 m2 500-1,000 mg bid.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity to levetiracetam or pyrrolidone derivatives.
Special Precautions
May cause drowsiness & hematologic disorders. Concomitant use w/ alcohol or alcoholic ingredients. Monitor for signs & symptoms of depression, suicidal tendencies & other unusual behavior changes. Discontinue if hypersensitivity reaction or unspecific rash occurs. Psychotic & behavioral symptoms especially in childn. Gradually w/draw. May affect ability to drive & use machines. Hepatic & renal impairment. Contraindicated in pregnancy. Lactation.
Adverse Reactions
Nasopharyngitis; somnolence, headache. Anorexia; depression, hostility/aggression, anxiety, insomnia, nervousness/irritability; convulsion, dizziness, lethargy, tremor; vertigo; cough; abdominal pain, diarrhea, dyspepsia, vomiting, nausea; rash. Toxic epidermal necrolysis, Stevens-Johnson syndrome.
Drug Interactions
Increased clearance in ped patients w/ hepatic enzyme-inducing anticonvulsants. Increased Cmax & decreased renal clearance w/ probenecid. Decreased clearance of methotrexate.
MIMS Class
ATC Classification
N03AX14 - levetiracetam ; Belongs to the class of other antiepileptics.
Presentation/Packing
Form
Millitam FC tab 500 mg
Packing/Price
6 × 10's
Form
Millitam FC tab 250 mg
Packing/Price
3 × 10's
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