Kepreptol

Kepreptol

levetiracetam

Manufacturer:

Whan In Pharm

Distributor:

Bell-Kenz Pharma

Marketer:

JLT Pharma
Concise Prescribing Info
Contents
Levetiracetam
Indications/Uses
Monotherapy in adults & adolescents from 16 yr w/ newly diagnosed epilepsy, & adjunctive therapy in adults & childn from 4 yr w/ epilepsy in partial onset seizures w/ or w/o secondary generalization. Adjunctive therapy in myoclonic seizures in adults, adolescents & childn from 12 yr w/ juvenile myoclonic epilepsy; & primary generalized tonic-clonic seizures in adults & adolescents from 4 yr w/ idiopathic generalized epilepsy.
Dosage/Direction for Use
Monotherapy Adult & adolescent ≥16 yr Initially 250 mg bid, increased to 500 mg bid after 2 wk. May be further increased by 500 mg daily (250 mg bid) every 2 wk depending upon the clinical response. Max: 3,000 mg (1,500 mg bid). Add-on therapy: Partial seizures Adult & adolescents 12-17 yr ≥50 kg Initially 500 mg bid, 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. Adolescent 12-17 yr & childn 4-11 yr <50 kg Initially 10 mg/kg bid, may be increased up to 60 mg/kg/day (30 mg/kg bid). Dose changes should not exceed increments or decrements of 10 mg/kg bid every 2 wk. Childn ≥50 kg Adult dose, 40.1-50 kg 20 mg/kg/day: 500 mg bid. 40 mg/kg/day: 1,000 mg bid. 60 mg/kg/day: 1,500 mg bid, 20.1-40 kg 20 mg/kg/day: 250 mg bid. 40 mg/kg/day: 500 mg bid. 60 mg/kg/day: 750 mg bid, 15-20 kg 20 mg/kg/day: 150-200 mg bid. 40 mg/kg/day: 300-400 mg bid. 60 mg/kg/day: 450-600 mg bid. Myoclonic seizure Childn ≥12 yr Initially 1,000 mg/day (500 mg bid), increased by 1,000 mg/day every 2 wk to the recommended daily dose of 3,000 mg. Primary generalized tonic-clonic seizures Adult & adolescent 12-17 yr ≥50 kg Initially 1,000 mg/day (500 mg bid). Additional dosing increments may be given (1,000 mg/day additional every 2 wk) to a max recommended daily dose of 3,000 mg (1,500 mg bid). Adolescent 12-17 yr <50 kg 20 mg/kg/day as 10 mg/kg bid. Additional dosing increments may be given at 20 mg/kg/day (10 mg/kg bid) additional every 2 wk to a max recommended daily dose of 60 mg/kg (30 mg/kg bid). Adult w/ impaired renal function 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, ESRD patient using dialysis 500-1,000 mg every 24 hr. 750 mg/kg loading dose on the 1st day of treatment. 250-500 mg supplemental dose following dialysis. Infant, childn & adolescent <60 kg w/ impaired renal function 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, ESRD patient using dialysis 10-20 mg/kg once daily. 15 mg/kg loading dose on the 1st day of treatment. 5-10 mg/kg supplemental dose following dialysis.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Contains lactose; rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
Special Precautions
Increased risk of suicidal thoughts or behavior. Monitor for the emergence or worsening of depression, suicidal thoughts or behavior, &/or any unusual changes in mood or behavior. W/draw therapy gradually to minimize the seizure onset frequency. Renal impairment. May affect ability to drive or operate machinery. Not recommended in women of childbearing potential not using contraception. Not recommended during pregnancy & lactation. Infant & childn <4 yr. Elderly.
Adverse Reactions
Asthenia, fatigue; somnolence. Amnesia, ataxia, convulsion, dizziness, headache, hyperkinesia, tremor, balance disorder, disturbance in attention, memory impairment; agitation, depression, emotional lability/mood swings, hostility/aggression, insomnia, nervousness/irritability, personality disorders, abnormal thinking; abdominal pain, diarrhea, dyspepsia, nausea, vomiting; anorexia, wt increase; vertigo; diplopia, blurred vision; myalgia, accidental injury; infection, nasopharyngitis; increased cough; eczema, pruritus, rash; thrombocytopenia.
MIMS Class
Anticonvulsants
ATC Classification
N03AX14 - levetiracetam ; Belongs to the class of other antiepileptics.
Presentation/Packing
Form
Kepreptol FC tab 500 mg
Packing/Price
60's (P34/film-coated tab)
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Already a member? Sign in
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Already a member? Sign in