Lentira

Lentira

levetiracetam

Manufacturer:

Akums Drug

Distributor:

Cathay YSS
Full Prescribing Info
Contents
Levetiracetam.
Description
Each film-coated tablet contains Levetiracetam 500 mg.
Action
Pharmacology: Pharmacokinetics: Absorption of Levetiracetam with peak plasma concentrations occurring in about an hour following oral administration in fasted subjects. The oral bioavailability of Levetiracetam tablet is 100% and the tablet and oral solution are bioequivalent in rate and extent of absorption. Food does not affect the extent of absorption or Levetiracetam but it decreases Cmax by 20% and delays Tmax by 1.5 hours. Levetiracetam is not extensively metabolized in humans. The major metabolic pathway is the enzymatic hydrolysis of the acetamide group. which produces the carboxylic acid, ucb L057 (24% of dose) and is not dependent on any liver cytochrome P450 isoenzymes. Levetiracetam plasma half-life in adults is 7±1 hour and is unaffected by either dose or repeated administration. Levetiracetam is eliminated from the systemic circulation by renal excretion as unchanged drug which represents 66% of administered dose.
Indications/Uses
Levetiracetam is used as an adjunct in the treatment of partial seizures with or without secondary generalizations, myoclonic seizures. and primary generalized tonic-clonic seizures.
Dosage/Direction for Use
Partial Onset Seizures: Adults 16 years and older: Initial daily dose of 1000 mg/day given as twice-daily dosing (500 mg twice daily).
4 years to <16 years: Initial daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily).
6 months to <4 years: Initial daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). The daily dose should be increased in 2 weeks by an increment of 20 mg/kg to the recommended daily dose of 50mg/kg (25 mg/kg twice daily).
1 month to <6 months: Initial daily dose of 14 mg/kg in two divided doses (7 mg/kg twice daily).
Myoclonic Seizures in patients 12 years of age and older: Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg.
Primary generalized tonic-clonic seizures: Adult 16 years and older: Treatments should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily).
Pediatric patients ages 6 to < 16 years: Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily).
Special Precautions
Levetiracetam should be used with caution and in reduced doses in patients with renal impairment, those undergoing haemodialysis and in patients with severe hepatic impairment.
Use in Pregnancy: The management of epilepsy during pregnancy may present problems for both the mother and the fetus. Evidence for any effect of the newer antiepileptic on the fetus is particular scanty. Limited data have not so far suggested a significant increase in risk with Levetiracetam.
Use in Lactation: Levetiracetam is transferred into breast milk in significant amounts. but serum concentrations in breast-fed infants are very low.
Use In Pregnancy & Lactation
The management of epilepsy during pregnancy may present problems for both the mother and the fetus. Evidence for any effect of the newer antiepileptic on the fetus is particular scanty. Limited data have not so far suggested a significant increase in risk with Levetiracetam.
Levetiracetam is transferred into breast milk in significant amounts. but serum concentrations in breast-fed infants are very low.
Adverse Reactions
The most common adverse effects associated with Levetiracetam are somnolence, weakness and dizziness. Anorexia, diarrhea, dyspepsia, nausea, ataxia, headache, amnesia, depression, emotional liability, insomnia. nervousness, tremor, vertigo, diplopia and rash may occur less frequently. A raised incidence of mild infections, such as the common cold and upper respiratory tract infections has been reported.
Other effects reported include abnormal behavior. aggression, anger, anxiety, confusion, hallucinations, irritability, psychotic disorders, neutropenia, pancytopenia and thrombocytopenia.
Drug Interactions
Potential pharmacokinetic interactions of or with Levetiracetam were assessed in clinical pharmacokinetic studies (phenytoin, valproate, warfarin. digoxin, oral contraceptive. probenecid) and through pharmacokinetic screening in the placebo-controlled clinical studies in epilepsy patients. Symptoms of carbamazepine toxicity have been reported when Levetiracetam was added to carbamazepine therapy; this interaction appeared to be due to Pharmacodynamics mechanism as blood levels of carbamazepine and its metabolite were not altered.
Storage
Store at temperatures not exceeding 30°C.
MIMS Class
ATC Classification
N03AX14 - levetiracetam ; Belongs to the class of other antiepileptics.
Presentation/Packing
FC tab 500 mg x 10's.
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