Levetam XR Tablet (Extended Release) XR Tablet 500 mg is a Product of the Generic Levetiracetam

What Is Levetam XR Tablet (Extended Release) XR Tablet 500 mg Indications and Uses?

Levetam XR is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalization in adults and adolescents from 16 years of age with newly diagnosed epilepsy. Levetam XR is indicated as adjunctive therapy- in the treatment of partial-onset seizures with or without secondary generalization in adults, adolescents, children and infants from 1 month of age with epilepsy. ... Read more Levetam XR is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalization in adults and adolescents from 16 years of age with newly diagnosed epilepsy. Levetam XR is indicated as adjunctive therapy- in the treatment of partial-onset seizures with or without secondary generalization in adults, adolescents, children and infants from 1 month of age with epilepsy. in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy. in the treatment of primary generalized tonic-clonic seizures in adults and adolescents from 12 years of age with Idiopathic Generalised Epilepsy.

Drug Interactions of Levetam XR Tablet (Extended Release) XR Tablet 500 mg

Antiepileptic medicinal products : Pre-marketing data from clinical studies conducted in adults indicate that Levetam XR did not influence the serum concentrations of existing antiepileptic medicinal products (phenytoin, carbamazepine, valproic acid, phenobarbital, lamotrigine, gabapentin and primidone) and that these antiepileptic medicinal products did not influence the pharmacokinetics of Levetam XR. Probenecid : Probenecid (500 mg four times daily), a renal tubular secretion blocking agent, has been shown to inhibit the renal clearance of the primary metabolite but not of Levetam XR. Nevertheless, the concentration of this metabolite remains low. Methotrexate : Concomitant administration of Levetam XR and methotrexate has been reported to decrease methotrexate clearance, resulting in increased/prolonged blood methotrexate concentration to potentially toxic levels. Blood methotrexate and Levetam XR levels should be carefully monitored in patients treated concomitantly with the two drugs. Laxatives : There have been isolated reports of decreased Levetam XR efficacy when the osmotic laxative macrogol has been concomitantly administered with oral Levetam XR. Therefore, macrogol should not be taken orally for one hour before and for one hour after taking Levetam XR. Food and alcohol : The extent of absorption of Levetam XR was not altered by food, but the rate of absorption was slightly reduced. No data on the interaction of Levetam XR with alcohol are available.

Side Effects of Levetam XR Tablet (Extended Release) XR Tablet 500 mg

Most common adverse reactions (incidence ≥ 5% more than placebo) include: Adult patients: somnolence, asthenia, infection and dizziness Pediatric patients: fatigue, aggression, nasal congestion, decreased appetite, and irritability

Precautions And Warnings for Levetam XR Tablet (Extended Release) XR Tablet 500 mg

Renal impairment : The administration of Levetam XR to patients with renal impairment may require dose adjustment. In patients with severely impaired hepatic function, assessment of renal function is recommended before dose selection. Acute kidney injury : The use of Levetam XR has been very rarely associated with acute kidney injury with a time to onset ranging from a few days to several months. Blood cell counts : Rare cases of decreased blood cell counts (neutropenia, agranulocytosis, leucopenia, thrombocytopenia and pancytopenia) have been described in association with Levetam XR administration, generally at the beginning of the treatment. Complete blood cell counts are advised in patients experiencing important weakness, pyrexia, recurrent infections or coagulation disorders. Suicide : Suicide, suicide attempt, suicidal ideation and behaviour have been reported in patients treated with anti-epileptic agents (including Levetam XR). A meta-analysis of randomized placebo-controlled trials of anti-epileptic medicinal products has shown a small increased risk of suicidal thoughts and behaviour. The mechanism of this risk is not known. Therefore patients should be monitored for signs of depression and/or suicidal ideation and behaviours and appropriate treatment should be considered. Patients (and caregivers of patients) should be advised to seek medical advice should signs of depression and/or suicidal ideation or behaviour emerge. Paediatric population : The tablet formulation is not adapted for use in infants and children under the age of 6 years. Available data in children did not suggest an impact on growth and puberty. However, long term effects on learning, intelligence, growth, endocrine function, puberty and childbearing potential in children remain unknown.

Use During Pregnancy and Lactation

Levetam XR Tablet (Extended Release) XR Tablet 500 mg (Levetiracetam) is not recommended during pregnancy and in women of childbearing potential not using contraception unless clinically necessary. Levetiracetam is excreted in human breast milk. Therefore, breastfeeding is not recommended. However, if levetiracetam treatment is needed during breastfeeding, the benefit/risk of the treatment should be weighed considering the importance of breastfeeding. No impact on fertility was detected in animal studies. No clinical data are available, the potential risk for humans is unknown.

Therapeutic Class

Adjunct anti-epileptic drugs

Storage Conditions of It

Store at a cool temperature (not exceeding 25°C) and dry place, protected from light. Pack Image: Levetam XR 500 mg XR Tablet Thanks for using MedEx! How would you rate your experience so far?