Lepsytam 500 mg (Tablet)

Unit Price: ৳ 30.00 (2 x 10: ৳ 600.00)
Strip Price: ৳ 300.00

Medicine Details

Indications

  • Monotherapy in treatment of partial-onset seizures in adults and adolescents
  • Adjunctive therapy in treatment of partial-onset seizures in adults, adolescents, children and infants
  • Treatment of myoclonic seizures in adults and adolescents with Juvenile Myoclonic Epilepsy
  • Treatment of primary generalized tonic-clonic seizures in adults and adolescents with Idiopathic Generalised Epilepsy

Mechanism of Action

  • Precise mechanism is unknown
  • Minimal activity in submaximal stimulation and threshold tests
  • Protection observed against secondarily generalized activity from focal seizures induced by pilocarpine and kainic acid
  • Inhibits burst firing without affecting normal neuronal excitability

Dosage

  • Recommended starting dose for adults and adolescents from 16 years of age is 250 mg twice daily
  • Initial therapeutic dose for adults (≥18 years) and adolescents (12 to 17 years) weighing 50 kg or more is 500 mg twice daily
  • Tablet formulation not adapted for use in infants and children under the age of 6 years
  • Monotherapy safety and efficacy not established for children and adolescents below 16 years
  • Pediatric add-on therapy starting dose for child or adolescent of 25 kg is 250 mg twice daily

Administration

  • Flm-coated tablets must be taken orally, swallowed with sufficient quantity of liquid
  • Administered in two equally divided doses

Interaction

  • No influence on serum concentrations of existing antiepileptic medicinal products
  • Probenecid inhibits renal clearance of the primary metabolite but not of Lepsytam
  • Concomitant administration with methotrexate may decrease methotrexate clearance
  • Reports of decreased Lepsytam efficacy when osmotic laxative macrogol is concomitantly administered
  • No alteration in absorption by food, but rate of absorption slightly reduced

Contraindications

  • Hypersensitivity to the active substance or other pyrrolidone derivatives or to any of the excipients

Side Effects

  • Most common adverse reactions include somnolence, asthenia, infection, dizziness in adult patients
  • In pediatric patients: fatigue, aggression, nasal congestion, decreased appetite, irritability

Pregnancy & Lactation

  • Not recommended during pregnancy and in women of childbearing potential not using contraception unless clinically necessary
  • Excreted in human breast milk, breastfeeding not recommended

Precautions & Warnings

  • Dose adjustment may be required for patients with renal impairment
  • Rare cases of decreased blood cell counts have been described at beginning of treatment
  • Monitoring for signs of depression and/or suicidal ideation and behaviours recommended
  • Tablet formulation not adapted for use in infants and children under the age of 6 years

Use in Special Populations

  • Adjustment of dose recommended in elderly patients with compromised renal function
  • Renal function-dependent individualized daily dose
  • No dose adjustment needed in patients with mild to moderate hepatic impairment

Overdose Effects

  • Somnolence, agitation, aggression, depressed level of consciousness, respiratory depression and coma observed
  • No specific antidote available
  • Symptomatic treatment may include haemodialysis

Therapeutic Class

  • Adjunct anti-epileptic drugs

Storage Conditions

  • Store at a cool temperature (not exceeding 25°C) and dry place, protected from light

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