Lepsytam 500 mg/5 ml (IV Infusion)

Indications

• Treatment of partial-onset seizures in adults and adolescents
• Monotherapy for newly diagnosed epilepsy in adults and adolescents
• Adjunctive therapy for epilepsy 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

Description

• Precise mechanism of antiepileptic effect is unknown
• Minimal activity in submaximal stimulation and threshold tests
• Protection against secondarily generalized activity from focal seizures
• Inhibition of burst firing without affecting normal neuronal excitability

Dosage

• Recommended starting dose for adults and adolescents from 16 years of age
• Initial therapeutic dose for adults (≥18 years) and adolescents (12 to 17 years) weighing 50 kg or more
• Maximum dose for adults and adolescents
• Tablet formulation not adapted for use in infants and children under the age of 6 years
• Dosing for children 50 kg or greater
• Dose adjustment for renal impairment

Administration

• Flm-coated tablets for oral administration
• Must be taken orally, swallowed with liquid
• Administered in two equally divided doses

Interaction

• No influence on serum concentrations of existing antiepileptic medicinal products
• Inhibition of renal clearance of the primary metabolite by probenecid
• Decreased methotrexate clearance when administered concomitantly
• Reports of decreased efficacy when concomitantly administered with osmotic laxative macrogol
• No alteration of absorption by food
• Slightly reduced rate of absorption by food

Contraindications

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

Side Effects

• Most common adverse reactions in adult and pediatric patients

Pregnancy & Lactation

• Not recommended during pregnancy and in women of childbearing potential not using contraception
• Excreted in human breast milk
• Benefit/risk of treatment during breastfeeding should be weighed

Precautions & Warnings

• Dose adjustment for renal impairment
• Rare cases of decreased blood cell counts
• Association with acute kidney injury
• Possible impact on growth, puberty, and endocrine function in children

Use in Special Populations

• Dose adjustment in elderly patients with compromised renal function
• Individualization of daily dose according to renal function
• No dose adjustment needed in patients with mild to moderate hepatic impairment
• 50% reduction of daily maintenance dose recommended in severe hepatic impairment

Overdose Effects

• Observed effects of Lepsytam overdoses
• No specific antidote available
• Symptomatic treatment and potential use of haemodialysis

Therapeutic Class

• Adjunct anti-epileptic drugs

Storage Conditions

• Cool temperature not exceeding 25°C
• Dry place, protected from light

Related Brands

• Lepsytam 500 mg/5 ml (Oral Solution) - healthcare-pharmaceuticals-ltd