Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Aventis Pharma Limited, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK Trading as: Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK
Pharmacotherapeutic group: Antiarrhythmias, Class Ia
ATC code: C01BA03
It decreases membrane responsiveness, prolongs the effective refractory period (ERP) and slows automaticity in cells with augmented automaticity. Effective refractory period of the atrium is lengthened, ERP of the A-V node is shortened and conduction in accessory pathways is prolonged.
Disopyramide is a myocardial depressant and has anti-cholinergic effects.
No controlled paediatric studies have been undertaken. One non-controlled study assessed the electrophysiologic effects of disopyramide in 14 children aged 7 months to 14 years with congenital heart disease. A single intravenous dose of disopyramide phosphate was administered (2 mg/kg, maximum 50 mg). Significant prolongations of the refractory periods of the atrium and the atrioventricular (AV) node, and also a significant prolongation of the His-ventricular (HV) interval were reported. No side effects were reported. In another study in 15 patients aged 9 days to 14 years with arrhythmia, oral disopyramide was started at 3 to 6 mg/kg and increased after 48h until the pre-dose plasma concentration of disopyramide attained >2 mg/L. The dose of disopyramide required to achieve a plasma concentration within the therapeutic range varied from 3 mg/kg to 36 mg/kg, with the highest requirement being found in the youngest patient. Seven out of fifteen subjects (46%) achieved arrhythmia control.
Elimination phase of plasma t1/2: 5-8 hours. Increased in hepatic impairment, cardiac and hepatic disease.
Protein binding: 50-60%. Saturable and concentration dependent.
Volume of distribution: Variable according to method of determination.
Metabolism: Approximately 25% of a dose metabolised to a mono-N-dealkylated derivative. Additional 10% as other metabolites.
Excretion: 75% unchanged drug via urine, remainder in faeces mono-N-dealkylated metabolite 25% in urine, 64% via faeces.
In the paediatric population, a higher plasma clearance and shorter half-life were observed compared to adults. This could be explained by a higher metabolic clearance in the paediatric population.
Not applicable.
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