RYTHMODAN Capsules Ref.[8067] Active ingredients: Disopyramide

Posology – Oral: 300 mg to 800mg daily in divided doses.

Elderly: A dose reduction due to reduced renal and hepatic function in the elderly (especially elderly non-smokers) should be considered (see section 4.4).

Paediatric population: The safety and efficacy of disopyramide in children less than 18 years has not been established. Current available evidence is available in section 4.4, 5.1 and 5.2.

Signs and symptoms

Toxic plasma levels are reflected by ECG abnormalities such as:

• marked prolongation of QT interval as a premonitory sign of other arrhythmias, in particular torsades de pointes which can result in repeated syncopes
• widening of the QRS complex
• variable degrees of atrioventricular block.

The clinical signs of overdose may include:

• bilateral mydriasis (suggestive of overdose)
• syncope, hypotension or shock
• cardiac arrest due to intraventricular block or asystole
• respiratory symptoms
• coma (with bilateral mydriasis) in cases of massive intoxication

Management

Apart from prostigmine derivatives which can be used to treat anticholinergic effects, there is no specific antidote for disopyramide.

Treatment of acute overdose should be carried out in an intensive care unit under continuous cardiac monitoring. Monitor vital signs and measure blood sugar, serum potassium, magnesium and calcium concentrations.

Symptomatic supportive measures may include:

• early gastric lavage,
• administration of a cathartic followed by activated charcoal by mouth or stomach tube,
• IV administration of isoprenaline, other vasopressors and/or positive inotropic agents,
• if needed – infusion of lactate and/or magnesium, electro–systolic assistance, cardioversion, insertion of an intra–aortic balloon for counterpulsion and mechanically assisted ventilation,
• haemodialysis, haemofiltration or haemoperfusion with activated charcoal has been employed to lower the serum concentration of the drug.

Glass Bottle: 36 months.

PVC Blister: 36 months.

Do not store above 25°C.

Glass Bottle containing 100 capsules.

PVC Blister containing 84 capsules.

Amber glass bottle with jaycap closure containing 100 capsules.

PVC/PVdC blister strips in cardboard cartons containing 84 capsules.

None.