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RYTHMODAN is a brand name for Disopyramide. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Rythmodan is used in the treatment of cardiac arrhythmias as follows 1. The prevention and treatment of arrhythmias occurring after myocardial infarction. 2. Maintenance of normal rhythm following electroconversion e.g. atrial fibrillation, atrial flutter. 3. Persistent ventricular extrasystoles. 4. Control of…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology:
Oral 300 mg to 800mg daily in divided doses. 4) Paediatric population The safety and efficacy of disopyramide in children less than 18 years has not been established. 2.
Cardiac:
It is accepted that the arrhythmogenic potential of disopyramide is weak. However, as with all antiarrhythmic drugs, disopyramide may worsen or provoke arrhythmias. This proarrhythmic effect is more likely to occur in the presence of hypokalemia with the associated use of antiarrhythmic drugs, in patients with severe structural heart disease with prolongation of the QT interval.
Intra–cardiac conduction abnormalities may occur:
QT interval prolongation, widening of the QRS complex, atrioventricular block and bundle–branch block.
Other types of arrhythmia have been reported:
Bradycardia, sinus block, ventricular fibrillation, ventricular tachycardia and torsades de pointes. Episodes of severe heart failure or even cardiogenic shock have also been described particularly in patients with severe structural heart disease.
The resulting low cardiac output can cause hypotension, renal insufficiency and/or acute hepatic ischemia. 4): o urinary: dysuria; acute urinary retention, especially in prostatism o ocular: disorders of accommodation; diplopia o gastrointestinal: dry mouth; abdominal pain; nausea, vomiting, anorexia, diarrhoea; constipation o impotence o cognitive disorders o psychiatric disorders.
• Skin reactions: very rarely, rashes. 4 Special warnings and precautions for use). In some cases, severe hypoglycaemia resulted in coma. • Very rarely: cholestatic jaundice, headache, dizzy sensation, neutropenia. • Agranulocytosis. Reporting of suspected adverse reactions Reporting of suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Antiarrhythmic drugs belonging to the class 1c (Vaughan Williams Classification) were included in the Cardiac Arrhythmia Suppression Trial (CAST), a long term multicentre randomised, double blind study in patients with asymptomatic non life–threatening ventricular arrhythmia who have had a myocardial infarction more than six days but less than two years previously.
A significant increase in mortality and non–fatal cardiac arrest rate was seen in patients treated with class 1c antiarrhythmic drugs when compared with a matched placebo group. The applicability of the CAST results to other antiarrhythmics and other populations (eg.
those without recent infarction) is uncertain. At present, it is best to assume that the risk extends to other antiarrhythmic agents for patients with structural heart disease. There is no evidence that prolonged suppression of ventricular premature contractions with antiarrhythmic drugs prevents sudden death.
For this reason, antiarrhythmic drugs should not be prescribed for the treatment of patients with asymptomatic ventricular premature contractions. All antiarrhythmic drugs can produce unwanted effects when they are used to treat symptomatic but not life threatening arrhythmia; the expected benefits should be balanced against their risks.
In patients with structural heart disease, proarrhythmia and cardiac decompensation are special risks associated with antiarrhythmic drugs. Special caution should be exercised when prescribing in this context. Disopyramide should not be used in patients with uncompensated congestive heart failure, unless this heart failure is secondary to cardiac arrhythmia.
If disopyramide is to be given under these circumstances, special care and monitoring are essential. Life-threatening and haemodynamically significant arrhythmias are difficult to treat and affected patients have a high mortality risk.
1. Disopyramide is contra–indicated in un–paced second or third degree atrioventricular block; bundle–branch block associated with first degree atrioventricular block; un-paced bifasicular block; pre-existing long QT syndromes; severe sinus node dysfunction and severe heart failure, unless secondary to cardiac arrhythmia.
5). The sustained release formulation is contra–indicated in patients with renal or hepatic impairment.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Treatment of these arrhythmias, by whatever modality, must be initiated in hospital. Disopyramide phosphate should be avoided in patients with glaucoma. In patients with a history or family history of glaucoma, intraocular pressure should be measured before initiating treatment.
This group may be specially sensitive to the negative inotropic properties of disopyramide. Such patients should be fully digitalised or controlled with other therapy before treatment with disopyramide is commenced. Aggravation of existing arrhythmia, or emergence of a new type of arrhythmia, demands urgent review of disopyramide treatment.
Similarly, if an atrioventricular block or a bifascicular block occurs during treatment, the use of disopyramide should be reviewed. There have been reports of ventricular tachycardia, ventricular fibrillation and Torsade de Pointes in patients receiving disopyramide.
These have usually, but not always, been associated with significant widening of the QRS complex or prolonged QT interval. The QT interval and QRS duration must be monitored and disopyramide should be stopped if these are increased by more than 25%.
If these changes or arrhythmias develop the drug should be discontinued. Disopyramide should be used only with caution in patients with atrial flutter or atrial tachycardia with block as conversion of a partial AV block to a 1:1 response may occur, leading to a potentially more serious tachyarrhythmia.
The occurrence of hypotension following disopyramide administration requires prompt discontinuation of the drug. This has been observed especially in patients with cardiomyopathy or uncompensated congestive heart failure. Any resumption of therapy should be at a lower dose with close patient monitoring.
Disopyramide should be used with caution in the treatment of digitalis intoxication.
Potassium imbalance:
Antiarrhythmic drugs may be hazardous in patients with potassium imbalance, as potassium abnormalities can induce arrhythmias. During treatment with disopyramide, potassium levels should be checked regularly. Patients treated with diuretics or stimulant laxatives are at particular risk of hypokalaemia.
Renal insufficiency:
In renal insufficiency, the dosage of disopyramide should be reduced by adjusting the interval between administrations.
Hepatic insufficiency:
Hepatic impairment causes an increase in the plasma half–life of Rythmodan and a reduced dosage may be required.
Hypoglycaemia:
Hypoglycaemia has been reported in association with disopyramide administration. The risk of hypoglycaemia, sometimes severe, occurs particularly in elderly or malnourished subjects, treated diabetics and patients with renal insufficiency or cardiac failure.
Blood sugar levels should be monitored in all patients. Strict adherence to the dosing recommendations is advised. If hypoglycaemia occurs then treatment with disopyramide should be stopped. Hypoglycaemia may be associated with interactions with drugs metabolised by hepatic CYP3A (see Section