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RYTHMODAN RETARD is a brand name for Disopyramide. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Properties: Prevention and control of a wide variety of cardiac arrhythmias, probably by slowing conduction in the his-Purkinje system and by increasing the effective refractory period of the atria and ventricles. Indications: 1. Maintenance of normal rhythm following conversion by parenteral drugs or…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Recommended dose for stabilised patients or those receiving disopyramide for the first time is one to one and a half tablets (250-375 mg) twice daily. Tablets should be swallowed and not crushed or chewed. 4). 3). 3). Method of administration Oral use.
The frequencies of possible undesirable effects listed below are currently defined as: Very common ≥ 1/10 Common ≥ 1/100 to < 1/10 Uncommon ≥ 1/1,000 to < 1/100 Rare ≥ 1/10,000 to < 1/1,000 Very rare < 1/10,000 Not known cannot be estimated from the available data Cardiac disorders: Not known: 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 hypokalaemia 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). In some cases, severe hypoglycaemia resulted in coma. • Nervous system disorders Very rare: headache, dizzy sensation • Hepatobiliary disorder Very rare: cholestatic jaundice • Skin and subcutaneous tissue disorders Very rare: rashes Reporting of suspected adverse reactions Reporting 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. g. 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. Treatment of these arrhythmias, by whatever modality, must be initiated in hospital. Disopyramide phosphate should be avoided in patients with glaucoma.
1. Disopyramide is contraindicated in unpaced second- or third-degree atrioventricular block; bundle-branch block associated with first-degree atrioventricular block; unpaced bifascicular 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 contraindicated in patients with renal or hepatic impairment. The sustained release formulation is contraindicated in children.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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In patients with a history or family history of glaucoma, intraocular pressure should be measured before initiating treatment. Owing to its negative inotropic effect, disopyramide should be used with caution in patients suffering from significant cardiac failure.
This group may be especially 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 Torsades 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.
3). 3). Hepatic impairment causes an increase in the plasma half-life of disopyramide 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. 5). 5), – aggravation of myasthenia gravis, – cognitive disorders, especially in elderly patients.
Sucrose Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. Glucose Patients with rare glucose-galactose malabsorption should not take this medicine.