Zuellig Pharma
Full Prescribing Info
Propafenone HCl.
For prophylaxis and treatment of ventricular and supraventricular tachycardias and extrasystoles.
Pharmacology: Rytmonorm is a highly effective antiarrhythmic agent with a basic local anaesthetic effect and a membrane-stabilizing effect on the cardiac muscle cell. It prolongs the refractory period in the atria and ventricles dose-dependently. Therefore, the action of Rytmonorm on cardiac arrhythmias of varying origin is pronounced and reliable.
Pharmacokinetics: After a rapid onset of effect (approximately 30 min), Rytmonorm tablet achieves its maximum effect after 2-3 hrs. The duration of effect is >8 hrs. Therefore Rytmonorm tablet is highly suitable for long-term or permanent treatment, and provides effective protection against paroxysmal tachycardias and tachyarrhythmias.
Prophylaxis and treatment of all types of ventricular and supraventricular extrasystoles, ventricular and supraventricular tachycardias and tachyarrhythmias, even in Wolff-Parkinson-White syndrome.
Dosage/Direction for Use
The dosage is as follows unless otherwise prescribed by the physician:
The individual maintenance dose should be determined under cardiological surveillance including ECG monitoring and repeated blood pressure control (adjustment phase). If the QRS phase is prolonged by >20% or the rate-dependent QT interval is lengthened, the dose should be reduced or discontinued until the ECG returns to normal. For initial and maintenance treatment, dose of 150-300 mg twice or thrice daily is recommended. This daily dose should be exceeded only in exceptional circumstances and under strict cardiological control.
These data apply to patients with a body weight of about 70 kg. The daily doses are to be reduced accordingly for patients with a lower body weight.
In the elderly or in patients with marked previous myocardial damage, the dose of Rytmonorm should, in conformity with other antiarrhythmic agents, be increased only slowly and gradually during the initial phase of treatment.
Because of the bitter taste and the surface anaesthetic action of propafenone, the tablets should be swallowed whole together with some liquid after meals.
Manifest heart failure; cardiogenic shock (except for shock induced by arrhythmia); severe bradycardia; preexisting high degree sinoatrial, atrioventricular and intraventricular disorders of impulse conduction; sick sinus syndrome (bradycardia-tachycardia syndrome); manifest disorders of the electrolyte balance; severe obstructive pulmonary diseases; marked hypotension.
Special Precautions
In impaired liver and/or renal functions, there may be drug accumulation after therapeutic doses. Even such cases may be well controlled with Rytmonorm under ECG control.
Use in pregnancy & lactation: In the 1st trimester of pregnancy and during lactation, the prescription of Rytmonorm should be given critical consideration in accordance with present views on the use of drugs.
Side Effects
On rare occasions, particularly with higher initial doses, gastrointestinal disturbances ie, anorexia, sensation of repletion, nausea, retching and vomiting, bitter taste and numbness of the mouth may occur, sporadically blurred vision and vertigo, very rarely fatigue and headache, restlessness, nightmares, sleep disorders, psychological disorders eg, states of anxiety and confusion, and extrapyramidal symptoms.
Convulsions have been observed extremely rare in cases of overdosage.
Occasionally, allergic skin reactions eg, reddening, pruritus, exanthema or urticaria may occur which are fully reversible after discontinuation of the drug. Circulatory dysregulation in orthostasis is occasionally seen, particularly in the elderly. These symptoms disappear after reduction of the dose or discontinuation of the drug. If blurred vision, dizziness, fatigue or circulatory disorders with a fall of blood pressure occur, the patient's speed of reactions may be impaired when operating machinery or motor vehicles.
In rare instances, there may be bradycardia, SA-, AV- or IV-blocks. Countermeasures in the case of SA- or AV-block: Atropine, orciprenaline; countermeasure in the case of IV-block: Electrotherapy. Existing heart failure may deteriorate.
As with other antiarrhythmic drugs or pharmaceuticals, cholestases may in rare cases occur under Rytmonorm therapy. It indicates individual hypersensitivity reactions of the hyperergic-allergic type. This symptom is not dose-related and is fully reversible after discontinuation of Rytmonorm.
As with other antiarrhythmic drugs, ventricular tachycardia or ventricular flutter, respectively fibrillation, may occur if high doses are given.
Very rarely, a decrease of the white cell count and platelet count, respectively, were observed which were fully reversible after discontinuation of Rytmonorm.
Drug Interactions
The possibility of potentiating the effect of Rytmonorm by local anaesthetics given simultaneously (eg, implantation of pacemaker, surgical or dental procedures) or by other drugs which inhibit the heart rate and/or contractility (eg, β-adrenergic blockers, tricyclic antidepressants) should be borne in mind.
Rises in propranolol, metoprolol, desipramine, cyclosporin or digoxin plasma levels, respectively, under concomitant administration of Rytmonorm have been reported. If symptoms of such overdosage occur, plasma concentrations should be determined and doses reduced, if required.
There have been reports of rises of the propafenone plasma concentrations when cimetidine was taken simultaneously.
Oral anticoagulants may interact with propafenone (potentiation of the effect of the anticoagulants). It is therefore recommended to thoroughly check the clotting parameters of such patients.
Decreases propafenone plasma concentration when used simultaneously with phenobarbital or rifampicin, possibly in subtherapeutic levels.
MIMS Class
ATC Classification
C01BC03 - propafenone ; Belongs to class Ic antiarrhythmics.
Film-coated tab 150 mg x 50's.
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