prolong the time to recurrence of symptomatic atrial fibrillation (AF) in patients with episodic (most likely paroxysmal or persistent) AF who do not have structural heart disease.
Propafenone works by slowing the influx of sodium ions into the cardiac muscle cells, causing a decrease in excitability of the cells. Propafenone is more selective for cells with a high rate, but also blocks normal cells more than class Ia or Ib. Propafenone differs from the prototypical class Ic antiarrhythmic in that it has additional activity as a beta-adrenergic blocker which can cause bradycardia and bronchospasm.
Ventricular arrhythmias (specialist supervision in hospital) | Paroxysmal supraventricular tachyarrhythmias which include paroxysmal atrial flutter or fibrillation and paroxysmal re-entrant tachycardias involving the AV node or accessory pathway, where standard therapy ineffective or contraindicated (specialist supervision in hospital) BY MOUTH Adult: Initially 150 mg 3 times a day, dose to be taken after food, monitor ECG and blood pressure, if QRS interval prolonged by more than 20%, reduce dose or discontinue until ECG returns to normal limits; increased if necessary to 300 mg twice daily (max. per dose 300 mg 3 times a day), dose to be increased at intervals of at least 3 days, reduce total daily dose for patients under 70 kg Elderly: Initially 150 mg 3 times a day, dose to be taken after food, monitor ECG and blood pressure, if QRS interval prolonged by more than 20%, reduce dose or discontinue until ECG returns to normal limits; increased if necessary to 300 mg twice daily (max. per dose 300 mg 3 times a day), dose to be increased at intervals of at least 5 days, reduce total daily dose for patients under 70 kg
Propafenone is metabolized by CYP2D6 (major pathway) and CYP1A2 and CYP3A4. Drugs that inhibit CYP2D6 (such as desipramine, paroxetine, ritonavir, sertraline), CYP1A2 (such as amiodarone) and CYP3A4 (such as ketoconazole, ritonavir, saquinavir, erythromycin and grapefruit juice) can be expected to cause increased plasma levels of propafenone. In addition, propafenone is an inhibitor of CYP2D6. Coadministration of propafenone with drugs metabolized by CYP2D6 (such as desipramine, imipramine, haloperidol, venlafaxine) might lead to increase plasma concentrations of these drugs.
Atrial conduction defects (unless adequately paced) . Brugada syndrome . bundle branch block (unless adequately paced) . cardiogenic shock (except arrhythmia induced) . distal block (unless adequately paced) . electrolyte disturbances . marked hypotension . myasthenia gravis . myocardial infarction within last 3 months . second degree or greater AV block (unless adequately paced) . severe bradycardia . severe obstructive pulmonary disease (due to weak beta-blocking activity) . sinus node dysfunction (unless adequately paced) . uncontrolled congestive heart failure with left ventricular ejection fraction less than 35%. Elderly . great caution in mild to moderate obstructive airways disease owing to beta-blocking activity . heart failure . pacemaker patients . potential for conversion of paroxysmal atrial fibrillation to atrial flutter with 2:1 or 1:1 conduction block
Common or very common Bradycardia . abdominal pain . anxiety . atrioventricular block . blurred vision . chest pain . constipation . diarrhoea . dizziness . dry mouth . dyspnoea . headache . intraventricular blocks . malaise . nausea . palpitation . sino-atrial block . sleep disorders . tachycardia . taste disturbance . vomiting Uncommon Abdominal distension . anorexia . ataxia . erectile dysfunction . flatulence . hypotension . paraesthesia . pro-arrhythmic effects . rash . syncope . thrombocytopenia . vertigo Frequency not known Agranulocytosis . cholestasis . confusion . convulsions . extrapyramidal symptoms . granulocytopenia . hepatitis . jaundice . leucopenia . lupus erythematosus-like syndrome . reduced sperm count (reversible on withdrawal) . restlessness
PREGNANCY Use only if potential benefit outweighs risk. BREAST FEEDING Use with caution?present in milk.
Store at 25° C. Store in a cool and dry place, protected from light. Keep out of children’s reach.
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