Zuellig Pharma
Concise Prescribing Info
Propafenone HCl
Symptomatic supraventricular tachyarrhythmias warranting treatment (eg, AV junctional tachycardias, supraventricular tachycardias in patients w/ Wolff-Parkinson-White syndrome or paroxysmal atrial fibrillation). Serious symptomatic ventricular tachyarrhythmias if life-threatening or necessitating treatment.
Dosage/Direction for Use
Initial & maintenance dose: 450-600 mg daily in 2-3 divided doses. May be increased to 900 mg daily.
May be taken with or without food: Swallow whole, do not chew/crush.
Hypersensitivity. Brugada syndrome. Incidence of MI w/in the last 3 mth. Significant structural heart disease eg, uncontrolled CHF where left ventricular output is <35%, cardiogenic shock (unless caused by arrhythmia), severe symptomatic bradycardia, presence of sinus node dysfunction, atrial conduction defects, 2nd degree or greater AV block or bundle branch block or distal block in the absence of an artificial pacemaker, severe hypotension. Electrolyte imbalance (eg, K metabolism disorders). Severe obstructive pulmonary disease. Myasthenia gravis. Concomitant use w/ ritonavir.
Special Precautions
Propafenone-like other antiarrhythmics may cause proarrhythmic effects ie, may cause new or worsen preexisting arrhythmias. Evaluate patients electrocardiographically & clinically prior to & during therapy. Perform ECG after initiation of therapy to rule out changes suggestive of Brugada syndrome. Check & re-program pacemaker function during therapy. Patients w/ significant structural heart disease; airway obstruction (eg, asthma). May affect the patient's speed of reaction & impair the individual's ability to operate machinery & motor vehicles. Patients w/ renal disease. Pregnancy & lactation. Elderly.
Adverse Reactions
Dizziness; cardiac conduction disorders, palpitations. Anxiety, sleep disorders; headache, dysgeusia; blurred vision; sinus bradycardia, bradycardia, tachycardia, atrial flutter; dyspnoea; abdominal pain, vomiting, nausea, diarrhoea, constipation, dry mouth; abnormal hepatic function; chest pain, asthenia, fatigue, pyrexia.
Drug Interactions
Possible potentiation of drug side effects w/ local anesth (eg, pacemaker implantation, surgery or dental work) & drugs which have an inhibitory effect on the heart rate &/or myocardial contractility (eg, β-blockers, TCAs). May increase plasma/blood levels of drugs metabolized by CYP2D6 (eg, venlafaxine); propranolol, metoprolol, desipramine, cyclosporine, theophylline & digoxin. Increased levels w/ inhibitors of CYP2D6, CYP1A2 & CYP3A4 (eg, ketoconazole, cimetidine, quinidine, erythromycin & grapefruit juice). Potential for increased plasma conc w/ ritonavir. May affect conduction & repolarization w/ amiodarone. Increased risk of CNS side effects w/ IV lidocaine. Phenobarb (chronic use). Reduced antiarrhythmic efficacy w/ rifampicin. May enhance the efficacy of oral anticoagulants (eg, phenprocoumon, warfarin) resulting in an increased prothrombin time. Elevated plasma levels w/ SSRIs (eg, fluoxetine & paroxetine).
MIMS Class
Cardiac Drugs
ATC Classification
C01BC03 - propafenone ; Belongs to class Ic antiarrhythmics.
Rytmonorm FC tab 150 mg
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