Generic Medicine Info
Should be taken with food. Swallow whole, do not chew/crush.
Significant structural heart disease, MI within the last 3 months, uncontrolled CHF with LVEF below 35%, cardiogenic shock (unless arrhythmia-induced), severe symptomatic bradycardia, severe hypotension, known Brugada syndrome, marked electrolyte imbalance (e.g. K metabolism disorders, hypomagnesaemia), myasthenia gravis, bronchospastic disorders or severe obstructive pulmonary disease; sinus node dysfunction, atrial conduction defects, 2nd degree or greater atrioventricular (AV) block, bundle branch block or distal block in the absence of a pacemaker. Concomitant use with ritonavir.
Special Precautions
Patients with pacemakers, mild to moderate obstructive airways disease (e.g. asthma). May potentially convert paroxysmal atrial fibrillation to atrial flutter with 2:1 or 1:1 conduction block. Renal and hepatic impairment. Elderly. Pregnancy and lactation. CYP2D6 ultrarapid, intermediate, and poor metabolisers. Patient Counselling This drug may cause dizziness, blurred vision, fatigue, or postural hypotension, if affected, do not drive or operate machinery. Monitoring Parameters Closely monitor ECG, blood pressure, and pulse at treatment initiation. Monitor vital signs, pacemaker function, and ANA titre.
Adverse Reactions
Significant: Cardiac conduction disorder (e.g. slows AV conduction), CNS effects (e.g. dizziness, blurred vision, fatigue), agranulocytosis, elevated antinuclear antibody (ANA) titre, hepatic abnormalities, fulminant hepatitis. Blood and lymphatic system disorders: Thrombocytopenia, leucopenia, granulocytopenia. Cardiac disorders: Palpitations, bradycardia, tachycardia. Gastrointestinal disorders: Nausea, vomiting, dry mouth, dysgeusia, constipation, diarrhoea, abdominal pain, flatulence. General disorders and administration site conditions: Asthenia, chest pain, pyrexia. Hepatobiliary disorders: Abnormal hepatic function, jaundice. Metabolism and nutrition disorders: Decreased appetite. Musculoskeletal and connective tissue disorders: Lupus-like syndrome. Nervous system disorders: Headache, paraesthesia, syncope, convulsion. Psychiatric disorders: Anxiety, sleep disorders, nightmare. Reproductive system and breast disorders: Erectile dysfunction. Respiratory, thoracic and mediastinal disorders: Dyspnoea. Skin and subcutaneous tissue disorders: Rash, pruritus, erythema, urticaria. Vascular disorders: Hypotension, orthostatic hypotension.
Potentially Fatal: Proarrhythmic effects (e.g. ventricular fibrillation, ventricular tachycardia, asystole, torsade de pointes).
Drug Interactions
Increased plasma levels with CYP2D6, CYP3A4 and CYP1A2 inhibitors (e.g. fluoxetine, paroxetine, sertraline, quinidine; ketoconazole, cimetidine, erythromycin, saquinavir, amiodarone, nicotine). Increased risk of adverse effects of lidocaine. Increased risk of conduction and repolarisation abnormalities with amiodarone. May reduce plasma levels with CYP3A4 inducers (e.g. phenobarbital, rifampicin). Increased risk of arrhythmia when used with antiarrhythmics/arrhythmogenic drugs. Increased plasma concentrations of oral anticoagulants (e.g. warfarin, phenprocoumon), propranolol, metoprolol, desipramine, ciclosporin, theophylline, digoxin, venlafaxine. Absorption may be reduced by orlistat.
CIMS Class
Cardiac Drugs
ATC Classification
C01BC03 - propafenone ; Belongs to class Ic antiarrhythmics.
Disclaimer: This information is independently developed by CIMS based on propafenone from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2022 CIMS. All rights reserved. Powered by
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