Classes
DEA Class; Rx
Common Brand Names; Rythmol, Rythmol SR
- Antidysrhythmics, Ic
Description
Oral class IC antiarrhythmic; used to suppress life-threatening ventricular arrhythmias; mechanism similar to encainide and flecainide; possesses beta-blocking activity; proarrhythmic; should be initiated in the hospital to allow for appropriate ECG monitoring.
Indications
Indicated for the treatment of sustained ventricular tachycardia that is deemed to be life-threatening.
Contraindications
Hypersensitivity
Bradycardia, asthma/bronchospastic disorders or severe obstructive pulmonary disease, marked hypotension, cardiogenic shock, intraventricular disorders of impulse generation and/or conduction including sick sinus node and syndrome AV block (unless artificial pacemaker present), electrolyte imbalances, CHF, severe hypotension, myasthenia gravis
Known Brugada syndrome
Concomitant ritonavir therapy
Adverse Effects
- Unusual taste (7-23%)
- Dizziness/lightheadedness (7-15%)
- N/V (3-11%)
- Constipation (4-8%)
- Headache (2-6%)
- Intraventricular conduction delay (4%)
- Fatigue (6%)
- Blurred vision (3%)
- Weakness (3%)
- Dyspnea (2%)
- Wild complex tachycardia (2%)
- Bradycardia (2%)
- Palpitations (2%)
- Tremor (2%)
- Anorexia (2%)
- Diarrhea (2%)
- Ataxia (2%)
- 1°AV block (2-5%)
- Angina (5%)
- Palpitations (3%)
- CHF (2-3% )
- Chest pain (2%)
- Bradyarrhythmia (2%)
- AF (1%)
- Bundle branch block (1%)
- 2nd degree AV block (1%)
- Hypotension (1%)
- Sinus arrest (1%)
- Lethargy
- Rash
- Dyspepsia
- Dry mouth
- Agranulocytosis
- Hepatotoxicity (rare)
- Systemic lupus erythematosus (rare)
- Bronchospasm (rare)
Warnings
May alter pacemaker thresholds
Elevated ANA titers reported with use; may consider discontinuing therapy in symptomatic patients with positive ANA titers
Use caution in patients with hematologic disorders, myasthenia gravis (may exacerbate condition), hepatic/renal impairment
Use with caution in patients with hypersensitivity to propranolol
There is a potential for increased mortality post-MI, as with encainide and flecainide (other class ICs)
May cause new or worsened arrhythmias; proarrhythmic effects include sudden death and life-threatening ventricular arrhythmias such as ventricular fibrillation, ventricular tachycardia, asystole, and torsade de pointes; important to evaluate patient electrocardiographically prior to and during therapy to determine whether response supports continued treatment; because propafenone prolongs QRS interval in electrocardiogram, changes in the QT interval are difficult to interpret
Through CYP3A inhibition, grapefruit juice consumption may decrease elimination (ie, increase serum levels)
Correct electrolyte imbalance, especially hypomagnesemia or hypokalemia before initiating therapy and throughout
Plasma concentration has poor correlation to antiarrhythmia effect
New or worsening HF may occur; propafenone exerts a negative inotropic activity on myocardium as well as beta-blockade effects and may provoke overt heart failure; CHF attributable to propafenone HCl develops rarely (less than 0.2%) in subjects with ventricular arrhythmia who had no previous history of CHF
Slows AV conduction and may cause AV block
Brugada syndrome may be unmasked after exposure to propafenone; perform ECG after initiation and discontinue the drug if changes are suggestive of Brugada Syndrome
Agranulocytosis reported (most within first 2 months of treatment)
Highly metabolized by liver; severe liver impairment increases bioavailability by 70%; carefully monitor patients with impaired hepatic function for excessive pharmacological effects
Pregnancy and Lactation
There are no studies in pregnant women; available data from published case reports and several decades of postmarketing experience with use in pregnancy have not identified any drug-associated risks of miscarriage, birth defects, or adverse maternal or fetal outcomes; untreated arrhythmias during pregnancy may pose a risk to pregnant woman and fetus; the drug and its metabolite, 5-OH-propafenone, cross the placenta in humans
Propafenone and its active metabolite, 5-OH-propafenone, are present in human milk, but levels are likely to be low; there are no data on effects on breastfed infant or on milk production
Maximum Dosage
900 mg/day PO immediate-release tablets (Rythmol); 850 mg/day PO extended-release capsules (Rythmol SR).
900 mg/day PO immediate-release tablets (Rythmol); 850 mg/day PO extended-release capsules (Rythmol SR).
Safety and efficacy have not been established.
Safety and efficacy have not been established; however, doses up to 600 mg/m2/day PO immediate-release tablets have been used off-label for WPW.
Safety and efficacy have not been established; however, doses up to 600 mg/m2/day PO immediate-release tablets have been used off-label for WPW.
How supplied
Propafenone hydrochloride
tablet
- 150mg
- 225mg
- 300mg
capsule, extended-release
- 225mg
- 325mg
- 425mg