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ALERT: U.S. Boxed Warning
The FDA-approved labeling includes a boxed warning. See Warnings/Precautions section for a concise summary of this information. For verbatim wording of the boxed warning, consult the product labeling or www.fda.gov.
Pronunciation
(pro PAF en one)
Generic Available (U.S.)
Yes
Index Terms
Brand Names: U.S.
Brand Names: Canada
Pharmacologic Category
Pharmacologic Category Synonyms
Use: Labeled Indications
Treatment of life-threatening ventricular arrhythmias; treatment of paroxysmal atrial fibrillation/flutter (PAF) or paroxysmal supraventricular tachycardia (PSVT) in patients with disabling symptoms and without structural heart disease
Extended release capsule: Prolong the time to recurrence of symptomatic atrial fibrillation in patients without structural heart disease
Use: Unlabeled
Cardioversion of recent-onset atrial fibrillation (single dose); supraventricular tachycardia in patients with Wolff-Parkinson-White syndrome
Pregnancy Risk Factor
C
Pregnancy Considerations
There are no adequate and well-controlled studies in pregnant women; use only if potential benefit to the mother justifies potential risk to the fetus.
Lactation
Enters breast milk/not recommended
Contraindications
Hypersensitivity to propafenone or any component of the formulation; sinoatrial, AV, and intraventricular disorders of impulse generation and/or conduction (except in patients with a functioning artificial pacemaker); sinus bradycardia; cardiogenic shock; uncompensated cardiac failure; hypotension; bronchospastic disorders or severe obstructive pulmonary disease; uncorrected electrolyte abnormalities; concurrent use of ritonavir
Warnings/Precautions
Boxed warnings:
• CAST trial: See “Other warnings/precautions” below.
Concerns related to adverse effects:
• Agranulocytosis: Agranulocytosis has been reported; generally occurring within the first 2 months of therapy. Upon therapy discontinuation, WBC usually normalized by 14 days.
• Conduction disturbances: Slows atrioventricular conduction, potentially leading to first degree AV block; degree of PR interval prolongation and increased QRS duration are dose and concentration related. Avoid in patients with conduction disturbances (unless functioning pacemaker present).
• Proarrhythmic effects: Can cause life-threatening drug-induced arrhythmias, including ventricular fibrillation, ventricular tachycardia, asystole, and torsade de pointes (Hii, 1991). The manufacturer notes that propafenone may increase the QT interval; however, due to QRS prolongation; changes in the QT interval are difficult to interpret. In an evaluation of propafenone (450 mg/day) in healthy individuals compared to other selected antiarrhythmic agents, propafenone did not affect repolarization time (eg, QT, QTc, JT, JTc) only depolarization time (ie, QRS interval) (Sarubbi, 1998). Monitor for proarrhythmic effects, and when necessary, adjust dose to prevent QTc prolongation.
Disease-related concerns:
• Electrolyte imbalance: Correct electrolyte disturbances, especially hypokalemia or hypomagnesemia, prior to use and throughout therapy.
• Heart failure (HF): Avoid use in patients with HF; similar agents have been shown to increase mortality in this population; may precipitate or exacerbate condition (Lindenfeld, 2010).
• Hepatic impairment: Use with caution in patients with hepatic impairment.
• Lupus erythematosus: Positive ANA titers have been reported with use. Titers have decreased with and without therapy discontinuation. Positive titers have not usually been associated with clinical symptoms, although at least one case of drug induced lupus erythematosus has been reported. Consider therapy discontinuation in symptomatic patients with positive ANA titers.
• Myasthenia gravis: Use with caution in patients with myasthenia gravis; may exacerbate condition.
• Pulmonary disease: The use of propafenone is not recommended in patients with obstructive lung disease (eg, COPD) (Fuster, 2006). Use in patients with bronchospastic disease or severe obstructive lung disease is contraindicated.
• Renal impairment: Use with caution in patients with renal impairment.
Concurrent drug therapy issues:
• CYP2D6 and CYP3A4 inhibitors: Avoid concurrent use with CYP2D6 inhibitor and CYP3A4 inhibitor; may result in an increased risk of proarrhythmia or exaggerated beta-adrenergic blocking activity
• Drugs with QT-prolongation potential: Concurrent use of propafenone with QT-prolonging agents has not been extensively evaluated. The manufacturer recommends withholding Class Ia or Class III antiarrhythmics for at least 5 half-lives prior to starting propafenone.
Other warnings/precautions:
• CAST trial: [U.S. Boxed Warning]: In the Cardiac Arrhythmia Suppression Trial (CAST), recent (>6 days but <2 years ago) myocardial infarction patients with asymptomatic, non-life-threatening ventricular arrhythmias did not benefit and may have been harmed by attempts to suppress the arrhythmia with flecainide or encainide. An increased mortality or nonfatal cardiac arrest rate (7.7%) was seen in the active treatment group compared with patients in the placebo group (3%). The applicability of the CAST results to other populations is unknown. Antiarrhythmic agents should be reserved for patients with life-threatening ventricular arrhythmias.
• Pacemakers: May alter pacing and sensing thresholds of artificial pacemakers.
Adverse Reactions
1% to 10%:
Cardiovascular: New or worsened arrhythmia (proarrhythmic effect) (2% to 10%), angina (2% to 5%), CHF (1% to 4%), ventricular tachycardia (1% to 3%), palpitation (1% to 3%), AV block (first-degree) (1% to 3%), syncope (1% to 2%), increased QRS interval (1% to 2%), chest pain (1% to 2%), PVCs (1% to 2%), bradycardia (1% to 2%), edema (0% to 1%), bundle branch block (0% to 1%), atrial fibrillation (1%), hypotension (0% to 1%), intraventricular conduction delay (0% to 1%)
Central nervous system: Dizziness (4% to 15%), fatigue (2% to 6%), headache (2% to 5%), ataxia (0% to 2%), insomnia (0% to 2%), anxiety (1% to 2%), drowsiness (1%)
Dermatologic: Rash (1% to 3%)
Gastrointestinal: Nausea/vomiting (2% to 11%), unusual taste (3% to 23%), constipation (2% to 7%), dyspepsia (1% to 3%), diarrhea (1% to 3%), xerostomia (1% to 2%), anorexia (1% to 2%), abdominal pain (1% to 2%), flatulence (0% to 1%)
Neuromuscular & skeletal: Tremor (0% to 1%), arthralgia (0% to 1%), weakness (1% to 2%)
Ocular: Blurred vision (1% to 6%)
Respiratory: Dyspnea (2% to 5%)
Miscellaneous: Diaphoresis (1%)
<1% (Limited to important or life-threatening), postmarketing, and/or case reports: Abnormal dreams, abnormal smell sensation, abnormal speech, abnormal vision, agranulocytosis, alopecia, amnesia, ANA titers positive (0.7%), anemia, apnea, asystole, AV block (second or third degree), AV dissociation, bleeding time increased, cardiac arrest, CHF, cholestasis (0.1%), coma, confusion, depression, eye irritation, flushing, gastroenteritis, granulocytopenia, hepatitis (0.03%), hyperglycemia, hyponatremia, impotence, kidney failure, leukopenia, mania, memory loss, muscle cramps, muscle weakness, nephrotic syndrome, numbness, pain, paresthesia, peripheral neuropathy, positive lupus erythematosus, prolonged PR interval, pruritus, psychosis, purpura, renal failure, seizure (0.3%), serum transaminases increased (0.2%), SIADH, sinus arrest, sinus node dysfunction, thrombocytopenia, tinnitus, torsade de pointes, ventricular fibrillation, vertigo
Metabolism/Transport Effects
Substrate of CYP1A2 (minor), CYP2D6 (major), CYP3A4 (minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential; Inhibits CYP1A2 (weak), CYP2D6 (weak)
Drug Interactions
Abiraterone Acetate: May increase the serum concentration of CYP2D6 Substrates. Management: Avoid concurrent use of abiraterone with CYP2D6 substrates that have a narrow therapeutic index whenever possible. When concurrent use is not avoidable, monitor patients closely for signs/symptoms of toxicity. Risk D: Consider therapy modification
Alfuzosin: May enhance the QTc-prolonging effect of QTc-Prolonging Agents. Risk C: Monitor therapy
Amiodarone: May enhance the adverse/toxic effect of Propafenone. Specifically, the combination may result in altered cardiac conduction and repolarization. Amiodarone may increase the serum concentration of Propafenone. Risk X: Avoid combination
ARIPiprazole: CYP2D6 Inhibitors (Weak) may increase the serum concentration of ARIPiprazole. Management: Monitor for increased aripiprazole pharmacologic effects. Aripiprazole dose adjustments may or may not be required based on concomitant therapy and/or indication. Consult product labeling for specific recommendations. Risk C: Monitor therapy
Artemether: May enhance the QTc-prolonging effect of QTc-Prolonging Agents. Risk X: Avoid combination
Barbiturates: May decrease the serum concentration of Propafenone. Risk C: Monitor therapy
Beta-Blockers: Propafenone may increase the serum concentration of Beta-Blockers. Propafenone possesses some independent beta blocking activity. Exceptions: Atenolol; Carteolol; Carteolol (Ophthalmic); Levobunolol; Metipranolol; Nadolol. Risk C: Monitor therapy
Boceprevir: May increase the serum concentration of Propafenone. Risk C: Monitor therapy
Cardiac Glycosides: Propafenone may increase the serum concentration of Cardiac Glycosides. Risk C: Monitor therapy
Chloroquine: May enhance the QTc-prolonging effect of QTc-Prolonging Agents. Risk C: Monitor therapy
Cimetidine: May increase the serum concentration of Propafenone. Risk C: Monitor therapy
Ciprofloxacin: May enhance the QTc-prolonging effect of QTc-Prolonging Agents. Risk C: Monitor therapy
Ciprofloxacin (Systemic): May enhance the QTc-prolonging effect of QTc-Prolonging Agents. Risk C: Monitor therapy
CYP2D6 Inhibitors (Moderate): Propafenone may increase the serum concentration of CYP2D6 Inhibitors (Moderate). Risk C: Monitor therapy
CYP2D6 Inhibitors (Strong): May increase the serum concentration of Propafenone. Risk C: Monitor therapy
CYP3A4 Inhibitors (Moderate): May increase the serum concentration of Propafenone. Risk C: Monitor therapy
CYP3A4 Inhibitors (Strong): May increase the serum concentration of Propafenone. Risk C: Monitor therapy
Cyproterone: May decrease the serum concentration of CYP1A2 Substrates. Risk C: Monitor therapy
Dronedarone: QTc-Prolonging Agents may enhance the QTc-prolonging effect of Dronedarone. Risk X: Avoid combination
Etravirine: May decrease the serum concentration of Propafenone. Risk C: Monitor therapy
FLUoxetine: May increase the serum concentration of Propafenone. Risk C: Monitor therapy
FluvoxaMINE: May increase the serum concentration of Propafenone. Risk C: Monitor therapy
Gadobutrol: May enhance the QTc-prolonging effect of QTc-Prolonging Agents. Risk D: Consider therapy modification
Indacaterol: May enhance the QTc-prolonging effect of QTc-Prolonging Agents. Risk C: Monitor therapy
Lumefantrine: May enhance the QTc-prolonging effect of QTc-Prolonging Agents. Risk X: Avoid combination
Nilotinib: May enhance the QTc-prolonging effect of QTc-Prolonging Agents. Risk X: Avoid combination
Orlistat: May decrease the serum concentration of Propafenone. Risk C: Monitor therapy
PARoxetine: May increase the serum concentration of Propafenone. Risk C: Monitor therapy
Peginterferon Alfa-2b: May decrease the serum concentration of CYP2D6 Substrates. Risk C: Monitor therapy
Pimozide: QTc-Prolonging Agents may enhance the QTc-prolonging effect of Pimozide. Risk X: Avoid combination
Propranolol: Propafenone may increase the serum concentration of Propranolol. Risk C: Monitor therapy
QTc-Prolonging Agents: May enhance the adverse/toxic effect of other QTc-Prolonging Agents. Their effects can be additive, causing life-threatening ventricular arrhythmias. Risk D: Consider therapy modification
QUEtiapine: May enhance the QTc-prolonging effect of QTc-Prolonging Agents. Risk X: Avoid combination
QuiNIDine: May enhance the QTc-prolonging effect of Propafenone. QuiNIDine may increase the serum concentration of Propafenone. Risk X: Avoid combination
QuiNINE: QTc-Prolonging Agents may enhance the QTc-prolonging effect of QuiNINE. QuiNINE may enhance the QTc-prolonging effect of QTc-Prolonging Agents. Risk X: Avoid combination
Rifamycin Derivatives: May decrease the serum concentration of Propafenone. Management: Monitor propafenone serum concentrations closely with rifamycin initiation/dose adjustments/discontinuation. Propafenone serum concentrations/therapeutic effects may decrease with rifamycins. Propafenone dose adjustments may be necessary. Risk D: Consider therapy modification
Ritonavir: May increase the serum concentration of Propafenone. Risk X: Avoid combination
Saquinavir: May enhance the arrhythmogenic effect of Propafenone. Saquinavir may increase the serum concentration of Propafenone. Risk X: Avoid combination
Telaprevir: May enhance the adverse/toxic effect of Propafenone. Risk C: Monitor therapy
Tetrabenazine: QTc-Prolonging Agents may enhance the QTc-prolonging effect of Tetrabenazine. Risk X: Avoid combination
Theophylline Derivatives: Propafenone may increase the serum concentration of Theophylline Derivatives. Exceptions: Dyphylline. Risk C: Monitor therapy
Thioridazine: QTc-Prolonging Agents may enhance the QTc-prolonging effect of Thioridazine. Risk X: Avoid combination
Tipranavir: May increase the serum concentration of Propafenone. Risk X: Avoid combination
Tocilizumab: May decrease the serum concentration of CYP3A4 Substrates. Risk C: Monitor therapy
Toremifene: QTc-Prolonging Agents may enhance the QTc-prolonging effect of Toremifene. The risk for potentially dangerous arrhythmias may be increased. Risk X: Avoid combination
Vandetanib: QTc-Prolonging Agents may enhance the arrhythmogenic effect of Vandetanib. Risk X: Avoid combination
Vemurafenib: QTc-Prolonging Agents may enhance the QTc-prolonging effect of Vemurafenib. Risk X: Avoid combination
Venlafaxine: Propafenone may increase the serum concentration of Venlafaxine. Management: Monitor for increased venlafaxine levels/adverse effects (e.g., hallucinations, agitation, confusion) with propafenone initiation/dose increase. Conversely, monitor for decreased venlafaxine levels with profapenone discontinuation/dose decrease. Risk C: Monitor therapy
Vitamin K Antagonists (eg, warfarin): Propafenone may increase the serum concentration of Vitamin K Antagonists. Risk C: Monitor therapy
Ziprasidone: QTc-Prolonging Agents may enhance the QTc-prolonging effect of Ziprasidone. The risk of a severe arrhythmia may be increased. Risk X: Avoid combination
Ethanol/Nutrition/Herb Interactions
Food: Propafenone serum concentrations may be increased if taken with food.
Herb/Nutraceutical: St John's wort may decrease propafenone levels. Avoid ephedra (may worsen arrhythmia).
Storage
Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).
Mechanism of Action
Propafenone is a class 1c antiarrhythmic agent which possesses local anesthetic properties, blocks the fast inward sodium current, and slows the rate of increase of the action potential. Prolongs conduction and refractoriness in all areas of the myocardium, with a slightly more pronounced effect on intraventricular conduction; it prolongs effective refractory period, reduces spontaneous automaticity and exhibits some beta-blockade activity.
Pharmacodynamics/Kinetics
Absorption: Well absorbed
Distribution: Vd: Adults: 252 L
Protein binding: 95% to alpha1-acid glycoprotein
Metabolism: Hepatic via CYP2D6, CYP3A4 and CYP1A2 to two active metabolites (5-hydroxypropafenone and N-depropylpropafenone) then ultimately to glucuronide or sulfate conjugates. Two genetically determined metabolism groups exist (extensive and poor metabolizers); 10% of Caucasians are poor metabolizers. Exhibits nonlinear pharmacokinetics; when dose is increased from 300-900 mg/day, serum concentrations increase tenfold; this nonlinearity is thought to be due to saturable first-pass effect.
Bioavailability: Immediate release (IR): 150 mg: 3.4%; 300 mg: 10.6%; relative bioavailability of extended release (ER) capsule is less than IR tablet; the bioavailability of an ER capsule regimen of 325 mg twice-daily regimen approximates an IR tablet regimen of 150 mg 3 times/day.
Half-life elimination: Extensive metabolizers: 2-10 hours; Poor metabolizers: 10-32 hours
Time to peak, serum: IR: 3.5 hours; ER: 3-8 hours
Excretion: Urine (<1% unchanged; remainder as glucuronide or sulfate conjugates); feces
Dosage
Oral: Adults: Note: Patients who exhibit significant widening of QRS complex or second- or third-degree AV block may need dose reduction.
Atrial fibrillation (to prevent recurrence): Extended release capsule: Initial: 225 mg every 12 hours; dosage increase may be made at a minimum of 5-day intervals; may increase to 325 mg every 12 hours; if further increase is necessary, may increase to 425 mg every 12 hours
Paroxysmal atrial fibrillation/flutter, paroxysmal supraventricular tachycardia, ventricular arrhythmias: Immediate release tablet: Initial: 150 mg every 8 hours; dosage increase may be made at minimum of 3- to 4-day intervals, may increase to 225 mg every 8 hours; if further increase is necessary, may increase to 300 mg every 8 hours
Atrial fibrillation, pharmacologic cardioversion (unlabeled use): Note: To prevent rapid AV conduction, start an AV nodal-blocking agent (eg, beta-blocker, nondihydropyridine calcium channel blocker) prior to pharmacologic cardioversion. Effect occurs between 2-6 hours after administration.
Immediate release tablet: 600 mg as single dose (Fuster, 2006)
Dosing adjustment in renal impairment: No dosage adjustments provided in manufacturer's labeling; however, 50% of propafenone metabolites (active) are excreted in the urine; use with caution in renal impairment
Dosing adjustment in hepatic impairment:
Immediate release tablet: Reduce dose by 70% to 80% in patients with hepatic impairment
Extended release capsule: Specific dosage adjustments are not provided in manufacturer's labeling; however, dosage reduction should be considered as drug undergoes hepatic metabolism.
Administration: Oral
Capsules should be swallowed whole; do not crush or chew; may be taken without regard to meals.
Monitoring Parameters
ECG, blood pressure, pulse (particularly at initiation of therapy)
Dietary Considerations
Capsule: May be taken without regard to meals.
Patient Education
You will need regular cardiac checkups. You may experience dizziness, drowsiness, insomnia, or blurred vision; abnormal taste, nausea, vomiting, or loss of appetite; headache; or muscle or joint pain. Report unusual weight gain, swelling of extremities, or respiratory difficulty. Report immediately or seek emergency help if you experience chest pain; palpitations; or increased, decreased, or erratic heartbeat.
Geriatric Considerations
Elderly may have age-related decreases in hepatic Phase I metabolism. Propafenone is dependent upon liver metabolism, therefore, monitor closely in the elderly and adjust dose more gradually during initial treatment. No differences in clearance noted with impaired renal function and, therefore, no adjustment for renal function in the elderly is necessary.
Cardiovascular Considerations
Propafenone is a class Ic antiarrhythmic with very weak beta-blocking properties. Avoid propafenone use in patients with cardiovascular disease, particularly recent myocardial infarction and heart failure, due to a possible increase in proarrhythmia and mortality.
"Pill-in-the Pocket" administration approach: Patients with a history of palpitations with an abrupt onset, were hemodynamically stable, and had 1-12 episodes of atrial fibrillation within the previous year (and no other cardiac symptoms) were candidates for a clinical trial evaluating flecainide or propafenone for conversion of their rhythm (Alboni, 2004). Patients had to have minimal, if any, heart disease. Only 12% of all patients evaluated for this trial were eligible for inclusion, thus this type of treatment is only for select patients meeting both inclusion and exclusion criteria. However, patients who had met inclusion criteria and were given either flecainide or propafenone in the hospital phase of the trial and converted to normal sinus rhythm were then enrolled into the ambulatory phase of the trial. Patients in this outpatient trial were to take either flecainide or propafenone at the first onset of palpitations. The doses were as follows: Flecainide 300 mg for patients ≥70 kg and 200 mg for patients <70 kg; propafenone 600 mg for patients ≥70 kg and 450 mg for patients <70 kg. Patients were instructed to sit or lie down after taking either drug until palpitations had stopped or for at least 4 hours. If palpitations had not subsided after 6–8 hours, then the patients were instructed to go to the emergency room. They were not to take more than one dose in a 24-hour period. This treatment regimen demonstrated that 94% of episodes in the 165 patients studied were successfully treated with a mean time to symptom resolution of 113 minutes. Adverse events were reported in 12 patients. One patient developed atrial flutter with a rapid ventricular response that required an emergency room visit. The other 11 patients complained of noncardiac side effects (eg, nausea, weakness, and vertigo). This therapy demonstrated a significant reduction in emergency room visits and hospitalization. The current atrial fibrillation guidelines recommend a single 600 mg dose instead of the weight-based approach (Fuster, 2006).
Selected patients with infrequent paroxysmal atrial fibrillation may be candidates for the “Pill-in-the-Pocket” regimen. An initial inpatient conversion trial should have been successful before sending patient home on this approach. Patient must be taking an AV nodal-blocking agent (eg, beta-blocker, nondihydropyridine calcium channel blocker) prior to initiation of antiarrhythmic. Many patients may not be appropriate candidates for this regimen, based on previous clinical studies − CAST, CAST 2, CASH; a number of exclusion criteria define the potential harm of these agents.
Dental Health: Effects on Dental Treatment
Key adverse event(s) related to dental treatment: Unusual taste and significant xerostomia (normal salivary flow resumes upon discontinuation).
Dental Health: Vasoconstrictor/Local Anesthetic Precautions
In some patients, propafenone has been reported to induce new or worsened arrhythmias (proarrhythmic effect). It is suggested that vasoconstrictors be used with caution since epinephrine has the potential to stimulate the heart rate when given in the anesthetic regimen. The manufacturer notes that propafenone may increase the QT interval; however, due to QRS prolongation; changes in the QT interval are difficult to interpret. Cases of torsade de pointes have been reported. The risk of drug-induced torsade de pointes is extremely low when a single QT interval prolonging drug is prescribed. In terms of epinephrine, it is not known what effect vasoconstrictors in the local anesthetic regimen will have in patients with a known history of congenital prolonged QT interval or in patients taking any medication that prolongs the QT interval. Until more information is obtained, it is suggested that the clinician consult with the physician prior to the use of a vasoconstrictor in suspected patients, and that the vasoconstrictor (epinephrine, mepivacaine and levonordefrin [Carbocaine® 2% with Neo-Cobefrin®]) be used with caution.
Dental Comment
Propafenone may prolong the QT interval. The QT interval is measured as the time and distance between the Q point of the QRS complex and the end of the T wave in the ECG tracing. After adjustment for heart rate, the QT interval is defined as prolonged if it is more than 450 msec in men and 460 msec in women. A long QT syndrome was first described in the 1950s and 60s as a congenital syndrome involving QT interval prolongation and syncope and sudden death. Some of the congenital long QT syndromes were characterized by a peculiar electrocardiographic appearance of the QRS complex involving a premature atria beat followed by a pause, then a subsequent sinus beat showing marked QT prolongation and deformity. This type of cardiac arrhythmia was originally termed “torsade de pointes” (translated from the French as “twisting of the points”). Propafenone is considered as having a risk of causing torsade de pointes. Since it is not known what effect vasoconstrictors in the local anesthetic regimen will have in patients with a known history of congenital prolonged QT interval or in patients taking any medication that prolongs the QT interval, a medical consult is suggested.
Mental Health: Effects on Mental Status
Dizziness and drowsiness are common; may cause anxiety
Mental Health: Effects on Psychiatric Treatment
May rarely cause agranulocytosis; use caution with clozapine and carbamazepine; use TCAs with caution; may cause QT prolongation
Nursing: Physical Assessment/Monitoring
Evaluate for use cautions (eg, bronchospastic disorders, hepatic dysfunction, myasthenia gravis). Correct electrolyte abnormalities prior to and throughout use. Assess cardiac status when beginning therapy, titrating dosage, and on a regular basis; may cause new or worsened arrhythmias.
Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Capsule, extended release, oral, as hydrochloride: 225 mg, 325 mg, 425 mg
Rythmol® SR: 225 mg, 325 mg, 425 mg [contains soy lecithin]
Tablet, oral, as hydrochloride: 150 mg, 225 mg, 300 mg
Rythmol®: 150 mg, 225 mg, 300 mg [DSC] [scored]
Pricing: U.S. (www.drugstore.com)
Capsule, 12-hour (Propafenone HCl)
225 mg (30): $179.98
325 mg (30): $189.99
425 mg (30): $199.98
Capsule, 12-hour (Rythmol SR)
225 mg (30): $189.99
325 mg (30): $247.78
425 mg (60): $512.97
Tablets (Propafenone HCl)
150 mg (90): $115.99
225 mg (90): $123.00
300 mg (30): $70.99
Tablets (Rythmol)
150 mg (30): $134.99
225 mg (30): $170.99
References
Alboni P, Botto GL, Baldi N, et al, "Outpatient Treatment of Recent-Onset Atrial Fibrillation With the "Pill-in-the-Pocket" Approach," N Engl J Med, 2004, 351(23):2384-91.
“A Randomized, Placebo-Controlled Trial of Propafenone in the Prophylaxis of Paroxysmal Supraventricular Tachycardia and Paroxysmal Atrial Fibrillation. UK Propafenone PSVT Study Group,” Circulation, 1995, 92(9):2550-7.
Blomström-Lundqvist C, Scheinman MM, Aliot EM, et al, “ACC/AHA/ESC Guidelines for the Management of Patients With Supraventricular Arrhythmias--Executive Summary. A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the European Society of Cardiology Committee for Practice Guidelines (Writing Committee to Develop Guidelines for the Management of Patients With Supraventricular Arrhythmias),” Circulation, 2003, 108(15):1871-909.
Boriani G, Capucci A, Lenzi T, et al, “Propafenone for Conversion of Recent-Onset Atrial Fibrillation. A Controlled Comparison Between Oral Loading Dose and Intravenous Administration,” Chest, 1995, 108(2):355-8.
Boriani G, Biffi M, Capucci A, et al, “Oral Propafenone to Convert Recent-Onset Atrial Fibrillation in Patients With and Without Underlying Heart Disease. A Randomized, Controlled Trial,” Ann Intern Med, 1997, 126(8):621-5.
Echt DS, Liebson PR, Mitchell LB, et al, “Mortality and Morbidity in Patients Receiving Encainide, Flecainide, or Placebo: The Cardiac Arrhythmia Suppression Trial,” N Engl J Med, 1991, 324(12):781-8.
Funck-Brentano C, Kroemer HK, Lee JT, et al, “Propafenone,” N Engl J Med, 1990, 322(8):518-25.
Fuster V, Ryden LE, Cannom DS, et al, “ACC/AHA/ESC 2006 Guidelines for the Management of Patients With Atrial Fibrillation-Executive Summary. A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the European Society of Cardiology Committee for Practice Guidelines (Writing Committee to Revise the 2001 Guidelines for the Management of Patients With Atrial Fibrillation). Developed in Collaboration With the European Heart Rhythm Association and the Heart Rhythm Society,” J Am Coll Cardiol, 2006, 48(4):854-906.
Hii JT, Wyse DG, Gillis AM, et al, “Propafenone-Induced Torsade de Pointes: Cross-Reactivity With Quinidine,” Pacing Clin Electrophysiol, 1991,14(11 Pt 1):1568-70.
Lindenfeld J, Albert NM, Boehmer JP, et al, “HFSA 2010 Comprehensive Heart Failure Practice Guideline,” J Card Fail, 2010, 16(6):e1-194.
Sarubbi B, Ducceschi V, Briglia N, et al, “Compared Effects of Sotalol, Flecainide and Propafenone on Ventricular Repolarization in Patients Free of Underlying Structural Heart Disease,” Int J Cardiol, 1998, 66(2):157-64.
Siddoway LA, Roden DM, and Woosley RL, “Clinical Pharmacology of Propafenone: Pharmacokinetics, Metabolism and Concentration-Response Relations,” Am J CArdiol, 1984, 54(9):9D-12D.
Skanes AC, Healey JS, Cairns JA, et al, “Focused 2012 Update of the Canadian Cardiovascular Society Atrial Fibrillation Guidelines: Recommendations for Stroke Prevention and Rate/Rhythm Control,” Can J Cardiol, 2012, 28(2):125-36.
Wann SL, Curtis AB, January CT, et al, “2011 ACCF/AHA/HRS Focused Update on the Management of Patients With Atrial Fibrillation (Updating the 2006 Guideline): A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines,” Circulation, 2011, 123 (1):104-23.
International Brand Names
Lexi-Comp.com
Last full review/revision March 2012
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