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Rythmol SR Label 021416 S 11 HIGHLIGHTS OF PRESCRIBING INFORMATION • Marked hypotension (4) These highlights do not include all the information needed to use • Bronchospastic disorders and severe obstructive pulmonary disease (4) RYTHMOL SR safely and effectively. See full prescribing information for • Marked electrolyte imbalance (4) RYTHMOL SR. ----------------------- WARNINGS AND PRECAUTIONS ---------------­ RYTHMOL SR (propafenone hydrochloride) Extended-Release Capsules • May cause new or worsened arrhythmias. Evaluate patients via ECG prior to for oral use and during therapy. (5.1) Initial U.S. Approval: 1989 • RYTHMOL SR may unmask Brugada or Brugada-like Syndrome. Evaluate WARNING: MORTALITY patients via ECG after initiation of therapy. (4, 5.2) See full prescribing information for complete boxed warning. • Avoid use with other antiarrhythmic agents or drugs that prolong the QT • An increased rate of death or reversed cardiac arrest rate was seen in patients interval. (5.3) treated with encainide or flecainide (Class IC antiarrhythmics) compared with • Avoid simultaneous use of propafenone with both a cytochrome P450 2D6 that seen in patients assigned to placebo. At present it is prudent to consider inhibitor and a 3A4 inhibitor. (5.4) any IC antiarrhythmic to have a significant risk of provoking proarrhythmic • May provoke overt heart failure. (5.5) events in patients with structural heart disease. • May cause dose-related first degree AV block or other conduction • Given the lack of any evidence that these drugs improve survival, disturbances. Should not be given to patients with conduction defects in antiarrhythmic agents should generally be avoided in patients with non-life­ absence of a pacemaker. (5.6) threatening ventricular arrhythmias, even if the patients are experiencing • May affect artificial pacemakers. Pacemakers should be monitored during unpleasant, but not life-threatening, symptoms or signs. therapy. (5.7) • Agranulocytosis: Patients should report signs of infection. (5.8) --------------------------- RECENT MAJOR CHANGES -------------------- • Contraindications (4) 02/2013 Administer cautiously to patients with impaired hepatic and renal function. Warnings and Precautions, Unmasking Brugada Syndrome (5.2) 02/2013 (5.9, 5.10) • Exacerbation of myasthenia gravis has been reported. (5.11) ----------------------------INDICATIONS AND USAGE --------------------­ RYTHMOL SR is an antiarrhythmic indicated to prolong the time to recurrence ------------------------------ ADVERSE REACTIONS ----------------------­ of symptomatic atrial fibrillation (AF) in patients with episodic (most likely The most commonly reported adverse events with propafenone (>5% and greater paroxysmal or persistent) AF who do not have structural heart disease. (1) than placebo) excluding those not reasonably associated with the use of the drug Usage Considerations: included the following: dizziness, palpitations, chest pain, dyspnea, taste • Use in patients with permanent atrial fibrillation or with atrial flutter or PSVT disturbance, nausea, fatigue, anxiety, constipation, upper respiratory tract has not been evaluated. Do not use to control ventricular rate during atrial infection, edema, and influenza. (6.1) fibrillation. (1) To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or • In patients with atrial fibrillation and atrial flutter, use RYTHMOL SR with www.fda.gov/medwatch. drugs that increase the atrioventricular nodal refractory period. (1) • The effect of propafenone on mortality has not been determined. (1) ------------------------------ DRUG INTERACTIONS ----------------------­ • Inhibitors of CYP2D6, 1A2, and 3A4 may increase propafenone levels which ----------------------- DOSAGE AND ADMINISTRATION ---------------­ may lead to cardiac arrhythmias. Simultaneous use with both a CYP3A4 and • Initiate therapy with 225 mg given every 12 hours. (2) CYP2D6 inhibitor (or in patients with CYP2D6 deficiency) should be • Dosage may be increased at a minimum of 5 day intervals to 325 mg every 12 avoided. (7.1) hours and, if necessary, to 425 mg every 12 hours. (2) • Propafenone may increase digoxin or warfarin levels. (7.2, 7.3) • Dose reduction should be considered in patients with hepatic impairment, • Orlistat may reduce propafenone concentrations. Abrupt cessation of orlistat significant widening of the QRS complex, or second or third degree AV in patients stable on RYTHMOL SR has resulted in convulsions, block. (2) atrioventricular block, and circulatory failure. (7.4) --------------------- DOSAGE FORMS AND STRENGTHS -------------­ • Concomitant use of lidocaine may increase central nervous system side Capsules: 225 mg, 325 mg, 425 mg. (3) effects. (7.6) ------------------------------- CONTRAINDICATIONS -----------------------­ • Heart failure (4) See 17 for PATIENT COUNSELING INFORMATION and FDA-approved • Cardiogenic shock (4) patient labeling. • Sinoatrial, atrioventricular, and intraventricular disorders of impulse Revised: 02/2013 generation and/or conduction in the absence of pacemaker (4) • Known Brugada Syndrome (4) • Bradycardia (4) FULL PRESCRIBING INFORMATION: CONTENTS* WARNING: MORTALITY 6 ADVERSE REACTIONS 1 INDICATIONS AND USAGE 6.1 Clinical Trials Experience 2 DOSAGE AND ADMINISTRATION 7 DRUG INTERACTIONS 3 DOSAGE FORMS AND STRENGTHS 7.1 CYP2D6 and CYP3A4 Inhibitors 4 CONTRAINDICATIONS 7.2 Digoxin 5 WARNINGS AND PRECAUTIONS 7.3 Warfarin 5.1 Proarrhythmic Effects 7.4 Orlistat 5.2 Unmasking Brugada Syndrome 7.5 Beta-Antagonists 5.3 Use with Drugs that Prolong the QT Interval and 7.6 Lidocaine Antiarrhythmic Agents 8 USE IN SPECIFIC POPULATIONS 5.4 Drug Interactions: Simultaneous Use with Inhibitors of 8.1 Pregnancy Cytochrome P450 Isoenzymes 2D6 and 3A4 8.2 Labor and Delivery 5.5 Use in Patients with a History of Heart Failure 8.3 Nursing Mothers 5.6 Conduction Disturbances 8.4 Pediatric Use 5.7 Effects on Pacemaker Threshold 8.5 Geriatric Use 5.8 Agranulocytosis 10 OVERDOSAGE 5.9 Use in Patients with Hepatic Dysfunction 11 DESCRIPTION 5.10 Use in Patients with Renal Dysfunction 12 CLINICAL PHARMACOLOGY 5.11 Use in Patients with Myasthenia Gravis 12.1 Mechanism of Action 5.12 Elevated ANA Titers 12.2 Pharmacodynamics 5.13 Impaired Spermatogenesis 12.3 Pharmacokinetics 1 Reference ID: 3261581 13 NONCLINICAL TOXICOLOGY 14 CLINICAL STUDIES 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 16 HOW SUPPLIED/STORAGE AND HANDLING 13.2 Animal Toxicology and/or Pharmacology 17 PATIENT COUNSELING INFORMATION 17.1 Information for Patients *Sections or subsections omitted from the full prescribing information are not listed. 1 FULL PRESCRIBING INFORMATION 2 WARNING: MORTALITY 3 • In the National Heart, Lung and Blood Institute’s Cardiac Arrhythmia Suppression 4 Trial (CAST), a long-term, multi-center, randomized, double-blind study in patients 5 with asymptomatic non-life-threatening ventricular arrhythmias who had a myocardial 6 infarction more than 6 days but less than 2 years previously, an increased rate of death 7 or reversed cardiac arrest rate (7.7%; 56/730) was seen in patients treated with 8 encainide or flecainide (Class IC antiarrhythmics) compared with that seen in patients 9 assigned to placebo (3.0%; 22/725). The average duration of treatment with encainide 10 or flecainide in this study was 10 months. 11 • The applicability of the CAST results to other populations (e.g., those without recent 12 myocardial infarction) or other antiarrhythmic drugs is uncertain, but at present, it is 13 prudent to consider any IC antiarrhythmic to have a significant proarrhythmic risk in 14 patients with structural heart disease. Given the lack of any evidence that these drugs 15 improve survival, antiarrhythmic agents should generally be avoided in patients with 16 non-life-threatening ventricular arrhythmias, even if the patients are experiencing 17 unpleasant, but not life-threatening, symptoms or signs. 18 1 INDICATIONS AND USAGE 19 RYTHMOL SR® is indicated to prolong the time to recurrence of symptomatic atrial 20 fibrillation (AF) in patients with episodic (most likely paroxysmal or persistent) AF who do not 21 have structural heart disease. 22 Usage Considerations: 23 • The use of RYTHMOL SR in patients with permanent AF or in patients exclusively with 24 atrial flutter or paroxysmal supraventricular tachycardia (PSVT) has not been evaluated. Do 25 not use RYTHMOL SR to control ventricular rate during AF. 26 • Some patients with atrial flutter treated with propafenone have developed 1:1 conduction, 27 producing an increase in ventricular rate. Concomitant treatment with drugs that increase the 28 functional atrioventricular (AV) nodal refractory period is recommended. 29 • The effect of propafenone on mortality has not been determined [see Boxed Warning]. 30 2 DOSAGE AND ADMINISTRATION 31 RYTHMOL SR can be taken with or without food. Do not crush or further divide the 32 contents of the capsule. 33 The dose of RYTHMOL SR must be individually titrated on the basis of response and 34 tolerance. Initiate therapy with RYTHMOL SR 225 mg given every 12 hours. Dosage may be 35 increased at a minimum of 5-day interval to 325 mg given every 12 hours. If additional 2 Reference ID: 3261581 36 therapeutic effect is needed, the dose of RYTHMOL SR may be increased to 425 mg given every 37 12 hours. 38 In patients with hepatic impairment or those with significant widening of the QRS 39 complex or second or third degree AV block, consider reducing the dose. 40 The combination of CYP3A4 inhibition and
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