uld be monitored during therapy. (5.6)
•Agranulocytosis: Patients should report signs of infection. (5.7)
•Administer cautiously to patients with impaired hepatic and renal function. (5.8, 5.9)
•Exacerbation of myasthenia gravis has been reported. (5.10)
ADVERSE REACTIONS
The most commonly reported adverse events with propafenone (>5% and greater than placebo) excluding those not reasonably associated with the use of the drug included the following: dizziness, palpitations, chest pain, dyspnea, taste disturbance, nausea, fatigue, anxiety, constipation, upper respiratory tract infection, edema, and influenza. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. (6)
DRUG INTERACTIONS
•Inhibitors of CYP2D6, 1A2, and 3A4 may increase propafenone levels which may lead to cardiac arrhythmias. Simultaneous use with both a CYP3A4 and CYP2D6 inhibitor (or in patient with CYP2D6 deficiency) should be avoided . (7.1)
•Propafenone may increase warfarin or digoxin levels. (7.2, 7.3)
•Concomitant use of lidocaine may increase central nervous system side effects. (7.3)
•Orlistat may reduce propafenone concentrations. Abrupt cessation of orlistat in patients stable on RHYTMOL SR has resulted in convulsions, atrioventricular block, and circulatory failure. (7.5)
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 03/2011
FULL PRESCRIBING INFORMATION: CONTENTS *
WARNING: MORTALITY
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Proarrhythmic Effects
5.2 Drug Interactions: Simultaneous Use with Inhibitors of Cytochrome P450 Isoenzymes 2D6 and 3A4
5.3 Use with Drugs that Prolong the QT Interval and Antiarrhythmic Agents
5.4 Use in Patients with a History of Heart Failure
5.5 Conduction Disturbances
5.6 Effects on Pacemaker Threshold
5.7 Agranulocytosis
5.8 Use in Patients with Hepatic Dysfunction
5.9 Use in Patients with Renal Dysfunction
5.10 Use in Patients with Myasthenia Gravis
5.11 Elevated ANA Titers
5.12 Impaired Spermatogenesis
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
7 DRUG INTERACTIONS
7.1 CYP2D6 and CYP3A4 Inhibitors
7.2 Digoxin
7.3 Warfarin
7.4 Orlistat
7.5 Beta-Antagonists
7.6 Lidocaine
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Labor and Delivery
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
13.2 Animal Toxicology and/or Pharmacology
14 CLINICAL STUDIES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
17.1 Information for Patients
*
Sections or subsections omitted from the full prescribing information are not listed.
FULL PRESCRIBING INFORMATION
WARNING: MORTALITY
•In the National Heart, Lung and Blood Institute’s Cardiac Arrhythmia Suppression Trial (CAST), a long-term, multi-center, randomized, double-blind study in patients with asymptomatic non-life-threatening ventricular arrhythmias who had a myocardial infarc |
