These highlights do not include all the information needed to use RYTHMOL SR safely and effectively. See full prescribing information for RYTHMOL SR.
Non-cardiac related adverse events occurring in greater than or equal to 2% of the patients in any of the RAFT propafenone SR treatment groups and more common with propafenone than with placebo, excluding those that are common in the population and those not plausibly related to drug therapy, included the following: blurred vision, constipation, diarrhea, dry mouth, flatulence, nausea, vomiting, fatigue, weakness, upper respiratory tract infection, blood alkaline phosphatase increased, hematuria, muscle weakness, dizziness (excluding vertigo), headache, taste disturbance, tremor, somnolence, anxiety, depression, ecchymosis.
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Rythmol official prescribing information for healthcare professionals. Includes: indications, dosage, adverse reactions, pharmacology and more.
Propafenone has caused new or worsened arrhythmias. Because propafenone prolongs the QRS interval in the electrocardiogram, changes in the QT interval are difficult to interpret. It is therefore essential that each patient given Rythmol be evaluated electrocardiographically prior to and during therapy to determine whether the response to Rythmol supports continued treatment. It may also worsen premature ventricular contractions or supraventricular arrhythmias, and it may prolong the QT interval. Such proarrhythmic effects include sudden death and life-threatening ventricular arrhythmias such as ventricular fibrillation, ventricular tachycardia, asystole, and torsade de pointes.
These laboratory findings were usually not associated with clinical symptoms, but there is one published case of drug-induced lupus erythematosis (positive rechallenge); it resolved compley upon discontinuation of therapy.
RYTHMOL (propafenone hydrochloride) is an antiarrhythmic drug supplied in scored, film-coated tablets of 150 and 225 mg for oral administration. What are the possible side effects of propafenone (Rythmol, Rythmol SR)? Therefore, avoid simultaneous use of RYTHMOL with both a CYP2D6.
There were 5 deaths, 3 in the pooled RYTHMOL SR group (0.8%) and 2 in the placebo group (1.6%). Concurrent use of propafenone with other antiarrhythmic agents has not been well studied. In a study of sustained-release propafenone (RYTHMOL SR), there were too few deaths to assess the long term risk to patients. In the overall RYTHMOL SR and RYTHMOL immediate-release database of 8 studies, the mortality rate was 2.5% per year on propafenone and 4.0% per year on placebo.
It is therefore essential that each patient given RYTHMOL be evaluated electrocardiographically prior to and during therapy to determine whether the response to RYTHMOL supports continued treatment.
This medication is used to treat certain types of serious (possibly fatal) irregular heartbeat (such as paroxysmal supraventricular tachycardia and atrial fibrillation). It is used to restore normal heart rhythm and maintain a regular, steady heartbeat. Propafenone is known as an anti-arrhythmic drug.
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Rythmol (propafenone hydrochloride) is a Class IC anti-arrhythmic used to prevent serious heart rhythm disorders.
Adverse reactions reported for > 1.5% of 474 SVT patients who received RYTHMOL in U.S. clinical trials are presented in Table 1 by incidence and percent discontinuation, reported to the nearest percent.
Cunha, DO, FACOEP. Medical Editor: John P.
Nervous System: Abnormal dreams, abnormal speech, abnormal vision, confusion, depression, memory loss, numbness, paresthesias, psychosis / mania, seizures (0.3%), tinnitus, unusual smell sensation, vertigo.
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