Product Description.:
5125 V
tablet , film-coated , white , scored , round round
RYTHMOL (propafenone hydrochloride) is an antiarrhythmic drug supplied in scored, film-coated tablets of 150, 225 and 300 mg for oral administration. Propafenone has some structural similarities to beta-blocking agents.
Propafenone hydrochloride occurs as colorless crystals or white crystalline powder with a very bitter taste. It is slightly soluble in water (20?C), chloroform and ethanol. The following inactive ingredients are contained in the tablet: corn starch, hypromellose, magnesium stearate, polyethylene glycol, polysorbate, povidone, propylene glycol, sodium starch glycolate and titanium dioxide.
INDICATIONS
In patients without structural heart disease, RYTHMOL (propafenone HCl) is indicated to prolong the time to recurrence of
* paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms.
* paroxysmal supraventricular tachycardia (PSVT) associated with disabling symptoms.
As with other agents, some patients with atrial flutter treated with propafenone have developed 1:1 conduction, producing an increase in ventricular rate. Concomitant treatment with drugs that increase the functional AV refractory period is recommended.
The use of propafenone HCl in patients with chronic atrial fibrillation has not been evaluated. Propafenone HCl should not be used to control ventricular rate during atrial fibrillation.
Propafenone HCl is also indicated for the treatment of
* documented ventricular arrhythmias, such as sustained ventricular tachycardia, that, in the judgement of the physician, are life-threatening. Because of the proarrhythmic effects of propafenone HCl, its use with lesser ventricular arrhythmias is not recommended, even if patients are symptomatic, and any use of the drug should be reserved for patients in whom, in the opinion of the physician, the potential benefits outweigh the risks.
Initiation of propafenone HCl treatment, as with other antiarrhythmics used to treat life-threatening ventricular arrhythmias, should be carried out in the hospital.
Propafenone HCl, like other antiarrhythmic drugs, has not been shown to enhance survival in patients with ventricular or atrial arrhythmias.
SIDE EFFECTS
Adverse reactions associated with propafenone HCl occur most frequently in the gastrointestinal, cardiovascular, and central nervous systems. About 20% of patients treated with propafenone HCl have discontinued treatment because of adverse reactions.
Adverse reactions reported for > 1.5% of 474 SVT patients who received propafenone in U.S. clinical trials are presented in the following table by incidence and percent discontinuation, reported to the nearest percent.
