propafenone hcl propafenone hydrochloride tablet film coated
1 INDICATIONS AND USAGE Propafenone hydrochloride is indicated to: prolong the time to recurrence of paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms in patients without structural heart disease. prolong the time to recurrence of paroxysmal supraventricular tachycardia (PSVT) associated with disabling symptoms in patients without structural heart disease. treat documented ventricular arrhythmias, such as sustained ventricular tachycardia that, in the judgment of the physician, are life-threatening. Initiate treatment in the hospital. Usage Considerations: The use of propafenone hydrochloride tablets in patients with permanent atrial fibrillation (AF) or in patients exclusively with atrial flutter or PSVT has not been evaluated. Do not use propafenone hydrochloride tablets to control ventricular rate during AF. 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 atrioventricular (AV) nodal refractory period is recommended. The use of propafenone hydrochloride tablets in patients with chronic atrial fibrillation has not been evaluated. Because of the proarrhythmic effects of propafenone hydrochloride, 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. The effect of propafenone on mortality has not been determined [see Boxed Warning ]. Propafenone hydrochloride is an antiarrhythmic indicated to: prolong the time to recurrence of symptomatic atrial fibrillation (AF) in patients with episodic (most likely paroxysmal or persistent) AF who do not have structural heart disease. ( 1 ) prolong the time to recurrence of paroxysmal supraventricular tachycardia (PSVT) associated with disabling symptoms in patients who do not have structural heart disease. ( 1 ) treat documented life-threatening ventricular arrhythmias. ( 1 ) Usage Considerations: Use in patients with permanent atrial fibrillation or with atrial flutter or PSVT has not been evaluated. Do not use to control ventricular rate during atrial fibrillation. ( 1 ) In patients with atrial fibrillation and atrial flutter, use propafenone hydrochloride with drugs that increase the atrioventricular nodal refractory period. ( 1 ) Because of proarrhythmic effects, use with lesser ventricular arrhythmias is not recommended, even if patients are symptomatic. ( 1 ) The effect of propafenone on mortality has not been determined. ( 1 )
actavis pharma, inc.
ROUND WHITE Watson 582
Watson 582 ROUND WHITE
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16 HOW SUPPLIED/STORAGE AND HANDLING
PROPAFENONE HYDROCHLORIDE Tablets USP, 150 mg are supplied as round, white, scored, film-coated tablets debossed with Watson 582 on one side and bisected on the other side.
PROPAFENONE HYDROCHLORIDE Tablets USP, 225 mg are supplied as round, white, scored, film-coated tablets debossed with Watson 583 on one side and bisected on the other side supplied in the following package sizes: 150 mg bottles of 100: NDC 0591-0582-01 225 mg bottles of 100: NDC 0591-0583-01 Storage: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature], at a relative humidity below 60%. Dispense in a tight, light-resistant container as defined in the USP.
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