12 HR Propafenone Hydrochloride 325 MG Extended Release Oral Capsule
1 INDICATIONS AND USAGE Propafenone hydrochloride extended-release capsules are 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. Usage Considerations: The use of propafenone hydrochloride extended-release capsules in patients with permanent AF or in patients exclusively with atrial flutter or paroxysmal supraventricular tachycardia (PSVT) has not been evaluated. Do not use propafenone hydrochloride extended-release capsules 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 effect of propafenone on mortality has not been determined [see Boxed Warning ] . Propafenone hydrochloride extended-release capsules are 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 ) Usage Considerations: Use in patients with permanent atrial fibrillation or with atrial flutter or paroxysmal supraventricular tachycardia (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 extended-release capsules with drugs that increase the atrioventricular nodal refractory period. ( 1 ) The effect of propafenone on mortality has not been determined. ( 1 )
Actavis Pharma, Inc.
CAPSULE WHITE WPI 2286
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16 HOW SUPPLIED/STORAGE AND HANDLING
PROPAFENONE HYDROCHLORIDE Extended-Release capsules are supplied as opaque white capsules containing either 225 mg, 325 mg, or 425 mg of propafenone HCl. The 225 mg capsule is printed with “WPI” on cap and “2285” on body in black ink. The 325 mg capsule is printed with “WPI” on cap and “2286” on body in black ink. The 425 mg capsule is printed with “WPI” on cap and “2287” on body in black ink. The capsules are filled with white circular biconvex minitablets plain on both sides. capsule Strength Bottle Count NDC 225 mg 60 0591-2285-60 325 mg 60 0591-2286-60 425 mg 60 0591-2287-60 Storage: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container.
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