propafenone hydrochloride 225 mg
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. 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 ) 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 ] .
upsher-smith laboratories, llc
CAPSULE WHITE UPSHER SMITH 0740 225 mg
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16 HOW SUPPLIED/STORAGE AND HANDLING
PROPAFENONE HYDROCHLORIDE extended-release capsules, USP are supplied as white, opaque, hard gelatin capsules containing either 225 mg, 325 mg, or 425 mg of
PROPAFENONE HYDROCHLORIDE. The 225 mg capsule is printed with "UPSHER-SMITH" over "0740" and "225mg" in black ink. Supplied as follows: Bottles of 60 capsules NDC 0832-0740-60 The 325 mg capsule is printed with "UPSHER-SMITH" over "0741" and "325mg" in black ink. Supplied as follows: Bottles of 60 capsules NDC 0832-0741-60 The 425 mg capsule is printed with "UPSHER-SMITH" over "0742" and "425mg" in black ink. Supplied as follows: Bottles of 60 capsules NDC 0832-0742-60 Storage: Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
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