12 HR Propafenone Hydrochloride 425 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 )
Mylan Pharmaceuticals Inc.
CAPSULE RED MYLAN 1261
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16 HOW SUPPLIED/STORAGE AND HANDLING Propafenone Hydrochloride Extended-Release capsules, USP are available containing 225 mg, 325 mg or 425 mg of propafenone hydrochloride, USP. The 225 mg capsules are hard-shell gelatin capsules with a standard red opaque cap and white opaque body filled with white to off-white pellets. The capsules are axially printed with MYLAN over 1258 in black ink on the cap and body. They are available as follows: NDC 0378-1258-91 bottles of 60 capsules The 325 mg capsules are hard-shell gelatin capsules with a standard red opaque cap and pink opaque body filled with white to off-white pellets. The capsules are axially printed with MYLAN over 1259 in black ink on the cap and body. They are available as follows: NDC 0378-1259-91 bottles of 60 capsules The 425 mg capsules are hard-shell gelatin capsules with a standard red opaque cap and orange opaque body filled with white to off-white pellets. The capsules are axially printed with MYLAN over 1261 in black ink on the cap and body. They are available as follows: NDC 0378-1261-91 bottles of 60 capsules Store at 20° to 25°C (68° to 77°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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