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 )
glenmark pharmaceuticals inc., usa
CAPSULE WHITE G 409
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16 HOW SUPPLIED/STORAGE AND HANDLING
PROPAFENONE HYDROCHLORIDE Extended-Release capsules USP are supplied as hard gelatin capsules containing either 225 mg, 325 mg or 425 mg of
PROPAFENONE HYDROCHLORIDE, USP. The 225 mg capsule has a white opaque body imprinted with “408” in black ink and white opaque cap imprinted with Glenmark logo “G” in black ink. They are available as follows: NDC 68462-408-60 Bottles of 60 capsules The 325 mg capsule has a white opaque body imprinted with “409” in black ink and white opaque cap imprinted with Glenmark logo “G” in black ink. They are available as follows: NDC 68462-409-60 Bottles of 60 capsules The 425 mg capsule has a white opaque body imprinted with “410” and single band in black ink and white opaque cap imprinted with Glenmark logo “G” and single band in black ink. They are available as follows: NDC 68462-410-60 Bottles of 60 capsules Storage: Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP.
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