País: Estados Unidos
Idioma: inglés
Fuente: NLM (National Library of Medicine)
PROPAFENONE HYDROCHLORIDE (UNII: 33XCH0HOCD) (PROPAFENONE - UNII:68IQX3T69U)
Bryant Ranch Prepack
ORAL
PRESCRIPTION DRUG
Propafenone HCl Extended Release Capsules, USP 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 ER 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 ER 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 ER capsules is contraindicated in the following circumstances: • Heart failure • Cardiogenic shock • Sinoatrial, atrioventricular, and in
Propafenone Hydrochloride Extended Release Capsules, USP, 325 mg are available as hard gelatin capsules containing 325 mg of propafenone HCl. The capsule is an orange opaque cap printed “par/210” in black ink and white opaque body printed “par/210” in black ink. NDC 63629-2271-1 Bottles of 90 capsules Storage: Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP.
Abbreviated New Drug Application
PROPAFENONE HYDROCHLORIDE- PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE BRYANT RANCH PREPACK ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE PROPAFENONE HYDROCHLORIDE EXTENDED RELEASE CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR PROPAFENONE HYDROCHLORIDE EXTENDED RELEASE CAPSULES. PROPAFENONE HYDROCHLORIDE EXTENDED RELEASE CAPSULES, FOR ORAL USE INITIAL U.S. APPROVAL: 1989 WARNING: MORTALITY _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ • AN INCREASED RATE OF DEATH OR REVERSED CARDIAC ARREST RATE WAS SEEN IN PATIENTS TREATED WITH ENCAINIDE OR FLECAINIDE (CLASS IC ANTIARRHYTHMICS) COMPARED WITH THAT SEEN IN PATIENTS ASSIGNED TO PLACEBO. AT PRESENT, IT IS PRUDENT TO CONSIDER ANY IC ANTIARRHYTHMIC TO HAVE A SIGNIFICANT RISK OF PROVOKING PROARRHYTHMIC EVENTS IN PATIENTS WITH STRUCTURAL HEART DISEASE. • GIVEN THE LACK OF ANY EVIDENCE THAT THESE DRUGS IMPROVE SURVIVAL, ANTIARRHYTHMIC AGENTS SHOULD GENERALLY BE AVOIDED IN PATIENTS WITH NON-LIFE-THREATENING VENTRICULAR ARRHYTHMIAS, EVEN IF THE PATIENTS ARE EXPERIENCING UNPLEASANT, BUT NOT LIFE-THREATENING, SYMPTOMS OR SIGNS. INDICATIONS AND USAGE Propafenone HCl Extended Release Capsules, USP 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) 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 ER capsules with drugs that increase the atrioventricular nodal refractory period. (1) • The effect of propafenone on mortality has not been determined. (1) DOSAGE AND ADMINISTRATION • Initiate therapy with 225 mg given every 12 Leer el documento completo