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 hydrochloride tablets are indicated to: - prolong the time to recurrence of paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms in patients without structural heart disease. prolong the time to recurrence of paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms in patients without structural heart disease. - prolong the time to recurrence of paroxysmal supraventricular tachycardia (PSVT) associated with disabling symptoms in patients without structural heart disease. prolong the time to recurrence of paroxysmal supraventricular tachycardia (PSVT) associated with disabling symptoms in patients without structural heart disease. - treat documented ventricular arrhythmias, such as sustained ventricular tachycardia that, in the judgment of the physician, are life-threatening. Initiate treatment in the hospital. treat documented ventricular arrhythmias, such as sustained ventricular tachycardia that, in the judgment of the physician, are life
Propafenone hydrochloride tablets, USP are supplied as white, scored, round, film-coated tablets in the following dosage strengths: 150 mg tablets debossed “5124” and “V” available as follows: STORE at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]. DISPENSE in a tight, light-resistant container as defined in the USP.
Abbreviated New Drug Application
PROPAFENONE HYDROCHLORIDE- PROPAFENONE HYDROCHLORIDE TABLET, FILM COATED BRYANT RANCH PREPACK ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE PROPAFENONE HYDROCHLORIDE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR PROPAFENONE HYDROCHLORIDE TABLETS. PROPAFENONE HYDROCHLORIDE TABLETS, 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 SUBJECTS TREATED WITH ENCAINIDE OR FLECAINIDE (CLASS IC ANTIARRHYTHMICS) COMPARED WITH THAT SEEN IN SUBJECTS 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. RECENT MAJOR CHANGES INDICATIONS AND USAGE Propafenone hydrochloride tablets 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) prolong the time to recurrence of paroxysmal supraventricular tachycardia (PSVT) associated with disabling symptoms in patients who do not have structural heart disease. (1) treat documented life-threatening ventricular arrhythmias. (1) USAGE CONSIDERATIONS: Use in patients with permanent atrial fibrillation or with atrial flutter or 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 tablets with drugs that increase the atrioventricular nodal refractory period. (1) Because Leer el documento completo