PROPAFENONE HCL- propafenone hydrochloride tablet, film coated

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

PROPAFENONE HYDROCHLORIDE (UNII: 33XCH0HOCD) (PROPAFENONE - UNII:68IQX3T69U)

Disponível em:

Actavis Pharma, Inc.

DCI (Denominação Comum Internacional):

PROPAFENONE HYDROCHLORIDE

Composição:

PROPAFENONE HYDROCHLORIDE 150 mg

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Propafenone hydrochloride is 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 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. Usage Considerations: - The use of propafenone hydrochloride tablets in patients with permanent atrial fibrillation (AF) or in patients exclusively with atrial flutter or PSVT has not been evaluated. Do not use propafenone hydrochloride tablets 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 

Resumo do produto:

Propafenone Hydrochloride Tablets USP, 150 mg are supplied as round, white, scored, film-coated tablets debossed with Watson 582 on one side and bisected on the other side. Propafenone Hydrochloride Tablets USP, 225 mg are supplied as round, white, scored, film-coated tablets debossed with Watson 583 on one side and bisected on the other side supplied in the following package sizes: 150 mg bottles of 100: NDC 0591-0582-01 225 mg bottles of 100: NDC 0591-0583-01 Storage:  Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature], at a relative humidity below 60%. Dispense in a tight, light-resistant container as defined in the USP.

Status de autorização:

Abbreviated New Drug Application

Características técnicas

PROPAFENONE HCL- PROPAFENONE HYDROCHLORIDE TABLET, FILM COATED
ACTAVIS PHARMA, INC.
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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.
INDICATIONS AND USAGE
Propafenone hydrochloride 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)
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 with drugs that increase the
atrioventricular nodal refractory period. (1)
Because of proarrhythmic effects, use with lesser ventri