PROPAFENONE HYDROCHLORIDE tablet, film coated

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Aurobindo Pharma Limited

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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 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 incr

Produkt oversigt:

Propafenone Hydrochloride Tablets, USP 150 mg is available for oral administration as white to off-white color, round shaped, biconvex, film-coated tablet debossed with “PR” above the break line, “OT” below the break line on one side and “150” on other side. Bottles of 100     NDC 59651-256-01 Bottles of 300      NDC 59651-256-33                                                     Propafenone Hydrochloride Tablets, USP 225 mg is available for oral administration as white to off-white color, round shaped, biconvex, film-coated tablet debossed with “PR” above the break line, “OT” below the break line on one side and “225” on other side. Bottles of 100       NDC 59651-257-01 Bottles of 300      NDC 59651-257-33 Propafenone Hydrochloride Tablets, USP 300 mg is available for oral administration as white to off-white color, round shaped, biconvex, film-coated tablet debossed with “PR” above the break line, “OT” below the break line on one side and “300” on other side. Bottles of 100      NDC 59651-258-01 Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container.

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

PROPAFENONE HYDROCHLORIDE - PROPAFENONE HYDROCHLORIDE TABLET, FILM
COATED
AUROBINDO PHARMA LIMITED
----------
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 tablets with drugs that
increase the atrioventricular nodal refractory period. (1)
Because of proarrhythmic effects