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:

Par Pharmaceutical, Inc.

INN (International Name):

PROPAFENONE HYDROCHLORIDE

Sammensætning:

PROPAFENONE HYDROCHLORIDE 150 mg

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 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

Produkt oversigt:

Propafenone hydrochloride tablets, USP are supplied as white, scored, round, film-coated tablets in three dosage strengths: 150 mg tablets debossed “5124” and “V” available as follows: 225 mg tablets debossed “5125” and “V” available as follows: 300 mg tablets debossed “5126” 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.

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

PROPAFENONE HYDROCHLORIDE- PROPAFENONE HYDROCHLORIDE TABLET, FILM
COATED
PAR PHARMACEUTICAL, INC.
----------
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)
Beca