PROPAFENONE HCL hydrochloride tablet film coated

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

Avera McKennan Hospital

INN (Alþjóðlegt nafn):

PROPAFENONE HYDROCHLORIDE

Samsetning:

PROPAFENONE HYDROCHLORIDE 225 mg

Gerð lyfseðils:

PRESCRIPTION DRUG

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

PROPAFENONE HCL- PROPAFENONE HYDROCHLORIDE TABLET, FILM COATED
AVERA MCKENNAN HOSPITAL
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HIGHLIGHTS OF PRESCRIBING INFORMATION
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
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 NONLIFE-THREATENING VENTRICULAR
ARRHYTHMIAS, EVEN IF THE PATIENTS
ARE EXPERIENCING UNPLEASANT, BUT NOT LIFE-THREATENING, SYMPTOMS OR
SIGNS.
RECENT MAJOR CHANGES
Contraindications (4) 3/2013
Warnings and Precautions, Unmasking Brugada Syndrome (5.2) 3/2013
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
pro