PROPAFENONE HYDROCHLORIDE tablet film coated

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

Bryant Ranch Prepack

INN (Rahvusvaheline Nimetus):

PROPAFENONE HYDROCHLORIDE

Koostis:

PROPAFENONE HYDROCHLORIDE 150 mg

Retsepti tüüp:

PRESCRIPTION DRUG

Volitamisolek:

Abbreviated New Drug Application

Toote omadused

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
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 NON- LIFE-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 tablets 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 hydrochlorid