PROPAFENONE HYDROCHLORIDE capsule, extended release

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

American Health Packaging

Manustamisviis:

ORAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

Propafenone HCl Extended Release Capsules, USP are 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. Usage Considerations: - The use of propafenone ER capsules in patients with permanent AF or in patients exclusively with atrial flutter or paroxysmal supraventricular tachycardia (PSVT) has not been evaluated. Do not use propafenone ER capsules 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 functional atrioventricular (AV) nodal refractory period is recommended. - The effect of propafenone on mortality has not been determined [see BOXED WARNING ]. Propafenone ER capsules are contraindicated in the following circumstances: - Heart failure - Cardiogenic shock - Sinoatrial, atrioventricular

Toote kokkuvõte:

Propafenone Hydrochloride Extended Release Capsules, USP, 225 mg are available as hard gelatin capsules containing 225 mg of propafenone HCl. The capsule is a white opaque cap printed “par/209” in black ink and white opaque body printed “par/209” in black ink. Unit dose packages of 20 (5 x 4) NDC 60687-185-32 Propafenone Hydrochloride Extended Release Capsules, USP, 325 mg are available as hard gelatin capsules containing 325 mg of propafenone HCl. The capsule is an orange opaque cap printed “par/210” in black ink and white opaque body printed “par/210” in black ink. Unit dose packages of 20 (5 x 4) NDC 68084-917-32 Storage: Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Volitamisolek:

Abbreviated New Drug Application

Toote omadused

PROPAFENONE HYDROCHLORIDE- PROPAFENONE HYDROCHLORIDE CAPSULE,
EXTENDED RELEASE
AMERICAN HEALTH PACKAGING
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PROPAFENONE
HYDROCHLORIDE EXTENDED RELEASE CAPSULES SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING
INFORMATION FOR PROPAFENONE HYDROCHLORIDE EXTENDED RELEASE CAPSULES.
PROPAFENONE HYDROCHLORIDE EXTENDED RELEASE CAPSULES, 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.
INDICATIONS AND USAGE
Propafenone HCl Extended Release Capsules, USP 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)
USAGE CONSIDERATIONS:
Use in patients with permanent atrial fibrillation or with atrial
flutter or paroxysmal supraventricular
tachycardia (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 ER capsules with drugs that increase
the atrioventricular nodal refractory period. ( 1)
The effect of propafenone on mortality has not been determined. ( 1)
DOSAGE AND ADMINISTRATION
Initiate therapy with 225 mg given every 12 hours. ( 2)
Dosa