PROPAFENONE HYDROCHLORIDE capsule, extended release

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

Par Pharmaceutical, Inc.

INN (nemzetközi neve):

PROPAFENONE HYDROCHLORIDE

Összetétel:

PROPAFENONE HYDROCHLORIDE 325 mg

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

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 is contraindicated in the following circumstances: • Heart failure • Cardiogenic shock • Sinoatrial, atrioventricular, and in

Termék összefoglaló:

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. NDC 49884-113-02 Bottles of 60 capsules NDC 49884-113-09 Bottles of 90 capsules NDC 49884-113-01 Bottles of 100 capsules NDC 49884-113-05 Bottles of 500 capsules NDC 49884-113-10 Bottles of 1000 capsules 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. NDC 49884-210-02 Bottles of 60 capsules NDC 49884-210-09 Bottles of 90 capsules NDC 49884-210-01 Bottles of 100 capsules NDC 49884-210-05 Bottles of 500 capsules NDC 49884-210-10 Bottles of 1000 capsules Propafenone Hydrochloride Extended Release Capsules, USP, 425 mg are available as hard gelatin capsules containing 425 mg of propafenone HCl. The capsule is a red opaque cap printed “par/211” in black ink and white opaque body printed “par/211” in black ink. NDC 49884-211-02 Bottles of 60 capsules NDC 49884-211-09 Bottles of 90 capsules NDC 49884-211-01 Bottles of 100 capsules NDC 49884-211-05 Bottles of 500 capsules NDC 49884-211-10 Bottles of 1000 capsules Storage: Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP.

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

PROPAFENONE HYDROCHLORIDE- PROPAFENONE HYDROCHLORIDE CAPSULE,
EXTENDED RELEASE
PAR PHARMACEUTICAL, INC.
----------
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