PROPAFENONE HYDROCHLORIDE capsule, extended release

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

AvKARE, Inc.

INN (Tarptautinis Pavadinimas):

PROPAFENONE HYDROCHLORIDE

Sudėtis:

PROPAFENONE HYDROCHLORIDE 325 mg

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

Propafenone HCl Extended Release Capsules is 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

Produkto santrauka:

Propafenone Hydrochloride Extended Release Capsules, 225 mg are available as hard gelatin capsules containing 225 mg of propafenone HCl. The capsule is a pink opaque cap printed “par/209” in black ink and white opaque body printed “par/209” in black ink. Propafenone Hydrochloride Extended Release Capsules, 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 42291-545-60  Bottles of 60 capsules Propafenone Hydrochloride Extended Release Capsules, 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 42291-546-60  Bottles of 60 capsules Propafenone Hydrochloride Extended Release Capsules, 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 42291-547-60  Bottles of 60 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.

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

PROPAFENONE HYDROCHLORIDE- PROPAFENONE HYDROCHLORIDE CAPSULE,
EXTENDED RELEASE
AVKARE, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
PROPAFENONE HYDROCHLORIDE EXTENDED RELEASE CAPSULES
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PROPAFENONE HCL
EXTENDED RELEASE CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
PROPAFENONE HCL EXTENDED RELEASE CAPSULES.
PROPAFENONE HYDROCHLORIDE EXTENDED RELEASE CAPSULES
INITIAL U.S. APPROVAL: 1989
_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) 2/2013
Warnings and Precautions, Unmasking Brugada Syndrome (5.2) 2/2013
INDICATIONS AND USAGE
Propafenone HCl Extended Release Capsules 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 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 HCl Extended Release with drugs that
increase the atrioventricular nodal refractory period. ( 1)
• The effect of propafenone on morta