PROPAFENONE HYDROCHLORIDE capsule, extended release

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

Golden State Medical Supply

INN (Nama Internasional):

PROPAFENONE HYDROCHLORIDE

Komposisi:

PROPAFENONE HYDROCHLORIDE 225

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

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, atrioven

Ringkasan produk:

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 60429-976-60 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.

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

PROPAFENONE HYDROCHLORIDE- PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED
RELEASE
GOLDEN STATE MEDICAL SUPPLY
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
PROPAFENONE HYDROCHLORIDE
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