PROPAFENONE HYDROCHLORIDE capsule, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Northstar Rx LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Propafenone hydrochloride extended-release capsules 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: Propafenone hydrochloride extended-release capsules are contraindicated in the following circumstances: Risk Summary In the absence of studies in pregnant women, available data from published case reports and several decades of post-marketing experience with use of propafenone hydrochloride extended-release capsules in pregnancy have not identified any drug-associated risks of miscarriage, birth defects, or adverse maternal or fetal outcomes. Untreated arrhythmias during pregnancy may pose a risk to the pregnant woman and fetus (see Clinical Considerations). Propafenone and its metabolite, 5-OH-propafenone, cross the placenta in humans. In animal studies, propafenone was not teratogenic. At maternally toxic doses (ranging from 2 to 6 times t

Product summary:

Propafenone Hydrochloride Extended-Release Capsules, USP are supplied as hard gelatin capsules containing either 225 mg, 325 mg or 425 mg of propafenone hydrochloride, USP. The 225 mg capsule has a white opaque body imprinted with “408” in black ink and white opaque cap imprinted with a “G” in black ink. They are available as follows: The 325 mg capsule has a white opaque body imprinted with “409” in black ink and white opaque cap imprinted with a “G” in black ink. They are available as follows: The 425 mg capsule has a white opaque body imprinted with “410” and single band in black ink and white opaque cap imprinted with a “G” and single band in black ink. They are available as follows: Storage: Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Dispense in a tight container.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PROPAFENONE HYDROCHLORIDE- PROPAFENONE HYDROCHLORIDE CAPSULE,
EXTENDED RELEASE
NORTHSTAR RX LLC
----------
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._
•
•
INDICATIONS AND USAGE
Propafenone hydrochloride extended-release capsules are 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:
•
•
•
DOSAGE AND ADMINISTRATION
•
•
•
DOSAGE FORMS AND STRENGTHS
Capsules: 225 mg, 325 mg, 425 mg. (3)
CONTRAINDICATIONS
•
•
•
•
•
•
•
•
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.
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 hydrochloride extended-release
capsules with drugs that increase the atriov