PROPAFENONE HYDROCHLORIDE- propafenone capsule, extended release

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

Proficient Rx LP

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

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 postmarketing experience with use of propafenone hydrochloride 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 the maximum recommended human

Tóm tắt sản phẩm:

Propafenone Hydrochloride Extended-Release Capsules, USP, 225 mg are supplied as white opaque cap and white opaque body, hard gelatin capsules containing either 225 mg, 325 mg, or 425 mg of propafenone HCl. The 225 mg capsule is imprinted with “" in red ink on the cap. Bottle of 60 (NDC 71205-940-60) The 325 mg capsule is imprinted with “" in red ink on the cap and also has one band around 3/4 of the circumference of the body in red ink. Bottle of 60 (NDC 71205-941-60) The 425 mg capsule is imprinted with “" in red ink on the cap and also has three bands around 3/4 of the circumference of the body in red ink. Bottle of 60 (NDC 71205-942-60) Storage: Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP.

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

PROPAFENONE HYDROCHLORIDE- PROPAFENONE CAPSULE, EXTENDED RELEASE
PROFICIENT RX LP
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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_
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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:
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Capsules: 225 mg, 325 mg, 425 mg (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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 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 atrioventricular nodal
refractory period