PROPAFENONE HYDROCHLORIDE tablet, coated

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:

Bryant Ranch Prepack

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

Propafenone Hydrochloride Tablets are indicated to: Usage Considerations: Propafenone hydrochloride tablets are contraindicated in the following circumstances: Risk Summary There are no studies of propafenone hydrochloride tablets in pregnant women. Available data from published case reports and several decades of postmarketing experience with use of propafenone hydrochloride tablets 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 dose [MRHD]), there was evidence of adverse developmental outcomes when administered to pregnant rabbits and rats during organogenesis or when administered to pregnant rat

Tóm tắt sản phẩm:

Propafenone Hydrochloride Tablets USP are supplied as: 150 mg – White, biconvex, round, film-coated tablets debossed with “ANI” over “230” and scored on one side and plain on the other side. This strength is supplied in bottles of 100 tablets under NDC 63629-2105-1. Storage: Store at 20° to 25°C (68° to 77°F); [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container.

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

PROPAFENONE HYDROCHLORIDE- PROPAFENONE HYDROCHLORIDE TABLET, COATED
BRYANT RANCH PREPACK
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PROPAFENONE
HYDROCHLORIDE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
PROPAFENONE HYDROCHLORIDE TABLETS.
PROPAFENONE HYDROCHLORIDE TABLETS, 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 Tablets are an antiarrhythmic indicated to:
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USAGE CONSIDERATIONS:
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Tablets: 150 mg, 225 mg, 300 mg. (3)
CONTRAINDICATIONS
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AN INCREASED RATE OF DEATH OR REVERSED CARDIAC ARREST RATE WAS SEEN IN
SUBJECTS
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
SUBJECTS 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.
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)
prolong the time to recurrence of paroxysmal supraventricular
tachycardia (PSVT) associated with
disabling symptoms in patients who do not have structural heart
disease. (1)
treat documented life-threatening ventricular arrhythmias. (1)
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 fibrilla