PROPAFENONE HYDROCHLORIDE SR- propafenone hydrochloride capsule, extended release

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

Prasco Laboratories

INN (nemzetközi neve):

PROPAFENONE HYDROCHLORIDE

Összetétel:

PROPAFENONE HYDROCHLORIDE 225 mg

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

Propafenone Hydrochloride extended-release (SR) 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 (SR) capsules are contraindicated in the following circumstances:   Risk Summary There are no studies of Propafenone Hydrochloride extended-release (SR) capsules in pregnant women. Available data from published case reports and several decades of postmarketing experience with use of Propafenone Hydrochloride extended-release (SR) 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

Termék összefoglaló:

Propafenone Hydrochloride extended-release (SR) capsules are supplied as white, opaque, hard gelatin capsules containing either 225 mg, 325 mg, or 425 mg of propafenone HCl. The 225-mg strength is imprinted in red with GS EUG followed by 225. The 325-mg strength is imprinted in red with GS F1Y followed by 325, and also has a single red band around ¾ of the circumference of the body. The 425-mg strength is imprinted in red with GS UY2 followed by 425, and also has 3 red bands around ¾ of the circumference of the body. Capsule Strength 60-count bottle NDC 225 mg 66993-114-60 325 mg 66993-115-60 425 mg 66993-116-60 Storage: Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Dispense in a tight container.

Engedélyezési státusz:

New Drug Application Authorized Generic

Termékjellemzők

PROPAFENONE HYDROCHLORIDE SR- PROPAFENONE HYDROCHLORIDE CAPSULE,
EXTENDED
RELEASE
PRASCO LABORATORIES
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PROPAFENONE HYDROCHLORIDE EXTENDED-
RELEASE (SR) CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR PROPAFENONE HYDROCHLORIDE
EXTENDED-RELEASE (SR) CAPSULES.
PROPAFENONE HYDROCHLORIDE EXTENDED-RELEASE (SR) 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 (SR) 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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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 (SR) capsules
with