PROPAFENONE HYDROCHLORIDE- propafenone hydrochloride tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

A-S Medication Solutions

INN (International Name):

PROPAFENONE HYDROCHLORIDE

Composition:

PROPAFENONE HYDROCHLORIDE 225 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Propafenone hydrochloride tablets are indicated to: Usage Considerations: Propafenone hydrochloride tablets are contraindicated in the following circumstances: Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Propafenone hydrochloride tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal Data: Teratogenic Effects: Propafenone has been shown to be embryotoxic (decreased survival) in rabbits and rats when given in oral maternally toxic doses of 150 mg/kg day (about 3 times the maximum recommended human dose [MRHD] on a mg/m2 basis) and 600 mg/kg/day (about 6 times the MRHD on a mg/m2 basis), respectively. Although maternally tolerated doses (up to 270 mg/kg/day, about 3 times the MRHD on a mg/m2 basis) produced no evidence of embryotoxicity in rats, post-implantation loss was elevated in all rabbit treatment groups (doses as low as 15 mg/kg/day, about 1/3 the MRHD on a mg/m2 basis). Non-teratogenic

Product summary:

Product: 50090-2949 NDC: 50090-2949-0 60 TABLET, FILM COATED in a BOTTLE

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PROPAFENONE HYDROCHLORIDE- PROPAFENONE HYDROCHLORIDE TABLET, FILM
COATED
A-S MEDICATION SOLUTIONS
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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 is 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, and 300 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.
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 fi