PROPAFENONE HYDROCHLORIDE tablet, coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

ANI Pharmaceuticals, Inc.

INN (International Name):

PROPAFENONE HYDROCHLORIDE

Composition:

PROPAFENONE HYDROCHLORIDE 150 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: 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

Product summary:

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 62559-230-01. 225 mg – White, biconvex, round, film-coated tablets debossed with “ANI” over “231” and scored on one side and plain on the other side. This strength is supplied in bottles of 100 tablets under NDC 62559-231-01. 300 mg – White, biconvex, round, film-coated tablets debossed with “ANI” over “232” and scored on one side and plain on the other side. This strength is supplied in bottles of 100 tablets under NDC 62559-232-01. Storage: Store at 20° to 25°C (68° to 77°F); [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PROPAFENONE HYDROCHLORIDE- PROPAFENONE HYDROCHLORIDE TABLET, COATED
ANI PHARMACEUTICALS, INC.
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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 fib