Propafenone

Propafenone
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Gerald Chi

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Black Box Warning

WARNING See full prescribing information for complete Boxed Warning. MORTALITY: In the National Heart, Lung, and Blood Institute’s Cardiac Arrhythmia Suppression Trial (CAST), a long-term, multi-center, randomized, double-blind trial in subjects with asymptomatic non-life-threatening ventricular arrhythmias who had a myocardial infarction more than 6 days but less than 2 years previously, an increased rate of death or reversed cardiac arrest rate (7.7%; 56/730) was seen in patients treated with encainide or flecainide (Class IC antiarrhythmics) compared with that seen in subjects assigned to placebo (3.0%; 22/725). The average duration of treatment with encainide or flecainide in this trial was 10 months. The applicability of the CAST results to other populations (e.g., those without recent myocardial infarction) or other antiarrhythmic drugs is uncertain, but at present, it is prudent to consider any IC antiarrhythmic to have a significant proarrhythmic risk 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.

Overview

Propafenone is an antiarrhythmic that is FDA approved for the {{{indicationType}}} of paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms in patients without structural heart disease, recurrent paroxysmal supraventricular tachycardia (PSVT) associated with disabling symptoms in patients without structural heart disease, and life-threatening ventricular arrhythmias, such as sustained ventricular tachycardia. There is a Black Box Warning for this drug as shown here. Common adverse reactions include chest pain, edema, palpitations, constipation, nausea, taste alteration, vomiting, dizziness, anxiety, dyspnea, and fatigue.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

PAF, PSVT or Ventricular Arrhythmia

• Dosing Information

• The dose of RYTHMOL must be individually titrated on the basis of response and tolerance.
• Initiate therapy with RYTHMOL 150 mg given every 8 hours (450 mg/day).

• Dosage may be increased at a minimum of 3 to 4 day intervals to 225 mg every 8 hours (675 mg/day).

• If additional therapeutic effect is needed, the dose of RYTHMOL may be increased to 300 mg every 8 hours (900 mg/day). The usefulness and safety of dosages exceeding 900 mg per day have not been established.
• In patients with hepatic impairment or those with significant widening of the QRS complex or second- or third-degree AV block, consider reducing the dose.
• As with other antiarrhythmic agents, in the elderly or in ventricular arrhythmia patients with marked previous myocardial damage, the dose of RYTHMOL should be increased more gradually during the initial phase of treatment.
• The combination of CYP3A4 inhibition and either CYP2D6 deficiency or CYP2D6 inhibition with the simultaneous administration of propafenone may significantly increase the concentration of propafenone and thereby increase the risk of proa

Condition2

• Dosing Information

• Dosage

Condition3

• Dosing Information

• Dosage

Condition4

• Dosing Information

• Dosage

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition1

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Propafenone in adult patients.

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Propafenone in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding FDA-Labeled Use of Propafenone in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Propafenone in pediatric patients.

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Propafenone in pediatric patients.

Contraindications

• Condition1

Warnings

WARNING See full prescribing information for complete Boxed Warning. MORTALITY: In the National Heart, Lung, and Blood Institute’s Cardiac Arrhythmia Suppression Trial (CAST), a long-term, multi-center, randomized, double-blind trial in subjects with asymptomatic non-life-threatening ventricular arrhythmias who had a myocardial infarction more than 6 days but less than 2 years previously, an increased rate of death or reversed cardiac arrest rate (7.7%; 56/730) was seen in patients treated with encainide or flecainide (Class IC antiarrhythmics) compared with that seen in subjects assigned to placebo (3.0%; 22/725). The average duration of treatment with encainide or flecainide in this trial was 10 months. The applicability of the CAST results to other populations (e.g., those without recent myocardial infarction) or other antiarrhythmic drugs is uncertain, but at present, it is prudent to consider any IC antiarrhythmic to have a significant proarrhythmic risk 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.

• Description

Precautions

• Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Propafenone in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Propafenone in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Drug Interactions

• Drug

• Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Propafenone in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Propafenone during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Propafenone with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Propafenone with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Propafenone with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Propafenone with respect to specific gender populations.

Race

There is no FDA guidance on the use of Propafenone with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Propafenone in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Propafenone in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Propafenone in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Propafenone in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

There is limited information regarding Monitoring of Propafenone in the drug label.

Condition1

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Propafenone in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Propafenone in the drug label.

Pharmacology

There is limited information regarding Propafenone Pharmacology in the drug label.

Mechanism of Action

Structure

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Propafenone in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Propafenone in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Propafenone in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Propafenone in the drug label.

Condition1

• Description

How Supplied

Storage

There is limited information regarding Propafenone Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Propafenone in the drug label.

Precautions with Alcohol

• Alcohol-Propafenone interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• Rythmol®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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