PROPAFENONE HYDROCHLORIDE

Electrolyte / Mineral

Brand names: PROPAFENONE HYDROCHLORIDE

Oral

Mechanism of Action

12.1 Mechanism of Action Propafenone is a Class 1C antiarrhythmic drug with local anesthetic effects and a direct stabilizing action on myocardial membranes. The electrophysiological effect of propafenone manifests itself in a reduction of upstroke velocity (Phase 0) of the monophasic action potential. In Purkinje fibers, and, to a lesser extent, myocardial fibers, propafenone reduces the fast inward current carried by sodium ions. Diastolic excitability threshold is increased and effective refractory period prolonged. Propafenone reduces spontaneous automaticity and depresses triggered activity. Studies in anesthetized dogs and isolated organ preparations show that propafenone has beta-sympatholytic activity at about 1/50 the potency of propranolol. Clinical studies employing isoproterenol challenge and exercise testing after single doses of propafenone indicate a beta-adrenergic blocking potency (per mg) about 1/40 that of propranolol in man. In clinical trials, resting heart rate de

Indications

such as sustained ventricular tachycardia that

in the judgment of the physician

its use with lesser ventricular arrhythmias is not recommended

even if patients are symptomatic

and any use of the drug should be reserved for patients in whom

in the opinion of the physician

Contraindications

• 4 CONTRAINDICATIONS Propafenone hydrochloride tablets are contraindicated in the following circumstances: Heart failure Cardiogenic shock Sinoatrial
• atrioventricular
• and intraventricular disorders of impulse generation or conduction (e.g.
• sick sinus node syndrome
• atrioventricular

FDA Warnings

5 WARNINGS AND PRECAUTIONS May cause new or worsened arrhythmias
Such proarrhythmic effects include sudden death and life-threatening ventricular arrhythmias such as ventricular fibrillation, ventricular tachycardia, asystole, and torsade de pointes
Case reports in patients treated with propafenone for atrial fibrillation/flutter have included increased premature ventricular contractions (PVCs), VT, VF, torsade de pointes, asystole, and death
The incidence of proarrhythmia in subjects with less serious or benign arrhythmias, which include subjects with an increase in frequency of PVCs, was 1

Known Side Effects

9 documented side effects by frequency

Drug Not Working

1-10%

Dizziness

1-10%

Shortness of Breath

1-10%

Nausea

1-10%

Fatigue

1-10%

Low Blood Pressure

1-10%

Weakness

1-10%

Falls

0.1-1%

Diarrhea

0.1-1%

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Formulations

Dosage Forms

Tablet

Route

Oral