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:

NCS HealthCare of KY, Inc dba Vangard Labs

INN (International Name):

PROPAFENONE HYDROCHLORIDE

Composition:

PROPAFENONE HYDROCHLORIDE 150 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

In patients without structural heart disease, propafenone HCl is indicated to prolong the time to recurrence of - –paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms. - –paroxysmal supraventricular tachycardia (PSVT) associated with disabling symptoms. As with other agents, some patients with atrial flutter treated with propafenone have developed 1:1 conduction, producing an increase in ventricular rate. Concomitant treatment with drugs that increase the functional AV refractory period is recommended. The use of propafenone HCl in patients with chronic atrial fibrillation has not been evaluated. Propafenone HCl should not be used to control ventricular rate during atrial fibrillation. Propafenone HCl is also indicated for the treatment of - –documented ventricular arrhythmias, such as sustained ventricular tachycardia, that, in the judgement of the physician, are life-threatening. Because of the proarrhythmic effects of propafenone HCl, its use with lesser ventricular arrhythmias

Product summary:

Propafenone HCl tablets are supplied as white, scored, round, film-coated tablets.  150 mg tablets embossed "5124" and "V" available in blisterpackss of 30.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PROPAFENONE HYDROCHLORIDE- PROPAFENONE HYDROCHLORIDE TABLET, FILM
COATED
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
----------
PROPAFENONE HYDROCHLORIDE TABLETS
RX ONLY
DESCRIPTION
Propafenone hydrochloride is an antiarrhythmic drug supplied in
scored, film-coated tablets of 150,
225, and 300 mg for oral administration. Propafenone has some
structural similarities to beta-blocking
agents.
The structural formula of propafenone hydrochloride is given below:
Propafenone hydrochloride occurs as colorless crystals or white
crystalline powder with a very bitter
taste. It is slightly soluble in water (20°C), chloroform and
ethanol. The following inactive ingredients
are contained in the tablet: carnauba wax, hypromellose, lactose,
magnesium stearate, microcrystalline
cellulose, povidone, pregelatinized corn starch, sodium starch
glycolate, stearic acid, titanium dioxide,
and triacetin.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Propafenone HCl is a Class 1C antiarrhythmic drug with local
anesthetic effects, and a direct stabilizing
action on myocardial membranes. The electrophysiological effect of
propafenone HCl 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 HCl 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 HCl 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 decreases of about 8% were noted at the higher end of the
therapeutic plasma concentration
range. At very high concentratio