PROPAFENONE HYDROCHLORIDE tablet, film coated

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

Physicians Total Care, Inc.

DCI (Denominação Comum Internacional):

PROPAFENONE HYDROCHLORIDE

Composição:

PROPAFENONE HYDROCHLORIDE 150 mg

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

In patients without structural heart disease, propafenone is indicated to prolong the time to recurrence of 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 Initiation of propafenone HCl treatment, as with other antiarrhythmics used to treat life-threatening ventricular arrhythmias, should be carried out in the hospital. Propafenone HCl, like other antiarrhythmic drugs, has not been shown to enhance survival in patients with ventricular or atrial arrhythmias. Propafenone HCl is contraindicated in the presence of uncontrolled congestive heart failure, cardiogenic shock, s

Resumo do produto:

Propafenone hydrochloride tablets are supplied as follows: Propafenone hydrochloride tablets 150 mg, white, round, scored, film-coated, debossed MP 511 Propafenone hydrochloride tablets 225 mg, white, round, scored, film-coated, debossed MP 512 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.

Status de autorização:

Abbreviated New Drug Application

Características técnicas

PROPAFENONE HYDROCHLORIDE - PROPAFENONE HYDROCHLORIDE TABLET, FILM
COATED
PHYSICIANS TOTAL CARE, INC.
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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:
2'-[2-Hydroxy-3-(propylamino)-propoxy]-3-phenylpropiophenone
hydrochloride
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, magnesium
stearate, polydextrose, polyethylene
glycol, polysorbate 80, povidone, pregelatinized starch (corn),
propylene glycol, sodium starch
glycolate, titanium dioxide, and triacetin.
CLINICAL PHARMACOLOGY
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 decreases of about 8% were noted at the higher end of the
t