PROPAFENONE HYDROCHLORIDE tablet film coated

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Cardinal Health

INN (שם בינלאומי):

PROPAFENONE HYDROCHLORIDE

הרכב:

PROPAFENONE HYDROCHLORIDE 150 mg

סוג מרשם:

PRESCRIPTION DRUG

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

PROPAFENONE HYDROCHLORIDE- PROPAFENONE HYDROCHLORIDE TABLET, FILM
COATED
CARDINAL HEALTH
----------
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
therapeutic pl