PROPAFENONE HYDROCHLORIDE tablet film coated

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

Cardinal Health

INN（国际名称）:

PROPAFENONE HYDROCHLORIDE

组成:

PROPAFENONE HYDROCHLORIDE 150 mg

处方类型:

PRESCRIPTION DRUG

授权状态:

Abbreviated New Drug Application

产品特点

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