propafenone hcl- Propafenone Hydrochloride tablet, film coated

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

Propafenone Hydrochloride (UNII: 33XCH0HOCD) (Propafenone - UNII:68IQX3T69U)

Disponibbli minn:

ETHEX

INN (Isem Internazzjonali):

Propafenone Hydrochloride

Għamla farmaċewtika:

TABLET, FILM COATED

Kompożizzjoni:

150 mg

Rotta amministrattiva:

ORAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

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 in patients with chronic atrial fibrillation has not been evaluated. Propafenone should not be used to control ventricular rate during atrial fibrillation. Propafenone is also indicated for the treatment of Initiation of propafenone treatment, as with other antiarrhythmics used to treat life-threatening ventricular arrhythmias, should be carried out in the hospital. Propafenone, like other antiarrhythmic drugs, has not been shown to enhance survival in patients w

Sommarju tal-prodott:

Propafenone HCl tablets are supplied as the following: 150 mg: White, scored, round film-coated tablets containing 150 mg of propafenone hydrochloride and debossed with “ ETH” on one side and “331” with a bisect on the other side.      100 Count Bottles…………. . . . . . .   NDC 58177-331-04      Unit Dose Blister Packs…..….... . . . .  NDC 58177-331-11 225 mg: White, scored, round film-coated tablets containing 225 mg of propafenone hydrochloride and debossed with “ ETH” on one side and “332” with a bisect on the other side.      100 Count Bottles…………. . . . . . .  NDC 58177-332-04 300 mg: White, scored, round film-coated tablets containing 300 mg of propafenone hydrochloride and debossed with “ ETH” on one side and “333” with a bisect on the other side.      100 Count Bottles…………… . . . .   NDC 58177-333-04 Store at 25°C (77°F); excursions permitted to 15°- 30°C (59° - 86°F) [see USP controlled room temperature]. Dispense in a tight, light-resistant container as defined in the USP. Manufactured by: KV Pharmaceutical Co. for ETHEX Corporation St. Louis, MO  63044

Karatteristiċi tal-prodott

PROPAFENONE HCL- PROPAFENONE HYDROCHLORIDE TABLET, FILM COATED
ETHEX
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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:
C H NO ·HCL M.W. = 377.90
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 each tablet: carnauba wax, hypromellose, magnesium
stearate, microcrystalline
cellulose, opadry white, povidone, pregelatinized starch, and sodium
starch glycolate.
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 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 plasma concentration
range. At very high concentrations _in vitro_, propafenone can inhibit
the