Země: Spojené státy
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
PROPAFENONE HYDROCHLORIDE (UNII: 33XCH0HOCD) (PROPAFENONE - UNII:68IQX3T69U)
Physicians Total Care, Inc.
PROPAFENONE HYDROCHLORIDE
PROPAFENONE HYDROCHLORIDE 150 mg
ORAL
PRESCRIPTION DRUG
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
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.
Abbreviated New Drug Application
PROPAFENONE HYDROCHLORIDE - PROPAFENONE HYDROCHLORIDE TABLET, FILM COATED PHYSICIANS TOTAL CARE, INC. ---------- 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 Přečtěte si celý dokument