PROCAINAMIDE HYDROCHLORIDE injection

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

PROCAINAMIDE HYDROCHLORIDE (UNII: SI4064O0LX) (PROCAINAMIDE - UNII:L39WTC366D)

Commercializzato da:

Medical Purchasing Solutions, LLC

Via di somministrazione:

INTRAVENOUS

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

Procainamide hydrochloride injection is indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that, in the judgement of the physician, are life-threatening. Because of the proarrhythmic effects of procainamide, its use with lesser arrhythmias is generally not recommended. Treatment of patients with asymptomatic ventricular premature contractions should be avoided. Initiation of procainamide treatment, as with other antiarrhythmic agents used to treat life-threatening arrhythmias, should be carried out in the hospital. Antiarrhythmic drugs have not been shown to enhance survival in patients with ventricular arrhythmias. Because procainamide has the potential to produce serious hematological disorders (0.5 percent) particularly leukopenia or agranulocytosis (sometimes fatal), its use should be reserved for patients in whom, in the opinion of the physician, the benefits of treatment clearly outweigh the risks. (see WARNINGS and Box

Dettagli prodotto:

Procainamide Hydrochloride Injection, USP is available in multiple-dose 10 mL vials providing 100 mg procainamide hydrochloride per mL and 2 mL vials providing 500 mg procainamide hydrochloride per mL. The solutions, which are clear and colorless initially, may develop a slightly yellow color in time. This does not indicate a change which should preclude its use, but a solution any darker than light amber or otherwise discolored should not be used. Store at 20 to 25°C (68 to 86°F). [See USP Controlled Room Temperature.] Nexus Pharmaceuticals Inc., Vernon Hills, IL 60061 USA            Revised 03/2017

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

PROCAINAMIDE HYDROCHLORIDE- PROCAINAMIDE HYDROCHLORIDE INJECTION
MEDICAL PURCHASING SOLUTIONS, LLC
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PROCAINAMIDE HYDROCHLORIDE INJECTION, USP
RX ONLY
WARNING: THE PROLONGED ADMINISTRATION OF PROCAINAMIDE OFTEN LEADS TO
THE DEVELOPMENT
OF A POSITIVE ANTI-NUCLEAR ANTIBODY (ANA) TEST, WITH OR WITHOUT
SYMPTOMS OF A LUPUS
ERYTHEMATOSUS-LIKE SYNDROME. IF A POSITIVE ANA TITER DEVELOPS, THE
BENEFIT VERSUS RISKS OF
CONTINUED PROCAINAMIDE THERAPY SHOULD BE ASSESSED.
DESCRIPTION
Procainamide Hydrochloride Injection, USP is a sterile, nonpyrogenic
solution of procainamide
hydrochloride in water for injection. Each milliliter of the 2 mL vial
contains procainamide
hydrochloride 500 mg; methylparaben 1 mg and sodium metabisulfite 1.8
mg added in water for
injection. Each milliliter of the 10 mL vial contains procainamide
hydrochloride 100 mg; methylparaben
1 mg and sodium metabisulfite 0.8 mg added in water for injection. In
both formulations, the solution
may contain hydrochloric acid and/or sodium hydroxide for pH
adjustment. pH 5.0 (4.0 to 6.0).
Headspace nitrogen gassed.
Procainamide Hydrochloride Injection is intended for intravenous or
intramuscular administration.
Procainamide hydrochloride, a Group 1A cardiac antiarrhythmic drug, is
p-amino-N-[2-(diethylamino)
ethyl] benzamide mono- hydrochloride. It has the following structural
formula:
M.W. 271.79
*(locus for acetylation to N-acetyl procainamide).
It differs from procaine which is the p-aminobenzoyl ester of
2-(diethylamino)-ethanol. Procainamide as
the free base has a pKa of 9.23; the monohydrochloride is very soluble
in water.
CLINICAL PHARMACOLOGY
Procainamide (PA) increases the effective refractory period of the
atria, and to a lesser extent the
bundle of His-Purkinje system and ventricles of the heart. It reduces
impulse conduction velocity in the
atria, His-Purkinje fibers, and ventricular muscle, but has variable
effects on the atrioventricular (A-V)
node, a direct slowing action and a weaker vagolytic effect which may
speed A-V conduction slightly.