PROCAINAMIDE HYDROCHLORIDE injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

McKesson Corporation

INN (International Name):

Procainamide Hydrochloride

Composition:

Procainamide Hydrochloride 100 mg in 1 mL

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 Boxed Warning.) Complete H

Product summary:

Product: 63739-459 NDC: 63739-459-05 10 mL in a VIAL, MULTI-DOSE / 1 in a BAG / 5 in a BOX

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PROCAINAMIDE HYDROCHLORIDE- PROCAINAMIDE HYDROCHLORIDE INJECTION,
SOLUTION
MCKESSON CORPORATION
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PROCAINAMIDE HYDROCHLORIDE INJECTION USP
PROCAINAMIDE HYDROCHLORIDE
Injection, USP Rx only
MULTIPLE-DOSE FLIPTOP VIAL NOVAPLUS
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
ρ-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 pK 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 actio