PROCAINAMIDE HYDROCHLORIDE injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Procainamide Hydrochloride (UNII: SI4064O0LX) (Procainamide - UNII:L39WTC366D)

Available from:

Nexus Pharmaceuticals LLC

INN (International Name):

Procainamide Hydrochloride

Composition:

Procainamide Hydrochloride 1000 mg

Administration route:

INTRAVENOUS

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 Hear

Product summary:

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 77°F). [See USP Controlled Room Temperature.] The container closure is not made with natural rubber latex. To report SUSPECTED ADVERSE REACTIONS contact Lambda Therapeutics Limited (Toll Free Number: 1-855-642-2594 or by email: [e-mail]) or the FDA (Toll Free Number: 1-800-FDA-1088 or by the MedWatch website at www.fda.gov/safety/MedWatch/). Manufactured in Italy for: Nexus Pharmaceuticals, Inc. Lincolnshire, IL 60069, USA PRAPI01ITR04 NEXUS PHARMACEUTICALS Revised: 09/2022

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PROCAINAMIDE HYDROCHLORIDE- PROCAINAMIDE HYDROCHLORIDE INJECTION
NEXUS PHARMACEUTICALS INC
----------
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:
*(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, HisPurkinje 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. Myocardial
excitabil