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:

International Medication Systems, Limited

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 He

Product summary:

Procainamide Hydrochloride Injection, USP in unit-use packages containing a Luer-Jet™ Luer-Lock Prefilled Syringe. Stock No. Concentration Size NDC No. Shrink Wrapped Packages of 5. Syringe Assembly Directions: USE ASEPTIC TECHNIQUE Do not assemble until ready to use. *CAUTION IMPROPER ENGAGING MAY CAUSE GLASS BREAKAGE AND SUBSEQUENT INJURY. 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].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PROCAINAMIDE HYDROCHLORIDE- PROCAINAMIDE HYDROCHLORIDE INJECTION
INTERNATIONAL MEDICATION SYSTEMS, LIMITED
----------
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 benefits 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. It is available in 100 mg per mL
concentration. The 100 mg per
mL potency contains 0.9% w/v benzyl alcohol and 0.09% sodium bisulfite
as preservatives. 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, 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 action and a weaker vagolytic effect which may
speed A-V conduction slightly.
Myocardial excitability is reduced in the atria, Purkinje fibers,
papillary muscles, and ventricles by an
increase in the threshold for excitation, combined with inhibition of
ectopic pacemaker activity by
retardation of the slow phase of diastolic depolarization, thus
decreasing automaticity especially in
ectopic s