Source: FDA, National Drug Code (US) Revision Year: 2024
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 pKa of 9.23; the monohydrochloride is very soluble in water.
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PROCAINAMIDE HCI INJECTION, USP is supplied in the following dosage forms. NDC 51662-1334-1 PROCAINAMIDE HCI INJECTION, USP 1gram/10mL TOTAL (100mg/mL) 10mL VIAL NDC 51662-1334-2 PROCAINAMIDE HCI INJECTION, USP 1gram/10mL TOTAL (100mg/mL) 10mL VIAL (1 vial per pouch) NDC 51662-1334-3 PROCAINAMIDE HCI INJECTION, USP 1gram/10mL TOTAL (100mg/mL) 10mL VIAL (1 vial per pouch, 25 pouches/box) HF Acquisition Co LLC, DBA HealthFirst, Mukilteo, WA 98275 Also supplied in the following manufacture supplied dosage forms 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. Distributed by: Hospira Inc., Lake Forest, IL 60045 USA |
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