Pouch Labeling (51662 1360 2 Pouch Label)
Procainamide Hydrochloride Injection
Product Images NDC 51662-1630
View Photos of Packaging, Regulatory Labels, and Product Appearance
Product Visual Gallery
This gallery contains 10 technical images submitted to the FDA as part of the official labeling for Procainamide Hydrochloride (NDC 51662-1630). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.
As provided by Hf Acquisition Co Llc, Dba Healthfirst, these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.
Product Images & Figures Index
Case Labeling (51662 1630 3 Case Label)
Serialized Label (51662 1630 3 Serialized Labeling)
Boxed Warning (Boxed Warning)
Carton (Carton Labeling)
Dosage (Dosage And Admin)
DILUTIONS AND RATES FOR INTRAVENOUS INFUSIONS:
This text provides instructions for the dilutions and rates for intravenous infusions of Procainamide Hydrochloride Injection. The initial loading infusion concentration is 20 mg/mL and volume of 50 mL, with a rate of 1 mL/min for up to 25-30 minutes. The maintenance infusion concentration can be either 2 mg/mL or 4 mg/mL, with various volumes and rates depending on factors such as body weight, renal elimination rate, and desired steady-state plasma level. All infusions should be made up to the final volume with 5% Dextrose Injection. It is important to closely monitor the flow rate to avoid high plasma levels and hypotension. Further details can be found in the DOSAGE AND ADMINISTRATION section.*
How Supplied (How Supplied)
Structure (Structure)
Syringe Label (Syringe Label)
Warnings (Warnings)
This text provides information on the mortality rates observed in the Cardiac Arrhythmia Suppression Trial (CAST). The trial evaluated patients with asymptomatic non-life-threatening ventricular arrhythmias who had a myocardial infarction. The study found that patients treated with encainide or flecainide had a higher mortality rate compared to those in the placebo group. The average duration of treatment was ten months. The applicability of these results to other populations is uncertain.
The text also mentions the risk of blood dyscrasias, such as agranulocytosis, bone marrow depression, neutropenia, hypoplastic anemia, and thrombocytopenia, in patients receiving procainamide hydrochloride. The reported rate of blood dyscrasias is approximately 0.5% in patients within the recommended dosage range. Fatalities have occurred in cases of agranulocytosis, with a mortality rate of 20-25%. It is recommended to monitor complete blood counts regularly during the first three months of therapy and periodically thereafter. If any signs of infection or hematologic disorders are identified, procainamide therapy should be discontinued. Blood counts usually return to normal within one month of discontinuation. Caution should be exercised in patients with pre-existing marrow failure or cytopenia.*
* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.
