FROM: Grant Carrow, Deputy Director, Bureau for Quality Assurance and Control
Abdullah Rehayem, Director, Office of Emergency Medical Services
DATE: July 17, 2007
RE: Diltiazem HCl (Cardizem Lyoject®)
This advisory is to notify ambulance services that Diltiazem HCl is no longer being produced in a Lyoject® form and that other forms will need to be utilized. Other available forms include, but are not necessarily limited to, multi-dose vials of Diltiazem HCl Injection or Diltiazem as part of a system designed to keep drug and diluent separate until the system is activated just prior to administration (e.g. ADD-Vantage®.System). This is also to remind ambulance services that they are required to follow the labeled storage and use requirements for all drug products, including Diltiazem HCl. Below, for your reference, please find summarized storage and use requirements for these forms of Diltiazem HCl.
Please be further advised that the Department of Public Health regulates the Schedules and types of pharmaceuticals that may be stocked and used by ambulance services. The Department does not regulate the particular forms of drug products that may be stocked and used. Ambulance services may choose which forms of approved pharmaceuticals to stock and use.
Utilizing Multi-Dose Vials
To prepare a dose for administration, the vial must be accessed using scrupulous sterile technique. Ambulances are required to ensure stability of Diltiazem HCl and all drug products according to the manufacturer's requirements. Diltiazem HCl Injection requires refrigeration and should be stored at 2 - 8º C (36 - 46º F). Diltiazem HCl Injection should not be frozen. Diltiazem HCl Injection may be stored at room temperature, as labeled, for up to one month, after which the product should be destroyed. The medication may not be recycled.
Utilizing the ADD-Vantage® System
The ADD-Vantage® System is a non-refrigerated option for Diltiazem storage and administration. The medication is in powder form, has a significant shelf life and must be mixed with a diluent prior to administration. Administration should be conducted as ordered by an EMS service's Affiliate Hospital Medical Director and in accordance with the Statewide Treatment Protocols.
This information is provided by the Drug Control Program within the Department of Public Health.