12-21-2017 01:33 PM
I would like your collective opinion on this.
Due to the current IV flluid shortages, we are considering batching ditiazem drips.
LexiComp, MIcromedex, Global RPh, and the package insert all list the stabillty of diltiazem in NS or D5W, at a maximum concentration of 1mg/ml, as 24 hours refrigerated.
I find one study from 2012 which concluded that "Diltiazem hydrochloride diluted to 1 mg/mL in 5% dextrose injection was stable for 30 days when stored at -20 °C, 2-6 °C, and 22-25 °C."
Can I use this one study to extend the BUD of this pharmacy compounded product (in D5W) to 14 days refrigerated (if we consider it to be low risk) or 9 days refrigerated (if we consider it medium risk)?
Thanks for your help.
01-11-2018 01:33 PM
Wondering if you were able to get any answer for information on this subject. We are in the same situation where we are running out of add-vantage bags for our diltiazem drips. Thank you for your help.
Kathryn Schwartz, R.Ph.
Pharmacy Technology Coordinator
01-11-2018 03:50 PM
What journal was this study published in? Did you evaluate the robustness of the data and did they use a stability indicating method when they tested the drug? Can you upload the article so everyone can look it over?
Trissel has published five rules that need to be checked when evaluating a study. They are:
Trissel Stability Criteria
02-07-2018 05:33 PM
Not sure what state you are in but here in california i would not extend the BUD past what the insert says. If the insert had no data I would use USP 797 med risk BUD 9 days refrigerated.