01-23-2018 01:23 PM
Due to the shortage of lidocaine with epinephrine and bupivacaine with epinephrine, our institution is preparing syringes by combining either lidocaine or bupivacaine with epinephrine for our OR to use. I am unable to find stablility studies to support a BUD beyond 24 hours. I am thinking that it would be reasonable to assign BUDs that are within USP 797 limitations (i.e. 9 days refrigerated). Does anyone else have any thoughts or information on this?
01-24-2018 03:03 PM
I also have been asked to compound lidocaine 1% with epi 1:100,000 for the OR, because the product is unavailable.
I have also searched for studies, or stability references of any kind - no success.
Without stability data, I am reluctant to do it at all - but I feel like we are between a rock and a hard place - how to support patient care safely?
I am concerned about pH (the pH adjustments listed on the lidocaine and lidocaine with epi vials are slightly different) and the sensitivity of epi to light and air (the manufactured vials say they are "filled under nitrogen") - I'm not sure how these affect stability. I am also not sure what role the bitartrate plays in the stability of the epi in the manufactured product.
Have you noticed any color changes or precipitates in your syringes? Are you protecting them from light?
Have you heard from anyone else who is compounding this?
Without stability data, I think we will use a 24 hr (or less) BUD, if we end up making this.
01-25-2018 09:35 PM
I have not heard of anyone else compounding this but I also have not asked around. We are not protecting the syringes from light and there have been no color changes noted. These syringes are prepared the evening prior and they honestly never hang around more than 12 hours before being used up.