Recipe - Compounding Worksheet
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These recipes are intended for use by the pharmacy manufacturing departments only.
LET Topical Gel   Lidocaine 4%-Epinephrine 0.1%-Tetracaine 0.5%
Lot No Expiry(mm/yyyy) Ingredients Master Formula
    lidocaine HCl USP    PWD  Container #1 
    tetracaine HCl   PWD  Container #1 
    epinephrine bitartrate    PWD  Container #1 
    sodium metabisulfite    PWD   
    Methylcellulose  4000 mPA-s  PWD  Container #2 - Total for all containers 
    Water, sterile        
Recipe Total Quantity:
Final Quantity Desired: mL

Directions: CONTAINER #1:
1. Measure lidocaine, tetracaine, epinephrine, and sodium metabisulfite powders, and slowly add to 100 mL of water. Mix until dissolved and pour into a 250 mL amber bottle. If a sterile solution is desired, filter through a 0.2 micron filter.
2. Divide the solution into 3 mL portions. Use 5 mL or equivalent size amber air tight containers.
3. Label as below:
Container #1. LET Solution (3 mL). Lidocaine 4%-Epinephrine 0.1%-Tetracaine 0.5%.
Mix with Container #2 prior to use.


CONTAINER #2
NOTE - THE TOTAL AMOUNT OF METHYLCELLULOSE MUST BE DIVIDED AS PER THE FOLLOWING INSTRUCTIONS:
4. Divide the total amount of methylcellulose powder into 150 mg portions. Use 7-dram plastic amber vials.
5. Label as below:
Container #2: Methylcellulose for LET gel (150 mg).
Add contents of Container #1 (LET Solution) to Container #2. Shake gently for 2 - 3 minutes until gel is formed. Apply immediately after mixing.

Notes As of January 2020, AHS standardized outsourcing of LET Gel to Gentes & Bolduc Compounding Services. In house compounding should be reserved for shortage/backorder scenarios only.

**MUST USE Epinephrine bitartrate ( = 55% epinephrine and 45% bitartrate.)

Package both containers in a zip lock bag. Label kit as below:
LET GEL KIT
1 X LET solution
1 X Methylcellulose powder

Inspect LET solution before mixing with Container #2: Methylcellulose for LET gel, if any discoloration (darking) of the LET solution is seen please properly dispose of this solution and do not use.

Since there is no stability data available, assign beyond use date using NAPRA Guidance Document For Pharmacy Compounding Of Non-Sterile Preparations:
Water-containing topical/dermal, mucosal liquid and semi-solid formulations The BUD is not later than 30 days.

Packaging:  Amber Plastic Bottle

Auxiliary Labels: Can be stored at room temperature or refrigerated
  For External Use Only
  Protect From Light

Storage/Expiry:Refrigerator: 30 days
  Room Temperature: 30 days

Last Date Revised: 9-Nov-21

References:Larson, T. A., Uden, D. L. & Schilling C. G. Stability of epinephrine hydrochloride in an extemporaneously compounded topical anesthetic solution of lidocaine, racepinephrine, and tetracaine. Am J Health-Sys Pharm 1996; 53: 659-662.

Madhok, M., Scribner-O'Pray, M. & Teele, M. No needless pain: Managing pediatric pain in minor injuries. Contemporary Pediatrics 2011; 28(11):16.
 
National Association of Pharmacy Regulatory Authorities (NAPRA). Guidance Document For Pharmacy Compounding Of Non-Sterile Preparations. Ottawa, ON: National Association of Pharmacy Regulatory Authorities (NAPRA); 2018.
Available at: https://napra.ca/sites/default/files/documents/Mdl_Stnds_Pharmacy_Compounding_Nonsterile_Preparations_Guidance_June2018_FINAL.pdf

Completed Compound Check
Lot NoDate Prepared Expiry DateTechnicianPharmacist
   6-Dec-2021         


This content is provided for general information purposes only. It is not intended to replace consultations with a health care professional or to provide medical advice, diagnosis or treatment. Always seek the advice of a physician or other qualified health care provider with any medical or health questions. Alberta Health Services accepts no responsibility for any modification or redistribution of this document and is not liable for any actions taken by individuals based on the information provided, or for any inaccuracies, errors, or omissions in the information in this document. These recipes are to be used as a reference and are not intended to be master formulation records. Not all recipes may be compliant with NAPRA or other standards.