||1. Reconstitute each 10 g vial with 95 mL of sterile water (water not included in ingredient list), to make a 100 mg/mL concentration.
2. Withdraw appropriate volume of reconstituted solution into a syringe and transfer to an amber bottle.
3. QS with normal saline to prepare a final concentration of 5 mg/mL.
||Storage in amber glass bottle is preferred, but can also be stored in amber plastic bottle.
Assign expiry date using USP 795 Guidelines, since no stability data available.
795 guidelines: Water-Containing Formulations:
The beyond-use date is not later than 14 days for liquid preparations when stored at cold temperature between 2°C - 8°C.
Since no stability data available, assign beyond use date using principles of NAPRA Guidance Document For Pharmacy Compounding Of Non-Sterile Preparations: Use the most conservative approach when there is conflicting information. As such, use the more conservative historical BUD of 14 days refrigerated rather than the arbitrary NAPRA BUD.
THIS FORMULATION IS NOT BASED ON LITERATURE, but is from unpublished data, historical use or physician/pharmacy experience.
|| Amber Glass Bottle
||For Rectal Use Only|
|Storage/Expiry:||Refrigerator: 14 days|
|Last Date Revised:
|References:||1. Adjunctive Intracolonic Vancomycin for Severe Clostridium difficile Colitis: Case Series and Review of the Literature. Clinical Infectious Diseases 2002, 35:690-696.|
2. Guidelines for the Diagnosis and Management of Clostridium difficile – Associated Diarrhea and Colitis. Amer J of Gastroenterology 1997; 92(5):739-750.
3. Treatment of Clostridium difficile infection in adults. UptoDate 2011.
4. Manufacturer package insert for Vancomycin Injection, PPC Inc Canada – July 2008.
5. USP 795 Guidelines: Pharmaceutical Compounding Non-Sterile Prep. (Reference for stability data)
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