Recipe - Compounding Worksheet
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These recipes are intended for use by the pharmacy manufacturing departments only.
Digoxin Oral Liquid   0.05 mg/mL (50 mcg/mL)
Lot No Expiry(mm/yyyy) Ingredients Master Formula
    digoxin  0.25 mg/mL  INJ   
    sodium chloride  0.9%  INJ   
Recipe Total Quantity:
Final Quantity Desired: mL

Directions: 1. Combine ingredients in final container.
2. Mix well.

Notes For use in emergency situations, if the commercial 50 mcg/mL oral elixir is not available.

ALL CLINICIANS AND PATIENTS MUST BE MADE AWARE OF ANY SWITCH BETWEEN FORMULATIONS, SO THEY MAY EMPLOY A HEIGHTENED LEVEL OF
VIGILANCE/SURVEILLANCE FOR EITHER THERAPEUTIC FAILURES OR ADVERSE DRUG REACTIONS.


Use a filter needle when drawing from glass ampoule.

Non-medicinal ingredients (for Sandoz Digoxin 0.25mg/mL Injection): Each mL contains: ethyl alcohol 10%, propylene glycol 40%, citric acid 0.08%, sodium phosphate 0.3% and water for injection.

Note on propylene glycol content of digoxin preparations:

Sandoz Digoxin 0.25mg/mL Injection (each mL contains propylene glycol 40%) therefore propylene glycol content would be 400mg/mL (for a total of 800mg of propylene glycol contained in this 10mL preparation (or 80mg/mL)).

ToloxinŽ Oral Solution 0.05mg/mL contains 52mg/mL of propylene glycol.

Maximum daily intake of propylene glycol, as per the World Health Organization (WHO), is up to 25 mg/kg body weight.

THIS FORMULATION IS NOT BASED ON LITERATURE, but is from unpublished data, historical use or physician/pharmacy experience.

Assign expiry date using USP 795 Guidelines.
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

Packaging: 10 mL Amber Glass Bottle

Auxiliary Labels: Refrigerate

Storage/Expiry:Refrigerator: 14 Days

Last Date Revised: 15-Aug-19

References:Trissel's LA. Handbook on Injectable Drugs 15th edition. Bethesda MD: American Society of Health-System Pharmacists Inc.; 2009.
 
McCrea J, Rappaport P, Stansfield S, Baker D, Dupuis LL. James G., Extemporaneous oral liquid dosage preparations. 1st ed. Toronto, ON: Canadian Society of Hospital Pharmacists; 1988.
 
McCrea J, Rappaport P, Stansfield S, Baker D, Dupuis LL. James G., Extemporaneous oral liquid dosage preparations. 1st ed. Toronto, ON: Canadian Society of Hospital Pharmacists; 1988.

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


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