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INGREDIENTS:

Vancomycin hydrochloride 10 g injection1 vial
Sterile water for injection100 mL
Ora-Sweet/distilled water*QSAD: 400 mL

EQUIPMENT AND SUPPLIES:

Powder containment hood, 4 × 18-G needles, 4 × 60-mL syringes, graduated cylinder

PREPARATION DETAILS:

  1. Reconstitute injectable powder vial with 100 mL of sterile water for injection.

  2. Transfer the solution to a graduated cylinder.

  3. Add vehicle to the graduated cylinder to achieve the total volume indicated above.

  4. Transfer contents of the graduated cylinder into an appropriately sized amber bottle.

  5. Shake well to mix.

Special Instructions — *Mix 150 mL of Ora-Sweet with 150 mL of distilled water. Use mixture as vehicle.

Quality-Control Procedures — Visually inspect for physical appearance of formulation and container closure integrity (no leakage, cracks in container, or improper seals).

Labeling Requirements — Extemporaneously compounded preparation. For oral use only. Store at room temperature or refrigerate. Shake well before use.

Storage Conditions/Stability — Store at room temperature or refrigerate. Stable for 75 days when refrigerated and 30 days in unit dose cups and 26 days in plastic bottles when stored at room temperature.

STABILITY STUDY DETAILS:

Study Container Type — Opaque blue polyethylene unit dose cup with aluminum seal and amber polyvinyl chloride prescription bottle

Referenced Manufacturers — Vancomycin hydrochloride injection (Pharmaceutical Partners of Canada); sterile water for injection (Baxter Healthcare Corp); Ora-Sweet (Paddock Laboratories, LLC); distilled water (Ripple FX Water, Inc).

Stability-Indicating Study — Yes

Commercially available — Use extemporaneously prepared formulation only when commercial product is unavailable.

REFERENCE

1.

Ensom MHH, Decarie D, Lakhani A. Stability of vancomycin 25 mg/mL in Ora-Sweet and water in unit-dose cups and plastic bottles at 4°C and 25°C. Can J Hosp Pharm. 2010;63(5):366372.

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