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Vancomycin Hydrochloride Ophthalmic Solution 31 mg/mL

in Extemporaneous Formulations
Free access

INGREDIENTS:

Vancomycin hydrochloride 500 mg injection1 vial
Sterile water for injection5 mL
Artificial tearsQSAD: 15 mL

EQUIPMENT AND SUPPLIES:

Laminar flow hood, 3 × 18-G needles, 3 × 5-mL syringes, 1 × 0.22-µm filter needle

PREPARATION DETAILS:

Must be prepared in compliance with USP <797>.

  1. Reconstitute injectable powder with 5 mL of sterile water for injection.

  2. Withdraw 4.6 mL of artificial tears from the 15-mL ophthalmic bottle and discard.

  3. Withdraw 4.6 mL of vancomycin injectable solution using a 5-mL syringe.

  4. Change to a 0.22-µm filter needle.

  5. Transfer the vancomycin solution into the ophthalmic bottle with the remaining artificial tears.

  6. Shake well to mix.

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 ophthalmic use only. Store at room temperature or refrigerate.

Storage Conditions/Stability — Store at room temperature or refrigerate. Stable for 10 days when refrigerated and 7 days when stored at room temperature.

STABILITY STUDY DETAILS:

Study Container Type — Ophthalmic dropper bottle

Referenced Manufacturers — Vancomycin hydrochloride injection (Vancocin, Eli Lily & Co); sterile water for injection (McGaw); artificial tears (Tears Naturale, Alcon Laboratories, Inc).

Stability-Indicating Study — Yes

Footnote — Artificial tears contain 0.3% hydroxypropyl methylcellulose, 0.1% dextran 70, 0.01% benzalkonium chloride, and 0.05% edetate disodium.

REFERENCES

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