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Free access

INGREDIENTS:

Tobramycin sulfate 40 mg/mL injection3.75 mL
Artificial tearsQSAD: 10 mL

EQUIPMENT AND SUPPLIES:

Laminar flow hood, 2 × 18-G needles, 1 × 5-mL syringe, 1 × 10-mL syringe, 1 × 0.22-µm filter needle

PREPARATION DETAILS:

Must be prepared in compliance with USP <797>.

  1. Withdraw 8.75 mL artificial tears from the 15-mL ophthalmic bottle and discard.

  2. Withdraw volume of tobramycin injectable solution using a 5-mL syringe.

  3. Change to a 0.22-µm filter needle.

  4. Transfer the tobramycin solution into the ophthalmic bottle with the remaining artificial tears.

  5. 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 28 days.

STABILITY STUDY DETAILS:

Study Container Type — Artificial tears dropper bottle

Referenced Manufacturers — Tobramycin sulfate injection (Elkins-Sinn, Inc); artificial tears (Liquifilm Tears, Allergan, Inc).

Stability-Indicating Study — No

Commercially available as a 0.3% (3 mg/mL) ophthalmic solution — Use extemporaneously prepared formulation only when commercial product is unavailable or a more concentrated ophthalmic solution is desired.

REFERENCE

1.

Charlton JF, Dalla KP, Kniska A. Storage of extemporaneously prepared ophthalmic antimicrobial solutions. Am J Health Syst Pharm. 1998;55(5):463466.

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