Standard Tobramycin Ophthalmic Bottle Volume
Standard tobramycin ophthalmic solution bottles contain 5 mL of solution at a concentration of 0.3% (3 mg/mL). 1
Bottle Contents and Specifications
The FDA-approved formulation specifies that tobramycin ophthalmic solution is supplied in:
- 5 mL sterile solution in an opaque white low-density polyethylene bottle
- Concentration: 0.3% (3 mg/mL)
- Total tobramycin content per bottle: 15 mg 1
Formulation Details
Each mL contains:
- Active ingredient: Tobramycin 3 mg
- Preservative: Benzalkonium chloride 0.1 mg (0.01%)
- Inactive ingredients: Boric acid, sodium sulfate, sodium chloride, tyloxapol, sodium hydroxide/sulfuric acid for pH adjustment, and water for injection 1
The solution has a pH range of 7.0-8.0 and osmolality of 260-320 mOsm/kg 1.
Storage Considerations
- Store at 2°C to 25°C (36°F to 77°F)
- After opening, the bottle can be used until the expiration date printed on the label 1
- For fortified preparations (14 mg/mL): Refrigeration is required, and the solution should be shaken well before instillation 2
Clinical Context
When fortified tobramycin is needed for severe bacterial keratitis, the standard 5 mL commercial bottle serves as the base: 2 mL of injectable tobramycin (40 mg/mL) is added to the 5 mL bottle to create a fortified 14 mg/mL solution 2. This fortified preparation maintains potency for 14 days at both refrigerated (4°C) and room temperature (24°C) 3.