Description
NDC: 70069-131-01
Tobramycin 0.3% Ophthalmic Solution, 5 mL — Somerset Therapeutics
| Active ingredients | Tobramycin 0.3% (3 mg/mL) |
| Dosage form | Ophthalmic solution |
| Route | Topical ophthalmic |
| Size | 5 mL |
| Manufacturer | Somerset Therapeutics |
| NDC | 70069-131-01 |
Indications and Usage
A topical antibiotic indicated for the treatment of external infections of the eye and its adnexa caused by susceptible bacteria. It has been shown to be safe and effective in pediatric patients.
Dosage and Administration
For mild to moderate disease, instill one or two drops into the affected eye(s) every four hours. In severe infections, instill two drops into the eye(s) hourly until improvement, after which treatment should be reduced prior to discontinuation.
Warnings and Precautions
- For topical ophthalmic use only; not for injection into the eye
- Sensitivity reactions may occur, ranging from local irritation to systemic hypersensitivity
- Prolonged use may result in overgrowth of nonsusceptible organisms, including fungi
- Do not wear contact lenses during treatment of an ocular infection
Contraindications
Contraindicated in patients with known hypersensitivity to tobramycin or any component of the product.
Adverse Reactions
The most frequent adverse reactions are localized ocular toxicity and hypersensitivity, including lid itching and swelling and conjunctival erythema, occurring in less than 3% of patients. Postmarketing reports include anaphylaxis, Stevens-Johnson syndrome, and erythema multiforme.
Storage and Handling
Store at 2°C to 25°C (36°F to 77°F). The product may be used until the expiration date on the container.
How Supplied
Supplied as a sterile ophthalmic solution, 5 mL fill in a white opaque LDPE bottle with a dropper tip and tamper-evident closure.
Professional use only. Clinical information summarized from FDA-approved prescribing information (Structured Product Labeling); refer to the full prescribing information via DailyMed for complete details.
