Label: TOBRAMYCIN solution

Tobramycin ophthalmic solution, USP 0.3% is a sterile topical ophthalmic antibiotic formulation prepared specifically for topical therapy of external ophthalmic infections.

Each mL of tobramycin ophthalmic solution, USP 0.3% contains: Active: tobramycin 0.3% (3 mg). Preservative: benzalkonium chloride 0.01% (0.1 mg). Inactives: boric acid, sodium sulfate, sodium chloride, tyloxapol, sodium hydroxide and/or sulfuric acid (to adjust pH) and purified water. Tobramycin ophthalmic solution, USP 0.3% has a pH range between 7.0 and 8.0 and an osmolality of 260-320 mOsm/kg.

Tobramycin is a water-soluble aminoglycoside antibiotic active against a wide variety of gram-negative and gram-positive ophthalmic pathogens.

The chemical structure of tobramycin is:

MW=467.52

Molecular Formula:C18H37N5O9

Chemical Name: 0-{3-amino-3-deoxy-α-D-gluco-pyranosyl-(1→4)} -0- {2,6-diamino-2,3,6-trideoxy-α-D-ribohexopyranosyl-(1→6) }-2-deoxystreptamine.

In Vitro Data

In vitro studies have demonstrated tobramycin is active against susceptible strains of the following microorganisms: Staphylococci, including S. aureus and S. epidermidis (coagulase-positive and coagulase-negative), including penicillin-resistant strains.

Streptococci, including some of the Group A-beta-hemolytic species, some nonhemolytic species, and some Streptococcus pneumoniae.

Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter aerogenes, Proteus mirabilis, Morganella morganii, most Proteus vulgaris strains, Haemophilus influenzae and H. aegyptius, Moraxella lacunata, Acinetobacter calcoaceticus and some Neisseria species. Bacterial susceptibility studies demonstrate that in some cases, microorganisms resistant to gentamicin retain susceptibility to tobramycin.

Tobramycin ophthalmic solution, USP 0.3% is a topical antibiotic indicated in the treatment of external infections of the eye and its adnexa caused by susceptible bacteria. Appropriate monitoring of bacterial response to topical antibiotic therapy should accompany the use of tobramycin ophthalmic solution, USP 0.3%. Clinical studies have shown tobramycin to be safe and effective for use in children.

Tobramycin ophthalmic solution, USP 0.3% is contraindicated in patients with known hypersensitivity to any of its components.

FOR TOPICAL OPHTHALMIC USE ONLY. NOT FOR INJECTION INTO THE EYE. Sensitivity to topically applied aminoglycosides may occur in some patients. If a sensitivity reaction to tobramycin ophthalmic solution, USP 0.3% occurs, discontinue use.

The most frequent adverse reactions to tobramycin ophthalmic solution, USP 0.3% are hypersensitivity and localized ocular toxicity, including lid itching and swelling, and conjunctival erythema. These reactions occur in less than three of 100 patients treated with tobramycin ophthalmic solution, USP 0.3%. Similar reactions may occur with the topical use of other aminoglycoside antibiotics. Other adverse reactions have not been reported from tobramycin ophthalmic solution, USP 0.3% therapy; however, if topical ocular tobramycin is administered concomitantly with systemic aminoglycoside antibiotics, care should be taken to monitor the total serum concentration.

To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc., at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Clinically apparent signs and symptoms of an overdose of tobramycin ophthalmic solution, USP 0.3% (punctate keratitis, erythema, increased lacrimation, edema and lid itching) may be similar to adverse reaction effects seen in some patients.

In 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, following which treatment should be reduced prior to discontinuation.

Product: 50090-3569

NDC: 50090-3569-0 5 mL in a BOTTLE, PLASTIC

Manufactured by Alcon Laboratories, Inc.
Fort Worth, Texas 76134 for
Sandoz Inc., Princeton, NJ 08540

Revised: August 2019
9017853

Store at 2° - 25°C (36° - 77°F).