Tobramycin Ophthalmic Solution, USP 0.3% Rx Only

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: C ₁₈H ₃₇N ₅O ₉

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 VitroData

In vitrostudies have demonstrated tobramycin is active against susceptible strains of the following microorganisms: Staphylococci,including S. aureusand 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 vulgarisstrains, Haemophilus influenzaeand H. aegyptius, Moraxella lacunata, Acinetobacter calcoaceticusand some Neisseriaspecies. Bacterial susceptibility studies demonstrate that in some cases, microorganisms resistant to gentamicin retain susceptibility to tobramycin.

Tobramycin ophthalmic solution, 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, 0.3%. Clinical studies have shown tobramycin to be safe and effective for use in children.

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

FOR TOPICAL OPHTHALMIC USE. NOT FOR INJECTION INTO THE EYE. Sensitivity to topically applied aminoglycosides may occur in some patients. Severity of hypersensitivity reactions may vary from local effects to generalized reactions such as erythema, itching, urticaria, skin rash, anaphylaxis, anaphylactoid reactions, or bullous reactions. If a sensitivity reaction to tobramycin ophthalmic solution, 0.3% occurs, discontinue use.

The most frequent adverse reactions to tobramycin ophthalmic solution, 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, 0.3%.

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.

Postmarketing Experience

Additional adverse reactions identified from post-marketing use include anaphylactic reaction, Stevens-Johnson syndrome, and erythema multiforme.

The following additional adverse reactions have been reported with systemic aminoglycosides: Neurotoxicity, ototoxicity and nephrotoxicity have occurred in patients receiving systemic aminoglycoside therapy. Aminoglycosides may aggravate muscle weakness in patients with known or suspected neuromuscular disorders, such as myasthenia gravis or Parkinson’s disease, because of their potential effect on neuromuscular function.

In mild to moderate disease, instill 1 or 2 drops into the affected eye(s) every 4 hours. In severe infections, instill 2 drops into the eye(s) hourly until improvement, following which treatment should be reduced prior to discontinuation.

Tobramycin ophthalmic solution, USP 0.3% is supplied as a 5 mL sterile solution, packaged in a 8 mL white plastic bottle with a plastic dispensing plug and white plastic closure as follows:

1. 5 mL containing tobramycin 0.3% (3 mg/mL) NDC 61314-643-05

Storage

Store at 2° to 25°C (36° to 77°F).

After opening, tobramycin ophthalmic solution, USP 0.3% can be used until the expiration date on the bottle.

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

Revised: August 2021

300049864-0821

NDC61314-643-05

Tobramycin
Ophthalmic
Solution, USP
0.3%
Rx only

STERILE
5 mL

SANDOZ