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Tobradex ST

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Tobradex ST

Tobradex ST

INDICATIONS

TOBRADEX® ST (tobramycin / dexamethasone ophthalmic suspension 0.3%/0.05%) ophthalmic suspension is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists.

Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns, or penetration of foreign bodies.

The use of a combination drug with an anti-infective component is indicated where the risk of superficial ocular infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye.

The particular anti-infective drug in this product is active against the following common bacterial eye pathogens: Staphylococci, including S. aureus and S. epidermidis (coagulase-positive and coagulase-negative), including penicillin-resistant isolates. Streptococci, including some Group A and other 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 isolates, Haemophilus influenzae , H. aegyptius, Moraxella lacunata, Acinetobacter calcoaceticus and some Neisseria species.

DOSAGE AND ADMINISTRATION

Recommended Dosing

Instill one drop into the conjunctival sac(s) every four to six hours. During the initial 24 to 48 hours, the dosage may be increased to one drop every two hours. Frequency should be decreased gradually as warranted by improvement in clinical signs. Care should be taken not to discontinue therapy prematurely. Prescription Guideline

Not more than 20 mL should be prescribed initially and the prescription should not be refilled without further evaluation as outlined in WARNINGS AND PRECAUTIONS.

HOW SUPPLIED

Dosage Forms And Strengths

TOBRADEX ST (tobramycin / dexamethasone ophthalmic suspension 0.3%/0.05%) ophthalmic suspension contains 3 mg/mL tobramycin and 0.5 mg/mL dexamethasone.

Storage And Handling

TOBRADEX® ST (tobramycin / dexamethasone ophthalmic suspension 0.3%/0.05%) is supplied as a 2.5 mL, 5 mL, or 10 mL suspension in a 4 mL, 8 mL or 10 mL natural polyethylene DROP-TAINER® bottle with a natural polyethylene dispenser tip and a pink polypropylene overcap. Tamper evidence is provided with a shrink band around the closure and neck area of the bottle.

NDC 0065-0652-25: 2.5 mL
NDC 0065-0652-05: 5 mL
NDC 0065-0652-10: 10 mL

Storage

Store at 2 to 25°C (36 to 77°F). Protect from light.

Alcon Laboratories, Inc., Fort Worth, Texas 76134 USA. Revised: February 2009

Last reviewed on RxList: 9/7/2010
This monograph has been modified to include the generic and brand name in many instances.

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Report Problems to the Food and Drug Administration

 

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