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Tobraflex (Tobramycin / Fluorometholone Acetate Ophthalmic) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Tobraflex™ 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 anti-infective drug in this product, tobramycin, is active against the following common bacterial eye pathogens: 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, and Acinetobacter calcoaceticus (Herellea vaginacola) and some Neisseria species.

DOSAGE AND ADMINISTRATION

One or two drops instilled into the conjunctival sac(s) every four to six hours. During the initial 24 to 48 hours, the dosage may be increased to one or two drops every two (2) hours. Frequency should be decreased gradually as warranted by improvement in clinical signs. Care should be taken not to discontinue therapy prematurely.

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

HOW SUPPLIED

Tobraflex™ is a sterile ophthalmic suspension supplied in Alcon's DROP-TAINER® package system.

TobraFlex™ is supplied as either a 2.5 mL or a 5 mL fill in a 5 mL natural polyethylene dispenser bottle with a natural polyethylene dropper tip and a white polypropylene overcap. Tamper evidence is provided with a shrink band around the closure and neck area of the package.

2.5 mL - NDC 0065-0651-25

5 mL - NDC 0065-0651-05

STORAGE

Store upright at 36° to 77°F (2° to 25°C) and shake well before using.

Rx Only

U.S. Patent No. 5,149,693 

©2001 Alcon Laboratories, Inc.

Alcon®

PHARMACEUTICALS

Alcon Laboratories, Inc.

Fort Worth, Texas 76134

Printed in USA

Rev: May 2001

345351-0501

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