NOT FOR INJECTION INTO THE EYE. Sensitivity to topically applied aminoglycosides may occur in some patients. If a sensitivity reaction does occur, discontinue use.
Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye. Prolonged use of steroids may result in glaucoma, with damage to the optic nerve, defects in visual acuity and fields of vision, and posterior subcapsular cataract formation. If used for more than 10 days, intraocular pressure should be routinely monitored even though it may be difficult in children and uncooperative patients. Prolonged use may suppress the host response and thus increase the hazard of secondary ocular infections. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids. In acute purulent conditions of the eye, steroids may mask infection or enhance existing infection.
There is currently no manufacturer warning information available for this drug.
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.
Tobraflex™ (tobramycin and fluorometholone acetate ophthalmic suspension, USP) is a sterile, multiple dose antibiotic and steroid combination for topical ophthalmic use. The chemical structures for tobramycin and fluorometholone acetate are presented below:
Tobramycin
Empirical Formula: C18H37N5O9
Chemical Name:
O-3-Amino-3-deoxy-α-D-glucopyranosyl-
(1->4)O-[2,6-diamino-2,3,6-trideoxy-
α-D-ribo-hexopyranosyl-(1->6)]-2-
deoxy-L-streptamine
Fluorometholone Acetate
Empirical Formula: C24H31FO5
Chemical Name:
9-Fluoro-11β, 17-dihydroxy-6α-
methylpregna-1,4-diene-3,20-
dione 17-acetate
Each mL contains: Active: Tobramycin 0.3% (3 mg) and Fluorometholone Acetate 0.1% (1 mg).
Preservative: Benzalkonium Chloride 0.01%. Inactive: Tyloxapol, Edetate Disodium, Sodium Chloride, Hydroxyethyl Cellulose, Hydrochloric Acid and Sodium Hydroxide (to adjust pH), Purified Water. The pH range is 6.0 -7.0. DM-00
