TobraDex
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TobraDex is a popular prescription medication marketed in the United States by Alcon Labs. The active ingredients are tobramycin 0.3% (an antibiotic) and dexamethasone 0.1% (a corticosteroid). The preservative used in TobraDex is benzalkonium chloride 0.01%. The inactive ingredients are tyloxapol, edetate disodium, hydroxyethyl cellulose, sodium sulfate, sulfuric acid and/or sodium hydroxide (to adjust pH) and purified water. TobraDex is a trademark of Alcon Labs. It is prescribed for a wide spectrum of bacterial eye infections.
Tobradex is sometimes prescribed for the treatment of ear infections.
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[edit] Clinical Pharmocology
Corticoids suppress the inflammatory response to a variety of agents and they probably delay or slow healing. Since corticoids may inhibit the body's defense mechanism against infection, a concomitant antimicrobial drug may be used when this inhibition is considered to be clinically significant. Dexamethasone is a potent corticoid.
The antibiotic component in the combination (tobramycin) is included to provide action against susceptible organisms. In vitro studies have demonstrated that tobramycin is active against susceptible strains of the following microorganisms: Staphylococci, including S. aureus and S. epidermidis (coagulase-positive and coagulase-negative,) including penicilllin-resistant strains; Streptococci, including some of the Group A-beta-hemolytic species, some nonhemolytic species, and some Strepococcus Pneumoniae; Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter aerogenes, Proteus mirabilis, Morganella morganii, most Proteus vulgaris strains, Haemophilus influenzae and Haemophilus aegyptius, Moraxella lacunata, Acinetobacter calcoaceticus and some Neisseria species.
Bacterial susceptibility studies demonstrate that in some cases microorganisms resistant to gentamicin remain susceptible to tobramycin.
No data are available on the extent of systemic absorption from TobraDex Opthalmic Suspension; however, it is known that some systemic absorption can occur with ocularly applied drugs. If the maximum dose of TobraDex Opthalmic Suspension is given for the first 48 hours (two drops in each eye every 2 hours) and complete systemic absorption occurs, which is highly unlikely, the daily dose of dexamethasone would be 2.4 mg. The usual physiologic replacement dose is 0.75 mg daily. If TobraDex Ophthalmic suspension is given after the first 48 hours as two drops in each eye every 4 hours, the administered dose of dexamethasone would be 1.2 mg daily.
[edit] Indications and Usage
TobraDex Opthalmic Suspension is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial 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 conjunctivides 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.
[edit] Contraindictions
Contradictions include epithelial herpes simplex keratitis (dendritix keratitis,) vaccinia, varicella as well asmany other viral diseases of the cornea and conjunctiva. Mycobacterial infection of the eye. Fungal diseases of ocular structures. Hypersensitivity to a component of the medication.
[edit] Warnings
Not for injection into the eye. Sensitivity to topically applied aminoglycosides may occur in some patients. If a sensitivity reaction does occur, discontinue use.
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. Intraocular pressure should be routinely monitored even though it may be difficult in pediatric patients 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.
Clinically apparent signs and symptoms of an overdosage of TobraDex Opthalmic Suspension (punctate keratitis, erythema, increased lacrimation, edema and lid itching) may be similar to adverse reaction effects seen in some patients.
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