Action and Clinical Uses:
Dexamethasone, a potent corticosteroid, suppresses the inflammatory response to chemical, immunological or mechanical irritants. The bactericidal activity of tobramycin is accomplished by specific inhibition of normal protein synthesis in susceptible bacteria.
Indications And Clinical Uses:
For steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial ocular infection exist.
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, thermal burns or penetration of foreign bodies.
Vaccinia, varicella, herpes simplex and other viral diseases of the cornea and conjunctiva; tuberculosis of the eye; fungal diseases of the eye; acute purulent untreated infections of the eye, which, like other diseases caused by microorganisms may be masked or enhanced by the presence of the steroid.:
Hypersensitivity to a component of the medication. Partial cross-allergenicity to other aminoglycosides has been established.
The use of this combination is always contraindicated after uncomplicated removal of a corneal foreign body.
Warnings in Clinical States:
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 corticosteroids may result in glaucoma, with damage to the optic nerve, defects in visual acuity and fields of vision, and posterior subcapsular cataract formation.
Prolonged use may suppress the host response and thus increase the hazard of secondary ocular infections.
Extended ophthalmic use of corticosteroid drugs may cause increased intraocular pressure in certain individuals and in those diseases causing thinning of the cornea, perforation has been known to occur. If treatment exceeds 9Â days, intraocular pressure should be routinely monitored.
General: Fungal infections of the cornea are particularly prone to develop coincidentally with long-term local steroid application; fungus invasion must be considered in any persistent corneal ulceration where a steroid has been used or is in use. As with other antibiotics, prolonged use may result in overgrowth of nonsusceptible organisms. As with all steroids, heating may be delayed if used in the uncomplicated removal of foreign bodies.
Ophthalmic examinations are recommended during long-term therapy. If there is no improvement after 5 or 7 days of therapy or if the condition worsens, the medication should be discontinued.
If topical ocular tobramycin is administered concomitantly with systemic aminoglycoside antibiotics, care should be taken to monitor the total serum concentration.
Patients should be advised to inform their physicians of any prior use of corticosteroids.
Patients should be advised regarding the use of contact lenses while on therapy.
Pregnancy: Animal reproduction studies have not been conducted with this product. It is not known whether the drug can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. TobraDex should be given to a pregnant woman only if clearly needed.
Lactation: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this product is administered to a nursing woman.
Children: Safety and effectiveness in children have not been established.
Adverse reactions have occurred with steroid/anti-infective combination drugs which can be attributed to the steroid component, the anti-infective component, or the combination. Exact incidence figures are not available.
The most frequent adverse reactions to topical ocular tobramycin are localized ocular toxicity and hypersensitivity, including lid itching and swelling, and conjunctival erythema. These reactions occur in less than 4% of patients. Other adverse reactions have not been reported from ocular tobramycin therapy.
The reactions due to the steroid component in decreasing order of frequency are: elevation of intraocular pressure (IOP) with possible development of glaucoma, and infrequent optic nerve damage; posterior subcapsular cataract formation; and delayed wound healing.
The development of secondary infection has occurred after use of combinations containing steroids and antimicrobials. Fungal infections of the cornea are particularly prone to develop coincidentally with long-term applications of steroid. The possibility of fungal invasion must be considered in any persistent corneal ulceration where steroid treatment has been used.
Symptoms And Treatment Of Overdose:
There is no known treatment of overdosage since overdosage in the use of topical ophthalmic preparations is a remote possibility. Discontinue medication when heavy or protracted use is suspected.
Dosage And Administration:
Ointment: Apply a 1.25 cm ribbon into the conjunctival sac(s) up to 3 or 4 times daily or may be used adjunctively with drops at bedtime.
Suspension: 1 to 2 drops instilled into the conjunctival sac every 4 hours. During the initial 24 to 48 hours the dosage may be increased to 1 or 2 drops every 2 hours. Frequency should be decreased gradually as warranted by improvement in clinical signs. Care should be taken not to discontinue therapy prematurely.
Special Instructions: Patients should be instructed to avoid contamination of dispensing tip.
Availability And Storage:
Ointment: Each g of sterile ophthalmic ointment contains: tobramycin 3 mg and dexamethasone 0.1% with chlorobutanol 0.5% as a preservative in a mineral oil and petrolatum base. Tubes of 3.5 g.
Suspension: Each mL of sterile, isotonic, aqueous suspension contains: tobramycin 3 mg and dexamethasone 0.1% with benzalkonium chloride 0.01% as a preservative. Nonmedicinal ingredients: edetate disodium, hyroxyethyl cellulose, purified water, sodium chloride, sodium hydroxide, sodium sulfate, sulfuric acid and tyloxapol. Drop-Tainer dispensers of 5 mL. Shake well before use. Store in an upright position. Store at room temperature.
TOBRADEX® Alcon Tobramycin-Dexamethasone Antibiotic-Corticosteroid
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