Dexatrol Special Precautions

For topical use only. Not for injection or ingestion. As with all antibacterial preparations, prolonged use may lead to overgrowth of nonsusceptible bacterial strains or fungi. If superinfection occurs, appropriate therapy should be initiated. Sensitivity to topically-applied aminoglycosides may occur in some patients. Cross-sensitivity to other aminoglycosides may also occur. If signs of serious reactions or hypersensitivity occur, discontinue use of Dexamethasone +Neomycin (as Sulfate) + Polymyxin-B-Sulfate (DEXATROL). Patients using ophthalmic preparations containing neomycin sulphate should be advised to consult a physician if ocular pain, redness, swelling, or irritation worsens or persists. Serious adverse reactions including neurotoxicity, ototoxicity and nephrotoxicity have occurred in patients receiving systemic neomycin or when applied topically to open wounds or damaged skin. Nephrotoxic and neurotoxic reactions have also occurred with systemic polymyxin B. Although these effects have not been reported following topical ocular use of this product, caution is advised when used concomitantly with systemic aminoglycoside or polymyxin B therapy. Prolonged use of ophthalmic steroids may result in ocular hypertension and/or glaucoma, with damage to the optic nerve, reduced visual acuity and visual field defects, and posterions subcapslar cataract formation. In patients receiving prolonged ophthalmic corticosteroid therapy, intraocular pressure should be checked routinely and frequently.
This is especially important in pediatric patients, as the risk of corticosteroid induced ocular hypertension may be greater in children and may occur earlier than in adults. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical corticosteroids. Corticosteroids may reduce resistance to and aid in the establishment of bacterial, viral, or fungal infections and mask the clinical signs of infection, preventing recognition of ineffectiveness of the antibiotic, or may suppress hypersensitivity reactions to substances in the product. Fungal infection should be suspected in patients with persistent corneal ulceration who have been or are receiving these drugs and corticosteroid therapy should be discontinued if fungal infection occurs. To avoid the risk of enhancement of herpetic corneal disease, frequent slit lamp examination is essential. Contact lens wear is not recommended during treatment of an ocular infection. Therefore patients should be advised not to wear contact lenses during treatment with Dexamethasone + Neomycin (as sulfate) + Polymyxin-B-Sulfate (Dexatrol). Dexamethasone + Neomycin (as sulfate) + Polymyxin-B-Sulfate (Dexatrol) ophthalmic suspension contains benzalkonium chloride as preservative which may cause eye irritation and is known to discolour soft contact lenses. Avoid contact with soft contact lenses. Remove contact lenses prior to application and wait at least 15 minutes before reinsertion.
Effects on ability to drive and use machines: Dexamethasone + Neomycin (as sulfate) + Polymyxin-B-Sulfate (Dexatrol) has no or negligible influence on the ability to drive and use machines. As with any other eye drop, temporarily blurred vision or other visual disturbances may affect the ability to drive or use machines. If transient blurred vision occurs upon instillation, the patient must wait until the vision occurs upon instillation, the patient must wait until the vision clears before driving or using machinery.