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TOBRADEX is a brand name for Tobramycin, supplied as a suspension. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................4 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
TOBRADEX is contraindicated in: Patients who are hypersensitive to tobramycin, dexamethasone or to any ingredient in the formulation or component of the container. For a complete listing, see the Dosage Forms, Composition and Packaging section of the product monograph.
Patients with known or suspected hypersensitivity to other aminoglycosides. Partial cross-allergenicity to other aminoglycosides has been established. Herpes simplex keratitis. Vaccinia, varicella, and other viral diseases of the cornea and conjunctiva.
Fungal diseases of the eye or untreated parasitic eye infections. Mycobacterial ocular infections, including tuberculosis 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.
After uncomplicated removal of a corneal foreign body. WARNINGS AND PRECAUTIONS General FOR TOPICAL OCULAR USE ONLY. NOT FOR INJECTION INTO THE EYE. NOT FOR OTIC USE. 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.
Patients should be advised to inform their physicians of any prior use of corticosteroids. Sensitivity to topically applied aminoglycosides may occur in some patients. Severity of hypersensitivity reactions may vary from local effects to generalized reactions, such as erythema, itching, urticaria, skin rash, anaphylaxis, anaphylactoid reactions or bulbous reactions.
If hypersensitivity develops during use of TOBRADEX, treatment should be discontinued. Cross-hypersensitivity to other aminoglycosides can occur, and the possibility that patients who become sensitized to topical tobramycin may also be sensitive to other topical and/or systemic aminoglycosides should be considered.
If topical ocular tobramycin is administered concomitantly with systemic aminoglycoside antibiotics, care should be taken to monitor the total aminoglycoside serum concentration. Serious adverse reactions, including neurotoxicity, ototoxicity and nephrotoxicity, have occurred in patients receiving systemic aminoglycoside therapy, including tobramycin.
Caution should be exercised if TOBRADEX is administered with systemic aminoglycosides or other drugs that have neurotoxic, ototoxic, or nephrotoxic effects, particularly in patients with known or suspected renal, auditory, vestibular, or neuromuscular dysfunction.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Tobramycin in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
TOBRADEX® Product Monograph Page 5 of 28 Caution should be exercised when prescribing TOBRADEX to patients with known or suspected neuromuscular disorders such as myasthenia gravis or Parkinson’s disease. Aminoglycosides, including tobramycin, may aggravate muscle weakness because of their known effect on neuromuscular function and potential to produce neuromuscular blockade.
Infections:
Prolonged use of corticosteroids may suppress the host response, and aid in the establishment of secondary ocular bacterial, viral, fungal or parasitic infections and mask the clinical signs of infection. 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.
If fungal infection occurs, corticosteroid therapy should be discontinued.
Delayed Healing:
Topical ophthalmic corticosteroids may slow corneal wound healing. Concomitant use of topical ophthalmic corticosteroids and topical NSAIDs may increase the potential for, and severity of, healing problems (see DRUG INTERACTIONS).
Driving and Using Machinery:
Temporary blurred vision or other visual disturbances may affect the ability to drive or use machines. If blurred vision occurs after instillation, the patient must wait until vision clears before driving or using machinery.
Susceptibility/Resistance Development of Drug Resistant Bacteria:
Prescribing TOBRADEX in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and risks the development of drug-resistant bacteria.
Potential for Microbial Overgrowth:
Prolonged use of antibacterials such as tobramycin may result in overgrowth of non-susceptible organisms, including fungi. If superinfection occurs, appropriate therapy should be initiated. Endocrine and Metabolism Cushing’s syndrome and/or adrenal suppression associated with systemic absorption of ophthalmic dexamethasone may occur after intensive or long-term continuous therapy in predisposed patients, including children and patients treated with CYP3A4 inhibitors (including ritonavir and cobicistat) (see DRUG INTERACTIONS).
In these cases, treatment should not be discontinued abruptly, but progressively tapered. The combination of CYP3A4 inhibitors with TOBRADEX should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side-effects, in which case patients should be monitored for systemic corticosteroid effects.
TOBRADEX® Product Monograph Page 6 of 28 Ophthalmologic Prolonged or intensive use of topical ophthalmic corticosteroids may result in ocular hypertension and/or glaucoma, with damage to the optic nerve, defects in visual acuity and fields of vision, and posterior subcapsular cataract formation.
This risk is higher in patients with diabetes. In patients with diseases causing thinning of the cornea or sclera, perforation has been known to occur with the use of topical corticosteroids. If treatment exceeds 9 days, intraocular pressure should be routinely and frequently monitored.
TOBRADEX suspension contains the preservative benzalkonium chloride. Benzalkonium chloride has been reported to cause punctate keratopathy and/or toxic ulcerative keratopathy. Contact lens wear is not recommended during treatment of ocular inflammation or infection.
Benzalkonium chloride may cause eye irritation and is known to bind to, and discolour, […]