For topical ophthalmic use only. Not for injection or ingestion.
Cross-hypersensitivity with other aminoglycosides can occur. The possibility that patients who become sensitized to topical ocular tobramycin may also be sensitive to other topical and/or systemic aminoglycosides should be considered.
Sensitivity to topically administered aminoglycosides may occur in some patients. Severity of hypersensitivity reactions may vary from local effects to generalized reactions such as erythema, itching, urticarial, skin rash, anaphylaxis, anaphylactoid reactions, or bullous reactions. If hypersensitivity develops during use of this medicine, treatment should be discontinued and other medications used (see Adverse Reactions).
Serious adverse reactions including neurotoxicity, ototoxicity and nephrotoxicity have occurred in patients receiving systemic tobramycin therapy. Caution is advised when using concomitant topical and systemic aminoglycosides and care should be taken to monitor total serum concentrations (see Adverse Reactions).
Caution should be exercised when prescribing TOBREX to patients with known or suspected neuromuscular disorders such as myasthenia gravis or Parkinson's disease. Aminoglycosides may aggravate muscle weakness because of their potential effect on neuromuscular function..
As with other antibiotic preparations, prolonged use of TOBREX may result in overgrowth of non-susceptible organisms, including fungi. If superinfection occurs, appropriate therapy should be initiated.
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 the product.
Additionally, TOBREX eye drops contains benzalkonium chloride which may cause irritation and is known to discolour soft contact lenses. Avoid contact with soft contact lenses. Patients must be instructed to remove contact lenses prior to application of TOBREX and wait 15 minutes after application of the dose before reinsertion.
After application of TOBREX eye drops following measures are useful to reduce systemic absorption: keep the eyelid closed for 2 minutes; close the lachrymal duct with the finger for 2 minutes.
Effects on ability to drive and use machines: TOBREX eye drops and eye ointment have no or negligible influence on the ability to drive and use machines. As with any other eye preparation, temporary blurred vision or other visual disturbances may affect the ability to drive or use machines. If blurred vision occurs at application, the patient must wait until the vision clears before driving or using machinery.