For ocular use only. Not for injection or ingestion.
For TOBRADEX 3 mg/ml + 1 mg/ml eye drops, suspension, after cap is removed, if tamper evident snap collar is loose, remove before using product.
The initial prescription and renewal thereof should be made only after examination of the patient with the aid of magnification such as slit-lamp biomicroscopy and, if necessary, fluorescein staining.
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.
Cross-hypersensitivity to other aminoglycosides can occur, and the possibility that patients who became sensitized to topical tobramycin may also be sensitive to other topical and/or systemic aminoglycosides should be considered.
Serious adverse reactions including neurotoxicity, ototoxicity and nephrotoxicity have occurred in patients receiving systemic aminoglycoside therapy. Caution is advised when TOBRADEX is used concomitantly with systemic aminoglycosides (see Adverse Reactions).
Caution should be exercised when prescribing TOBRADEX 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.
Excessive and/or prolonged use of topical ophthalmic corticosteroids increases the risk of ocular complications and could cause systemic side effects. If the inflammatory condition does not improve within a reasonable period during the course of the therapy, other forms of therapy should be instituted to reduce these risks.
Topical application of corticosteroids may be accompanied by a decrease in the urinary secretion of cortisol as well as a decrease in plasma cortisol concentration. Corticosteroids have been associated with hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's Syndrome, and a decreased rate of growth in children, especially with high-dose or long-term treatment.
Prolonged use of ophthalmic corticosteroids may result in ocular hypertension and/or glaucoma, with damage to the optic nerve, reduced visual acuity and visual field defects, and posterior subcapsular cataract formation. In patients receiving ophthalmic corticosteroid therapy for 10 days or longer, intraocular pressure should be checked routinely and frequently, even though it may be difficult in children and uncooperative patients. This is especially important in paediatric patients, as the risk of corticosteroid-induced ocular hypertension may be greater in children and may occur earlier than in adults. Patients with a family or personal history of glaucoma have a higher risk of a corticosteroid-induced rise in intraocular pressure. Patients with glaucoma should be monitored weekly.
Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.
Cushing's syndrome and/or adrenal suppression associated with systemic absorption of ocular 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). In these cases, treatment should be progressively discontinued.
Prolonged use of corticosteroids may also reduce resistance to and aid in the establishment of bacterial, viral, fungal or parasitic infections and mask the clinical signs of infection, preventing recognition of ineffectiveness of the antibiotic. TOBRADEX should therefore only be used in acute purulent infections of the eye when treatment with a steroid/anti-infective combination product is medically necessary. Fungal infection should be suspected in patients with persistent corneal ulceration. If fungal infection occurs, corticosteroids therapy should be discontinued.
The use of antibiotics such as tobramycin may also result in overgrowth of non-susceptible organisms, including fungi. If superinfection occurs, appropriate therapy should be initiated.
Ocular herpes simplex has occurred in patients under systemic or local corticosteroid therapy for other conditions. Using corticosteroid medication in the treatment of herpes simplex other than epithelial herpes simplex keratitis, in which it is contraindicated, requires great caution; periodic slit-lamp microscopy is essential.
In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical corticosteroids.
Topical ophthalmic corticosteroids may slow corneal wound healing. Topical NSAIDs are also known to slow or delay healing. Concomitant use of topical NSAIDs and topical steroids may increase the potential for healing problems. (See Interactions.)
Treatment should not be discontinued prematurely as a flare-up of the infectious or inflammatory condition may occur with the sudden interruption of a treatment with antibiotics or high doses of corticosteroids, respectively.
The risk of corticosteroid-induced raised intraocular pressure and/or cataract formation is increased in predisposed patients (e.g. diabetes).
Contact lens wear is not recommended during treatment of an ocular infection or inflammation.
TOBRADEX eye drops: This medicine contains 0.1 mg benzalkonium chloride in each ml, which is equivalent to 0.5 mg per 5 ml. Benzalkonium chloride may be absorbed by soft contact lenses and may change the colour of the contact lenses. Patients should be advised to remove contact lenses before using this medicine and to put them back 15 minutes afterwards. Benzalkonium chloride may also cause eye irritation, especially if the patient has dry eyes or disorders of the cornea.
After application of the eye drops following measures are useful to reduce systemic resorption: 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: TOBRADEX has no or negligible influence on the ability to drive and use machines. However, 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 machines.
Use in Children: It is advisable that the intraocular pressure be checked frequently. This is especially important in paediatric patients receiving dexamethasone-containing products, as the risk of steroid-induced ocular hypertension may be greater in children below 6 years of age and may occur earlier than a steroid response in adults. The frequency and duration of treatment should be carefully considered, and the IOP should be monitored from the outset of treatment, recognizing the risk for earlier and greater steroid-induced IOP increases in the paediatric patients.