Tobrexa Eye 3.0 mg/3 mg Solution

TOBREX is a topical antibiotic indicated in the treatment of external bacterial infections of the eye and its adnexa caused by susceptible organisms. Appropriate monitoring of bacterial response to topical antibiotic therapy should accompany the use of TOBREX.

Posology
TOBREX eye drops, solution :
u2022 For mild to moderate infections, Instil 1 to 2 drops into the conjunctival sac of the affected eye(s) every four hours for seven days.
u2022 In severe infections instil two drops into the conjunctival sac of the affected eye(s) every hour until improvement following which, dosage should be reduced prior to discontinuation.
TOBREX eye ointment :
u2022 In mild to moderate disease, apply a ribbon of about 10 mm (1/2 inch) into the affected eye(s) two or three times per day.
u2022 In severe infections, instil a ribbon of about 10 mm (1/2 inch) into the affected eye(s) every three to four hours until improvement following which treatment should be reduced prior to discontinuation.

TOBREX is contra-indicated in patients hypersensitive to tobramycin or to any of the excipients.

• Sensitivity to topically applied aminoglycosides may occur in some patients. If a sensitivity reaction to tobramycin occurs, discontinue use.
• Cross-hypersensitivity to other aminoglycosides can occur, and 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.
• Serious adverse reactions including neurotoxicity, ototoxicity and nephrotoxicity have occurred in patients receiving systemic aminoglycoside therapy. Caution is advised when TOBREX is used concomitantly with systemic aminoglycosides.
• Caution should be exercised when prescribing TOBREX to patients with known or suspected neuromuscular disorders such as myasthenia gravis or Parkinsonu2019s disease. Aminoglycosides may aggravate muscle weakness because of their potential effect on neuromuscular function.
• Localised ocular toxicity and hypersensitivity can occur. If topical ocular tobramycin is administered concomitantly with systemic aminoglycoside antibiotics, care should be taken to monitor the total serum concentration.
• Prolonged use may lead to skin sensitisation or result in overgrowth of non-susceptible organisms, including fungi. If superinfection occurs, appropriate therapy should be initiated.
• Ophthalmic ointments may retard corneal healing.
• As the possibility of adverse effects on the corneal permeability and the danger of disruption of the corneal epithelium with prolonged or repeated usage of benzalkonium chloride preserved preparations such as TOBREX cannot be excluded, regular ophthalmological examination is required. Caution should be exercised in the use of benzalkonium chloride preserved topical medication over an extended period in patients with extensive ocular surface disease.
• Contact lens wear is not recommended during treatment of an ocular infection.
• TOBREX Eye Drops contain benzalkonium chloride which may cause eye irritation and is known to discolour soft contact lenses. Avoid contact with soft contact lenses.
• In case patients are allowed to wear contact lenses, they must be instructed to remove contact lenses prior to application of TOBREX Eye Drops and wait at least 15 minutes before reinsertion.

No clinically relevant interactions have been described with topical ocular dosing. Care should be exercised when tobramycin is given to patients receiving other drugs with neuromuscular blocking activity or which are ototoxic. Tobramycin and carbenicillin have been reported to have an enhanced effect. However, since an in vitro incompatibility with carbenicillin sodium has been demonstrated, the two antibiotics should be administered separately when both are required.

Fertility
Not applicable
Pregnancy
There are no adequate and well controlled studies of tobramycin in pregnant women. Therefore, this drug should only be used during pregnancy if the potential benefits outweigh the possible risks
Breastfeeding
Because of the potential for adverse reactions in nursing infants from TOBREX, a decision should be made whether to discontinue nursing the infant or discontinue the drug, taking into account the importance of the drug to the mother.

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.

The following adverse reactions have been reported during clinical trials with TOBREX and are classified according to the subsequent convention: very common (u22651/10), common (u22651/100 to <1/10), uncommon (u22651/1,000 to <1/100), rare (u22651/10,000 to <1/1,000) and very rare (<1/10,000). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
System Organ Classification Adverse reactions
Immune system disorders Uncommon: hypersensitivity
Nervous system disorders Uncommon: headache
Eye disorders Common: ocular discomfort, ocular hyperaemia
Uncommon: keratitis, corneal abrasion, visual impairment, vision blurred, erythema of eyelid, conjunctival oedema, eyelid oedema, eye pain, dry eye, eye discharge, eye pruritus, lacrimation increased.
Skin and Subcutaneous Tissue Disorders Uncommon: urticaria, dermatitis, madarosis, leukoderma, pruritus, dry skin
Additional adverse reactions identified from post-marketing surveillance include the following. Frequencies cannot be estimated from the available data.
System Organ Classification Adverse reactions
Immune system disorders Anaphylactic reaction
Eye disorder Eye allergy, eye irritation, eyelids pruritus
Skin and subcutaneous tissue disorders Rash

Due to the characteristics of this preparation, no toxic effects are to be expected with an ocular overdose of this product, or in the event of accidental ingestion of the contents of one bottle or tube. In overdose, side effects can be precipitated and/or be of increased severity, see section 4.8.