Tobrex Ophthalmic Ointment

/ Novartis

Posology:
– In mild disease: a small amount of ointment 2 to 3 times per day,
– In more severe infections: a small amount of ointment every 3 to 4 hours until improvement, following which treatment should be reduced prior to
discontinuation. The length of the treatment is dependent on the origin of the infection and may vary from a couple of days up to some weeks.
Method of administration: For ocular use. To prevent contamination of the tube tip and ointment, care must be taken not to Touch the eyelids, surrounding areas, or other surfaces with the tube tip. Keep the tube tightly closed when not in use. In case of concomitant therapy with other topical ocular medicines, an interval of 5 – 10 minutes should be allowed between successive applications.

Antibiotic for the treatment of superficial eye infections caused by bacteria sensitive to Tobramycin.

Hypersensitivity to the active substance or to any of the excipients.
Hypersensitivity to aminoglycosides.

FOR TOPICAL OPHTHALMIC USE ONLY. NOT FOR INJECTION INTO THE EYE.
Hypersensitivity: 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 with this product, discontinue use and institute appropriate therapy.
If Tobrex Eye Ointment is administered concomitantly with systemic aminoglycoside antibiotics, care should be taken to monitor the total serum concentration.
Serious adverse reactions including neurotoxicity, ototoxicity and nephrotoxicity have occurred in patients receiving systemic aminoglycosides therapy. Caution is advised when Tobrex Eye Ointment is used concomitantly with systemic aminoglycosides.
Caution should be exercised when prescribing Tobrex Eye Ointment 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.
General: As with any antibiotic, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, appropriate therapy should be initiated.
Cross-sensitivity to other aminoglycoside antibiotics may occur. The possibility that patients that become sensitised to topical ocular tobramycin may also be sensitive to other topical and/or systemic aminoglycosides should be considered.
Eye ointments may retard corneal wound healing.
Paediatric use: Safety and effectiveness in children below the age of 1 year have not been established.
Use in the elderly: No overall differences in safety or effectiveness have been observed between elderly and other adult patients.
Renal, auditory, vestibular, or neuromuscular impairment: Patients receiving concomitant parenteral tobramycin (aminoglycoside) and topical tobramycin therapies should be monitored as clinically appropriate. Caution should be exercised with known or suspected renal, auditory, vestibular, or neuromuscular dysfunction.
Renal and hepatic impairment: Tobrex Eye Ointment has not been studied in these patient populations. However, due to low systemic absorption of tobramycin after topical administration of this product, dose adjustment is not necessary.
Contact lenses: Tobrex Eye Ointment should not be instilled while the patient is wearing contact lenses. Contact lens wear is not recommended during treatment of an ocular infection.
Due to the nature of the ointment base, patients should be advised not to wear their contact lenses while they are being treated with Tobrex Eye Ointment.

The most frequent adverse reactions to Tobrex Eye Ointment are localised ocular toxicity and hypersensitivity, including punctate keratitis, eye and lid itching, lid swelling, ocular hyperaemia, conjunctival erythema and lacrimation. These reactions occur in approximately 3% of patients treated with Tobrex.
Other adverse reactions associated with ophthalmic tobramycin are burning and stinging of the eyes. For ophthalmic ointment dosage form: blurred vision.
See prescribing information for full details.

If Tobrex Eye Ointment is used while the patient is on a systemic aminoglycoside antibiotic, the patient’s total serum aminoglycoside concentration should be monitored.
Concurrent and/or sequential use of Tobrex with other drugs with neurotoxic or ototoxic potential should be avoided.
Do not use Tobrex simultaneously with a topical beta lactam type antibiotic as this is likely to result in inactivation of tobramycin.

Pregnancy: Category B3. There are no adequate, well-controlled studies using the topical administration of Tobrex (tobramycin) Eye Ointment in pregnant women.
A published retrospective assessment of women receiving parenteral aminoglycosides during pregnancy suggested no detectable teratogenic risk to the fetus. The number of women treated with parenteral tobramycin in this study was very small, 2 in the case group and 4 in the control group and so no firm specific conclusions with regard to tobramycin exposure can be drawn from this study. However, the study concluded that parenteral administration of gentamicin and oral neomycin during pregnancy presents no detectable terotogenic risk to the fetus, when restricted to structural developmental abnormalities. This conclusion can be extended to the class of aminoglycoside antibiotics as a whole.
There are no firm data concerning the detectable blood concentrations in mothers or tissue concentrations in the fetus. The systemic absorption of tobramycin after topical administration of Tobrex is expected to be low.
Tobrex should be used during pregnancy only if the potential benefit for the mother justifies the potential risk to the fetus otherwise tobramycin is not recommended during pregnancy.
Lactation: There are no adequate, well-controlled studies using the topical administration of Tobrex Eye Ointment in women who are breast feeding. It is unknown whether tobramycin is excreted in human milk following topical ocular administration.
Tobramycin is excreted in human milk after systemic administration. Risk to the breast fed child cannot be excluded.
Tobrex should be used only if the potential benefit for the mother justifies the potential risk to the infant.
See prescribing information for full details.

Clinically apparent signs and symptoms of Tobrex Eye Ointment overdose are not expected when used as above nor in the event of accidental ingestion of the contents of tube. However, excessive local reactions may occur. In such cases treatment should be discontinued and appropriate treatment instituted.
A topical overdose of Tobrex may be flushed from the eye(s) with lukewarm water.

Storage: Do not store above 25ºC. Contents should be discarded four weeks after first opening.