Tobrex 2X

/ Novartis

The dose is one drop of TOBREX 2X eye drops into the conjunctival sac two times daily (morning and evening) for 7±1 days.
To prevent contamination of the dropper tip and solution, care must be taken not to touch the eyelids, surrounding areas, or other surfaces with the dropper tip of the bottle. Keep the bottle tightly closed when not in use.
After cap is removed, if the tamper evident snap collar is loose, remove before using the product.
In case of concomitant therapy with other topical ocular medicines, an interval of 5-10 minutes should be allowed between successive applications.
Use in elderly: No dosage adjustment in elderly patients is necessary.
Paediatric Population: TOBREX 2X eye drops may be used in children 1 year of age and older at the same dose as in adults. Currently available data is described in Section 5.1 at the attached doctor’s leaflet. The safety and efficacy in children younger than 1 year of age have not been established, and no data are available.
Use in hepatic and renal impairment: Ocular application of tobramycin gives very little systemic exposure. In case of concomitantly administered systemic treatment with aminoglycoside antibiotics, care should be taken to monitor the total serum concentration in order to ensure that an appropriate therapeutic level is maintained.

Treatment of superficial bacterial infections caused by bacteria sensitive to Tobramycin.

Hypersensitivity to the active substance or any of the excipients.

For ocular use only. Not for injection or ingestion. Sensitivity to topically administered aminoglycosides may occur in some patients. If hypersensitivity develops during the use of this medicine, treatment should be discontinued. 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 tobramycin therapy. Caution is advised when used concomitantly with aminoglycosides. As with other antibiotic preparations, prolonged use of TOBREX 2X 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, this product contains benzododecinium bromide 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 2X and wait 15 minutes after instillation of the dose before reinsertion.

The most frequently reported adverse reactions were ocular hyperaemia and ocular discomfort, occurring in approximately 1.4% and 1.2% of patients. Additional common adverse reactions were: Eye allergy and Eyelids pruritus.
For full details see prescribing information.

No interaction studies have been performed. Topical corticosteroids, when used in combination with tobramycin 3 mg/ml, may mask the clinical signs of bacterial, fungal, or viral infections and may suppress hypersensitivity reactions. If more than one topical ophthalmic medicinal product is being used, the medicines must be administered at least 5 minutes apart. Eye ointments should be administered last.

Pregnancy: High systemic doses of tobramycin, well above those encountered with topical ocular use, have been associated with nephrotoxicity and ototoxicity. Tobramycin crosses the placenta into the foetal circulation and amniotic fluid. A study of orally and parenterally administered aminoglycosides (including tobramycin) to pregnant women demonstrated no detectable risk to the foetus. Systemic exposure following ocular administration is expected to be low. There are no or limited amount of data from the use of TOBREX 2X in pregnant women. Animal studies have shown reproductive toxicity. TOBREX 2X is not recommended during pregnancy.
Lactation: Tobramycin is excreted in human milk at exposures associated with oral or parenteral administration. When instilled topically, systemic exposure is low, and therefore excretion of tobramycin in human milk is considered unlikely when using TOBREX 2X eye drops. However, a risk to the suckling child cannot be excluded. A decision should be made whether to discontinue breastfeeding or to discontinue/abstain from TOBREX 2X therapy taking into account the benefit of breastfeeding for the child and benefit of therapy for the woman.

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. Clinically apparent signs and symptoms of an overdose of TOBREX 2X (punctate keratitis, erythema, increased lacrimation, oedema, and lid itching) may be similar to adverse reaction effects seen in some patients. A topical overdose of TOBREX 2X may be flushed from the eye(s) with lukewarm water.

Shelf life: 2 years. Discard 28 days after first opening.
Storage: Store below 30°C.