TOBREX STERILE OPHTHALMIC SOLUTION 0.3% [SIN04451P]

Product Info

TOBREX STERILE OPHTHALMIC SOLUTION 0.3%

[SIN04451P]

4.1 Therapeutic indications
Tobrex® Ophthalmic Solution contains tobramycin, a water-soluble aminoglycoside antibiotic active against a wide variety of gram- negative and gram-positive ophthalmic pathogens.

Tobrex® Ophthalmic Solution is a topical antibiotic indicated in the treatment of external infections of the eye and its adnexa caused by susceptible bacteria. Appropriate monitoring of bacterial response to topical antibiotic therapy should accompany the use of Tobrex® Ophthalmic Solution. Clinical studies have shown tobramycin to be safe and effective for use in children.

4.2 Posology and method of administration
Posology
As indicated by physician:
In mild to moderate disease, instill 1 to 2 drops into the affected eye(s) every 4 hours. In severe infections, instill 2 drops into the eye(s) hourly until improvement, following which treatment should be reduced prior to discontinuation.
Tobrex® ophthalmic ointment may be used in conjunction with Tobrex® ophthalmic solution.

Use in children
The safety and efficacy of Tobrex® ophthalmic solution in children younger than 1 year of age have not been established.

Use in patients with hepatic or renal impairment
The safety and efficacy of Tobrex® ophthalmic solution in patients with hepatic or renal impairment have not been established.

Use in elderly population
No overall clinical differences in safety or efficacy have been observed between the elderly and other adult populations.

Method of administration
For ocular use.
Keep the bottle tightly closed when not in use. After cap is removed, if tamper evident snap collar is loose, it should be removed before using the product.
To avoid contamination, the dropper tip should not touch any surface. The dropper tip should also not come into contact with the eye as this may cause injury to the eye.
Either nasolacrimal occlusion or gently closing the eyelid(s) after administration is recommended. This may reduce the systemic absorption of medicinal products administered via ocular route and result in a decrease in systemic adverse reactions.
If more than one topical ophthalmic product is being used, the products must be administered at least 5 minutes apart. Eye ointments should be administered last.

4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.