TOBRABACT Eye drops, solution Ref.[50600] Active ingredients: Tobramycin

Pharmacological category: Antibiotic, topical aminoglycoside
ATC code: S: sensory organs

Tobramycin belongs to the aminoglycoside group of antibiotics and exerts a bactericidal effect by interfering with the protein synthesis of bacterial cells. Tobramycin belongs to the antibiotics displaying a post-antibiotic effect which is defined as persistent suppression of bacterial growth following wash-out. Cross resistance with other aminoglycoside antibiotics (neomycin, gentamicin) is possible.

Spectrum of antibacterial activity:

The following MIC breakpoints separate susceptible from intermediately susceptible and intermediately susceptible from resistant organisms:

S ≤ 4 mg/l and R > 8 mg/l

The prevalence of acquired resistance may vary geographically and with time for selected species and local information of resistance is desirable, particularly when treating severe infections. This information gives only approximate guidance on probabilities whether micro-organisms will be susceptible to tobramycin.

Where resistance patterns for particular species are known to vary within Europe, this is shown below:

^*: The frequency of resistance to methicillin for all Staphylococci may reach 50% in someEuropean countries and is usually observed in hospitals.
NB: This spectrum corresponds to that of the systemic forms of tobramycin. With localpharmaceutical forms, the concentrations attained in situ are far higher than plasmaconcentrations. Some doubts remain as to the kinetics of concentrations in situ, the local physical and chemical conditions which may modify the activity of the antibiotic and the stability of the product in situ.

Paediatric population

More than 600 paediatric patients, over 10 clinical studies, received tobramycin in the form of eye drops or eye ointment for the treatment of bacterial conjunctivitis, blepharitis or blepharoconjunctivitis. These patients were aged between 1 and 18. Overall, the safety profile in paediatric patients was similar to that of adult patients. Given the lack of data, no dosing recommendations could be provided for children under the age of 1 year.