Serum Forex concentrations should be monitored in patients with known or suspected auditory or renal dysfunction. If oto- or nephrotoxicity occurs in a patient receiving Fotex, Fotex should be discontinued until serum concentrations fall below 2 µg/ml. Tobramycin should be used with caution in patients with known or suspected renal dysfunction. Fotex should be discontinued in the case of nephrotoxicity until serum concentration of tobramycin fall below 2 µg/mL. In a randomised, double-blind, placebo-controlled, multicentre study, Fotex 112 mg was administered twice daily, for three cycles of 28 days on-treatment and 28 days off-treatment . Patients who were randomised to the placebo treatment group received placebo during the first treatment cycle and Fotex in the subsequent two cycles. Patients in this study had no exposure to inhaled tobramycin for at least 4 months prior to study start.

In clinical studies, inhaled showed a small but clear increase in Fotex, amikacin and gentamycin MIC for P. aeruginosa isolates tested. Each additional six months of treatment resulted in incremental increases similar in magnitude to that observed in the six months of controlled studies. P. aeruginosa isolated from CF patients has also been shown to exhibit adaptive aminoglycoside resistance that can be characterised by a reversion to susceptibility when the antibiotic is removed. In a second open-label, multicentre study, patients received treatment with either Fotex Podhaler or tobramycin 300 mg/5 ml nebuliser solution , administered twice daily for three cycles.

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If a patient reports occurrence of tinnitus or hearing loss, the physician should refer the patient for audiological assessment. Patients dotbig sign in receiving concomitant parenteral aminoglycoside therapy should be appropriately monitored taking into account the risk of toxicity.


In patients with a predisposing risk due to previous prolonged systemic therapy with aminoglycosides, it may be necessary to consider audiological assessment before starting therapy with tobramycin. The occurrence of tinnitus warrants caution, since it represents an ototoxic symptom. If the patient reports about tinnitus or hearing loss during the therapy with aminoglycosides, the physician should consider whether audiologic tests are necessary. When feasible, it is recommended that serial audiograms are performed in patients on continuous therapy, which are at particular high risk of ototoxicity.

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Tinnitus may be a sentinel symptom of ototoxicity, and therefore the onset of this symptom warrants caution. The main resistance mechanisms are drug efflux and drug inactivation by modifying enzymes. No studies on the effect on the ability to drive and use machines have been performed. dotbig company On the basis of reported adverse drug reactions, tobramycin is presumed to be unlikely to produce an effect on ability to drive and use machinery. Ototoxicity, manifested as both auditory and vestibular toxicity has been reported with the parenteral aminoglycosides.


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