Tobramycin Nebuliser Solution is indicated for the management of cystic fibrosis in patients infected with Pseudomonas aeruginosa. The safety and effectiveness of this medicine have not been established in children below 6 years of age, in patients with a predicted forced expiratory volume (FEV1) of less than 25% or greater than 75%, or in patients colonized with Burkholderia cepacia.

Tobramycin Nebuliser Solution is a sterile, clear, slightly yellow, non-pyrogenic aqueous solution. Its pH and salinity are specifically adjusted for administration by nebuliser. Tobramycin is an aminoglycoside antibiotic that primarily works by disrupting bacterial protein synthesis, which leads to altered cell membrane permeability and ultimately causes bacterial cell death. It is bactericidal and active against a wide range of Gram-negative organisms, including Pseudomonas aeruginosa.

The 300 mg dose of Tobramycin is same for all patients regardless of age or weight (Tobramycin has not been studied in patients less than 6 years old). The recommended dose is one single-use ampoule (300 mg) to be inhaled b.i.d for 28 days. The dose should be taken as close to 12 hours apart as possible; they should not be taken less than 6 hours apart. If patient is taking several medications, the recommended order is as follows: bronchodilator first, followed by chest physiotherapy, then other inhaled medications & finally Tobramycin. Patient should take Tobramycin in repeated cycles of 28 days on drug, followed by 28 days off drug.

Patients using Tobramycin together with beta-agonists, inhaled corticosteroids, other anti-pseudomonal antibiotics, or parenteral aminoglycosides have shown adverse effects. Concurrent or sequential use of Tobramycin with other medicines that have neurotoxic or ototoxic potential should be avoided whenever possible. Certain diuretics may increase the toxicity of Tobramycin. Therefore, Tobramycin should not be used together with ethacrynic acid, furosemide, urea, or mannitol.

Tobramycin is contraindicated in patients with known hypersensitivity to tobramycin or to any other aminoglycoside antibiotic. Tobramycin Nebuliser Solution is intended for inhalation use only through a nebuliser and must not be injected or taken by mouth.

Inhaled Tobramycin is generally well tolerated. Voice changes and tinnitus are reported more frequently during periods when the medicine is being used. However, these effects are usually temporary and often resolve without stopping treatment. Other effects, such as dizziness and an increase in serum creatinine, have been reported at rates similar to those seen with placebo.

Tobramycin is classified as Pregnancy Category D. Its use is not recommended during pregnancy or breastfeeding.

Tobramycin should be used with caution in patients with known or suspected renal, auditory, vestibular, or neuromuscular disorders. Patients who are receiving Tobramycin together with other aminoglycosides should be monitored as clinically appropriate. Possible complications associated with Tobramycin include ototoxicity, neuromuscular problems, bronchospasm, and nephrotoxicity.

Aminoglycoside antibiotic.

Store refrigerated at 2°C to 8°C and protect from light. A slight change in color when kept unrefrigerated does not necessarily indicate any loss of product quality. However, the solution should not be used if it becomes cloudy, if particles are visible, or if it has been stored at room temperature for more than 28 days.