Tobasol Respirator Solution

Tobasol Respirator Solution is indicated for the management of cystic fibrosis patients with Pseudomonas aeruginosa. Also indicated for severe COPD patients colonized with Pseudomonas aeruginosa. Safety and efficacy have not been demonstrated in patients below the age of 6 years, patients with a forced expiratory volume <25% or >75% predicted, or patients colonized with Burkholderia cepacia.

Tobramycin interferes with bacterial protein synthesis by binding to 30S and 50S ribosomal subunits, resulting in a defective bacterial cell membrane.

The recommended dosage for, both adult and paediatric patients, 6 years of age and older, is one single-use ampoule (300 mg) administered b.i.d for 28 days. Dosage is not adjusted by weight.

The doses should be taken as close to 12 hours apart as possible; they should not be taken less than 6 hours apart.

If you are taking several medications, the recommended order is as follows: bronchodilator first, followed by chest physiotherapy, then other inhaled medications and finally Tobramycin.

You should take Tobramycin in repeated cycles of 28 days on drug, followed by 28 days off drug. You should take Tobramycin twice a day during the 28 day period on drug.

Patients taking Tobasol concomitantly with beta agonists, inhaled corticosteroids, other anti pseudomonal antibiotics or parenteral aminoglycosides demonstrated adverse experience profiles.

Tobramycin is contraindicated in patients with a known hypersensitivity to any aminoglycoside.

Inhaled Tobasol is generally well-tolerated. Voice alterations and tinnitus are more common in the on-drug periods. However all the episodes are transient and resolved without discontinuation of the regimen. Others like dizziness and increase in serum creatinine were similar to those occurring with placebo.

If you are a nursing mother, pregnant or want to become pregnant, ask your doctor about the possibility of Tobramycin causing any harm.

It should be used with care in patients with known or suspected renal, auditory, vestibular, or neuromuscular dysfunction. Patients receiving concomitant aminoglycoside therapy should be monitored as clinically appropriate. It must be used with caution in patients with ototoxicity and nephrotoxicity. Discuss the use of Tobasol with your doctor if you have kidney problems or changes in hearing. Respirator Solution must only be used by inhalation from a nebulizer and must not be injected or swallowed.

Renal Impairment: Inhalation: Dosage adjustment needed.

Symptoms: Nephrotoxicity, auditory and vestibular toxicity (e.g. dizziness, tinnitus, vertigo, loss of high-tone hearing acuity), neuromuscular blockade or resp failure.

Management: Initiate resuscitative measures if resp paralysis occurs. Ca salts may be given to reverse neuromuscular blockade. Haemodialysis or peritoneal dialysis will help remove drug serum levels.

Aminoglycosides

Store under refrigeration at 2-8° C, and protected from light. Slight color change when unrefrigerated do not indicate any change in the quality of the product. The preparation must not be used if it is cloudy, particles appear in the solution or has been stored at room temperature for over 28 dyas. For use only under the prescription of a registered physician. Do not use Tobasol® beyond the expiration date stamped on the ampoule.