Use of Aerosolized Antibiotics in Patients With Cystic Fibrosis: Recommendations for the Use of Aerosolized Antibiotics in CF
Evidence-based recommendations for aerosolized antibiotic use in CF are possible only regarding their use as suppressive therapy. Although aminoglycosides, semisynthetic penicillins, and Coly-Mycin have demonstrated a variable clinical benefit, adequately powered trials have not been performed, with the exception of studies of preservative-free 300-mg per dose tobramycin. This preparation has undergone the most extensive clinical, safety, and pharmacokinetic testing.
Recommendations for the Use of Aerosolized Antibiotics in CF
1. The following patients may be considered as candidates for aerosolized preservative-free tobramycin: (1) > 6 years of age; (2) FEV1 > 25% and < 75% predicted; (3) colonized with P aeruginosa; and (4) able to comply with the prescribed medical regimen (consensus grade I). add comment
Comment: The decision to initiate preservative-free 300-mg per dose tobramycin therapy should be based on the physician’s clinical judgment that the risk-benefit ratio is favorable for the patient. Potential clinical benefits include improved pulmonary function, decrease in hospitalization, and a decrease in antipseudomonal antibiotic use. This preparation was effective in patients receiving inhaled agents such as rhDNase, corticosteroids, and/or ^-agonists. Potential risks include nephrotoxicity, ototoxicity, hoarseness, bronchospasm, acquisition of other intrinsically resistant organisms, and development of antibiotic resistance*. Several relative contraindications to the use of aerosolized tobramycin exist. To our knowledge, there are no data regarding the use of inhaled tobramycin in pregnant women. In addition, tobramycin should be used with caution in patients with renal insufficiency or ototoxicity.
2. Physicians prescribing unapproved formulations of aerosolized antibiotics should do the following: (1) inform patients that the safety profile by the aerosolized route is unknown; (2) review known toxic reactions of the drug by other routes (ie, IV) with the patient; (3) establish an individualized monitoring program based on the known systemic toxic reactions; and (4) describe known complications of aero-solization (consensus grade III).