Safety Considerations With Aerosolized Antimicrobial Therapy

Generally, aerosol administration of antimicrobial therapies is considered safe; however, respiratory and nonrespiratory side effects occur frequently. Some patients experience bronchoconstriction associated with administration. This has been reported when the parenteral form of gentamicin and tobramycin was aerosolized, and may be attributed to other components of the products, including preservatives [29,30]. Cutaneous rashes have developed rarely, and a sore throat may occur.

With aminoglycosides, systemic therapy is associated with a risk of ototoxicity and nephrotoxicity. However, no toxicity has been reported in several well-controlled trials of inhaled tobramycin in which subjects received repetitive courses [31,32].

After deposition, antimicrobial therapies are cleared from the lung by various mechanisms, including mucociliary clearance, coughing, and absorption into the systemic circulation. The drug is then metabolized or eliminated, depending on its properties. The systemic concentrations are severalfold less that what would be achieved with parenteral therapy and would not be expected to cause toxicity. However, more research is warranted to evaluate the impact of patient characteristics on systemic exposure to inhaled antimicrobial therapies. In the clinical trials of the commercially available inhaled tobramycin preparation, the mean concentration achieved one hour after inhalation was approximately 1 mg/mL.

There are few data from which to draw conclusions about the safety of other inhaled antibiotics. Aerosolized colistin has been generally well tolerated in published reports. The most frequent adverse event reported has been chest tightness associated with administration in some patients. Systemic use of colistin carries the risk for nephrotoxicity and neurotoxicity. Additional research about the safety of aerosolized colistin is warranted.

Similarly, information about the safety of inhaled beta lactams is lacking. One concern that has not surfaced in the limited reports is the potential for hypersensitivity reactions based on the prevalence of this problem in the general population. Again, investigations into the risks and benefits of these therapies by aerosolization are needed.

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