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- 2. Pulmonary Drug Delivery Strategies Eitherfor local deposition or for systemic delivery Non-invasive High permeability Large absorptive surface area Good blood supply The capacity for overcoming first-pass metabolism Deliver the optimum concentration of the drug
- 3. Why deliver antimicrobials by inhalation? Nidus of infection is more directly accessible via the respiratory tract than the circulatory system High concentrations deposition directly at the site of infection Without the systemic exposures that would be necessary to achieve similar airway levels by oral or intravenous (IV) delivery Reduced potential for the dose-limiting systemic toxicities associated with many antimicrobials Overwhelm acquired microbial resistance mechanisms by elevated local drug exposure
- 4. Shortcomings Inhalation canonly deliver drug to ventilated areas of the airway cannot deliver drugs past airway obstruction Ventilation inhomogeneity can result in variable deposition within different ventilated regions
- 5. Adverse Effects Local adverseevents, including but not limited to Cough Bronchospasm Hoarseness Dysphagia Dysgeusia These tend to be reversible events and there is evidence that their incidence and severity can decrease with exposure,
- 6. Current Available nebulised and inhaled formulations TobramycinDry Powder Inhalation NebulisedTobramycin Colistimethate sodium Dry Powder Inhalation Nebulised Colistimethate sodium Nebulised Aztreonam
- 7. Uses of Inhaled/ Nebulised Antibiotics P. aeruginosain Cystic Fibrosis Off label use: Acute exacerbations of bronchiectasis (non-cystic fibrosis) Nebulisation of injectable formulations of antibiotics
- 8. Airways infection in Cystic Fibrosis key complications of patients with CF is chronic bacterial infection P. aeruginosa can be isolated by selective culture from patient airway secretions early in life The most common bacterial opportunist in adult patients Associated with worse symptoms, more pulmonary exacerbations, and earlier death
- 10. P. aeruginosa in CysticFibrosis Periodic surveillance cultures of respiratory secretions The first observation of a culture positive for P. aeruginosa is defined as first infection Patients are able to clear an initial infection spontaneously The infection persists but is intermittently below the level of detection using standard culture techniques Ultimately, repeated airway cultures will become mostly, or always, positive for P. aeruginosa When >50% of airway cultures are positive for P. aeruginosa over the course of a year, a patient is considered to be chronically infected Experience has demonstrated that chronic infection is impossible to eradicate
- 11. Eradication Treatment If aperson with cystic fibrosis develops a new Pseudomonas aeruginosa infection (that is, recent respiratory secretion sample cultures showed no infection): if they are clinically well: commence eradication therapy with a course of oral or intravenous antibiotics, together with an inhaled antibiotic follow this with an extended course of oral and inhaled antibiotics if they are clinically unwell: commence eradication therapy with a course of intravenous antibiotics together with an inhaled antibiotic follow this with an extended course of oral and inhaled antibiotics.
- 12. Sustained Treatment If eradication treatmentis not successful despite treatment as recommended, offer sustained treatment with an inhaled antibiotic. Consider nebulised colistimethate sodium as first-line treatment
- 13. Colistimethate sodium Nebulised Colistimethatesodium would be first choice for chronic pulmonary infection caused by Pseudomonas aeruginosa If patient cannot tolerate nebulised form and they would clinically benefit from continued colistimethate sodium, Colistimethate sodium dry powder for inhalation (DPI) is recommended as an option If patient cannot tolerate both, tobramycin therapy would be considered Dose: By inhalation of nebulised solution: 1-2 million Units twice daily, adjust according to response. Increased to 2 million units 3 times daily for subsequent respiratory isolates for Pseudomonas Aeruginosa By inhalation of powder: 1.66 million units twice daily
- 14. For peoplewith chronic Pseudomonas aeruginosa infection who are clinically deteriorating despite regular inhaled colistimethate sodium, consider nebulised aztreonam, nebulised tobramycin, or tobramycin DPI
- 15. Tobramycin Tobramycin DPIis recommended as an option for treating chronic pulmonary infection caused by Pseudomonas aeruginosa in people with cystic fibrosis only if: nebulised tobramycin is considered an appropriate treatment, that is, when colistimethate sodium is contraindicated, is not tolerated or has not produced an adequate clinical response and Dose: By inhalation of nebulised solution: 300mg every 12 hours for 28 days, subsequent courses repeated after 28-day interval without tobramycin nebuliser solution By inhalation of powder: 112mg every 12 hours for 28 days, subsequent courses repeated after 28-day interval without tobramycin inhalation powder
- 16. Other Organisms in CF Forpeople with cystic fibrosis who have chronic Burkholderia cepacia complex infection and declining pulmonary status consider sustained treatment with an inhaled antibiotic to suppress the infection seek specialist microbiological advice on which antibiotic to use stop this treatment if there is no observed benefit.
- 17. Inhaled antibiotics in acute exacerbations of bronchiectasis (non-cystic fibrosis) NCFB is a heterogeneous, complex disease Can lead to disability and poor quality of life Especially for patients with chronic airway infection with P. aeruginosa and frequent exacerbations. Long-term inhaled antibiotics are currently used off-label for ‘difficult to treat’ NCFB patients with chronic airway infection with P. aeruginosa based on evidence from positive trials in CF and accumulating evidence in NCFB. Trials with long-term inhaled antibiotics in NCFB have indicated some benefits Patients having 3 or more exacerbations per year requiring antibiotic therapy or patients with fewer exacerbations that are causing significant morbidity he BTS guideline states that further studies are needed to identify the optimal antibiotic choice and doses
- 18. Off label useof Injectable formulations Injectable formulations of gentamicin, tobramycin, amikacin, ceftazidime, and amphotericin are currently nebulized "off-label" to manage non-CF bronchiectasis, drug-resistant nontuberculous mycobacterial infections, ventilator-associated pneumonia, and post-transplant airway infections
- 19. References 1. Pulmonary drugdelivery strategies: A concise, systematic review, J. S. Patil and S. Sarasija 2. Clinical applications of pulmonary delivery of antibiotics, Patrick A. Flume, MD and Donald R.VanDevanter, PhD 3. Cystic fibrosis: diagnosis and management NICE guidance 4. PNF 76 ed. 5. Inhaled antibiotics for lower airway infections. Quon BS1, Goss CH, Ramsey BW. 6. Non-cystic fibrosis bronchiectasis: inhaled tobramycin NICE guidance 7. Guideline for non-CF Bronchiectasis BritishThoracic Society 8. Oxford Academic; InhaledAntibiotics for Hospital-Acquired and Ventilator-Associated Pneumonia; Lindsay M. Daniels Jonathan Juliano Ashley Marx David J.Weber 9. Assessing effects of inhaled antibiotics in adults with non-cystic fibrosis bronchiectasis––experiences from recent clinical trials Sheyla Paredes Aller, Alexandra L. Quittner, Matthias A. Salathe & Andreas Schmid
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Editor's Notes
- #10 Prevalence of bacterial species cultured from respiratory specimens in CF patients.[7]. These data are derived from the US CF Patient Registry and represent a cross-sectional analysis of the respiratory culture results include 27,804 unique patients in 2012. MDR-PA: multi-drug resistant P. aeruginosa