Cayston
aztreonam
Manufacturer: Gilead Sciences, Inc.
FDA-Approved Indications (2)
To improve respiratory symptoms in cystic fibrosis (CF) patients with Pseudomonas aeruginosa
indicated to improve respiratory symptoms in cystic fibrosis (CF) patients with Pseudomonas aeruginosa
Population: pediatric ≥7 years, FEV1 25-75% predicted, without Burkholderia cepacia colonization
Indications & Usage
1 INDICATIONS AND USAGE CAYSTON ® is indicated to improve respiratory symptoms in cystic fibrosis (CF) patients with Pseudomonas aeruginosa . Safety and effectiveness have not been established in pediatric patients below the age of 7 years, patients with FEV 1 <25% or >75% predicted, or patients colonized with Burkholderia cepacia [see Clinical Studies (14) ]. To reduce the development of drug-resistant bacteria and maintain the effectiveness of CAYSTON and other antibacterial drugs, CAYSTON should be used only to treat patients with CF known to have Pseudomonas aeruginosa in the lungs. CAYSTON is a monobactam antibacterial indicated to improve respiratory symptoms in cystic fibrosis (CF) patients with Pseudomonas aeruginosa . Safety and effectiveness have not been established in pediatric patients below the age of 7 years, patients with FEV 1 <25% or >75% predicted, or patients colonized with Burkholderia cepacia . ( 1 )
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