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HIGHLIGHTS OF PRESCRIBING INFORMATION |
These highlights do not include all the information needed to use CAYSTON safely and effectively. See full prescribing information for CAYSTON.
CAYSTON® (aztreonam for inhalation solution)
Initial U.S. Approval: 1986
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 cystic fibrosis (CF) known to have Pseudomonas aeruginosa in the lungs.
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INDICATIONS AND USAGE
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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 FEV1 <25% or >75% predicted, or patients colonized with Burkholderia cepacia. (1)
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DOSAGE AND ADMINISTRATION
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Administer one dose (one single use vial and one ampule of diluent) 3 times a day for 28 days. (2.1)
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Use dose immediately after reconstitution. (2.2)
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Administer only with the Altera® Nebulizer System. Do not administer with any other type of nebulizer. (2.3)
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DOSAGE FORMS AND STRENGTHS
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Lyophilized aztreonam (75 mg/vial) (3)
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Diluent (0.17% sodium chloride): 1 mL/ampule (3)
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CONTRAINDICATIONS
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Do not administer to patients with a known allergy to aztreonam. (4)
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WARNINGS AND PRECAUTIONS
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Allergic reaction to CAYSTON was seen in clinical trials. Stop treatment if an allergic reaction occurs. Use caution when CAYSTON is administered to patients with a known allergic reaction to beta-lactams. (5.1)
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Bronchospasm has been reported with CAYSTON. Stop treatment if chest tightness develops during nebulizer use. (5.2)
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ADVERSE REACTIONS
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Common adverse reactions (more than 5%) occurring more frequently in CAYSTON patients are cough, nasal congestion, wheezing, pharyngolaryngeal pain, pyrexia, chest discomfort, abdominal pain and vomiting. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Gilead Sciences, Inc. at 1-800-GILEAD5, option 3 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling |
Revised: 02/2010 |
