Aztreonam is a monobactam antibacterial sold in the U.S. under 3 brand and generic names, for cellulitis, endometritis and pseudomonas infections. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Cayston (application NDA050814). Other aztreonam products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Administer one dose (one single use vial and one ampule of diluent) 3 times a day for 28 days. ( 2.1 ) Use dose immediately after reconstitution. ( 2.2 ) Administer only with the Altera ® Nebulizer System. Do not administer with any other type of nebulizer. ( 2.3 ) 2.1 Dosing Information The recommended dose of CAYSTON for both adults and pediatric patients 7 years of age and older is one single-use vial (75 mg of aztreonam) reconstituted with 1 mL of sterile diluent administered 3 times a day for a 28-day course (followed by 28 days off CAYSTON therapy). Dosage is not based on weight or adjusted for age. Doses should be taken at least 4 hours apart. CAYSTON is administered by inhalation using an Altera ® Nebulizer System. Patients should use a bronchodilator before administration of CAYSTON. 2.2 Instructions for CAYSTON Reconstitution CAYSTON should be administered immediately after reconstitution. Do not reconstitute CAYSTON until ready to administer a dose. Take one amber glass vial containing CAYSTON and one diluent ampule from the carton. To open the glass vial, carefully remove the blue cap and metal ring and remove the gray rubber stopper. Twist the tip off the diluent ampule and squeeze the liquid into the glass vial. Replace the rubber stopper, then gently swirl the vial until contents have completely dissolved. The empty vial, stopper, and diluent ampule should be…
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. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of drugs cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of CAYSTON was evaluated in 344 patients from two placebo-controlled trials and one open-label follow-on trial. In controlled trials, 146 patients with CF received 75 mg CAYSTON 3 times a day for 28 days. Table 1 displays adverse reactions reported in more than 5% of patients treated with CAYSTON 3 times a day in placebo-controlled trials. The listed adverse reactions occurred more frequently in CAYSTON-treated patients than in placebo-treated patients. Table 1 Adverse Reactions Reported in more than 5% of Patients Treated with CAYSTON in the Placebo-Controlled Trials Event (Preferred Term) Placebo (N=160) n (%) CAYSTON 75 mg 3 times a day (N=146) n (%) Cough 82 (51%) 79 (54%) Nasal congestion 19 (12%) 23 (16%) Wheezing 16…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
|---|---|---|---|---|---|---|---|
| 1 | 72/100 | Prescription | Injectable | — | — | View → | |
| 2 | 70/100 | Prescription | Kit | — | — |
A combination is a different drug — different dosing, different warnings. It is listed here so you can find it, not so you can substitute it.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
CAYSTON is contraindicated in patients with a known allergy to aztreonam. Contraindicated in patients with a known allergy to aztreonam. ( 4 )
No formal clinical studies of drug interactions with CAYSTON have been conducted.
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| 3 | Not yet rated | Prescription | Injectable | — | — | View → |