cayston
Pharmaranks rates Cayston 3.5/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Cayston (Aztreonam) is a medication used to treat Cellulitis, Endometritis, Pseudomonas Infections, Respiratory Tract Infections.
Aztreonam · by Gilead Sciences Inc
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Aztreonam
- Form
- Kit
- Strength
- Aztreonam 75MG/VIAL
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- cellulitis, endometritis, pseudomonas infections
- Manufacturer
- Gilead Sciences Inc
- FDA application
- NDA050814
What is Cayston?
From the FDA label:A dose of CAYSTON consists of a 2 mL amber glass vial containing lyophilized aztreonam (75 mg) and lysine (46.7 mg), and a low-density polyethylene ampule containing 1 mL sterile diluent (0.17% sodium chloride). The reconstituted solution is for inhalation. The formulation contains no preservatives or arginine. The active ingredient in CAYSTON is aztreonam, a monobactam antibacterial. The monobactams are structurally different from beta-lactam antibiotics (e.g., penicillins, cephalosporins, carbapenems) due to a monocyclic nucleus. This nucleus contains several side chains; sulfonic acid in the 1-position activates the nucleus, an aminothiazolyl oxime side chain in the 3-position confers specificity for aerobic Gram-negative bacteria including Pseudomonas spp ., and a methyl group in the 4-position enhances beta-lactamase stability. Aztreonam is designated chemically as ( Z )-2-[[[(2-amino-4-thiazolyl)[[(2 S ,3 S )-2-methyl-4-oxo-1-sulfo-3-azetidinyl]carbamoyl]methylene]amino]oxy]-2-methylpropionic acid. The structural formula is presented below: CAYSTON is a white to off-white powder. CAYSTON is sterile, hygroscopic, and light sensitive. Once reconstituted with the supplied diluent, the pH range is 4.5 to 6.0. Chemical Structure
How to use
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…
Side effects
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…
Warnings
Important safety information
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 ) Bronchospasm has been reported with CAYSTON. Stop treatment if chest tightness develops during nebulizer use. ( 5.2 ) 5.1 Allergic Reactions Severe allergic reactions have been reported following administration of aztreonam for injection to patients with no known history of exposure to aztreonam. In addition, allergic reaction with facial rash, facial swelling, and throat tightness was reported with CAYSTON in clinical trials. If an allergic reaction to CAYSTON occurs, stop administration of CAYSTON and initiate treatment as appropriate. Caution is advised when administering CAYSTON to patients if they have a history of beta-lactam allergy, although patients with a known beta-lactam allergy have received CAYSTON in clinical trials and no severe allergic reactions were reported. A history of allergy to beta-lactam antibiotics, such as penicillins, cephalosporins, and/or carbapenems, may be a risk factor, since cross-reactivity may occur. 5.2 Bronchospasm Bronchospasm is a complication associated with nebulized therapies, including CAYSTON. Reduction of 15% or more in forced expiratory volume in 1 second (FEV 1 ) immediately following administration of study medication after pretreatment with a bronchodilator was observed in 3% of patients treated with CAYSTON. 5.3 Decreases in FEV 1 After 28-Day Treatment Cycle In clinical trials, patients with increases in FEV 1 during a 28-day course of CAYSTON were sometimes treated for pulmonary exacerbations when FEV 1 declined after the treatment period. Healthcare providers should consider a patient's baseline FEV 1 measured prior to CAYSTON therapy and the presence of other symptoms when evaluating whether post-treatment changes in FEV 1 are caused by a pulmonary exacerbation. 5.4 Development of Drug-Resistant Bacteria Prescribing CAYSTON in the absence of known Pseudomonas aeruginosa infection in patients with CF is unlikely to provide benefit and increases the risk of development of drug-resistant bacteria.
Who should not take Cayston
CAYSTON is contraindicated in patients with a known allergy to aztreonam. Contraindicated in patients with a known allergy to aztreonam. ( 4 )
Overdose — what happens if you take too much
No overdoses have been reported with CAYSTON in clinical trials to date. In clinical trials, 225 mg doses of CAYSTON via inhalation were associated with higher rates of drug-related respiratory adverse reactions, particularly cough. Since the peak plasma concentration of aztreonam following administration of CAYSTON (75 mg) is approximately 0.6 mcg/mL, compared to a serum concentration of 54 mcg/mL following administration of aztreonam for injection (500 mg), no systemic safety issues associated with CAYSTON overdose are anticipated.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
No formal clinical studies of drug interactions with CAYSTON have been conducted.
May treat (source: NIH RxClass)
Dosage forms
Kit
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
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Use copay cards
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Frequently asked questions
- What does Cayston treat?
- Cayston (Aztreonam) may be used to treat cellulitis, endometritis, pseudomonas infections, respiratory tract infections, urinary tract infections, sepsis, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How is Cayston rated?
- pharmaranks gives Cayston a composite score of 3.5 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- Is there a coupon or discount for Cayston?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Cayston. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Cayston?
- Cayston is marketed by Gilead Sciences Inc. You can see Gilead Sciences Inc's full profile, rating, and other products on pharmaranks.
- Is Cayston a brand-name or generic drug?
- Cayston is a brand-name product with the active ingredient Aztreonam.
- Is Cayston available over the counter?
- No. Cayston is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Cayston come in?
- Cayston is currently marketed as kit, per the FDA's National Drug Code Directory.
- Is Cayston FDA-registered?
- Cayston is on record with the U.S. FDA under application number NDA050814. You can verify this on its official FDA label.
- Has Cayston been recalled by the FDA?
- Cayston has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Cayston safe?
- There's no single safe-or-not verdict. pharmaranks gives Cayston a recall-safety score of 70/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Cayston?
- Cayston's side effects are taken directly from its FDA label. From the label: 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,… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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cayston
70/100