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CAYSTON is a brand name for Aztreonam, supplied as a powder for solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ........................................................................................................ 3 CONTRAINDICATIONS ............................................................................................................................. 3 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
General CAYSTON (aztreonam for inhalation solution) should only be used with the Altera® Nebulizer System manufactured by PARI Respiratory Equipment, Inc. CAYSTON is not for oral, intravenous, subcutaneous, intramuscular, or intrathecal administration.
CAYSTON has been specifically formulated with the amino acid lysine. , aztreonam for injection) in the Altera Nebulizer System. Aztreonam for injection has not been formulated for inhalation, and contains arginine, a substance known to cause pulmonary inflammation.
Certain antibiotics (eg. , resulting in antagonism to many beta-lactam antibiotics including aztreonam. These in vitro findings suggest that such beta-lactamase inducing antibiotics should not be used concurrently with aztreonam lysine.
Severe Cutaneous Adverse Reactions Severe cutaneous adverse reactions (SCAR) such as acute generalized exanthematous pustulosis (AGEP), drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN) have been reported in association with beta-lactam treatment.
When SCAR is suspected, Cayston should be discontinued and appropriate therapy and/or measures should be taken.
Immune Allergic Reactions:
Severe allergic reactions have been reported following administration of aztreonam for injection (aztreonam arginine) to patients with no known history of exposure to aztreonam. CAYSTON is contraindicated in patients with a known history of aztreonam allergy.
If an allergic reaction to CAYSTON does occur, stop administration of the drug and initiate treatment as appropriate. The occurrence of rash may be indicative of an allergic reaction to CAYSTON. A history of allergy to beta-lactam antibiotics, such as penicillins, cephalosporins, and/or carbapenems, may be a risk factor for an allergic reaction to CAYSTON, since cross- reactivity may occur.
Caution is advised when administering CAYSTON to patients if they have a history of beta-lactam allergy.
Respiratory Bronchospasm:
Bronchospasm is a potential complication associated with nebulized therapies. In placebo- controlled trials, reduction of ≥15% in forced expiratory volume in 1 second (FEV1) immediately following administration of study medication after pretreatment with a CAYSTON (aztreonam for inhalation solution) Product Monograph 5 bronchodilator was observed in 3% of patients treated with CAYSTON and 4% of patients receiving placebo.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Decreases in FEV1 After 28-Day Treatment Cycle:
In clinical trials, patients with increases in FEV1 during a 28-day course of CAYSTON were sometimes treated for pulmonary exacerbations when FEV1 declined after the treatment period. Healthcare providers should consider a patient’s baseline FEV1 measured prior to CAYSTON therapy and the presence of other symptoms when evaluating whether post- treatment changes in FEV1 are caused by a pulmonary exacerbation.
Susceptibility/Resistance Development of Drug Resistant Bacteria:
Prescribing CAYSTON in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and risks the development of drug-resistant bacteria.
Special Populations Pregnant Women:
No adequate and well-controlled studies of CAYSTON or aztreonam for injection (aztreonam arginine) have been conducted in pregnant women. Because animal reproduction studies are not always predictive of human response, CAYSTON should be used during pregnancy only if the potential benefit outweighs the risk.
Aztreonam for injection (aztreonam arginine) has been shown to cross the placenta and enter fetal circulation. No evidence of embryo- or fetotoxicity or teratogenicity has been shown in studies with pregnant rats and rabbits treated with daily doses up to 15 and 5 times, respectively, the human dose of aztreonam for injection (aztreonam arginine).
The systemic concentration of aztreonam following inhaled administration of 75 mg CAYSTON (3 times a day) is approximately 1% of the concentration resulting from a 500 mg dose of aztreonam for injection (aztreonam arginine).
Nursing Women:
Following administration of aztreonam for injection (aztreonam arginine), aztreonam is excreted in human milk at concentrations that are less than 1 percent of those determined in simultaneously obtained maternal serum. Systemic concentration of aztreonam following inhaled administration of CAYSTON is approximately 1% of the concentration resulting from a standard dose of aztreonam for injection (aztreonam arginine).
Therefore use of CAYSTON during breastfeeding is unlikely to pose a risk to infants.
Pediatrics (<18 years of age):
Safety and efficacy have not been studied in patients under the age of 6 years. Eighty-three patients between 6 and 18 years of age received CAYSTON in the controlled trials. No dose adjustments were made for pediatric patients. Pyrexia was more commonly reported in pediatric patients than in adult patients.
CAYSTON (aztreonam for inhalation solution) Product Monograph 6 Geriatrics (>65 years of age): Clinical studies with CAYSTON did not include sufficient numbers of patients aged 65 years old and over to determine whether they responded differently from younger patients.
Renal Impairment:
Aztreonam is known to be excreted by the kidney. Controlled clinical trials with CAYSTON excluded patients with abnormal baseline renal function (defined as serum creatinine greater than 2 times the upper limit of normal range). Given the low systemic exposure of aztreonam following administration of CAYSTON, clinically relevant accumulation of aztreonam is unlikely to occur in patients with renal impairment.
Therefore, CAYSTON may be administered to patients with mild, moderate and severe renal impairment with no dosage adjustment.
Hepatic Impairment:
There are no data on the use […]