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Drug overview for CAYSTON (aztreonam lysine):
Generic name: AZTREONAM LYSINE (az-TREE-oh-nam)
Drug class: Inhaled Monobactams
Therapeutic class: Respiratory Therapy Agents
Aztreonam is a synthetic monocyclic beta-lactam (i.e., monobactam) antibiotic.
Aztreonam is used for the treatment of infections caused by susceptible gram-negative pathogens including Pseudomonas aeruginosa; such infections include intra-abdominal infections (e.g., peritonitis), gynecologic infections (e.g., endometritis, pelvic cellulitis), lower respiratory tract infections (e.g., pneumonia, bronchitis), septicemia, skin and skin structure infections (including those associated with postoperative wounds or ulcers and burns), and complicated and uncomplicated urinary tract infections (e.g., pyelonephritis, cystitis). Aztreonam is commercially available as a parenteral preparation for IM or IV use; the drug is also available as an inhalation solution for administration via nebulization to improve respiratory symptoms in cystic fibrosis patients with Pseudomonas aeruginosa in the lungs. Aztreonam has no useful activity against gram-positive bacteria or anaerobes, and therefore should not be used alone for empiric therapy in seriously ill patients if there is a possibility that the infection may be caused by gram-positive bacteria, or if a mixed aerobic-anaerobic bacterial infection is suspected.
If potential pathogens also include gram-positive or anaerobic bacteria, an anti-infective active against such bacteria should be used concomitantly with aztreonam pending results of in vitro culture and susceptibility testing. Aztreonam has been used safely and effectively in conjunction with vancomycin, clindamycin, an aminoglycoside, erythromycin, metronidazole, or a penicillin. However, anti-infectives that have been shown to be potent inducers of beta-lactamase production in gram-negative aerobes in vitro (e.g., cefoxitin, imipenem) should not be used concomitantly with aztreonam since the drugs may antagonize the antibacterial activity of aztreonam. If an aminoglycoside is used concomitantly with aztreonam, renal function should be monitored, especially if high aminoglycoside dosage is used or if concomitant therapy is prolonged.
Generic name: AZTREONAM LYSINE (az-TREE-oh-nam)
Drug class: Inhaled Monobactams
Therapeutic class: Respiratory Therapy Agents
Aztreonam is a synthetic monocyclic beta-lactam (i.e., monobactam) antibiotic.
Aztreonam is used for the treatment of infections caused by susceptible gram-negative pathogens including Pseudomonas aeruginosa; such infections include intra-abdominal infections (e.g., peritonitis), gynecologic infections (e.g., endometritis, pelvic cellulitis), lower respiratory tract infections (e.g., pneumonia, bronchitis), septicemia, skin and skin structure infections (including those associated with postoperative wounds or ulcers and burns), and complicated and uncomplicated urinary tract infections (e.g., pyelonephritis, cystitis). Aztreonam is commercially available as a parenteral preparation for IM or IV use; the drug is also available as an inhalation solution for administration via nebulization to improve respiratory symptoms in cystic fibrosis patients with Pseudomonas aeruginosa in the lungs. Aztreonam has no useful activity against gram-positive bacteria or anaerobes, and therefore should not be used alone for empiric therapy in seriously ill patients if there is a possibility that the infection may be caused by gram-positive bacteria, or if a mixed aerobic-anaerobic bacterial infection is suspected.
If potential pathogens also include gram-positive or anaerobic bacteria, an anti-infective active against such bacteria should be used concomitantly with aztreonam pending results of in vitro culture and susceptibility testing. Aztreonam has been used safely and effectively in conjunction with vancomycin, clindamycin, an aminoglycoside, erythromycin, metronidazole, or a penicillin. However, anti-infectives that have been shown to be potent inducers of beta-lactamase production in gram-negative aerobes in vitro (e.g., cefoxitin, imipenem) should not be used concomitantly with aztreonam since the drugs may antagonize the antibacterial activity of aztreonam. If an aminoglycoside is used concomitantly with aztreonam, renal function should be monitored, especially if high aminoglycoside dosage is used or if concomitant therapy is prolonged.
DRUG IMAGES
CAYSTON 75 MG INHAL SOLUTION
The following indications for CAYSTON (aztreonam lysine) have been approved by the FDA:
Indications:
Respiratory cystic fibrosis with Pseudomonas aeruginosa colonization
Professional Synonyms:
None.
Indications:
Respiratory cystic fibrosis with Pseudomonas aeruginosa colonization
Professional Synonyms:
None.
The following dosing information is available for CAYSTON (aztreonam lysine):
Dosage and route of administration of aztreonam should be determined by the type and severity of infection, susceptibility of the causative organism, and patient condition. Do not use dosages lower than those usually recommended.
For most infections, continue parenteral aztreonam treatment for at least 48 hours after the patient becomes asymptomatic or evidence of eradication of the infection has been obtained. Persistent infections may require several weeks of treatment.
The usual parenteral dosage of aztreonam for the treatment of moderately severe systemic infections in adults is 1 g IV or IM or 2 g IV every 8 or 12 hours. For the treatment of severe systemic or life-threatening infections, including infections caused by Pseudomonas aeruginosa, the usual adult dosage of aztreonam is 2 g IV every 6 or 8 hours.
The manufacturers state that the maximum recommended IV or IM dosage of aztreonam in adults is 8 g daily.
The manufacturers recommend that pediatric patients 9 months of age or older with normal renal function receive aztreonam in a dosage of 30 mg/kg IV every 8 hours for the treatment of mild to moderate infections or 30 mg/kg IV every 6 or 8 hours for the treatment of moderate to severe infections. The manufacturers state that the maximum recommended dosage of aztreonam for pediatric patients is 120 mg/kg daily; however, higher dosages may be warranted in those with cystic fibrosis.
A dosage of 50 mg/kg IV every 6 or 8 hours (i.e., 150-200 mg/kg daily) has been suggested by some clinicians for the treatment of infections in children with cystic fibrosis.
Although safe use of aztreonam in neonates+ has not been established, the American Academy of Pediatrics (AAP) states that neonates 7 days of age or younger may receive 30 mg/kg of aztreonam IV every 12 hours if their gestational age is less than 34 weeks or 30 mg/kg IV every 8 hours if their gestational age is 34 weeks or more. Neonates 8-28 days of age may receive 30 mg/kg IV every 8 hours if their gestational age is less than 34 weeks or 30 mg/kg IV every 6 hours if their gestational age is 34 weeks or more.
For pediatric patients beyond the neonatal period, AAP recommends an aztreonam dosage of 90-120 mg/kg daily given IV or IM in 3 or 4 divided doses.
When the commercially available aztreonam powder for inhalation solution is used in cystic fibrosis patients with Ps. aeruginosa in the lungs, the recommended dosage for adults and pediatric patients 7 years of age or older is 75 mg of aztreonam 3 times daily for 28 days via nebulization. Administer oral inhalation doses at least 4 hours apart (e.g., in the morning, after school, at bedtime).
In clinical trials, adults and pediatric patients with cystic fibrosis received up to 9 courses of aztreonam oral inhalation therapy; each course consisted of 28 days of aztreonam oral inhalation therapy (75 mg 3 times daily), followed by 28 days without such therapy.
If aztreonam is administered intraperitoneally+ for the treatment of peritonitis in adults undergoing continuous ambulatory peritoneal dialysis (CAPD), some clinicians recommend that a 1-g loading dose of the drug be given IV followed by maintenance doses of 500 mg intraperitoneally in 2 L of dialysate every 6 hours. For empiric gram-negative coverage in the treatment of peritonitis in patients undergoing CAPD, some clinicians recommend a continuous aztreonam dosage regimen consisting of a loading dose of 1 g per L of dialysate followed by maintenance doses of 250 mg per L of dialysate.
For most infections, continue parenteral aztreonam treatment for at least 48 hours after the patient becomes asymptomatic or evidence of eradication of the infection has been obtained. Persistent infections may require several weeks of treatment.
The usual parenteral dosage of aztreonam for the treatment of moderately severe systemic infections in adults is 1 g IV or IM or 2 g IV every 8 or 12 hours. For the treatment of severe systemic or life-threatening infections, including infections caused by Pseudomonas aeruginosa, the usual adult dosage of aztreonam is 2 g IV every 6 or 8 hours.
The manufacturers state that the maximum recommended IV or IM dosage of aztreonam in adults is 8 g daily.
The manufacturers recommend that pediatric patients 9 months of age or older with normal renal function receive aztreonam in a dosage of 30 mg/kg IV every 8 hours for the treatment of mild to moderate infections or 30 mg/kg IV every 6 or 8 hours for the treatment of moderate to severe infections. The manufacturers state that the maximum recommended dosage of aztreonam for pediatric patients is 120 mg/kg daily; however, higher dosages may be warranted in those with cystic fibrosis.
A dosage of 50 mg/kg IV every 6 or 8 hours (i.e., 150-200 mg/kg daily) has been suggested by some clinicians for the treatment of infections in children with cystic fibrosis.
Although safe use of aztreonam in neonates+ has not been established, the American Academy of Pediatrics (AAP) states that neonates 7 days of age or younger may receive 30 mg/kg of aztreonam IV every 12 hours if their gestational age is less than 34 weeks or 30 mg/kg IV every 8 hours if their gestational age is 34 weeks or more. Neonates 8-28 days of age may receive 30 mg/kg IV every 8 hours if their gestational age is less than 34 weeks or 30 mg/kg IV every 6 hours if their gestational age is 34 weeks or more.
For pediatric patients beyond the neonatal period, AAP recommends an aztreonam dosage of 90-120 mg/kg daily given IV or IM in 3 or 4 divided doses.
When the commercially available aztreonam powder for inhalation solution is used in cystic fibrosis patients with Ps. aeruginosa in the lungs, the recommended dosage for adults and pediatric patients 7 years of age or older is 75 mg of aztreonam 3 times daily for 28 days via nebulization. Administer oral inhalation doses at least 4 hours apart (e.g., in the morning, after school, at bedtime).
In clinical trials, adults and pediatric patients with cystic fibrosis received up to 9 courses of aztreonam oral inhalation therapy; each course consisted of 28 days of aztreonam oral inhalation therapy (75 mg 3 times daily), followed by 28 days without such therapy.
If aztreonam is administered intraperitoneally+ for the treatment of peritonitis in adults undergoing continuous ambulatory peritoneal dialysis (CAPD), some clinicians recommend that a 1-g loading dose of the drug be given IV followed by maintenance doses of 500 mg intraperitoneally in 2 L of dialysate every 6 hours. For empiric gram-negative coverage in the treatment of peritonitis in patients undergoing CAPD, some clinicians recommend a continuous aztreonam dosage regimen consisting of a loading dose of 1 g per L of dialysate followed by maintenance doses of 250 mg per L of dialysate.
Administer aztreonam by IV injection or infusion, or by deep IM injection. Aztreonam also is administered by oral inhalation via nebulization in patients with cystic fibrosis. Aztreonam has been administered intraperitoneally+ in dialysis fluid.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| CAYSTON 75 MG INHAL SOLUTION | Maintenance | Adults inhale 1 milliliter (75 mg) via nebulizer by inhalation route 3 times per day for 28 days |
No generic dosing information available.
The following drug interaction information is available for CAYSTON (aztreonam lysine):
There are 1 contraindications.
These drug combinations generally should not be dispensed or administered to the same patient. A manufacturer label warning that indicates the contraindication warrants inclusion of a drug combination in this category, regardless of clinical evidence or lack of clinical evidence to support the contraindication.
| Drug Interaction | Drug Names |
|---|---|
| Live Typhoid Vaccine/Antimicrobials SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient. MECHANISM OF ACTION: The antimicrobial may be active against the organism in the live-vaccine. Antimicrobial therapy may prevent the vaccine organism from replicating enough to trigger an immune response.(1) CLINICAL EFFECTS: Vaccination may be ineffective. PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Do not give oral typhoid vaccine until 72 hours after the last dose of antimicrobial. If possible, to optimize vaccine effectiveness, do not start antibacterial drugs for 72 hours after the last dose of oral typhoid vaccine. A longer interval should be considered for long-acting antimicrobials, such as azithromycin.(3) DISCUSSION: Because antimicrobial therapy may prevent sufficient vaccine-organism replication to generate an immune response, the manufacturer of live-attenuated typhoid vaccine and the Centers for Disease Control (CDC) state that the vaccine should not be administered to patients receiving antimicrobial therapy.(1-3) |
VIVOTIF |
There are 1 severe interactions.
These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.
| Drug Interaction | Drug Names |
|---|---|
| Fecal Microbiota Spores/Antibiotics SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Fecal microbiota spores is a suspension of live bacterial spores, which may be compromised by concurrent use of antibiotics.(1) CLINICAL EFFECTS: Antibiotics may decrease the effectiveness of fecal microbiota spores.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Antibiotics should not be used concurrently with fecal microbiota spores. Antibacterial treatment should be completed for 2 to 4 days before initiating treatment with fecal microbiota spores.(1) DISCUSSION: Antibiotics may compromise the effectiveness of fecal microbiota spores. |
VOWST |
There are 0 moderate interactions.
The following contraindication information is available for CAYSTON (aztreonam lysine):
Drug contraindication overview.
*Known hypersensitivity to aztreonam or any component of the formulation.
*Known hypersensitivity to aztreonam or any component of the formulation.
There are 0 contraindications.
There are 0 severe contraindications.
There are 1 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Bronchospastic pulmonary disease |
The following adverse reaction information is available for CAYSTON (aztreonam lysine):
Adverse reaction overview.
Adverse effects reported with IV or IM aztreonam are similar to those reported with other beta-lactam antibiotics, and the drug generally is well tolerated. Adverse effects have been reported in 7% or less of patients receiving parenteral aztreonam and have required discontinuance in about 2% of patients.
Adverse effects reported with IV or IM aztreonam are similar to those reported with other beta-lactam antibiotics, and the drug generally is well tolerated. Adverse effects have been reported in 7% or less of patients receiving parenteral aztreonam and have required discontinuance in about 2% of patients.
There are 4 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. | None. |
| Rare/Very Rare |
|---|
|
Dyspnea Facial edema Skin rash Throat constriction |
There are 11 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Acute abdominal pain Chest discomfort Cough Fever Nasal congestion Vomiting Wheezing |
Bronchospastic pulmonary disease Sore throat |
| Rare/Very Rare |
|---|
|
Arthralgia Arthritis |
The following precautions are available for CAYSTON (aztreonam lysine):
The manufacturers state that use of IV aztreonam in children 9 months of age or older is supported by evidence from adequate and well-controlled studies in adults and additional efficacy, safety, and pharmacokinetic data from noncomparative clinical studies in pediatric patients. However, data are insufficient to date to determine safety and efficacy of IV aztreonam in pediatric patients 9 months of age or older for the treatment of septicemia or skin and skin structure infections (when skin infection suspected or known to be caused by Haemophilus influenzae type b). In addition, the manufacturers state that data are insufficient to date to evaluate IM administration of aztreonam in pediatric patients or use of the drug in pediatric patients with impaired renal function.
In clinical studies evaluating parenteral aztreonam in pediatric patients, discontinuance of the drug because of adverse effects was required in less than 1% of patients. Rash, diarrhea, and fever have been reported in 1-4.3% of pediatric patients.
In pediatric patients receiving IV aztreonam, pain was reported in 12% and erythema, induration, or phlebitis were reported in 0.9-2.9% of patients overall; in US patients, pain occurred in 1.5%
and other local reactions occurred in about 0.5%. Eosinophilia, neutropenia, or increased platelet count has been reported in 6.3,
3.2, or 3.6% of pediatric patients, respectively, and increased serum AST, ALT, or serum creatinine has been reported in 3.8-6.5%.
In US pediatric studies, neutropenia (absolute neutrophil count less than 1000/mm3) occurred in 11.3% of patients younger than 2 years of age receiving aztreonam in a dosage of 30 mg/kg every 6 hours and increased serum AST and ALT (greater than 3 times the upper limit of normal) occurred in 15-20% of patients 2 years of age or older receiving a dosage of 50 mg/kg every 6 hours. It is unclear whether the increased frequency of these adverse effects was related to increased severity of illness in the patients or aztreonam dosage administered.
Aztreonam has been used IM or IV in a limited number of neonates and infants as young as 1 month of age+ without unusual adverse effects. Safety and efficacy of aztreonam administered by oral inhalation via nebulization have not been established in pediatric patients younger than 7 years of age. The drug has been used by oral inhalation via nebulization for the treatment of newly acquired Ps.
aeruginosa respiratory tract infections in a limited number of cystic fibrosis patients 3 months through 6 years of age+ without unusual adverse effects. In clinical trials evaluating aztreonam inhalation therapy in cystic fibrosis patients 7 years of age or older, pyrexia was reported more frequently in pediatric patients than in adults.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
In clinical studies evaluating parenteral aztreonam in pediatric patients, discontinuance of the drug because of adverse effects was required in less than 1% of patients. Rash, diarrhea, and fever have been reported in 1-4.3% of pediatric patients.
In pediatric patients receiving IV aztreonam, pain was reported in 12% and erythema, induration, or phlebitis were reported in 0.9-2.9% of patients overall; in US patients, pain occurred in 1.5%
and other local reactions occurred in about 0.5%. Eosinophilia, neutropenia, or increased platelet count has been reported in 6.3,
3.2, or 3.6% of pediatric patients, respectively, and increased serum AST, ALT, or serum creatinine has been reported in 3.8-6.5%.
In US pediatric studies, neutropenia (absolute neutrophil count less than 1000/mm3) occurred in 11.3% of patients younger than 2 years of age receiving aztreonam in a dosage of 30 mg/kg every 6 hours and increased serum AST and ALT (greater than 3 times the upper limit of normal) occurred in 15-20% of patients 2 years of age or older receiving a dosage of 50 mg/kg every 6 hours. It is unclear whether the increased frequency of these adverse effects was related to increased severity of illness in the patients or aztreonam dosage administered.
Aztreonam has been used IM or IV in a limited number of neonates and infants as young as 1 month of age+ without unusual adverse effects. Safety and efficacy of aztreonam administered by oral inhalation via nebulization have not been established in pediatric patients younger than 7 years of age. The drug has been used by oral inhalation via nebulization for the treatment of newly acquired Ps.
aeruginosa respiratory tract infections in a limited number of cystic fibrosis patients 3 months through 6 years of age+ without unusual adverse effects. In clinical trials evaluating aztreonam inhalation therapy in cystic fibrosis patients 7 years of age or older, pyrexia was reported more frequently in pediatric patients than in adults.
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
There are no adequate and controlled studies to date using parenteral aztreonam or aztreonam administered by oral inhalation via nebulization in pregnant women. Use parenteral or orally inhaled aztreonam during pregnancy only when clearly needed. Aztreonam crosses the placenta in pregnant women and enters fetal circulation.
No evidence of embryotoxicity, fetotoxicity, or teratogenicity was found in reproduction studies in pregnant rats and rabbits using daily parenteral aztreonam dosages up to 1.8 and 1.2 g/kg, respectively; these aztreonam dosages were 2.2-
and 2.9-fold greater than the maximum recommended human dosage (MRHD) based on body surface area. There was no evidence of drug-induced changes in any maternal, fetal, or neonatal parameters when parenteral aztreonam was used in a perinatal/postnatal study in rats; the highest dosage used in this study (1.8 g/kg daily) was 2.2
times the MRHD based on body surface area. However, in a 2-generation reproduction study in rats using parenteral aztreonam dosages up to 2.4 g/kg daily (2.9-fold greater than the MRHD), there was a slightly reduced survival rate during the lactation period in offspring of rats that received the highest dosage, but not in offspring of rats that received lower dosages.
No evidence of embryotoxicity, fetotoxicity, or teratogenicity was found in reproduction studies in pregnant rats and rabbits using daily parenteral aztreonam dosages up to 1.8 and 1.2 g/kg, respectively; these aztreonam dosages were 2.2-
and 2.9-fold greater than the maximum recommended human dosage (MRHD) based on body surface area. There was no evidence of drug-induced changes in any maternal, fetal, or neonatal parameters when parenteral aztreonam was used in a perinatal/postnatal study in rats; the highest dosage used in this study (1.8 g/kg daily) was 2.2
times the MRHD based on body surface area. However, in a 2-generation reproduction study in rats using parenteral aztreonam dosages up to 2.4 g/kg daily (2.9-fold greater than the MRHD), there was a slightly reduced survival rate during the lactation period in offspring of rats that received the highest dosage, but not in offspring of rats that received lower dosages.
Because aztreonam is distributed into milk in low (<1%) concentrations following parenteral administration and because safety of aztreonam in neonates has not been fully evaluated to date, consider temporary discontinuance of nursing if parenteral aztreonam is used in lactating women. Aztreonam 75 mg administered by oral inhalation via nebulization in lactating women produced peak plasma concentrations approximately 1% of peak plasma concentrations reported following a 500-mg IV dose of the drug. Systemic absorption of aztreonam following inhaled administration is likely minimal, but the effects on the infant or on milk production are unknown.
Clinical studies evaluating IV or IM aztreonam or aztreonam administered by oral inhalation via nebulization did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently than younger patients. Other reported clinical experience with parenteral aztreonam has not identified differences in responses between geriatric patients and younger adults. Aztreonam is substantially eliminated by the kidneys, and the risk of adverse effects may be greater in those with impaired renal function. Because geriatric patients are more likely to have reduced renal function, select IV or IM dosage of aztreonam with caution and monitor renal function.
The following prioritized warning is available for CAYSTON (aztreonam lysine):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for CAYSTON (aztreonam lysine)'s list of indications:
| Respiratory cystic fibrosis p. aeruginosa colonization | |
| B96.5 | Pseudomonas (aeruginosa) (mallei) (pseudomallei) as the cause of diseases classified elsewhere |
| E84.0 | Cystic fibrosis with pulmonary manifestations |
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