Aztreonam (Monograph)

Brand names: Azactam, Cayston
Drug class: Monobactams

Medically reviewed by Drugs.com on Jul 25, 2023. Written by ASHP.

Introduction

Antibacterial; monocyclic β-lactam antibiotic; monobactam.¹ ⁴² ⁴³ ⁴⁴ ²⁴⁶ ²⁵³ ³⁰⁶

Uses for Aztreonam

Intra-abdominal Infections

Treatment of intra-abdominal infections (including peritonitis) caused by susceptible gram-negative bacteria, including Citrobacter (including C. freundii), Enterobacter (including E. cloacae), E. coli, Klebsiella (including K. pneumoniae), Ps. aeruginosa, or Serratia (including S. marcescens).¹ ¹⁷³ ¹⁷⁷ ²¹³ ²¹⁴ ²⁵³ ²⁶⁷

Do not use alone for empiric treatment of intra-abdominal infections since these usually are polymicrobial and frequently are mixed aerobic-anaerobic bacterial infections.¹⁷³ ²¹³ ²¹⁴ ²⁶⁷

Although aztreonam has good in vitro activity against many gram-negative bacteria, it has relatively poor activity against extended-spectrum β-lactamase (ESBL)-producing strains of E. coli and K. pneumoniae.⁷⁰⁹

For the treatment of peritoneal dialysis-associated peritonitis, aztreonam has been administered intraperitoneally ^{† [off-label]}.³¹² ³¹³ ³¹⁴ ³¹⁵

Gynecologic Infections

Treatment of gynecologic infections (e.g., endometritis, pelvic cellulitis) caused by susceptible gram-negative bacteria, including Enterobacter (including E. cloacae), E. coli, K. pneumoniae, or P. mirabilis.¹ ¹⁷¹ ¹⁷³ ¹⁸³ ¹⁹² ²¹¹ ²⁵³

Do not use alone for empiric treatment of gynecologic infections since these usually are polymicrobial and frequently are mixed aerobic-anaerobic bacterial infections.¹⁷¹ ¹⁷³ ¹⁸³ ²¹¹ Clindamycin or metronidazole generally used concomitantly if aztreonam used for initial treatment of gynecologic infections.¹⁷¹ ¹⁷³ ¹⁷⁷ ¹⁸³ ²¹¹ ²¹³ ²¹⁴ ²⁶⁷ ²⁶⁸ ³²¹

The combination of clindamycin and gentamicin has been the gold standard for treatment of endometritis; however, a regimen consisting of aztreonam plus clindamycin has been used.³²¹

Oral or topical antibiotics (e.g., clindamycin, metronidazole) are generally used for the treatment of other common gynecologic infections (e.g., bacterial vaginosis).²⁵⁷

Respiratory Tract Infections

Treatment of lower respiratory tract infections (e.g., pneumonia, bronchitis) caused by susceptible gram-negative bacteria, including Enterobacter, E. coli, H. influenzae, K. pneumoniae, Ps. aeruginosa, P. mirabilis, or S. marcescens.¹ ¹⁶⁵ ¹⁶⁷ ¹⁶⁸ ¹⁶⁹ ¹⁷³ ¹⁷⁶ ¹⁷⁷ ¹⁹² ²⁰⁶ ²⁰⁸ ²²² ²⁵³

Also has been used for treatment of lower respiratory tract infections caused by susceptible Citrobacter^{† [off-label]},¹⁶⁷ ¹⁶⁸ ¹⁷⁶ ²⁰⁶ ²⁰⁸ ²⁶⁷ Hafnia^{† [off-label]}, K. oxytoca^{† [off-label]},¹⁶⁸ Morganella^{† [off-label]},²⁰⁶ ²⁰⁸ P. vulgaris^†,¹⁶⁵ Providencia stuartii^†,¹⁹² or Moraxella catarrhalis^†.¹⁶⁵ ²⁰⁸

Do not use alone for empiric treatment of lower respiratory tract infections since these infections frequently are caused by gram-positive and/or anaerobic bacteria.¹ ⁴⁸ ¹⁶⁴ ¹⁶⁵ ¹⁷⁶ ¹⁸⁶ ²⁰² ²⁰⁶ ²⁰⁸ ²²³ ²³⁵ ²⁴¹ ²⁵³ ²⁶⁶ ²⁶⁸

A joint guideline by the American Thoracic Society (ATS) and the Infectious Diseases Society of America (IDSA) includes aztreonam as an empiric treatment option for Ps. aeruginosa in adults with community-acquired pneumonia treated in the inpatient setting.⁵¹² The guideline recommends empiric coverage for Ps. aeruginosa only if locally validated risk factors for the pathogen are present.⁵¹²

In adults with hospital-acquired and ventilator-associated pneumonia, IDSA suggests aztreonam as an empiric treatment option for gram-negative/antipseudomonal coverage; if patient has a severe penicillin allergy and aztreonam is used instead of a β-lactam-based antibiotic, coverage for methicillin-sensitive S. aureus (MSSA) should be included.⁷⁵⁰

Also has been used alone or in conjunction with an aminoglycoside for treatment of acute exacerbations of bronchopulmonary Ps. aeruginosa infections in some patients with cystic fibrosis.⁴⁸ ¹⁷⁷ ²⁰⁷ ²⁰⁸ ²⁷⁵ ²⁸⁰

Aztreonam for inhalation solution (Cayston) is used via nebulization to improve respiratory symptoms in cystic fibrosis patients ≥7 years of age with Ps. aeruginosa in the lungs.³⁰⁶ ³⁰⁷ ³⁰⁸ ³⁰⁹ ³¹⁰ ³¹⁹ Safety and efficacy of this preparationnot established in pediatric patients <7 years of age, in patients with FEV₁ <25% or >75% of predicted, or in patients colonized with Burkholderia cepacia.³⁰⁶

Septicemia

Treatment of septicemia caused by susceptible gram-negative bacteria, including Enterobacter, E. coli, K. pneumoniae, Ps. aeruginosa, P. mirabilis, or S. marcescens.¹ ¹⁷³ ¹⁷⁶ ¹⁷⁷ ¹⁸⁶ ¹⁹² ²²¹ ²²² ²²³ ²⁵³

Also has been used for treatment of septicemia caused by susceptible Citrobacter^†²⁶⁷ or H. influenzae^†.¹⁸⁶ ¹⁹²

The Surviving Sepsis Campaign guidelines recommend immediate administration of appropriate antimicrobials in adults with possible sepsis or septic shock.²⁵⁸ Empiric antimicrobials with adequate coverage should be selected based on patient’s risk for certain pathogens (e.g., MRSA, multidrug-resistant organisms).²⁵⁸

Skin and Skin Structure Infections

Treatment of skin and skin structure infections (including those associated with postoperative wounds, ulcers, and burns) caused by susceptible gram-negative bacteria, including Citrobacter, Enterobacter, E. coli, K. pneumoniae, P. mirabilis, Ps. aeruginosa, or S. marcescens.¹ ¹⁷³ ¹⁷⁷ ¹⁹² ²²² ²²³ ²⁵³

Adjunct to surgery in management of abscesses, cutaneous infections, infections complicating hollow viscus perforations, or infections of serous surfaces caused by susceptible gram-negative aerobic bacteria.¹ ²⁵³

Aztreonam is not included as a potential antimicrobial of choice in IDSA guidelines on the management of skin and skin structure infections; when broad-spectrum empiric treatment is necessary for suspected polymicrobial infection, other antibiotics are generally recommended.⁵⁴³

When empiric treatment of moderate or severe diabetic foot infections is indicated, IDSA recommends a broad-spectrum regimen pending results of in vitro culture and susceptibility testing.⁵⁴⁴ When probable pathogens include MRSA, Enterobacteriaceae, Pseudomonas, and obligate anaerobes, IDSA recommends an empiric regimen of vancomycin in conjunction with ceftazidime, cefepime, piperacillin/tazobactam, aztreonam, or a carbapenem.⁵⁴⁴ If aztreonam, ceftazidime, or cefepime is used in conjunction with vancomycin, the empiric regimen should also include an additional anti-infective for anaerobic coverage.⁵⁴⁴

Urinary Tract Infections (UTIs)

Treatment of uncomplicated or complicated UTIs (including pyelonephritis and initial or recurrent cystitis) caused by susceptible gram-negative bacteria, including Citrobacter, E. cloacae, E. coli, K. pneumoniae, K. oxytoca, P. mirabilis, Ps. aeruginosa, or S. marcescens.¹ ⁹⁰ ¹⁶⁰ ¹⁶² ¹⁷⁰ ¹⁷⁵ ¹⁷⁶ ¹⁷⁷ ¹⁹⁰ ¹⁹² ²¹⁸ ²¹⁹ ²²³ ²⁵³

Also has been used for treatment of UTIs caused by susceptible E. aerogenes^†,¹⁷⁶ ²¹⁸ Morganella morganii^†,¹⁷⁶ ²¹⁸ ²⁶⁷ P. vulgaris^†,²¹⁸ or Providencia^†.¹⁷⁷ ²¹⁸

Has been effective for treatment of cystitis or pyelonephritis caused by gram-negative aerobic bacteria resistant to aminopenicillins, first or second generation cephalosporins, and/or aminoglycosides.¹⁷⁰ ²¹⁸

Bone and Joint Infections

Treatment of bone and joint infections^† (including osteomyelitis or septic arthritis) caused by susceptible gram-negative bacteria, including Enterobacter, Escherichia coli, Haemophilus influenzae^†, Klebsiella, Proteus mirabilis, Pseudomonas aeruginosa, or Serratia marcescens.⁴⁸ ¹⁶⁶ ¹⁷² ¹⁷³ ¹⁷⁷ ¹⁷⁸ ²²⁰ ²⁶⁷ ²⁶⁸ ²⁸²

If gram-positive bacteria known or suspected to also be involved, regimen should also include an antistaphylococcal anti-infective (e.g., penicillinase-resistant penicillin, vancomycin).¹⁷⁷

IDSA states aztreonam is an alternative for treatment of native vertebral osteomyelitis^† caused by Ps. aeruginosa if a drug of first choice (i.e., cefepime, meropenem, doripenem) cannot be used because of severe penicillin allergy and ciprofloxacin cannot be used because of quinolone-resistant strains.⁵⁹⁰

CNS Infections

Treatment of healthcare-associated ventriculitis and meningitis^† caused by susceptible aerobic gram-negative bacteria in patients with anaphylaxis or other contraindications to β-lactam therapy (including carbapenems).⁷⁶⁰

Has been effective for adults and children with meningitis due to Ps. aeruginosa, H. influenzae, and other Enterobacteriaceae.⁷⁶¹ ⁷⁶² ⁷⁶³ ⁷⁶⁴ ⁷⁶⁵ ⁷⁶⁶ ⁷⁶⁷

IDSA guidelines suggest that choice between aztreonam and other alternatives (such as ciprofloxacin for Ps. aeruginosa or trimethoprim-sulfamethoxazole for β-lactamase-producing Enterobacteriacea) should consider local susceptibility patterns and known co-infecting organisms.⁷⁶⁰

Antimicrobial Prophylaxis in Surgery

Antimicrobial prophylaxis^† in patients undergoing certain surgical procedures in which aerobic gram-negative bacteria are common pathogens;³⁶⁰ ³⁷⁴ used in conjunction with other anti-infectives.³⁶⁰ ³⁷⁴

Regimen of vancomycin (or clindamycin) in conjunction with aztreonam recommended as an alternative for perioperative prophylaxis in patients undergoing gastroduodenal or biliary tract surgery, hysterectomy (vaginal or abdominal), or certain organ transplant procedures (liver, pancreas, pancreas-kidney).³⁷⁴ Regimen of clindamycin and aztreonam also considered an alternative in patients undergoing appendectomy, colorectal or small intestine surgery, or urologic surgery involving an implanted prosthesis.³⁷⁴

Some clinicians recommend concomitant use of an anti-infective active against enteric gram-negative bacilli (e.g., aztreonam, aminoglycoside, fluoroquinolone) when vancomycin used for perioperative prophylaxis in patients undergoing neurosurgery or cardiac, orthopedic, or vascular surgery.³⁶⁰

Empiric Therapy in Febrile Neutropenic Patients

Has been used in conjunction with vancomycin (with or without amikacin) for empiric anti-infective therapy in febrile granulocytopenic adults^†.¹⁸⁰ ²¹⁶

An anti-infective active against staphylococci (e.g., vancomycin) also should be used if aztreonam is used for empiric therapy in these patients.²¹⁵ ²⁶⁸ ⁴⁵⁷ Some guidelines have suggested a regimen of aztreonam and vancomycin as an alternative empiric regimen in patients with immediate-type penicillin hypersensitivity.⁴⁵⁷

Aztreonam Dosage and Administration

Administration

Administer by IV injection¹ ²⁵³ or infusion¹ ²⁵³ or by deep IM injection.¹ ²⁵³

Also administered by oral inhalation via nebulization using the commercially available powder for inhalation solution.³⁰⁶

Has been administered intraperitoneally^† in dialysis fluid.³⁶ ⁵⁶ ¹⁹⁶ ²²⁷ ³¹³ ³¹⁴ ³¹⁵

IV Injection

Reconstitution

For direct intermittent IV injection, reconstitute single-dose vials containing 500 mg, 1 g, or 2 g by adding 6–10 mL of sterile water for injection.¹ ²⁵³ Shake immediately and vigorously after diluent is added.¹ ²⁵³

Rate of Administration

Inject appropriate dose of reconstituted solution slowly over a period of 3–5 minutes either directly into a vein or into the tubing of a compatible IV solution.¹ ²⁵³

IV Infusion

When given IV via a common administration tubing used to administer another drug, especially one incompatible with aztreonam, flush tubing before and after aztreonam administration with an IV infusion solution compatible with both drugs;¹ ²⁵³ do not give the drugs simultaneously.¹ ²⁵³ When a Y-type IV administration set is used, give careful attention to the calculated volume of aztreonam solution to ensure that entire dose is infused.¹ ²⁵³

Reconstitution and Dilution

For intermittent IV infusion, reconstitute single-dose vial containing 500 mg, 1 g, or 2 g of aztreonam by adding at least 1.5, 3, or 6 mL, respectively, of sterile water for injection.¹ ²⁵³ Shake immediately and vigorously after diluent is added.¹ ²⁵³ Then, dilute further by adding reconstituted solution to a compatible IV infusion solution¹ ²⁵³ to provide a solution with a final concentration ≤20 mg/mL. A volume control IV administration set may be used to add the appropriate dose of reconstituted aztreonam solution to the compatible IV infusion solution during administration;¹ ²⁵³ this final dilution should provide a solution with a concentration ≤20 mg/mL.¹ ²⁵³

Rate of Administration

Administer by IV infusion over 20–60 minutes.¹ ²⁵³

IM Injection

Inject appropriate dose of reconstituted IM solution deeply into a large muscle (e.g., upper outer quadrant of gluteus maximus, lateral part of thigh) using usual techniques and precautions.¹ ²⁵³

Generally well tolerated when given IM;¹ ²⁵³ do not admix with local anesthetic agents.¹ ²⁵³

Reconstitution

For IM injection, reconstitute single-dose vial containing 500 mg, 1 g, or 2 g by adding at least 1.5, 3, or 6 mL, respectively, of sterile water for injection, 0.9% sodium chloride injection, bacteriostatic water for injection (with benzyl alcohol or parabens), or bacteriostatic sodium chloride injection (with benzyl alcohol).¹ ²⁵³ Shake immediately and vigorously after diluent is added.¹ ²⁵³

Oral Inhalation via Nebulization

For administration by oral inhalation via nebulization, aztreonam is commercially available in a kit containing single-dose vials of aztreonam powder for inhalation solution and single-dose ampuls of 0.17% sodium chloride diluent.³⁰⁶

Reconstitute aztreonam powder for inhalation solution using only the diluent provided by the manufacturer;³⁰⁶ do not reconstitute until it is time to administer a dose.³⁰⁶

Following reconstitution, administer the inhalation solution via nebulization using only an Altera nebulizer system.³⁰⁶ Do not administer using any other type of nebulizer and do not administer IV or IM.³⁰⁶

Patients receiving aztreonam oral inhalation therapy should use a bronchodilator before aztreonam is administered.³⁰⁶ Short-acting bronchodilators can be taken between 15 minutes and 4 hours prior to each aztreonam dose.³⁰⁶ Alternatively, long-acting bronchodilators can be taken 0.5–12 hours prior to administration of aztreonam.³⁰⁶

For patients taking multiple inhaled therapies, recommended order of administration is a bronchodilator, mucolytics, and, lastly, aztreonam.³⁰⁶

Reconstitution

To prepare a dose, add the contents of a single-dose ampul of diluent provided by the manufacturer to a single-dose vial of aztreonam lyophilized powder for inhalation solution.³⁰⁶ Gently swirl vial until powder dissolves completely.³⁰⁶

Administer the inhalation solution via nebulization immediately after reconstitution.³⁰⁶

Nebulization

Pour reconstituted aztreonam inhalation solution into handset of Altera nebulizer system and turn unit on.³⁰⁶ Do not mix reconstituted inhalation solution with any other drug in the Altera nebulizer handset.³⁰⁶

Patient should be seated in a relaxed, upright position.³⁰⁶ Place mouthpiece of nebulizer handset into the mouth;³⁰⁶ with lips closed around mouthpiece, patient should breathe normally through the mouthpiece.³⁰⁶

About 2–3 minutes are required to administer the complete dose of reconstituted inhalation solution using the nebulizer system.³⁰⁶

Consult manufacturer's information for additional information on administration via the nebulizer.³⁰⁶ Consult information included with the nebulizer system for instructions on testing nebulizer functionality and cleaning the handset.³⁰⁶

Dosage

Dosage and route of administration should be determined by type and severity of infection, susceptibility of causative organism, and patient condition.¹ ²⁵³ Do not use dosages lower than those usually recommended.¹ ²⁵³

For most infections, continue parenteral therapy for at least 48 hours after patient becomes asymptomatic or evidence of eradication of infection obtained.¹ ²⁵³ Persistent infections may require several weeks of treatment.¹ ²⁵³

Pediatric Patients

General Dosage for Neonates†

IV

Neonates ≤7 days of age^†: AAP recommends 30 mg/kg every 12 hours in those whose gestational age is <34 weeks or 30 mg/kg every 8 hours in those whose gestational age is ≥34 weeks.²⁹²

Neonates 8–28 days of age^†: AAP recommends 30 mg/kg every 8 hours in those whose gestational age is <34 weeks or 30 mg/kg every 6 hours in those whose gestational age is ≥34 weeks.²⁹²

General Pediatric Dosage

IV

Children ≥9 months of age: Manufacturer recommends 30 mg/kg every 8 hours for treatment of mild to moderate infections or 30 mg/kg every 6 or 8 hours for treatment of moderate to severe infections.¹ ²⁵³

Children beyond the neonatal period^†: AAP recommends 90–120 mg/kg daily given in 3 or 4 divided doses.²⁹²

Children with cystic fibrosis: Dosage of 50 mg/kg every 6 or 8 hours (i.e., 150–200 mg/kg daily) suggested by some clinicians.²⁶⁹ ²⁷⁰ ²⁷⁵ ²⁷⁶ ²⁸⁰

Intra-abdominal Infections

IV

30 mg/kg IV every 6–8 hours has been used in children >9 months of age.⁷⁰⁹ Higher doses may be reasonable in critically ill pediatric patients who may have an increased volume of distribution and/or accelerated clearance of antimicrobial agents.⁷⁰⁹

Cystic Fibrosis Patients with Ps. Aeruginosa

Oral Inhalation via Nebulization

Children ≥7 years of age: 75 mg 3 times daily for 28 days.³⁰⁶ Administer doses at least 4 hours apart (e.g., in the morning, after school, at bedtime).³⁰⁶ Follow 28-day treatment with 28-day period without the drug.³⁰⁶

In clinical trials, up to 9 courses used;³⁰⁹ ³¹⁰ each course consisted of 28 days of aztreonam oral inhalation therapy (75 mg 3 times daily), followed by 28 days without such therapy.³⁰⁹ ³¹⁰

Adults

General Adult Dosage

Moderately Severe Systemic Infections

IV or IM

1 or 2 g every 8 or 12 hours.¹ ²⁵³

Severe Systemic or Life-threatening Infections

2 g every 6 or 8 hours.¹ ²⁵³

Bone and Joint Infections†

IV

Osteomyelitis^† caused by Ps. aeruginosa: 2 g every 8 hours for 6 weeks recommended by IDSA.⁵⁹⁰

Intra-abdominal Infections

IV

Usual dosage 1–2 g IV every 8 hours.⁷⁰⁹ In patients with impaired renal function, an initial dose of 1–2 g IV followed by 0.5–1 g IV every 6–12 hours is usually given.⁷⁰⁹

Urinary Tract Infections (UTIs)

IV or IM

500 mg or 1 g every 8 or 12 hours.¹ ¹⁶⁰ ¹⁶¹ ¹⁶² ¹⁶⁵ ¹⁷⁷ ¹⁸⁶ ¹⁹⁰ ²⁵³

Uncomplicated UTIs usually treated for 5–10 days;¹⁶⁰ ¹⁹⁰ complicated UTIs usually treated for ≥10–18 days.¹⁶⁰ ¹⁶² ¹⁶⁴ ¹⁶⁵

Perioperative Prophylaxis†

IV or IM

2 g within 1 hour prior to initial incision.³⁷⁴ During prolonged procedures (>4 hours) or if major blood loss occurs, may give additional intraoperative doses every 4 hours.³⁷⁴

Duration of prophylaxis should be <24 hours for most procedures;³⁶⁰ ³⁷⁴ no evidence to support continuing prophylaxis after wound closure or until all indwelling drains and intravascular catheters are removed.³⁶⁰

Cystic Fibrosis Patients with Ps. Aeruginosa

Oral Inhalation via Nebulization

75 mg 3 times daily for 28 days.³⁰⁶ Administer doses at least 4 hours apart (e.g., in the morning, after school, at bedtime).³⁰⁶ Follow 28-day treatment with 28-day period without the drug.³⁰⁶

In clinical trials, up to 9 courses used;³⁰⁹ each course consisted of 28 days of aztreonam oral inhalation therapy (75 mg 3 times daily), followed by 28 days without such therapy.³⁰⁹ ³¹⁰

Peritonitis in Patients Undergoing CAPD†

IV and/or Intraperitoneal†

1-g loading dose given IV followed by maintenance doses of 500 mg given intraperitoneally^† in 2 L of dialysate every 6 hours.³⁶ ²²⁷

Alternatively, intraperitoneal loading dose of 1 g per L of dialysate followed by intraperitoneal maintenance doses of 250 mg per L of dialysate.³¹²

Prescribing Limits

Pediatric Patients

Treatment of Infections

IV

Maximum recommended in pediatric patients ≥9 months of age is 120 mg/kg daily, but higher dosage may be warranted in those with cystic fibrosis.¹ ²⁵³

Adults

Treatment of Infections

IV or IM

Maximum 8 g daily.¹ ²⁵³

Special Populations

Hepatic Impairment

Treatment of Infections

IV or IM

Dosage adjustments probably not needed in patients with stable primary biliary cirrhosis or other chronic hepatic disease, unless renal function also impaired.³² ⁵⁶ ²⁷⁶ Serum half-life only slightly prolonged in patients with hepatic impairment.¹ ²⁵³

Although some clinicians recommend dosage be decreased by 20–25% in patients with alcoholic cirrhosis, especially if long-term therapy required,⁴⁶ ⁴⁷ others suggest this decrease not needed, unless renal function also impaired.²⁷⁶ ²⁷⁷

Renal Impairment

Treatment of Infections

IV or IM

Adults with Cl_cr ≤30 mL/minute: Modify doses and/or frequency of administration based on degree of renal impairment.¹ ³⁰ ³³ ³⁶ ²⁰³ ²²⁷ ²⁵³

Pediatric patients with impaired renal function: Data insufficient to date to make dosage recommendations.¹ ²⁵³

S_cr alone may not be sufficiently accurate to assess degree of renal impairment, especially in geriatric adults;¹ dosage preferably should be based on patient’s measured or estimated Cl_cr.¹ ²⁵³

Adults with Cl_cr 10–30 mL/minute per 1.73 m²: 1- or 2-g loading dose followed by maintenance doses equal to one-half the usual dose (i.e., 250 mg, 500 mg, or 1 g) given at the usual dosage intervals.¹ ²⁵³

Adults with Cl_cr <10 mL/minute per 1.73 m²: Loading dose equal to the usual dose (i.e., 500 mg, 1 g, or 2 g) followed by maintenance doses equal to one-fourth the usual dose (i.e., 125 mg, 250 mg, or 500 mg) given at the usual dosage intervals.¹ ³⁶ ²⁵³

Adults undergoing hemodialysis: Loading dose equal to the usual dose (i.e., 500 mg, 1 g, or 2 g) followed by maintenance doses equal to one-fourth the usual dose (i.e., 125 mg, 250 mg, or 500 mg) given at the usual dosage intervals.¹ ³⁶ ⁴⁸ ⁵⁶ In those with serious or life-threatening infections, also give a supplemental dose equal to one-eighth the initial dose (i.e., 62.5 mg, 125 mg, or 250 mg) immediately after each dialysis period.¹ ³⁰ ³⁶ ²⁵³ ²⁷⁶ ²⁷⁷ One modeling study suggests that aztreonam 1 g (for MICs up to 4 mg/L) or 2 g (for MICs up to 8 mg/L) daily after hemodialysis would yield adequate concentrations.⁷⁵⁸

Adults undergoing CAPD: Some clinicians suggest IV loading dose equal to the usual dose (i.e., 500 mg, 1 g, or 2 g) followed by maintenance doses equal to one-fourth the usual dose (i.e., 125 mg, 250 mg, or 500 mg) given at the usual dosage intervals.³⁶ ²²⁷

Oral Inhalation via Nebulization

Mild, moderate, or severe renal impairment: Dosage adjustments not needed.³⁰⁶

Geriatric Patients

Select dosage with caution because of age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.¹ ²⁵³

Monitor renal function;¹ ²⁵³ make appropriate dosage adjustments if necessary.¹ ²⁵³

Cautions for Aztreonam

Contraindications

Hypersensitivity to aztreonam or any component in the formulation.¹ ²⁵³ ³⁰⁶

Warnings/Precautions

Hypersensitivity

Immediate hypersensitivity reactions, including anaphylaxis,¹ ²⁵³ bronchospasm,¹ ²⁵³ generalized urticaria with or without palpebral and lingual edema and respiratory impairment,²⁹⁰ ²⁹⁵ ²⁹⁶ and shock, rash, and eosinophilia,¹⁷⁵ reported with parenteral aztreonam.¹ ¹⁷⁵ Toxic epidermal necrolysis reported rarely.¹ ²⁵³

Rash reported with orally inhaled aztreonam.³⁰⁶ Allergic reactions with facial rash, facial swelling, and throat tightness also reported.³⁰⁶

Hypersensitivity reactions may occur in patients with or without prior exposure to the drug.¹ ²⁵³ ³⁰⁶

Prior to initiation of therapy, assess whether patient has had previous hypersensitivity reactions to β-lactam antibiotics, other drugs, or allergens.¹ ²⁵³ ³⁰⁶ Use with caution in patients hypersensitive to β-lactam antibiotics (e.g., penicillins, cephalosporins, cephamycins).¹ ²⁵³ ³⁰⁶

If hypersensitivity reaction occurs, discontinue aztreonam and initiate appropriate treatment (e.g., vasopressors, antihistamines, corticosteroids, maintenance of ventilation).¹ ²⁵³ ³⁰⁶ Serious hypersensitivity reactions may require epinephrine and other emergency measures.¹ ²⁵³

Consider possibility that cross-sensitivity to aztreonam may occur in patients with history of hypersensitivity to other β-lactam antibiotics.¹ ²⁵³ ³⁰⁶

Clostridioides difficile-associated Diarrhea and Colitis

Treatment with anti-infectives alters normal colon flora and may permit overgrowth of Clostridiodes difficile.¹ ²⁵³ ³⁰² ³⁰³ C. difficile infection (CDI) and C. difficile-associated diarrhea and colitis (CDAD; also known as antibiotic-associated diarrhea and colitis or pseudomembranous colitis) reported with nearly all systemic anti-infectives, including aztreonam, and may range in severity from mild diarrhea to fatal colitis.¹ ²⁵³ ³⁰² ³⁰³ ³⁰³

Consider CDAD if diarrhea develops during or after therapy and manage accordingly.¹ ²⁵³ ³⁰² ³⁰³ Obtain careful medical history since CDAD may occur as late as 2 months or longer after anti-infective therapy is discontinued.¹ ²⁵³ ³⁰² ³⁰³

If CDAD is suspected or confirmed, discontinue anti-infectives not directed against C. difficile whenever possible.¹ ²⁵³ ³⁰² ³⁰³ Initiate appropriate supportive therapy (e.g., fluid and electrolyte management, protein supplementation), anti-infective therapy directed against C. difficile (e.g., metronidazole, vancomycin), and surgical evaluation as clinically indicated.¹ ²⁵³ ³⁰² ³⁰³

Toxic Epidermal Necrolysis

Toxic epidermal necrolysis reported in a few patients undergoing bone marrow transplant; these patients had multiple risk factors including sepsis and radiation therapy, and were receiving other drugs associated with toxic epidermal necrolysis.¹

Selection and Use of Anti-infectives

To reduce development of drug-resistant bacteria and maintain effectiveness of aztreonam and other antibacterials, use only for treatment or prevention of infections proven or strongly suspected to be caused by susceptible bacteria.¹ ²⁵³

When selecting or modifying anti-infective therapy, use results of culture and in vitro susceptibility testing.¹ ²⁵³ In the absence of such data, consider local epidemiology and susceptibility patterns when selecting anti-infectives for empiric therapy.¹ ²⁵³

Because aztreonam has little or no activity against gram-positive bacteria and anaerobes, another anti-infective active against such bacteria should be used concomitantly got empiric treatment of infections that may involve gram-positive bacteria or anaerobes (e.g., gynecologic, intra-abdominal, or respiratory tract infections).¹ ¹⁷¹ ¹⁷³ ¹⁸³ ²¹¹ ²¹³ ²¹⁴ ²⁵³

Overgrowth of Nonsusceptible Organisms

Possible emergence and overgrowth of nonsusceptible bacteria (e.g., S. aureus, E. faecalis) or fungi.¹ ²⁵³ Institute appropriate therapy if superinfection occurs.¹ ²⁵³

Precautions Related to Oral Inhalation Therapy

Use only to treat patients with cystic fibrosis who are known to have Ps. aeruginosa in the lungs.³⁰⁶ Use in the absence of known Ps. aeruginosa infection unlikely to provide benefit and increases risk of development of drug-resistant bacteria.³⁰⁶

Safety and efficacy not established in pediatric patients <7 years of age, in patients with FEV₁ <25% or >75% of predicted, or in patients colonized with Burkholderia cepacia.³⁰⁶

Consider that bronchospasm is a known complication associated with nebulized therapies, including aztreonam.³⁰⁶ In clinical trials in patients pretreated with a bronchodilator, a reduction of ≥15% in FEV₁ reported in 3% of patients immediately following a dose of aztreonam given by oral inhalation via nebulization.³⁰⁶

Some patients with increases in FEV₁ during 28-day course of aztreonam oral inhalation therapy were sometimes treated for pulmonary exacerbations when FEV₁ declined after the treatment period.³⁰⁶ When evaluating whether change in FEV₁ after treatment is caused by a pulmonary exacerbation, consider patient's baseline FEV₁ measured prior to initiation of aztreonam oral inhalation therapy and presence of other symptoms.³⁰⁶

Instruct patients to use a bronchodilator prior to administration of aztreonam inhalation solution.³⁰⁶ In patients receiving several inhaled drugs, recommended order is bronchodilator, mucolytics, and, lastly, aztreonam.³⁰⁶

Specific Populations

Pregnancy

No adequate and controlled studies to date in pregnant women.¹ ²⁵³ ³⁰⁶ Do not use during pregnancy unless clearly needed.¹ ²⁵³ ³⁰⁶

Crosses placenta and enters fetal circulation.¹ ²⁵³ ³⁰⁶

Lactation

IV or IM: Low concentrations (<1%) distributed into milk.¹ ²⁵³ Consider temporarily discontinuing breast-feeding during aztreonam therapy.¹ ²⁵³

Oral inhalation via nebulization: Peak plasma concentrations following 75-mg dose by oral inhalation via nebulization are approximately 1% of peak plasma concentrations following 500-mg IV dose.³⁰⁶ Systemic absorption following inhaled administration is likely minimal.³⁰⁶ Effects on the infant or on milk production are unknown.³⁰⁶

Pediatric Use

IV or IM: Use in children 9 months to 16 years of age supported by evidence from adequate and well-controlled studies in adults with additional efficacy, safety, and pharmacokinetic data from noncomparative clinical studies in pediatric patients.¹ Adverse effects reported in pediatric patients similar to those reported in adults.¹

IV or IM: Data insufficient regarding treatment of septicemia or skin and skin structure infections (where skin infection known or suspected to be caused by H. influenzae type b) in pediatric patients <9 months of age.¹ Data also insufficient regarding IM route in pediatric patients or use of the drug in pediatric patients with impaired renal function.¹ ²⁵³

IV or IM: Higher dosage may be warranted in pediatric patients with cystic fibrosis.¹

Oral inhalation via nebulization: Safety and efficacy not established in pediatric patients <7 years of age;³⁰⁶ has been used for 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.³¹⁸ In clinical trials evaluating aztreonam inhalation therapy in cystic fibrosis patients ≥7 years of age, pyrexia reported more frequently in pediatric patients than in adults.³⁰⁶

Geriatric Use

Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults.¹ ²⁵³

Select IV or IM dosage with caution because of the greater frequency of decreased hepatic, renal, and/or cardiac function and of concomitant disease and drug therapy observed in geriatric patients.¹ ²⁵³

Substantially eliminated by kidneys;¹ ²⁵³ risk of toxicity may be greater in patients with impaired renal function.¹ ²⁵³ Since geriatric patients are more likely to have renal impairment, monitor renal function and adjust IV or IM dosage if needed.¹ ²⁵³

Hepatic Impairment

Monitor hepatic function;¹ ²⁵³ ²⁷⁶ ²⁷⁷ adjustment of IV or IM dosage probably not needed, unless renal function also impaired.³² ⁵⁶ ²⁷⁶

Renal Impairment

Monitor renal function.¹ ²⁵³ Adjust IV or IM dosage is adults based on degree of renal impairment.¹ ²⁵³

Common Adverse Effects

IV or IM: Local reactions at injection site (e.g., phlebitis/thrombophlebitis following IV administration or discomfort/swelling following IM administration);¹ ²⁵³ GI effects (diarrhea, nausea, vomiting);¹ ²⁵³ hypersensitivity (rash).¹ ²⁵³

Oral inhalation via nebulization: Cough, nasal congestion, wheezing, bronchospasm, pharyngolaryngeal pain, pyrexia, chest discomfort, rash, abdominal pain, vomiting.³⁰⁶

Drug Interactions

Drug interactions based on parenteral aztreonam.¹ ²⁵³ Formal interaction studies not conducted to date using aztreonam by oral inhalation via nebulization.³⁰⁶

Specific Drugs and Laboratory Tests

Drug or Test	Interaction	Comments
Aminoglycosides	No clinically important effects on aztreonam pharmacokinetics¹ ²⁵³ In vitro evidence of additive or synergistic antibacterial effects against Ps. aeruginosa¹ ³⁸ ⁴⁸ ⁵⁷ ⁷⁸ ⁸⁸ ¹⁰⁷ ¹¹¹ ¹¹² ¹²⁸ ¹³¹ ¹⁴⁰ and some strains of Ps. cepacia⁴⁸ ¹⁰⁷ ¹³¹ Ps. fluorescens,¹³¹ or Ps. maltophilia¹³¹ In vitro evidence of synergistic antibacterial effects against Enterobacteriaceae (e.g., Enterobacter, E. coli, Klebsiella, Serratia)¹ ⁵⁷ ⁷⁸ ⁸⁸ ¹⁴⁰ In vitro synergism reported occasionally against Acinetobacter, but usually only additive or indifferent¹³¹ Indifference reported against gram-positive bacteria (e.g., S. aureus, S. epidermidis, E. faecalis)⁸⁸ ⁹² ¹³¹	Monitor renal function, especially if high aminoglycoside dosage used or if therapy is prolonged;¹ ²⁵³ risk of aminoglycoside-associated nephrotoxicity and ototoxicity¹ ²⁵³
Chloramphenicol	In vitro studies using K. pneumoniae indicate chloramphenicol can antagonize bactericidal activity of aztreonam¹³⁹	If used concomitantly, some clinicians suggest administering chloramphenicol a few hours after aztreonam;¹³⁹ necessity of this precaution not established¹³⁹
Clavulanic acid	In vitro evidence of synergistic effects against some β-lactamase-producing Enterobacter, Klebsiella, or B. fragilis;⁴⁸ ⁸⁸ antagonism also may occur¹²⁷ ²⁷⁶ Concomitant use does not alter in vitro susceptibility of S. aureus to aztreonam since resistance to the drug in these organisms is intrinsic²³⁴
Clindamycin	Possible increased total urinary excretion of aztreonam, but other pharmacokinetic parameters not affected¹⁵⁴ In vitro evidence of synergistic effects against some strains of E. coli, Klebsiella, or Enterobacter, indifferent or additive effects reported more frequently⁷⁷ Indifferent or slightly additive effects reported against anaerobic bacteria³⁸	Not considered clinically important¹ ¹⁵⁴ ²⁵³
Furosemide	Possible increased serum aztreonam concentrations¹	Not considered clinically important¹
β-lactam antibiotics	Nafcillin: No clinically important pharmacokinetic interactions¹ ²⁵³ In vitro evidence of additive or synergistic antibacterial effects with some β-lactams (piperacillin, cefotaxime) against some strains of Ps. aeruginosa;⁷⁸ antagonism with imipenem against Ps. aeruginosa⁹² In vitro evidence of indifferent or only slightly additive effects with some β-lactams (ampicillin, piperacillin, cefotaxime) against Enterobacteriaceae, including Enterobacter, E. coli, S. marcescens, or Klebsiella⁷⁷ ⁷⁸ ⁹² In vitro evidence of synergism with cefoxitin against some strains of Enterobacter, E. coli, Klebsiella, S. marcescens, Salmonella, or Shigella;⁷⁷ antagonism also reported against some Enterobacter or S. marcescens⁷⁷ ¹²⁷	Because of potential for antagonism, do not use β-lactams that are potent inducers of β-lactamase production (e.g., cefoxitin, imipenem) concomitantly with aztreonam¹ ²⁵³
Metronidazole	Possible decreased peak serum concentrations of aztreonam;¹⁵⁴ other pharmacokinetic parameters not affected¹⁵⁴ In vitro evidence of indifferent or slightly additive effects against anaerobic bacteria³⁸	Not considered clinically important¹ ¹⁵⁴ ²⁵³
Probenecid	Decreased rate of renal tubular secretion of aztreonam and increased aztreonam concentrations:¹ ² ³⁴ ⁵⁶ ²⁵³ decreased binding of aztreonam to plasma proteins¹ ² ³⁴ ⁵⁶ ²⁵³	Not sufficient to be of therapeutic benefit¹ ² ³⁴ ⁵⁶ ²⁵³
Tests for glucose	Possible false-positive reactions in urine glucose tests using Clinitest, Benedict’s solution, or Fehling’s solution²⁴⁰	Use glucose tests based on enzymatic glucose oxidase reactions (e.g., Clinistix, Tes-Tape)²⁴⁰

Aztreonam Pharmacokinetics

Absorption

Bioavailability

IM: Rapidly and completely absorbed following IM administration;² ⁶ ⁷ ²⁹ ⁴⁶ ⁴⁷ ⁴⁸ ⁵⁶ ²⁵⁶ peak serum concentrations generally attained within 1 hour after an IM dose.¹ ² ⁶ ⁷ ²⁹ ⁴⁶ Peak serum concentrations attained with IM dose are slightly lower than those attained with equivalent IV dose, but serum aztreonam concentrations ≥1 hour after dosing are similar.¹ ²

Oral inhalation via nebulization: Variable concentrations enter systemic circulation;³⁰⁶ ³⁰⁷ ³⁰⁸ accumulation does not occur following multiple doses.³⁰⁶ ³⁰⁷ ³⁰⁸

Special Populations

IV: Pharmacokinetics in pediatric patients ≥9 months of age similar to those in adults.¹

Distribution

Extent

IV or IM: Widely distributed into body tissues and fluids.²¹ ⁴⁶ ⁴⁸ Distributed into skeletal muscle,¹ ²¹ ²⁵ ²⁶⁶ adipose tissue,¹ ²¹ ²⁶⁶ skin,¹ ²¹ bone,¹ ²⁰ ²⁵ gallbladder,¹ ²¹ liver,¹ ²¹ lungs,¹ ²⁵ ²⁰⁸ kidneys,¹ ² ²² ²⁶⁶ atrial appendage,¹ ²⁵ intestines,¹ ²¹ prostatic tissue,¹ ²⁴ ⁴⁸ ⁵⁶ myometrium,²⁶⁶ endometrium,¹ ²⁵ ²⁶⁶ fallopian tubes,¹ ²⁶⁶ ovaries,¹ and cervical and vaginal tissue.²⁶⁶ Also distributed into saliva,¹ ² ⁵⁶ sputum,⁴⁸ ²⁶⁶ bronchial secretions,¹ ⁴⁸ ²⁰⁸ ²²⁶ aqueous humor,² ⁶ ⁵⁶ and bile,¹ ² ⁷ ²¹ ³¹ ⁴⁸ ⁵⁶ and into pericardial,¹ ²⁵ pleural,¹ ²⁵ ²⁰⁸ peritoneal,¹ ² ⁴⁸ ⁵⁶ ²¹² synovial,¹ ²⁰ and blister fluids.¹ ² ²³ ⁴⁶ ⁴⁸ ⁵⁶

IV: Distributed into CSF in adults and pediatric patients;¹ ² ¹⁵ ¹⁷ ¹⁸ ¹⁹ ⁴⁶ ⁴⁸ ⁵⁶ ²²³ CSF concentrations generally higher in patients with inflamed meninges than in those with uninflamed meninges.² ¹⁷ ¹⁸ ⁴⁶ ⁴⁸ ⁵⁶

Oral inhalation via nebulization: Sputum concentrations exhibit considerable interindividual variation;³⁰⁶ ³⁰⁷ ³⁰⁸ accumulation does not occur following multiple doses.³⁰⁶ ³⁰⁷ ³⁰⁸

Crosses the placenta and is distributed into amniotic fluid.¹ ²⁸ ⁴⁶ ⁴⁸ ⁵⁶

Distributed into milk in low concentrations.¹ ²⁷ ⁴⁶ ⁴⁸ ⁵⁶

Plasma Protein Binding

46–60% bound to serum proteins in healthy adults¹ ² ⁶ ¹⁰ ¹⁴ ³³ ³⁴ ⁴⁸ ⁵⁶ ²³⁴ at serum concentrations of 1–100 mcg/mL.⁶ ¹⁰ ²³⁴

Adults with impaired renal function and decreased serum albumin concentrations: 22–49% bound to serum proteins.¹³ ³³ ⁴⁶ ⁴⁸

77% protein binding after oral inhalation via nebulization.³⁰⁶

Elimination

Metabolism

Partially metabolized to several microbiologically inactive metabolites;² ⁶ ⁷ ¹⁷ ³³ ⁴⁶ ⁴⁸ ⁵⁶ no active metabolites have been found in serum or urine.² ⁶ ⁷ ¹⁷ ²⁹ ⁴⁸ ⁵⁶

Elimination Route

Eliminated principally in urine as unchanged drug¹ ² ⁴ ⁶ ⁷ ¹⁰ ²³ ²⁹ ³⁴ ⁴⁶ ⁴⁸ ⁵⁶ ²¹² via both glomerular filtration and tubular secretion.¹ ² ⁶ ²³ ³³ ³⁴ ⁴⁶ ⁴⁸ ⁵⁶ ²¹² Partially excreted in feces,¹ ² ⁷ ⁴⁶ ⁴⁸ ⁵⁶ ¹⁵² presumably via biliary elimination.² ⁷ ²³ ⁴⁶ ⁴⁸ ⁵⁶

IM or IV: Approximately 58–74% of a dose excreted in urine unchanged,¹ ² ³ ⁴ ⁶ ⁷ ¹⁴ ²³ ³³ ⁴⁶ ⁴⁸ ⁵⁶ 1–7% excreted as SQ 26,992 (an inactive metabolite),¹ ² ⁶ ⁷ ¹⁴ ²³ ³³ ⁴⁸ ⁵⁶ and 3–4% excreted as unidentified inactive metabolites.² ⁴⁸ Urinary excretion of unchanged drug essentially complete 8–12 hours after single dose,¹ ⁴ ⁶ ⁷ ¹⁰ ¹⁴ ²⁹ ³⁴ but SQ 26,992 excreted for up to 48 hours after the dose.⁷ ¹⁰ ¹⁴

IV: Approximately 1% of single dose excreted in feces unchanged,² ⁷ ⁴⁸ ⁵⁶ 3% as SQ 26,992,² ⁷ and 7.5–10.8% as unidentified inactive metabolites.² ⁷

Oral inhalation via nebulization: Approximately 10% of total dose excreted unchanged in urine;³⁰⁶ glomerular filtration and tubular secretion equally involved.³⁰⁶

Removed by hemodialysis.² ³⁰ ³⁶ ⁴⁶ ⁴⁷ ¹⁷⁷ ²⁰³ ²⁵⁶ Removed to a lesser extent by peritoneal dialysis.¹ ³⁶ ⁴⁷ ²²⁷

Half-life

Adults with normal renal and hepatic function: Distribution half-life averages 0.2–0.7 hours² ⁴ ⁶ ⁷ ⁹ ¹⁰ ¹⁴ ²⁹ ³³ ⁴⁶ ⁴⁸ ⁵⁶ and elimination half-life averages 1.3–2.2 hours.² ⁴ ⁶ ⁷ ⁹ ¹⁰ ¹⁴ ²³ ²⁹ ³³ ³⁴ ⁴⁶ ⁴⁷ ⁴⁸ ⁵⁶

Children 2 months to 12 years of age: Elimination half-life averages 1.7 hours.¹⁵

Neonates: Half-life is longer than in older children and adults and is inversely related to age and birthweight.¹⁵ In neonates <7 days of age, elimination half-life averages 5.5–9.9 hours in those weighing <2.5 kg⁵ ¹⁵ and 2.6 hours in those weighing >2.5 kg.¹⁵ In neonates 1 week to 1 month of age, elimination half-life averages 2.4 hours.¹⁵

Oral inhalation via nebulization in adults with cystic fibrosis: Plasma elimination half-life of systemically absorbed drug is approximately 2.1 hours.³⁰⁶

Special Populations

Geriatric adults: Elimination half-life is slightly longer than in younger adults¹ ¹⁴ ⁹⁰ ²⁶⁶ and ranges from 1.7–4.3 hours in adults 64–82 years of age with renal function normal for their age.¹⁴ ⁹⁰ ²⁶⁶

Cystic fibrosis patients: May eliminate aztreonam at a faster rate than healthy individuals.⁴⁶ ⁴⁸ ¹⁷⁷ ²⁶⁹ ²⁷⁰ Serum half-life averaged 1–1.3 hours in several patients with cystic fibrosis.¹⁷⁷ ²⁶⁹ ²⁷⁰

Patients with hepatic impairment: Half-life is only slightly prolonged since the liver is a minor elimination pathway for the drug.¹ Elimination half-life in patients with cirrhosis but with normal renal function averages 2.2 hours in those with primary biliary cirrhosis and 3.2 hours in those with alcoholic cirrhosis.³²

Patients with renal impairment: Serum concentrations of aztreonam are higher and serum half-life prolonged.¹ ² ³⁰ ³³ ⁴⁶ ⁴⁷ ⁴⁸ ⁵⁶ ²⁰³ ²¹² In adults with renal impairment, elimination half-life averages 3.4–3.6, 5.3–5.9, 7.8–7.9, or 8.4–8.7 hours in adults with Cl_cr of 30–80, 10–29, 3–9, or <2 mL/minute, respectively.³⁰

Stability

Storage

Parenteral

Powder for Injection

Room temperature (20–25°C);¹ ²⁵³ avoid excessive heat.¹ ²⁵³

At a concentration of ≤20 mg/mL, aztreonam is chemically and physically stable for 48 hours at 15–30°C or for 7 days when refrigerated at 2–8°C in the following IV infusion solutions: 0.9% sodium chloride injection; 5 or 10% dextrose injection; Ringer’s; lactated Ringer’s; 5% dextrose and 0.2, 0.45, or 0.9% sodium chloride; (1/6) M sodium lactate; 5 or 10% mannitol; 5% dextrose with lactated Ringer’s; 5% dextrose with Plasma-Lyte M; Ionosol B with 5% dextrose; Isolyte E; Isolyte E with 5% dextrose; Isolyte M with 5% dextrose; Normosol-R; Normosol-R with 5% dextrose; or Normosol-M with 5% dextrose.¹ ²⁵³ At concentrations >20 mg/mL, aztreonam is stable for 48 hours at 2–8°C in sterile water for injection or 0.9% sodium chloride injection; solutions containing >20 mg/mL prepared using other compatible IV solutions should be used immediately.¹ ²⁵³ ²⁷⁷

IM solutions prepared using sterile water for injection or 0.9% sodium chloride injection are stable for 48 hours at 15–30°C or for 7 days when refrigerated at 2–8°C. IM injections prepared using bacteriostatic water for injection (with benzyl alcohol or parabens) or bacteriostatic sodium chloride injection (with benzyl alcohol or parabens) should be used immediately after reconstitution.²⁷⁷

Powder for Inhalation Solution

Kit containing single-dose vials of lyophilized powder for inhalation solution and single-dose ampuls of diluent: 2–8°C.³⁰⁶ After removal from refrigerator, kit may be stored at room temperature (up to 25°C) for up to 28 days.³⁰⁶

Protect lyophilized drug from light;³⁰⁶ do not use if stored at room temperature for longer than 28 days.³⁰⁶ Do not use diluent if it is cloudy or contains particles.³⁰⁶

Use immediately following reconstitution.³⁰⁶

Actions and Spectrum

Monobactam antibiotic.¹ ⁴² ⁴³ ⁴⁴ ²⁴⁶ ²⁵³ ³⁰⁶ Unlike other currently available β-lactam antibiotics, which are bicyclic and contain an adjoining ring fused to the β-lactam ring (e.g., carbapenems, cephalosporins, cephamycins, penicillins),¹ ³ ⁴³ ⁵⁷ ²⁴¹ ²⁴⁶ ²⁵³ ³⁰⁶ monobactams are monocyclic β-lactam antibiotics.¹ ³ ³⁸ ³⁹ ⁴⁰ ⁴¹ ⁴² ⁴³ ⁴⁴ ⁴⁵ ⁴⁶ ⁵⁵ ⁵⁷ ⁶⁰ ⁹⁶ ²³⁴ ²⁴¹ ²⁴⁶ ²⁵⁶ ²⁵³ ³⁰⁶
Usually bactericidal,¹ ⁴⁶ ⁴⁸ ⁵⁵ ⁶⁷ ⁷⁹ ⁸⁸ ¹³⁷ ²⁵³ but not as rapidly bactericidal as some other β-lactam antibiotics (e.g., imipenem, cefotaxime, cefoxitin, ceftriaxone).¹³⁷ ¹⁴² ²⁴⁷
Like other β-lactam antibiotics, antibacterial activity results from inhibition of bacterial cell wall synthesis.¹ ³⁸ ⁴⁶ ⁵⁷ ⁵⁹ ⁶⁰ ²⁴⁷ ²⁵³
Narrow spectrum of activity.³⁸ ⁴⁰ ⁴⁴ ⁴⁶ ⁵⁵ ⁵⁷ ⁵⁹ ⁷⁶ ⁷⁷ ⁸³ ⁸⁵ ⁹⁶ ²³⁴ ²⁴¹ Active against many gram-negative aerobic bacteria, but has little or no activity against gram-positive aerobic bacteria or anaerobic bacteria.¹ ³ ³⁸ ³⁹ ⁴⁰ ⁴⁴ ⁴⁶ ⁴⁷ ⁴⁸ ⁵⁵ ⁵⁷ ⁵⁹ ⁶⁹ ⁷⁰ ⁷⁶ ⁸³ ⁸⁴ ⁸⁵ ⁹⁶ ²³⁴ ²⁴¹ ²⁸⁰ ²⁵³ Inactive against Chlamydia,²⁷⁸ Mycoplasma, fungi, and viruses.²⁷⁶ ²⁷⁷
Gram-negative aerobes: Active in vitro and in clinical infections against Citrobacter (including C. freundii), Enterobacter (including E. cloacae), Escherichia coli, Haemophilus influenzae (including β-lactamase-producing strains),³ ³⁸ ⁴⁸ ⁵⁵ ⁶² ⁶³ ⁶⁵ ⁶⁶ ⁷³ ⁷⁶ ⁸³ ⁸⁴ ¹⁰⁰ ¹³⁰ Klebsiella oxytoca, K. pneumoniae, Proteus mirabilis, and Pseudomonas aeruginosa.¹ ³ ³⁸ ⁴⁶ ⁴⁷ ⁴⁸ ⁵⁵ ⁵⁷ ⁶² ⁶³ ⁶⁵ ⁶⁶ ⁶⁷ ⁶⁸ ⁶⁹ ⁷⁰ ⁷¹ ⁷² ⁷³ ⁷⁵ ⁷⁶ ⁸³ ⁸⁴ ⁹⁶ ⁹⁹ ¹⁰⁰ ¹⁰⁶ ¹⁰⁹ ¹¹⁰ ¹¹¹ ¹¹² ¹¹⁷ ¹³⁰ ¹³¹ ²³⁴ Also active in vitro against Aeromonas hydrophila,¹ ⁸⁴ ⁹⁷ ¹¹⁹ ¹²³ Moraxella catarrhalis (including β-lactamase-producing strains),¹⁰⁰ ¹³⁰ Morganella morganii, Neisseria gonorrhoeae (including penicillinase-producing strains),¹ ³ ³⁸ ⁴⁸ ⁶² ⁶⁵ ⁶⁶ ⁷⁶ ⁸³ ⁸⁴ ¹⁰⁰ ¹⁰² ¹⁰³ ¹³⁰ Neisseria meningitidis,³ ⁵⁵ ⁶³ ⁸⁴ ¹³⁰ Pasteurella multocida,¹ ⁸⁴ Plesiomonas shigelloides,⁸⁴ Providencia rettgeri, P. stuartii, Serratia marcescens, Salmonella, Shigella, and Yersinia enterocolitica.³ ⁴⁶ ⁴⁷ ⁴⁸ ⁵⁵ ⁵⁷ ⁸⁴ ⁹⁶ ²³⁴
Inactive against Alcaligenes,⁶⁴ ⁷⁰ ⁷⁴ ²³⁴ Bordetella bronchiseptica,⁶⁴ ⁷² Brucella melitensis,¹²⁵ Burkholderia (including B. cepacia, B. cenocepacia, B. gladioli, B. multivorans),³ ⁶⁴ ⁶⁵ ⁶⁶ ⁶⁹ ⁷² ⁷⁴ ⁸⁴ ¹⁰⁰ ²³⁴ ³¹¹ Flavobacterium meningosepticum,⁶⁴ Legionella pneumophila,¹²⁰ and Stenotrophomonas maltophilia.³ ⁶⁴ ⁶⁵ ⁶⁶ ⁶⁹ ⁷² ⁷⁴ ⁸⁴ ¹⁰⁰ ¹³¹ ²³⁴
Gram-positive aerobes: May be active against some strains of Streptococcus pyogenes (group A β-hemolytic streptococci, GAS) and groups C and G streptococci, but most are resistant.³ ⁵⁵ ⁵⁷ ⁶³ ⁷³ ⁷⁶ ⁸³ ⁸⁶ ⁹⁹ ¹⁰⁰ ¹¹⁷ ¹³⁰ S. agalactiae (group B streptococci, GBS),³ ⁵⁵ ⁷³ ⁸³ ¹¹⁷ ¹³⁰ viridans streptococci,⁸³ ⁸⁴ ¹¹⁷ nonenterococcal group D streptococci,³ ⁸³ enterococci,³ ⁵⁵ ⁶³ ⁷³ ⁷⁶ ⁸³ ⁸⁶ ⁹⁷ ¹⁰⁰ ¹¹⁷ ¹³⁰ ¹³¹ ²³⁴ Staphylococcus aureus,³ ⁵⁵ ⁶³ ⁷³ ⁷⁶ ⁸⁰ ⁸³ ⁸⁴ ⁸⁶ ⁹⁷ ¹⁰⁰ ¹¹⁷ ¹³⁰ ¹³¹ ²³⁴ S. epidermidis,³ ⁸⁴ ⁸⁶ ⁹⁷ ¹¹⁷ ¹³¹ S. saprophyticus,⁷³ Listeria monocytogenes,⁸⁴ ⁸⁶ and Nocardia⁴⁸ ¹²¹ are resistant.
Anaerobes: Not active against most gram-positive and -negative anaerobes, including Clostridium perfringens,⁸⁴ C. difficile,⁸⁴ Eubacterium,⁸³ ²³⁴ Peptococcus,⁸³ Peptostreptococcus,⁸³ ⁹⁷ Fusobacterium,⁶³ ⁸³ Veillonella,⁸³ Bacteroides fragilis, and Prevotella melaninogenica.⁶³ ⁷³ ⁷⁶ ⁸³ ⁹⁷ ¹⁰⁰ ²³⁴

Advice to Patients

Advise patients that antibacterials (including aztreonam) should only be used to treat bacterial infections and not used to treat viral infections (e.g., the common cold).¹ ²⁵³
Advise patients to complete the full course of therapy, even if feeling better after a few days.¹ ²⁵³
Advise patients that skipping doses or not completing the full course of therapy may decrease effectiveness and increase the likelihood that bacteria will develop resistance and will not be treatable with aztreonam or other antibacterials in the future.¹ ²⁵³
Advise patients to discontinue therapy and inform their clinician if an allergic reaction occurs.¹ ²⁵³
Advise patients that diarrhea is a common problem caused by systemic anti-infectives and usually ends when the drug is discontinued.¹ ²⁵³ Advise patients to contact a clinician if watery and bloody stools (with or without stomach cramps and fever) occur during or as late as ≥2 months after the last dose.¹ ²⁵³
Oral inhalation via nebulization: Advise patients to reconstitute the powder for inhalation solution using only the diluent provided by the manufacturer and to administer reconstituted solution only with the Altera nebulizer system.³⁰⁶
Oral inhalation via nebulization: Advise patients to complete the full 28-day oral inhalation regimen, even if feeling better;³⁰⁶ if a dose is missed, advise patient to take all 3 daily doses as long as the doses are at least 4 hours apart.³⁰⁶
Oral inhalation via nebulization: Advise patients to inform their clinician if they have new or worsening symptoms and to immediately contact a clinician if possible allergic reaction occurs.³⁰⁶
Advise patients to inform their clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, and any concomitant illnesses.¹ ²⁵³ ³⁰⁶
Advise women to inform their clinician if they are or plan to become pregnant or plan to breast-feed.¹ ²⁵³ ³⁰⁶
Inform patients of other important precautionary information.¹ ²⁵³ ³⁰⁶ (See Cautions.)

Additional Information

The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer’s labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Aztreonam oral inhalation (Cayston) can only be obtained through designated specialty pharmacies.⁷⁵⁹ Contact manufacturer or consult the Cayston website ([Web]) for specific availability information.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Aztreonam
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral Inhalation	Kit	Aztreonam 75 mg powder for inhalation solution for nebulization 0.17% sodium chloride diluent	Cayston	Gilead
Parenteral	For injection	1 g*	Azactam	Squibb
			Aztreonam for Injection
		2 g*	Azactam	Squibb
			Aztreonam for Injection

† Off-label: Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

1. Bristol-Meyers Squibb. Azactam (aztreonam) for injection prescribing information. Princeton, NJ; 2021 Mar.

2. Swabb EA. Review of the clinical pharmacology of the monobactam antibiotic aztreonam. Am J Med. 1985; 78(Suppl 2A):11-8. http://www.ncbi.nlm.nih.gov/pubmed/3881946?dopt=AbstractPlus

3. Neu HC. Structure-activity relations of new β-lactam compounds and in vitro activity against common bacteria. Rev Infect Dis. 1983; 5(Suppl 2):S319-36. http://www.ncbi.nlm.nih.gov/pubmed/6342103?dopt=AbstractPlus

4. Swabb EA, Leitz MA, Pilkiewicz FG et al. Pharmacokinetics of the monobactam SQ 26,776 after single intravenous doses in healthy subjects. J Antimicrob Chemother. 1981; 8(Suppl E):131-40. http://www.ncbi.nlm.nih.gov/pubmed/7199041?dopt=AbstractPlus

5. Likitnukul S, McCracken GH, Threlkeld N et al. Pharmacokinetics and plasma bactericidal activity of aztreonam in low-birth-weight infants. Antimicrob Agents Chemother. 1987; 31:81-3. http://www.ncbi.nlm.nih.gov/pubmed/3105443?dopt=AbstractPlus

6. Haroche G, Salvanet A, Lafaix CH et al. Pharmacokinetics of aztreonam in the aqueous humour. J Antimicrob Chemother. 1986; 18:195-8. http://www.ncbi.nlm.nih.gov/pubmed/3759730?dopt=AbstractPlus

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226. Bechard DL, Hawkins SS, Dhruv R et al. Penetration of aztreonam into human bronchial secretions. Antimicrob Agents Chemother. 1985; 27:263-4. http://www.ncbi.nlm.nih.gov/pubmed/4039120?dopt=AbstractPlus

227. Bolton ND, Gerig JS, Scheld WM et al. Peritoneal transfer of aztreonam in patients during continuous ambulatory peritoneal dialysis. Kidney Int. 1984; 25:255.

228. Berne TV, Yellin AE, Appleman MD et al. Surgically treated gangrenous or perforated appendicitis. Ann Surg. 1987; 205:133-7. http://www.ncbi.nlm.nih.gov/pubmed/3545106?dopt=AbstractPlus

229. Buscher KH, Cullmann W, Dick W et al. Selection frequency of resistant variants by various β-lactam antibiotics in clinical Enterobacter cloacae isolates. Chemotherapy. 1987; 33:40-51. http://www.ncbi.nlm.nih.gov/pubmed/3493886?dopt=AbstractPlus

230. Agnelli G, Guerciolini R, Grasselli S et al. Effects of the monobactam antibiotic aztreonam on platelet function and blood coagulation. Chemotherapy. 1987; 33:9-14. http://www.ncbi.nlm.nih.gov/pubmed/2951237?dopt=AbstractPlus

231. Joubert PH, Teichler C. Evaluation of aztreonam in serious gram-negative infections. Curr Ther Res Clin Exp. 1987; 41:1-5.

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More about aztreonam

Drug Status

Availability Prescription only Rx

Pregnancy & Lactation Risk data available

CSA Schedule* Not a controlled drug N/A

Approval History Drug history at FDA

User Reviews & Ratings

Review this drug

Aztreonam (Monograph)

Introduction

Uses for Aztreonam

Intra-abdominal Infections

Gynecologic Infections

Respiratory Tract Infections

Septicemia

Skin and Skin Structure Infections

Urinary Tract Infections (UTIs)

Bone and Joint Infections

CNS Infections

Antimicrobial Prophylaxis in Surgery

Empiric Therapy in Febrile Neutropenic Patients

Related/similar drugs

Aztreonam Dosage and Administration

Administration

IV Injection

Reconstitution

Rate of Administration

IV Infusion

Reconstitution and Dilution

Rate of Administration

IM Injection

Reconstitution

Oral Inhalation via Nebulization

Reconstitution

Nebulization

Dosage

Pediatric Patients

General Dosage for Neonates†

IV

General Pediatric Dosage

IV

Intra-abdominal Infections

IV

Cystic Fibrosis Patients with Ps. Aeruginosa

Oral Inhalation via Nebulization

Adults

General Adult Dosage

Moderately Severe Systemic Infections

Severe Systemic or Life-threatening Infections

Bone and Joint Infections†

IV

Intra-abdominal Infections

IV

Urinary Tract Infections (UTIs)

IV or IM

Perioperative Prophylaxis†

IV or IM

Cystic Fibrosis Patients with Ps. Aeruginosa

Oral Inhalation via Nebulization

Peritonitis in Patients Undergoing CAPD†

IV and/or Intraperitoneal†

Prescribing Limits

Pediatric Patients

Treatment of Infections

IV

Adults

Treatment of Infections

IV or IM

Special Populations

Hepatic Impairment

Treatment of Infections

IV or IM

Renal Impairment

Treatment of Infections

IV or IM

Oral Inhalation via Nebulization

Geriatric Patients

Cautions for Aztreonam

Contraindications

Warnings/Precautions

Hypersensitivity

Clostridioides difficile-associated Diarrhea and Colitis

Toxic Epidermal Necrolysis

Selection and Use of Anti-infectives

Overgrowth of Nonsusceptible Organisms

Precautions Related to Oral Inhalation Therapy

Specific Populations

Pregnancy