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Generic Name: Aztreonam
Class: Monobactams
Chemical Name: [2S - [2α,3β(Z)]] - 2 - [[[1 - (2 - Amino - 4 - thiazolyl) - 2 - [2 - methyl - 4 - oxo - 1 - sulfo - 3 - azetidinyl)amino] - 2 - oxoethylidene]amino]oxy] - 2 - methylpropanoic acid
CAS Number: 78110-38-0

Introduction

Antibacterial; monocyclic β-lactam antibiotic; monobactam.1 42 43 44 246 253 287 306

Uses for Azactam

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

Consult current IDSA clinical practice guidelines available at for additional information on management of osteomyelitis.590

Gynecologic Infections

Treatment of gynecologic infections (including endometritis and pelvic cellulitis) caused by susceptible gram-negative bacteria, including Enterobacter (including E. cloacae), E. coli, K. pneumoniae, or P. mirabilis.1 171 173 183 192 211 253 287

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.171 173 177 183 211 267

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).1 173 177 213 214 253 267 287

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 Clindamycin or metronidazole generally used concomitantly if aztreonam used for initial treatment of intra-abdominal infections.173 177 213 214 228

For initial empiric treatment of high-risk or severe community-acquired, extrabiliary, complicated intra-abdominal infections in adults, IDSA states that aztreonam in conjunction with metronidazole is an alternative regimen, but an additional anti-infective active against gram-positive bacteria is recommended pending results of in vitro culture and susceptibility tests.708

Consult current IDSA clinical practice guidelines available at for additional information on management of intra-abdominal infections.708

Intraperitoneal: Has been used for treatment of peritonitis in patients undergoing CAPD.312 313 314 315 Some clinicians suggest that intraperitoneal anti-infectives are preferred over IV anti-infectives for empiric treatment of peritonitis in CAPD patients;312 regimen should provide coverage against both gram-positive and gram-negative bacteria pending results of in vitro culture and susceptibility testing.312 Intraperitoneal vancomycin in conjunction with intraperitoneal aztreonam has been used;314 315 aztreonam recommended as an alternative for gram-negative coverage in CAPD patients allergic to cephalosporins.312

Respiratory Tract Infections

Treatment of lower respiratory tract infections (including pneumonia and bronchitis) caused by susceptible gram-negative bacteria, including Enterobacter, E. coli, H. influenzae, K. pneumoniae, Ps. aeruginosa, P. mirabilis, or S. marcescens.1 165 167 168 169 173 176 177 192 206 208 222 253 287

Also has been used for treatment of lower respiratory tract infections caused by susceptible Citrobacter,167 168 176 206 208 264 267 Hafnia,264 K. oxytoca,168 Morganella,206 208 264 P. vulgaris,165 Providencia stuartii,192 or Moraxella catarrhalis.165 208 264

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 48 164 165 176 186 202 206 208 223 235 241 253 266 268 287

Clindamycin in conjunction with aztreonam has been used for initial empiric treatment of lower respiratory tract infections (especially nosocomial infections).165 167 206 235 268

Consult current IDSA clinical practice guidelines available at for additional information on management of respiratory tract infections, including community-acquired pneumonia (CAP).512 513

Oral inhalation via nebulization: Used to improve respiratory symptoms in cystic fibrosis patients ≥7 years of age with Ps. aeruginosa in the lungs.306 307 308 309 310 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

Septicemia

Treatment of septicemia caused by susceptible gram-negative bacteria, including Enterobacter, E. coli, K. pneumoniae, Ps. aeruginosa, P. mirabilis, or S. marcescens.1 173 176 177 186 192 221 222 223 253 287

Also has been used for treatment of septicemia caused by susceptible Citrobacter264 267 or H. influenzae.186 192 264

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.1 173 177 192 222 223 253 287

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.1 253 287

Consult current IDSA clinical practice guidelines available at for additional information on management of skin and skin structure infections.543 544

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 90 160 162 170 175 176 177 190 192 218 219 223 253 287

Also has been used for treatment of UTIs caused by susceptible E. aerogenes,176 218 Morganella morganii,176 218 264 267 P. vulgaris,218 or Providencia.177 218 264

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.170 218 264 Although aztreonam generally is associated with less toxicity than aminoglycosides, colonization or superinfection with gram-positive bacteria (especially Enterococcus faecalis) has been reported more frequently with aztreonam than with aminoglycosides.46 90 160 164 175 188

Perioperative Prophylaxis

Perioperative 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 Because gram-positive bacteria (especially Staphylococcus epidermidis) reported with increasing frequency in febrile granulocytopenic patients and because aztreonam is inactive against these organisms, 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 A regimen of aztreonam and vancomycin is considered an alternative empiric regimen in patients with immediate-type penicillin hypersensitivity.457

Consult published protocols for treatment of infections in febrile neutropenic patients for specific recommendations regarding selection of initial empiric regimen, when to change the initial regimen, possible subsequent regimens, and duration of therapy in these patients.457

Azactam Dosage and Administration

Administration

Parenteral: Administer by IV injection1 253 or infusion1 253 287 or by deep IM injection.1 253

Oral inhalation: Administer by oral inhalation via nebulization.306

Has been administered intraperitoneally in dialysis fluid.36 56 196 227 312 313 314 315

IV route preferred (instead of IM) in patients with septicemia, localized parenchymal abscess (such as intra-abdominal abscess), peritonitis, or other severe systemic or life-threatening infection and when individual doses >1 g are to be administered.1 253

Administer commercially available frozen premixed aztreonam injection in dextrose only by IV infusion.287

Administer commercially available powder for inhalation solution only by oral inhalation via nebulization.306

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;1 253 287 do not give the drugs simultaneously.1 253 287 When a Y-type IV administration set 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 253 264 to provide a solution with a final concentration ≤20 mg/mL.264 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;1 253 264 this final dilution should provide a solution with a concentration ≤20 mg/mL.1 253 264

Alternatively, thaw the commercially available premixed injection (frozen) at room temperature (25° C) or in a refrigerator (2–8°C);287 do not thaw by immersion in a water bath or by exposure to microwave radiation.287 A precipitate may have formed in the frozen injection, but should dissolve with little or no agitation after reaching room temperature.287 Discard thawed injection if an insoluble precipitate is present or if container seals or outlet ports are not intact or leaks are found.287 Do not use in series connections with other plastic containers;287 such use could result in air embolism from residual air being drawn from the primary container before administration of fluid from the secondary container is complete.287 Manufacturer recommends that the IV administration set be replaced every 48 hours.287

Rate of Administration

Give by IV infusion over 20–60 minutes.1 253 287

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 condition of the patient.1 253 287 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.1 253 287 Persistent infections may require several weeks of treatment.1 253 287

Pediatric Patients

General Dosage for Neonates
IV or IM

Neonates ≤7 days of age: AAP recommends 30 mg/kg every 12 hours in those weighing ≤2 kg or 30 mg/kg every 8 hours in those weighing >2 kg.292

Neonates 8–28 days of age: AAP recommends 30 mg/kg every 8–12 hours in those weighing ≤2 kg or 30 mg/kg every 6 hours in those weighing >2 kg.292

Pseudomonas infections in neonates ≤28 days of age: AAP states it may be necessary to use doses of 50 mg/kg.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.1 253 287

Children beyond the neonatal period: AAP recommends 90 mg/kg daily given in 3 divided doses for mild to moderate infections or 90–120 mg/kg daily given in 3 or 4 divided doses for severe infections.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

IM

Children >1 month of age: AAP recommends 90 mg/kg daily given in 3 divided doses for mild to moderate infections or 90–120 mg/kg daily given in 3 or 4 divided doses for severe infections.292

Intra-abdominal Infections
IV

90–120 mg/kg daily given in divided doses every 6–8 hours recommended by IDSA.708 Usual duration for complicated infections is 4–7 days, unless it is difficult to achieve adequate source control.708

Cystic Fibrosis Patients with Ps. aeruginosa
Oral Inhalation via Nebulization

Children ≥7 years of age: 75 mg 3 times daily for 28 days.306 Take 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.1 253 287

Severe Systemic or Life-threatening Infections
IV

2 g every 6 or 8 hours.1 253 287

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

1–2 g every 6–8 hours recommended by IDSA.708 Usual duration for complicated infections is 4–7 days, unless it is difficult to achieve adequate source control.708

Urinary Tract Infections (UTIs)
IV or IM

500 mg or 1 g every 8 or 12 hours.1 160 161 162 165 177 186 190 253 287

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 Take 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.1 253 287

Adults

Treatment of Infections
IV or IM

Maximum 8 g daily.1 253 287

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.1 253 287

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 Clcr ≤30 mL/minute: Modify doses and/or frequency of administration based on degree of renal impairment.1 30 33 36 203 227 253 287

Pediatric patients with impaired renal function: Data insufficient to date to make dosage recommendations.1 253 287

Scr 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 Clcr.1 253 287

Adults with Clcr 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.1 253 287

Adults with Clcr <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 36 253 287

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 36 253 276 277 287

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.1 253 287

Monitor renal function;1 253 287 make appropriate dosage adjustments if necessary.1 253 287 (See Renal Impairment under Dosage and Administration.)

Cautions for Azactam

Contraindications

  • Hypersensitivity to aztreonam or any component in the formulation.1 253 287 306

Warnings/Precautions

Warnings

Superinfection/Clostridium difficile-associated Colitis

Possible emergence and overgrowth of nonsusceptible bacteria (e.g., S. aureus, E. faecalis) or fungi.1 253 287 Institute appropriate therapy if superinfection occurs.1 253 287

Treatment with anti-infectives alters normal colon flora and may permit overgrowth of Clostridium difficile.1 253 287 302 303 304 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.1 253 287 302 303 304 C. difficile produces toxins A and B which contribute to the development of CDAD; hypertoxin-producing strains of C. difficile are associated with increased morbidity and mortality since they may be refractory to anti-infectives and colectomy may be required.1 253 287 302 303 304

Consider CDAD if diarrhea develops during or after therapy and manage accordingly.1 253 287 302 303 304 Obtain careful medical history since CDAD may occur as late as 2 months or longer after anti-infective therapy is discontinued.1 253 287 302 303 304

If CDAD is suspected or confirmed, discontinue anti-infectives not directed against C. difficile whenever possible.1 253 287 302 303 304 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.1 253 287 302 303 304

Sensitivity Reactions

Hypersensitivity Reactions

IV or IM: Immediate hypersensitivity reactions, including anaphylaxis,1 253 264 bronchospasm,1 253 264 generalized urticaria with or without palpebral and lingual edema and respiratory impairment,290 295 296 and a severe episode of shock, rash, and eosinophilia,175 reported.1 175 264 Toxic epidermal necrolysis reported rarely.1 253

Oral inhalation via nebulization: Rash reported.306 Allergic reactions with facial rash, facial swelling, and throat tightness also reported.306

Hypersensitivity reactions to aztreonam may occur in patients with or without prior exposure to the drug.1 253 287 306

If hypersensitivity reaction occurs, discontinue aztreonam and initiate appropriate treatment (e.g., vasopressors, antihistamines, corticosteroids, maintenance of ventilation).1 253 287 306 Serious hypersensitivity reactions may require epinephrine and other emergency measures.1 253 287

Cross-Hypersensitivity

Consider possibility that cross-sensitivity to aztreonam may occur in patients with history of hypersensitivity to other β-lactam antibiotics.1 253 287 306

Partial cross-allergenicity occurs among bicyclic β-lactam antibiotics (e.g., penicillins, cephalosporins, cephamycins).151 157 243 248 263 289 Although there appears to be little cross-allergenicity between aztreonam and bicyclic β-lactam antibiotics,1 44 45 46 47 48 151 157 241 243 248 253 264 274 275 287 289 306 316 317 hypersensitivity reactions to aztreonam (e.g., localized or urticarial rash, pharyngeal edema) have occurred rarely when the drug was used in patients with a history of hypersensitivity to penicillins and/or cephalosporins.1 173 192 205 264 290 296 Cross-allergenicity between ceftazidime and aztreonam has been reported in some individuals.320 In studies that included individuals with documented immediate (IgE-mediated) or nonimmediate (T cell-mediated) hypersensitivity to penicillins who had positive skin test reactions to at least 1 penicillin reagent, all individuals had negative skin test reactions to aztreonam and there were no reactions to aztreonam in those individuals willing to receive an IM aztreonam challenge.316 317

Prior to initiation of therapy, make careful inquiry concerning previous hypersensitivity reactions to β-lactam antibiotics, other drugs, or allergens.1 253 264 287 306 Use with caution in patients hypersensitive to β-lactam antibiotics (e.g., penicillins, cephalosporins, cephamycins).1 253 287 306

General Precautions

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.1 253 287

When selecting or modifying anti-infective therapy, use results of culture and in vitro susceptibility testing.1 253 287 In the absence of such data, consider local epidemiology and susceptibility patterns when selecting anti-infectives for empiric therapy.1 253 287

Because aztreonam has little or no activity against gram-positive bacteria and anaerobes, another anti-infective active against such bacteria should be used concomitantly if IV or IM aztreonam used empirically in infections that may involve gram-positive bacteria or anaerobes (e.g., gynecologic, intra-abdominal, or respiratory tract infections).1 171 173 183 211 213 214 253 287

Precautions Related to Oral Inhalation via Nebulization

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

In clinical trials, 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 (See Oral Inhalation via Nebulization under Dosage and Administration.)

Specific Populations

Pregnancy

Category B.1 253 287 306

IV, IM, or oral inhalation via nebulization: No adequate and controlled studies to date in pregnant women.1 253 287 306 Do not use during pregnancy unless clearly needed.1 253 287 306

Crosses placenta in pregnant women and enters fetal circulation.1 253 287 306

Lactation

IV or IM: Low concentrations distributed into milk.1 253 287 Consider temporarily discontinuing breast-feeding during aztreonam therapy.1 253 287

Oral inhalation via nebulization: Manufacturer states unlikely to pose risk to breast-feeding infants since peak plasma concentrations following 75-mg dose by oral inhalation via nebulization are approximately 1% of peak plasma concentrations reported following 500-mg IV dose.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.1 253 287

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.1 253 287

Substantially eliminated by kidneys;1 253 287 risk of toxicity may be greater in patients with impaired renal function.1 253 287 Since geriatric patients are more likely to have renal impairment, monitor renal function and adjust IV or IM dosage if needed.1 253 287

Hepatic Impairment

Monitor hepatic function;1 253 276 277 287 adjustment of IV or IM dosage probably not needed, unless renal function also impaired.32 56 276 (See Hepatic Impairment under Dosage.)

Renal Impairment

Monitor renal function.1 253 287 Adjust IV or IM dosage is adults based on degree of renal impairment.1 253 287 (See Renal Impairment under Dosage.)

Common Adverse Effects

IV or IM: Local reactions at injection site (e.g., phlebitis/thrombophlebitis following IV administration or discomfort/swelling following IM administration);1 253 287 GI effects (diarrhea, nausea, vomiting);1 253 287 hypersensitivity (rash).1 253 287

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

Interactions for Azactam

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 264

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 264

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 264 253

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 264

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

Azactam 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 2 264

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 48 264 Distributed into skeletal muscle,1 21 25 264 266 adipose tissue,1 21 264 266 skin,1 21 264 bone,1 20 25 264 gallbladder,1 21 264 liver,1 21 264 lungs,1 25 208 264 kidneys,1 2 22 264 266 atrial appendage,1 25 264 intestines,1 21 264 prostatic tissue,1 24 48 56 264 myometrium,264 266 endometrium,1 25 264 266 fallopian tubes,1 264 266 ovaries,1 264 and cervical and vaginal tissue.266 Also distributed into saliva,1 2 56 sputum,48 266 bronchial secretions,1 48 208 226 264 aqueous humor,2 6 56 and bile,1 2 7 21 31 48 56 264 and into pericardial,1 25 264 pleural,1 25 208 264 peritoneal,1 2 48 56 212 synovial,1 20 264 and blister fluids.1 2 23 46 48 56 264

IV: Distributed into CSF in adults and pediatric patients;1 2 15 17 18 19 46 48 56 223 264 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 56 264

Plasma Protein Binding

46–60% bound to serum proteins in healthy adults1 2 6 10 14 33 34 48 56 234 264 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

Elimination

Metabolism

Partially metabolized to several microbiologically inactive metabolites;2 6 7 17 33 46 48 56 264 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 56 152 264 presumably via biliary elimination.2 7 23 46 48 56 264

IM or IV: Approximately 58–74% of a dose excreted in urine unchanged,1 2 3 4 6 7 14 23 33 46 48 56 264 1–7% excreted as SQ 26,992 (an inactive metabolite),1 2 6 7 14 23 33 48 56 264 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 56 203 212 264 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 Clcr of 30–80, 10–29, 3–9, or <2 mL/minute, respectively.30

Stability

Storage

Parenteral

Powder for IV or IM Use

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.1 253 264 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.1 253 264 277

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.264 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.264 277

Injection (Frozen) for IV Infusion

-20° C or lower.287 After thawing, may store up to 48 hours at room temperature (25°C) or up to 14 days at 2–8° C.287

Do not refreeze after thawing.287

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

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Parenteral

Solution Compatibility1 253 HID

Compatible

Dextrose 5% in 0.2, 0.45, or 0.9% sodium chloride

Dextrose 5% in Ringer's injection, lactated

Dextrose 5 or 10% in water

Ionosol B with dextrose 5%

Isolyte E

Isolyte B, E, or M with dextrose 5%

Mannitol 5 or 10%

Normosol R

Normosol R or M with dextrose 5%

Plasma-Lyte M with dextrose 5%

Ringer's injection

Ringer's injection, lactated

Sodium chloride 0.9%

Sodium lactate (1/6) M

Drug Compatibility
Admixture CompatibilityHID

Compatible

Ampicillin sodium and sulbactam sodium

Cefazolin sodium

Ciprofloxacin

Clindamycin phosphate

Gentamicin sulfate

Linezolid

Tobramycin sulfate

Incompatible

Metronidazole

Nafcillin sodium

Variable

Ampicillin sodium

Cefoxitin sodium

Vancomycin HCl

Y-Site CompatibilityHID

Compatible

Allopurinol sodium

Amifostine

Amikacin sulfate

Aminophylline

Ampicillin sodium

Ampicillin sodium and sulbactam sodium

Bivalirudin

Bleomycin sulfate

Bumetanide

Buprenorphine HCl

Butorphanol tartrate

Calcium gluconate

Carboplatin

Carmustine

Caspofungin acetate

Cefazolin sodium

Cefotaxime sodium

Cefotetan disodium

Cefoxitin sodium

Ceftazidime

Ceftriaxone sodium

Cefuroxime sodium

Ciprofloxacin

Cisplatin

Clindamycin phosphate

Co-trimoxazole

Cyclophosphamide

Cytarabine

Dacarbazine

Dactinomycin

Daptomycin

Dexamethasone sodium phosphate

Dexmedetomidine HCl

Diltiazem HCl

Diphenhydramine HCl

Dobutamine HCl

Docetaxel

Dopamine HCl

Doxorubicin HCl

Doxorubicin HCl liposomal

Doxycycline hyclate

Droperidol

Enalaprilat

Etoposide

Etoposide phosphate

Famotidine

Fenoldopam mesylate

Filgrastim

Floxuridine

Fluconazole

Fludarabine phosphate

Fluorouracil

Foscarnet sodium

Furosemide

Gallium nitrate

Gemcitabine HCl

Gentamicin sulfate

Granisetron HCl

Haloperidol lactate

Heparin sodium

Hetastarch in lactated electrolyte injection (Hextend)

Hydrocortisone sodium succinate

Hydromorphone HCl

Hydroxyzine HCl

Idarubicin HCl

Ifosfamide

Imipenem and cilastatin sodium

Insulin, regular

Leucovorin calcium

Linezolid

Magnesium sulfate

Mannitol

Mechlorethamine HCl

Melphalan HCl

Meperidine HCl

Mesna

Methotrexate sodium

Methylprednisolone sodium succinate

Metoclopramide HCl

Morphine sulfate

Nalbuphine HCl

Nicardipine HCl

Ondansetron HCl

Pemetrexed disodium

Piperacillin sodium and tazobactam sodium

Potassium chloride

Promethazine HCl

Propofol

Quinupristin/dalfopristin

Ranitidine HCl

Remifentanil HCl

Sargramostim

Sodium bicarbonate

Teniposide

Theophylline

Thiotepa

Ticarcillin disodium and clavulanate potassium

Tigecycline

Tobramycin sulfate

Vinblastine sulfate

Vincristine sulfate

Vinorelbine tartrate

Zidovudine

Incompatible

Acyclovir sodium

Amphotericin B

Amphotericin B cholesteryl sulfate complex

Amsacrine

Azithromycin

Chlorpromazine HCl

Daunorubicin HCl

Ganciclovir sodium

Lansoprazole

Lorazepam

Oritavancin diphosphate

Metronidazole

Mitomycin

Mitoxantrone HCl

Prochlorperazine edisylate

Streptozocin

Variable

Vancomycin HCl

Actions and Spectrum

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).1 253 287

  • Importance of completing full course of therapy, even if feeling better after a few days.1 253 287

  • 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.1 253 287

  • Importance of discontinuing therapy and informing clinician if an allergic reaction occurs.1 253 287

  • Advise patients that diarrhea is a common problem caused by systemic anti-infectives and usually ends when the drug is discontinued.1 253 287 Importance of contacting 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.1 253 287

  • 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

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, and any concomitant illnesses.1 253 287 306

  • Importance of women informing clinician if they are or plan to become pregnant or plan to breast-feed.1 253 287 306

  • Importance of advising patients of other important precautionary information.1 253 287 306 (See Cautions.)

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.

* 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

500 mg*

Aztreonam for Injection

1 g*

Azactam

Squibb

Aztreonam for Injection

2 g*

Azactam

Squibb

Aztreonam for Injection

Aztreonam in Dextrose

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Parenteral

Injection (frozen), for IV infusion

20 mg/mL (1 g) in 3.4% Dextrose

Azactam in Iso-osmotic Dextrose Injection (Galaxy [Baxter])

Squibb

40 mg/mL (2 g) in 1.4% Dextrose

Azactam in Iso-osmotic Dextrose Injection (Galaxy [Baxter])

Squibb

AHFS DI Essentials. © Copyright 2017, Selected Revisions October 7, 2016. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

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

References

1. E. R. Squibb & Sons. Azactam (aztreonam) for injection prescribing information. Princeton, NJ; 2013 Jun.

2. Swabb EA. Review of the clinical pharmacology of the monobactam antibiotic aztreonam. Am J Med. 1985; 78(Suppl 2A):11-8. [IDIS 199811] [PubMed 3881946]

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. [IDIS 171036] [PubMed 6342103]

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. [PubMed 7199041]

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. [IDIS 224826] [PubMed 3105443]

6. Haroche G, Salvanet A, Lafaix CH et al. Pharmacokinetics of aztreonam in the aqueous humour. J Antimicrob Chemother. 1986; 18:195-8. [PubMed 3759730]

7. Swabb EA, Singhvi SM, Leitz MA et al. Metabolism and pharmacokinetics of aztreonam in healthy subjects. Antimicrob Agents Chemother. 1983; 24:394-400. [IDIS 175803] [PubMed 6685455]

8. Swabb EA, Sugerman AA, Stern M. Oral bioavailability of the monobactam aztreonam (SQ 26,776) in healthy subjects. Antimicrob Agents Chemother. 1983; 23:548-50. [IDIS 170007] [PubMed 6683094]

9. Scully BE, Swabb EA, Neu HC. Pharmacology of aztreonam after intravenous infusion. Antimicrob Agents Chemother. 1983; 24:18-22. [IDIS 173439] [PubMed 6684898]

10. Swabb EA, Sugerman AA, McKinstry DN. Multiple-dose pharmacokinetics of the monobactam aztreonam (SQ 26,776) in healthy subjects. Antimicrob Agents Chemother. 1983; 23:125-32. [IDIS 164456] [PubMed 6681947]

11. Mattie H, Matze-van der Lans A. Pharmacokinetics of aztreonam in infected patients. J Antimicrob Chemother. 1986; 17:215-9. [PubMed 3700287]

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14. Creasey WA, Platt TB, Frantz M et al. Pharmacokinetics of aztreonam in elderly male volunteers. Br J Clin Pharmacol. 1985; 19:233-7. [IDIS 198042] [PubMed 4039189]

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16. Lavoie GY, Bergeron MG. Influence of four modes of administration on penetration of aztreonam, cefuroxime, and ampicillin into interstitial fluid and fibrin clots and on in vivo efficacy against Haemophilus influenzae. Antimicrob Agents Chemother. 1985; 28:404-12. [IDIS 205215] [PubMed 3878128]

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18. Greenman RL, Arcey SM, Dickinson GM et al. Penetration of aztreonam into human cerebrospinal fluid in the presence of meningeal inflammation. J Antimicrob Chemother. 1985; 15:637-40. [PubMed 4040132]

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20. MacLeod CM, Bartley EA, Galante JO et al. Aztreonam penetration into synovial fluid and bone. Antimicrob Agents Chemother. 1986; 29:710-2. [IDIS 215032] [PubMed 3707115]

21. Concon RE, Friedhoff LT, Edmiston CE et al. Aztreonam concentration in abdominal tissues and bile. Antimicrob Agents Chemother. 1986; 29:1101-3. [IDIS 216625] [PubMed 3729362]

22. Watson AJ, Stout RL, Whelton A. The intrarenal distribution of aztreonam in healthy and diseased kidneys: clinical therapeutic implications. J Infect Dis. 1984; 150:631-5. [PubMed 6541673]

23. Wise R, Dyas A, Hegarty A et al. Pharmacokinetics and tissue penetration of azthreonam. Antimicrob Agents Chemother. 1982; 22:969-71. [IDIS 161988] [PubMed 6891575]

24. Madsen PO, Dhruv R, Friedhoff LT. Aztreonam concentrations in human prostatic tissue. Antimicrob Agents Chemother. 1984; 26:20-1. [IDIS 187626] [PubMed 6383208]

25. Beam TR, Galask RP, Friedhoff LT et al. Aztreonam concentrations in human tissues obtained during thoracic and gynecologic surgery. Antimicrob Agents Chemother. 1986; 30:505-7. [IDIS 220937] [PubMed 3777914]

26. Swabb EA, Sugerman AA. Review of single- and multiple-dose pharmacokinetics of the monobactam, aztreonam (SQ 26,776) in healthy subjects. Chemotherapy. 1983; 29:313-21. [IDIS 175163] [PubMed 6684541]

27. Fleiss PM, Richwald GA, Gordon J et al. Aztreonam in human serum and breast milk. Br J Clin Pharmacol. 1985; 19:509-11. [IDIS 199563] [PubMed 4039600]

28. Hayashi R, Devlin RG, Frantz M et al. Concentration of aztreonam in body fluids in mid-pregnancy. Clin Pharmacol Ther. 1986; 35:246.

29. Swabb EA, Sugerman AA, Platt TB et al. Single-dose pharmacokinetics of the monobactam azthreonam (SQ 26,776) in healthy subjects. Antimicrob Agents Chemother. 1982; 21:944-9. [IDIS 151720] [PubMed 7202343]

30. Fillastre JP, Leroy A, Baudoin C et al. Pharmacokinetics of aztreonam in patients with chronic renal failure. Clin Pharmacokinet. 1985; 10:91-100. [IDIS 195801] [PubMed 4038635]

31. Martiney OV, Levi JU, Devlin RG. Biliary excretion of aztreonam in patients with biliary tract disease. Antimicrob Agents Chemother. 1984; 25:358-61. [IDIS 183094] [PubMed 6539092]

32. MacLeod CM, Bartley EA, Payne JA et al. Effects of cirrhosis on kinetics of aztreonam. Antimicrob Agents Chemother. 1984; 26:493-7. [IDIS 193523] [PubMed 6542764]

33. Mihindu JC, Scheld WM, Bolton ND et al. Pharmacokinetics of aztreonam in patients with various degrees of renal dysfunction. Antimicrob Agents Chemother. 1983; 24:252-61. [IDIS 174913] [PubMed 6685452]

34. Swabb EA, Sugerman AA, Frantz M et al. Renal handling of the monobactam azthreonam in healthy subjects. Clin Pharmacol Ther. 1983; 33:609-14. [IDIS 170492] [PubMed 6682362]

35. Pilkiewicz FG, Remsburg BJ, Fisher SM et al. High-pressure liquid chromatographic analysis of aztreonam in sera and urine. Antimicrob Agents Chemother. 1983; 23:852-6. [IDIS 172592] [PubMed 6684412]

36. Gerig JS, Bolton ND, Swabb EA et al. Effect of hemodialysis and peritoneal dialysis on aztreonam pharmacokinetics. Kidney Int. 1984; 26:308-18. [PubMed 6542606]

37. Paton TW, Cornish WR, Manuel MA et al. Drug therapy in patients undergoing peritoneal dialysis: clinical pharmacokinetic considerations. Clin Pharmacokinet. 1985; 10:404-26. [IDIS 207151] [PubMed 3899455]

38. Sykes RB, Bonner DP. Aztreonam: the first monobactam. Am J Med. 1985; 78(Suppl 2A):2-10. [IDIS 199810] [PubMed 3871589]

39. Ekstrom B. Basic design of beta-lactam antibiotics: penams and analogues and monocyclic beta-lactams. Scand J Infect Dis. 1984; 42(Suppl):38-49.

40. Neu HC. Trends in the development of beta-lactam antibiotics. Scand J Infect Dis. 1984; 42(Suppl):7-16.

41. Bonner DP, Sykes RB. Structure activity relationships among the monobactams. J Antimicrob Chemother. 1984; 14:313-27. [PubMed 6389473]

42. Breuer H, Cimarusti CM, Denzel T et al. Monobactams—structure-activity relationships leading to SQ 26,776. J Antimicrob Chemother. 1981; 8(Suppl E):21-8. [PubMed 7199044]

43. Parker WL, Cimarusti CM, Floyd DM et al. Monobactams: isolation and structure determination. J Antimicrob Chemother. 1981; 8(Suppl E):17-20. [PubMed 7199043]

44. Sykes RB, Bonner DP, Bush K et al. Monobactams—monocyclic β-lactam antibiotics produced by bacteria. J Antimicrob Chemother. 1981; 8(Suppl E):1-16. [PubMed 6976959]

45. O’sullivan J, Gillum AM, Aklonis CA et al. Biosynthesis of monobactam compounds: origin of the carbon atoms in the β-lactam ring. Antimicrob Agents Chemother. 1982; 21:558-64. [PubMed 6805424]

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48. Brogden RN, Heel RC. Aztreonam: a review of its antibacterial activity, pharmacokinetic properties and therapeutic use. Drugs. 1986; 31:96-130. [IDIS 212455] [PubMed 3512234]

49. Marble DA, Bosso JA, Townsend RJ. Stability of clindamycin phosphate with aztreonam, ceftazidime sodium, ceftriaxone sodium, or piperacillin sodium in two intravenous solutions. Am J Hosp Pharm. 1986; 43:1732-6. [IDIS 218582] [PubMed 3529949]

50. Riley CM, Lipford LC. Interaction of aztreonam with nafcillin intravenous admixtures. Am J Hosp Pharm. 1986; 43:2221-4. [IDIS 220584] [PubMed 3766577]

51. Bell RG, Lipford LC, Massanari MJ et al. Stability of intravenous admixtures of aztreonam and cefoxitin, gentamicin, metronidazole, or tobramycin. Am J Hosp Pharm. 1986; 43:1444-53. [IDIS 216920] [PubMed 3728479]

52. Riley CM, James MJ. Stability of intravenous admixtures containing aztreonam and cefazolin. Am J Hosp Pharm. 1986; 43:925-7. [IDIS 213763] [PubMed 3706339]

53. James MJ, Riley CM. Stability of intravenous admixtures of aztreonam and clindamycin phosphate. Am J Hosp Pharm. 1985; 42:1984-6. [IDIS 205287] [PubMed 4050817]

54. James MJ, Riley CM. Stability of intravenous admixtures of aztreonam and ampicillin. Am J Hosp Pharm. 1985; 42:1095-100. [IDIS 199657] [PubMed 4039889]

55. Barry AL, Thornsberry C, Jones RN et al. Aztreonam: antibacterial activity, β-lactamase stability, and interpretive standards and quality control guidelines for disk-diffusion susceptibility tests. Rev Infect Dis. 1985; 7(Suppl 4):S594-604. [IDIS 209587] [PubMed 3909316]

56. Swabb EA. Clinical pharmacology of aztreonam in healthy recipients and patients: a review. Rev Infect Dis. 1985; 7(Suppl 4):S605-12.

57. Sykes RB, Bonner DP. Discovery and development of the monobactams. Rev Infect Dis. 1985; 7(Suppl 4):S579-93. [IDIS 209586] [PubMed 3909315]

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