pharmacopeia
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/api/v1/drug/aztreonam

Mechanism of action

Sourced from openFDA

Aztreonam is a bactericidal agent that acts by inhibition of bacterial cell wall synthesis. Aztreonam has activity in the presence of some beta-lactamases, both penicillinases and cephalosporinases, of Gram-negative and Gram-positive bacteria.

Indications

Sourced from openFDA
  • To reduce the development of drug-resistant bacteria and maintain the effectiveness of aztreonam for injection, USP and other antibacterial drugs, aztreonam for injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy.

Contraindications

Sourced from openFDA
  • This preparation is contraindicated in patients with known hypersensitivity to aztreonam or any other component in the formulation.contraindicated

Dosage & administration

Sourced from openFDA

Dosage in Adult Patients Aztreonam for injection may be administered intravenously or by intramuscular injection. Dosage and route of administration should be determined by susceptibility of the causative organisms, severity and site of infection, and the condition of the patient. Table 2: Aztreonam for Injection Dosage Guidelines for Adults* * Maximum recommended dose is 8 g per day. Type of Infection Dose Frequency (hours) Urinary tract infections 500 mg or 1 g 8 or 12 Moderately severe systemic infections 1 g or 2 g 8 or 12 Severe systemic or life-threatening infections 2 g 6 or 8 Because of the serious nature of infections due to Pseudomonas aeruginosa , dosage of 2 g every six or eight hours is recommended, at least upon initiation of therapy, in systemic infections caused by this organism. The intravenous route is recommended for patients requiring single doses greater than 1 g or those with bacterial septicemia, localized parenchymal abscess (e.g., intra-abdominal abscess), peritonitis, or other severe systemic or life-threatening infections. The duration of therapy depends on the severity of infection. Generally, aztreonam for injection should be continued for at least 48 hours after the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. Persistent infections may require treatment for several weeks. Doses smaller than those indicated should not be used. Renal Impairment in Adult Patients Prolonged serum levels of aztreonam may occur in patients with transient or persistent renal insufficiency.

Warnings & precautions

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Both animal and human data suggest that aztreonam for injection, USP is rarely cross-reactive with other beta-lactam antibiotics and weakly immunogenic. Treatment with aztreonam can result in hypersensitivity reactions in patients with or without prior exposure. (See CONTRAINDICATIONS . ) Careful inquiry should be made to determine whether the patient has any history of hypersensitivity reactions to any allergens. While cross-reactivity of aztreonam with other beta-lactam antibiotics is rare, this drug should be administered with caution to any patient with a history of hypersensitivity to beta-lactams (e.g., penicillins, cephalosporins, and/or carbapenems). Treatment with aztreonam can result in hypersensitivity reactions in patients with or without prior exposure to aztreonam. If an allergic reaction to aztreonam occurs, discontinue the drug and institute supportive treatment as appropriate (e.g., maintenance of ventilation, pressor amines, antihistamines, corticosteroids). Serious hypersensitivity reactions may require epinephrine and other emergency measures. (See ADVERSE REACTIONS . ) Clostridium difficile- associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including aztreonam for injection, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile . C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin-producing strains of C.

Adverse reactions

Sourced from openFDA

To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Local reactions such as phlebitis/thrombophlebitis following intravenous administration, and discomfort/swelling at the injection site following intramuscular administration occurred at rates of approximately 1.9% and 2.4%, respectively. Systemic reactions (considered to be related to therapy or of uncertain etiology) occurring at an incidence of 1% to 1.3% include diarrhea, nausea and/or vomiting, and rash. Reactions occurring at an incidence of less than 1% are listed within each body system in order of decreasing severity: Hypersensitivity —anaphylaxis, angioedema, bronchospasm Hematologic —pancytopenia, neutropenia, thrombocytopenia, anemia, eosinophilia, leukocytosis, thrombocytosis Gastrointestinal —abdominal cramps; rare cases of C. difficile -associated diarrhea, including pseudomembranous colitis, or gastrointestinal bleeding have been reported. Onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment. (See WARNINGS .

Use in specific populations

Sourced from openFDA

Pregnancy In pregnant women, aztreonam crosses the placenta and enters the fetal circulation. Developmental toxicity studies in pregnant rats and rabbits with daily doses of aztreonam up to 1,800 and 1,200 mg/kg, respectively, revealed no evidence of embryotoxicity or fetotoxicity or teratogenicity. These doses, based on body surface area, are 2.2- and 2.9-fold greater than the MRHD for adults of 8 g per day. A peri/postnatal study in rats revealed no drug-induced changes in any maternal, fetal, or neonatal parameters. The highest dose used in this study, 1,800 mg/kg/day, is 2.2 times the MRHD based on body surface area. There are no adequate and well-controlled studies of aztreonam on human pregnancy outcomes. Because animal reproduction studies are not always predictive of human response, aztreonam should be used during pregnancy only if clearly needed.

Overdosage

Sourced from openFDA

If necessary, aztreonam may be cleared from the serum by hemodialysis and/or peritoneal dialysis.

Approval history

Sourced from openFDA
  • Dec 31, 1986NDANDA050580Labs Delbert
  • Feb 22, 2010NDANDA050814Gilead
  • Jun 18, 2010ANDAANDA065439Fresenius Kabi Usa
  • Nov 8, 2021ANDAANDA206517Hospira
  • Feb 7, 2025NDANDA217906Abbvie

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
7,065 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Infective Pulmonary Exacerbation Of Cystic Fibrosis84612%
  2. 2Dyspnoea4366.2%
  3. 3Hospitalisation3855.4%
  4. 4Off Label Use3665.2%
  5. 5Cough3565.0%
  6. 6Death2984.2%
  7. 7Pneumonia2944.2%
  8. 8Pyrexia2904.1%
  9. 9Cystic Fibrosis2874.1%
  10. 10Infection2483.5%
  11. 11Condition Aggravated2113.0%
  12. 12Rash2052.9%
  13. 13Drug Ineffective1912.7%
  14. 14Haemoptysis1902.7%
  15. 15Eosinophilia1802.5%

Literature

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Recent PubMed references pinned to Aztreonam as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 78 ClinicalTrials.gov registrations naming Aztreonam as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Aztreonam work?
Aztreonam is a bactericidal agent that acts by inhibition of bacterial cell wall synthesis. Aztreonam has activity in the presence of some beta-lactamases, both penicillinases and cephalosporinases, of Gram-negative and Gram-positive bacteria.
What is Aztreonam used for?
According to FDA labeling, Aztreonam carries indications including: To reduce the development of drug-resistant bacteria and maintain the effectiveness of aztreonam for injection, USP and other antibacterial drugs, aztreonam for injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Aztreonam?
Aztreonam is classified as Monobactams, Monobactam Antibacterial, Antibody-Receptor Interactions, Decreased Cell Wall Synthesis & Repair.
What are the brand names for Aztreonam?
Aztreonam is marketed under brand names including Azactam, Cayston, Emblaveo.
What are the contraindications for Aztreonam?
Aztreonam labeling lists contraindications including: This preparation is contraindicated in patients with known hypersensitivity to aztreonam or any other component in the formulation.. Always consult the full prescribing information and a clinician.
Note. Data for aztreonam is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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