for injection, USP) contains the active ingredient aztreonam, a monobactam.
It was originally isolated from Chromobacterium violaceum.
It is a synthetic bactericidal antibiotic.
having a unique monocyclic beta-lactam nucleus, are structurally different
from other beta-lactam antibiotics (eg, penicillins, cephalosporins, cephamycins).
The sulfonic acid substituent in the 1-position of the ring activates the
beta-lactam moiety; an aminothiazolyl oxime side chain in the 3-position and
a methyl group in the 4-position confer the specific antibacterial spectrum
and beta-lactamase stability.
To reduce the development of drug-resistant
bacteria and maintain the effectiveness of AZACTAM (aztreonam for injection,
USP) and other antibacterial drugs, AZACTAM 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. In the
absence of such data, local epidemiology and susceptibility patterns may contribute
to the empiric selection of therapy.
AZACTAM is indicated
for the treatment of the following infections caused by susceptible Gram-negative
Urinary Tract Infections (complicated
and uncomplicated), including pyelonephritis and cystitis (initial and recurrent)
caused by Escherichia coli, Klebsiella pneumoniae, Proteus
mirabilis, Pseudomonas aeruginosa, Enterobacter
cloacae, Klebsiella oxytoca *, Citrobacter species*,
and Serratia marcescens *.
Respiratory Tract Infections, including pneumonia and bronchitis caused
by Escherichia coli, Klebsiella pneumoniae, Pseudomonas
aeruginosa, Haemophilus influenzae, Proteus
mirabilis, Enterobacter species, and Serratia
by Escherichia coli, Klebsiella pneumoniae, Pseudomonas
aeruginosa, Proteus mirabilis *, Serratia
marcescens *, and Enterobacter species.
and Skin-Structure Infections, including those associated with postoperative
wounds, ulcers, and burns, caused by Escherichia coli, Proteus
mirabilis, Serratia marcescens, Enterobacter species, Pseudomonas
aeruginosa, Klebsiella pneumoniae, and Citrobacter species*.
Infections, including peritonitis caused by Escherichia coli, Klebsiella species
including K. pneumoniae, Enterobacter species
including E. cloacae *, Pseudomonas aeruginosa, Citrobacter species*
including C. freundii *, and Serratia species*
including S. marcescens *.
Infections, including endometritis and pelvic cellulitis caused by Escherichia
coli, Klebsiella pneumoniae *, Enterobacter species*
including E. cloacae *, and Proteus mirabilis *.
is indicated for adjunctive therapy to surgery in the management of infections
caused by susceptible organisms, including abscesses, infections complicating
hollow viscus perforations, cutaneous infections, and infections of serous
surfaces. AZACTAM is effective against most of the commonly encountered Gram-negative
aerobic pathogens seen in general surgery.
Efficacy for this organism in this organ system was studied in fewer than
Concurrent initial therapy with other
antimicrobial agents and AZACTAM is recommended before the causative organism(s)
is known in seriously ill patients who are also at risk of having an infection
due to Gram-positive aerobic pathogens. If anaerobic organisms are also suspected
as etiologic agents, therapy should be initiated using an anti-anaerobic agent
concurrently with AZACTAM (see
DOSAGE AND ADMINISTRATION).
Certain antibiotics (eg, cefoxitin, imipenem) may induce high levels of beta-lactamase in
vitro in some Gram-negative aerobes such as Enterobacter and Pseudomonas species,
resulting in antagonism to many beta-lactam antibiotics including aztreonam.
These in vitro findings suggest that such beta-lactamase-inducing
antibiotics not be used concurrently with aztreonam. Following identification
and susceptibility testing of the causative organism(s), appropriate antibiotic
therapy should be continued.
Published Studies Related to Azactam (Aztreonam)
Aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis, mild lung impairment, and P. aeruginosa. [2011.07]
BACKGROUND: Previous aztreonam for inhalation solution (AZLI) studies included patients with cystic fibrosis, Pseudomonas aeruginosa (PA) airway infection, and forced expiratory volume in 1s (FEV(1)) 25% to 75% predicted. This double-blind, multicenter, randomized, placebo-controlled trial enrolled patients (>/=6 years) with FEV(1)>75% predicted... CONCLUSIONS: Effects on respiratory symptoms were modest; however, FEV(1) improvements and bacterial density reductions support a possible role for AZLI in these relatively healthy patients. Copyright (c) 2011 European Cystic Fibrosis Society. Published by Elsevier B.V. All rights reserved.
Efficacy and safety of tigecycline monotherapy compared with vancomycin-aztreonam in the treatment of complicated skin and skin structure infections in patients from India and Taiwan. [2011.04]
BACKGROUND: To compare the monotherapy of tigecycline with vancomycin-aztreonam in hospitalized patients from India and Taiwan with complicated skin and skin structure infections (cSSSIs)... CONCLUSIONS: Tigecycline monotherapy is a safe and effective therapy for cSSSIs in geographically distinct populations in Asia. Copyright (c) 2011. Published by Elsevier B.V.
Efficacy and safety of tigecycline monotherapy compared with vancomycin-aztreonam
in the treatment of complicated skin and skin structure infections in patients
from India and Taiwan. 
structure infections (cSSSIs)... CONCLUSIONS: Tigecycline monotherapy is a safe and effective therapy for cSSSIs
An 18-month study of the safety and efficacy of repeated courses of inhaled aztreonam lysine in cystic fibrosis. [2010.11]
Chronic airway infection with Pseudomonas aeruginosa (PA) causes morbidity and mortality in patients with cystic fibrosis (CF)... AZLI is a safe and effective new therapy in patients with CF and PA airway infection.
Integrated analysis of CANVAS 1 and 2: phase 3, multicenter, randomized,
double-blind studies to evaluate the safety and efficacy of ceftaroline versus
vancomycin plus aztreonam in complicated skin and skin-structure infection. 
and modified intent-to-treat (MITT) patient populations... CONCLUSIONS: Ceftaroline achieved high clinical cure rates, was efficacious
Clinical Trials Related to Azactam (Aztreonam)
Aztreonam Lysine for Pseudomonas Infection Eradication Study [Completed]
This is an open-label, multi-center study in pediatric patients age 3 months to less than 18
years with cystic fibrosis (CF) and newly detected Pseudomonas aeruginosa (PA) pulmonary
colonization/infection. All eligible participants will be treated with a 28-day course of
Aztreonam for Inhalation Solution (AZLI) 75 mg 3 times daily. After completion of study
drug, subjects will be followed up through Day 196 for safety and recurrence of PA.
The primary objective is to evaluate the proportion of participants with PA-negative
cultures at all time points during a 6-month monitoring period (through Day 196) after
cessation of AZLI treatment. Microbiological cultures will be obtained at Baseline, Day 28
(end of AZLI treatment), Day 56 (1 month after completing AZLI treatment), Day 112 (3 months
after completing AZLI treatment), and Day 196 (6 months after completing AZLI treatment).
Delafloxacin Versus Vancomycin and Aztreonam for the Treatment of Acute Bacterial Skin and Skin Structure Infections [Completed]
The purpose of this study is to evaluate the effects of Delafloxacin versus Vancomycin plus
Aztreonam in the treatment of patients with complicated bacterial and soft tissue
Aztreonam for Inhalation Solution vs Tobramycin Inhalation Solution in Patients With Cystic Fibrosis & Pseudomonas Aeruginosa [Completed]
The purpose of this study was to assess the comparative safety and effectiveness of
aztreonam for inhalation solution versus tobramycin inhalation solution in adult and
pediatric patients with cystic fibrosis (CF) and pulmonary Pseudomonas aeruginosa (PA)
Safety Study of Aztreonam Lysine for Inhalation (AZLI) in the Treatment of Early Bronchiolitis Obliterans Syndrome (BOS) [Completed]
This study is a pilot two- center study to determine if aztreonam lysine for inhalation AZLI
can be safely and self-administered in lung transplant recipients with newly diagnosed
bronchiolitis obliterans syndrome, grade 1 (BOS) and obtain pilot data regarding its effect
on lung function in order to appropriately design and power a larger multicenter randomized
The hypothesis is that AZLI is a safe and effective treatment for declining lung function in
lung transplant recipients with early stage BOS.
Phase 3 Study of Aztreonam for Inhalation Solution (AZLI) in a Continuous Alternating Therapy Regimen for the Treatment of Chronic Pseudomonas Aeruginosa Infection in Patients With CF [Completed]
This study is to investigate whether using a continuous alternating therapy (CAT) regimen of
2 antibiotics of different classes and with different mechanisms of action may provide the
clinical benefits of reducing acute pulmonary exacerbations, maintaining lung function, and
controlling respiratory symptoms for cystic fibrosis (CF) patients while minimizing the risk
of emergence of antibiotic-resistant Pseudomonas aeruginosa (PA) strains.
After screening, eligible participants will be enrolled into the study and begin a 28-day
run in period of tobramycin inhalation solution (TIS) twice daily. After the run-in,
participants will return to the clinic and be randomized to either the Aztreonam for
Inhalation Solution (AZLI) arm or the placebo arm. The AZLI arm has 3 cycles of AZLI three
times daily for 28 days alternating with TIS twice daily for 28 days. The placebo arm has 3
cycles of placebo three times daily for 28 days alternating with 3 cycles of TIS twice daily
for 28 days. Participants will return to the clinic for evaluation after each cycle of
antibiotics for evaluation. There will be 9 scheduled study visits per participant.
Reports of Suspected Azactam (Aztreonam) Side Effects
Incorrect Route of Drug Administration (1),
Expired Drug Administered (1),
Incorrect Storage of Drug (1),
Medication Error (1),
Injection Site Extravasation (1),
Mental Impairment (1),
Asthenia (1), more >>