AZACTAM SUMMARY
AZACTAM® (aztreonam for injection, USP) contains the active ingredient aztreonam, a monobactam. It was originally isolated from
Chromobacterium violaceum. It is a synthetic bactericidal antibiotic.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of AZACTAM® (aztreonam for injection, USP) and other anti-bacterial 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 (aztreonam for injection, USP) is indicated for the treatment of the following infections caused by susceptible gram-negative microorganisms:
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 *.
Lower Respiratory Tract Infections, including pneumonia and bronchitis caused by
Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Haemophilus influenzae, Proteus mirabilis, Enterobacter
species and
Serratia marcescens *.
Septicemia caused by
Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Proteus mirabilis *, Serratia marcescens * and
Enterobacter
species.
Skin 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 *.
Intra-abdominal 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 *.
Gynecologic Infections, including endometritis and pelvic cellulitis caused by
Escherichia coli, Klebsiella pneumoniae *, Enterobacter
species * including
E. cloacae * and
Proteus mirabilis *.
*Efficacy for this organism in this organ system was studied in fewer than ten infections.
AZACTAM 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.
Concurrent initial therapy with other antimicrobial agents and AZACTAM® (aztreonam for injection, USP) 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 (e.g., 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.
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NEWS HIGHLIGHTS
Published Studies Related to Azactam (Aztreonam)
Lack of pharmacokinetic drug interactions following concomitant administration of telavancin with aztreonam or piperacillin/tazobactam in healthy participants. [2009.07]
This randomized crossover study in healthy participants assessed pharmacokinetic interactions between telavancin, aztreonam, and piperacillin/tazobactam... Administration of aztreonam or piperacillin/tazobactam with telavancin had no clinically significant effect on the pharmacokinetic disposition of any of these drugs.
Efficacy and safety of inhaled aztreonam lysine for airway pseudomonas in cystic fibrosis. [2009.05]
BACKGROUND: We assessed the short-term efficacy and safety of aztreonam lysine for inhalation (AZLI [an aerosolized monobactam antibiotic]) in patients with cystic fibrosis (CF) and Pseudomonas aeruginosa (PA) airway infection... CONCLUSIONS: In patients with CF, PA airway infection, moderate-to-severe lung disease, and no recent use of antipseudomonal antibiotics or azithromycin, 28-day treatment with AZLI significantly improved respiratory symptoms and pulmonary function, and was well tolerated. Trial registration: Clinicaltrials.gov Identifier: NCT00112359.
Piperacillin/tazobactam plus ceftazidime versus sulbactam/ampicillin plus aztreonam as empirical therapy for fever in severely neutropenic pediatric patients. [2009.04]
CONCLUSIONS: PIPC/TAZ+CAZ and SBT/ABPC+AZT are effective and safe for initial empirical treatment of febrile episodes in neutropenic pediatric patients. The clinical efficacy of SBT/ABPC+AZT is equivalent or superior to that of PIPC/TAZ+CAZ, the effect of which is already proven against febrile neutropenia. Therefore, SBT/ABPC+AZT may be a treatment of choice for febrile neutropenia in pediatric cancer patients.
Inhaled aztreonam lysine for chronic airway Pseudomonas aeruginosa in cystic fibrosis. [2008.11.01]
RATIONALE: The effectiveness and safety of aztreonam lysine for inhalation (AZLI) in patients with cystic fibrosis (CF) on maintenance treatment for Pseudomonas aeruginosa (PA) airway infection was evaluated in this randomized, double-blind, placebo-controlled study. OBJECTIVES: To evaluate the safety and efficacy of inhaled aztreonam lysine in controlling PA infection in patients with CF... CONCLUSIONS: AZLI was effective in patients with CF using frequent TIS therapy. AZLI delayed time to need for inhaled or intravenous antipseudomonal antibiotics, improved respiratory symptoms and pulmonary function, and was well tolerated. Clinical trial registered with www.clinicaltrials.gov (NCT 00104520).
Cefepime vs. Ampicillin/Sulbactam and Aztreonam as antibiotic prophylaxis in neurosurgical patients with external ventricular drain: result of a prospective randomized controlled clinical trial. [2006.06]
CONCLUSION: Single board spectrum antibiotic prophylaxis with Cefepime was an effective alternative regimen for neurosurgical patients with an EVD in situ.
Clinical Trials Related to Azactam (Aztreonam)
Aztreonam for Inhalation Solution (AZLI) vs Tobramycin Inhalation Solution (TOBI®) in Patients With CF & P. Aeruginosa [Recruiting]
The purpose of this study is to assess the comparative safety and effectiveness of Aztreonam
for Inhalation Solution versus Tobramycin Nebuliser Solution in adult and pediatric patients
with CF and pulmonary Pseudomonas aeruginosa (PA) infection.
Comparative Study of Ceftaroline vs. Vancomycin Plus Aztreonam in Adult Subjects With Complicated Skin Infections [Completed]
The purpose of this study is to determine whether ceftaroline is effective and safe in the
treatment of complicated skin infections in adults.
Aztreonam Lysine for Inhalation in Patients With Cystic Fibrosis, Mild Lung Disease, and P. Aeruginosa [Recruiting]
The primary objective of this study is to assess the safety and efficacy of a 28-day course
of aztreonam lysine for inhalation (AZLI) in patients with cystic fibrosis (CF), mild lung
disease, FEV1 > 75% predicted (forced expiratory volume in one second), and Pseudomonas
aeruginosa (PA).
Expanded Access Program for Aztreonam Lysine for Inhalation in Canadian Patients With Cystic Fibrosis [Available]
This program is to provide expanded access to aztreonam lysine for inhalation (AZLI) prior
to its commercial availability to patients with cystic fibrosis (CF) and chronic P.
aeruginosa airway infection who have limited treatment options and are at risk for disease
progression.
Aztreonam Lysine for Inhalation in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Airway Infection [Available]
The primary objective of this program is to provide expanded access to aztreonam lysine for
inhalation (AZLI) 75 mg prior to its commercial availability to patients with cystic
fibrosis (CF) and chronic P. aeruginosa airway infection who have limited treatment options
and are at risk for disease progression.
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