Azactam (Aztreonam) - Summary

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 *.

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)

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. [2011]
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. [2010]
and modified intent-to-treat (MITT) patient populations... CONCLUSIONS: Ceftaroline achieved high clinical cure rates, was efficacious

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Clinical Trials Related to Azactam (Aztreonam)

Aztreonam Lysine for Pseudomonas Infection Eradication Study [Recruiting]
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 subjects will begin a 28-day course of AZLI 75 mg 3 times daily (TID). After completion of study drug, subjects will be followed up through Day 196 for safety and recurrence of PA.

Safety Study of Aztreonam Lysine for Inhalation (AZLI) in the Treatment of Early Bronchiolitis Obliterans Syndrome (BOS) [Not yet recruiting]
This study is a pilot two- center study to determine if aztreonam lysine for inhalation AZLI can be safely and continuously administered over 4 month period in lung transplant recipients with bronchiolitis obliterans syndrome (BOS) and obtain pilot data regarding its effect on lung function in order to appropriately design and power a larger multicenter randomized study.

The hypothesis is that AZLI is a safe and effective treatment for declining lung function in lung transplant recipients with early stage BOS.

Evaluation of Ceftaroline Fosamil Versus Vancomycin Plus Aztreonam in the Treatment of Patients With Skin Infections [Recruiting]
The purpose of this study is to evaluate the effects of Ceftaroline Fosamil versus Vancomycin plus Aztreonam in treatment of patients with complicated bacterial skin and soft tissue infections.

To Investigate the Safety and Tolerability of Aztreonam-Avibactam (ATM-AVI) [Recruiting]
This is a randomised, double-blind, 3-part study designed to investigate the safety and tolerability of ATM-AVI. The study aims to characterise the pharmacokinetics of ATM-AVI, when both drugs are administered alone (ATM or AVI) and in combination (ATM-AVI), following single administration, and following multiple administrations of ATM-AVI in healthy male and female (females of nonchildbearing potential) volunteers both young and elderly.

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 [Recruiting]
Using a Continuous Alternating Therapy (CAT)regimen of 2 antibiotics of different classes with different mechanisms of action may provide the clinical benefits of reducing acute exacerbations, maintaining lung function and controlling respiratory symptoms for CF patients while minimizing the risk of emergence of antibiotic-resistant Pseudomonas aeruginosa (PA) strains.

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Reports of Suspected Azactam (Aztreonam) Side Effects

Death (3),  Incorrect Route of Drug Administration (1),  Pruritus (1),  Expired Drug Administered (1),  Incorrect Storage of Drug (1),  Medication Error (1),  Injection Site Extravasation (1),  Lethargy (1),  Mental Impairment (1),  Asthenia (1), more >>