Aztreonam (injection)

{{DrugProjectFormSinglePage |authorTag=Alberto Plate [1] |genericName=Aztreonam |aOrAn=a |drugClass=monobactam antibiotic |indicationType=treatment |indication=urinary tract infections (complicated and uncomplicated), lower respiratory tract infections, septicemia, skin and skin-structure infections, intra-abdominal infections and gynecologic infections. AZACTAM 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 |adverseReactions=chest discomfort, abdominal pain, vomiting, alkaline phosphatase raised, ALT/SGPT level raised, AST/SGOT level raised, serum creatinine raised, cough, nasal congestion, Pain in throat, wheezing, fever. |blackBoxWarningTitle=TITLE |blackBoxWarningBody=Condition Name: (Content) |fdaLIADAdult=AZACTAM, an intravenous solution in GALAXY plastic containers (PL 2040), is intended for intravenous use only. Dosage should be determined by susceptibility of the causative organisms, severity and site of infection, and the condition of the patient.

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 (eg, intra-abdominal abscess), peritonitis, or other severe systemic or life-threatening infections.

The duration of therapy depends on the severity of infection. Generally, AZACTAM 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. |offLabelAdultGuideSupport=There is limited information regarding Off-Label Guideline-Supported Use of Aztreonam in adult patients. |offLabelAdultNoGuideSupport=There is limited information regarding Off-Label Non–Guideline-Supported Use of Aztreonam in adult patients. |fdaLIADPed=AZACTAM should be administered intravenously to pediatric patients with normal renal function. There are insufficient data regarding intramuscular administration to pediatric patients or dosing in pediatric patients with renal impairment.

|offLabelPedGuideSupport=There is limited information regarding Off-Label Guideline-Supported Use of Aztreonam in pediatric patients. |offLabelPedNoGuideSupport=There is limited information regarding Off-Label Non–Guideline-Supported Use of Aztreonam in pediatric patients. |contraindications=This preparation is contraindicated in patients with known hypersensitivity to aztreonam or any other component in the formulation. |warnings=Both animal and human data suggest that AZACTAM (aztreonam injection) 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. 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 (eg, 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 (eg, maintenance of ventilation, pressor amines, antihistamines, corticosteroids). Serious hypersensitivity reactions may require epinephrine and other emergency measures.

Clostridium difficile–associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including AZACTAM, 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. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over 2 months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

Rare cases of toxic epidermal necrolysis have been reported in association with aztreonam in patients undergoing bone marrow transplant with multiple risk factors including sepsis, radiation therapy, and other concomitantly administered drugs associated with toxic epidermal necrolysis. |clinicalTrials=Local reactions (eg, phlebitis/thrombophlebitis; discomfort/swelling) following intravenous administration occurred at rates of approximately 1.9%.

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
• CDAD
• Onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment.

Dermatologic

• Toxic epidermal necrolysis
• Purpura
• Erythema multiforme
• Exfoliative dermatitis
• urticaria
• Petechiae
• Pruritus
• Diaphoresis

Cardiovascular

• Hypotension
• Transient ECG changes (ventricular bigeminy and PVC)
• Flushing

Respiratory

• Wheezing
• Dyspnea
• Chest pain

Hepatobiliary

• Hepatitis
• Jaundice

Nervous System

• Seizure
• Confusion
• Vertigo
• Paresthesia
• Insomnia
• Dizziness

Musculoskeletal

• Muscular aches

Special Senses

• Tinnitus,
• Diplopia
• Mouth ulcer
• Altered taste
• Numb tongue
• Sneezing
• Nasal congestion
• Halitosis

Other

• Vaginal candidiasis
• Vaginitis
• Breast tenderness

Body as a Whole

• [[Weakness]
• Headache
• Fever
• Malaise

|alcohol=Alcohol-Aztreonam interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication. }}

Aztreonam
AZACTAM® FDA Package Insert
Description
Clinical Pharmacology
Microbiology
Indications and Usage
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions
Overdosage
Dosage and Administration
How Supplied
Labels and Packages

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [2]; Associate Editor(s)-in-Chief: Chetan Lokhande, M.B.B.S [3]

Overview

Aztreonam' (Azactam®) is a synthetic monocyclic beta-lactam antibiotic (a monobactam) originally isolated from Chromobacterium violaceum. It was approved by the FDA in 1986. It is resistant to some beta-lactamases, but is inactivated by extended-spectrum beta-lactamases.

Category

Monobactam

US Brand Names

AZACTAM^®

FDA Package Insert

Description | Clinical Pharmacology | Microbiology | Indications and Usage | Contraindications | Warnings and Precautions | Adverse Reactions | Drug Interactions | Overdosage | Clinical Studies | Dosage and Administration | How Supplied | Labels and Packages

Mechanism of Action

Aztreonam is similar in action to penicillin. It inhibits mucopeptide synthesis in the bacterial cell wall. It has a very high affinity for penicillin-binding protein 3 (PBP-3) and mild affinity for PBP-1a. Aztreonam binds the penicillin-binding proteins of gram-positive and anaerobic bacteria very poorly and is largely ineffective against them. Aztreonam is bactericidal but less so than some of the cephalosporins.