FOR US HEALTHCARE PROFESSIONALS

AZACTAM® aztreonam injection

For the treatment of infections caused by susceptible Gram-negative microorganisms

INDICATIONS and USAGE:

Dosing should be determined by susceptibility of the causative organisms, severity and site of infection, and the condition of the patient. AZACTAM (aztreonam injection) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

 

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.

* Efficacy for this organism in this organ system was studied in fewer than 10 infections.

IMPORTANT SAFETY INFORMATION:

Contraindications

AZACTAM (aztreonam injection) is contraindicated in patients with known hypersensitivity to aztreonam or any other component in the formulation.


Warning and Precautions

 

Hypersensitivity reaction(s) in patients with or without prior exposure can occur. 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). If an allergic reaction to aztreonam occurs, discontinue the drug and institute supportive treatment as appropriate (eg, maintenance of ventilation, pressor amines, antihistamines, corticosteroids).

 

Clostridium difficile-associated diarrhea (CDAD) occurs with the use of nearly all antibacterial agents, including AZACTAM, and severity ranges from mild diarrhea to fatal colitis. Antibacterial agent use alters the normal flora of the colon leading to overgrowth of C. difficile. Consider CDAD in all patients presenting with diarrhea following antibiotic use. If CDAD is suspected or confirmed, antibiotic use not directed against
C. difficile may need to be discontinued.

 

Rare cases of toxic epidermal necrolysis have been reported in association with AZACTAM in patients undergoing bone marrow transplant with multiple risk factors.

 

Prescribing AZACTAM in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

 

In patients with impaired hepatic or renal function, appropriate monitoring is recommended during therapy. Specific dosing recommendations for patients with renal insufficiency are in the Dosage and Administration section of the Full Prescribing Information.

 

In patients treated with an aminoglycoside and AZACTAM; monitor for the potential of nephrotoxicity and ototoxicity.

 

The use of antibiotics may promote the overgrowth of nonsusceptible organisms, including Gram-positive organisms (Staphylococcus aureus and Streptococcus faecalis) and fungi. Should superinfection occur during therapy, appropriate measures should be taken.

Adverse Reactions

 

Local reactions (e.g., phlebitis/thrombophlebitis; discomfort/swelling) following IV administration occurred at rates of approximately 1.9%.

 

Systemic reactions occurring at 1 to 1.3% include diarrhea, nausea and/or vomiting and rash.

 

Pediatric Adverse Reactions

 

Comparable systemic reactions were observed in pediatric patients in US clinical trials with rates as follows: rash (4.3%), diarrhea (1.4%), and fever (1.0%).

 

In 343 pediatric patients receiving IV therapy, the following local reactions were noted: pain (12%), erythema (2.9%), induration (0.9%), and phlebitis (2.1%). In the US patient population, pain occurred in 1.5% of patients, while each of the remaining 3 local reactions had an incidence of 0.5%.

 

Laboratory adverse events include increased eosinophils (6.3%), increased platelets (3.6%), neutropenia (3.2%), increased AST (3.8%), increased ALT (6.5%), and increased serum creatinine (5.8%).

 

In US pediatric clinical trials, neutropenia occurred in 11.3% of patients (8/71) younger than 2 years receiving 30 mg/kg every 6 hours. AST and ALT elevations to greater than 3 times the upper limit of normal were noted in 15-20% of patients aged 2 years or above receiving AZACTAM 50 mg/kg every 6 hours.

 

Pediatric Use: The safety and effectiveness of intravenous AZACTAM have been established in the age groups 9 months to 16 years.

 

Pregnancy: AZACTAM should be used during pregnancy only if clearly needed. Aztreonam is excreted in human milk so consideration should be given to temporary discontinuation of nursing and use of formula feedings.

 

Thawing of Plastic Containers: Do Not Force Thaw by Immersion in Water Baths or by Microwave Irradiation; Do Not Add Supplementary Medication; Do Not Refreeze Thawed Antibiotics.

 

Please see the accompanying Full Prescribing Information for
AZACTAM (aztreonam injection)


Please click here for Full Prescribing Information for
AZACTAM in GALAXY Plastic Container.