INDICATIONS:
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.
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IMPORTANT SAFETY INFORMATION:
AZACTAM is contraindicated in patients with known hypersensitivity to aztreonam or any other component in the formulation. 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.
Rare cases of toxic epidermal necrolysis have been reported in association with AZACTAM in patients undergoing bone marrow transplant with multiple risk factors.
Phlebitis/thrombophlebitis following IV administration, and discomfort/swelling at injection site following IM administration occurred at rates of approximately 1.9% and 2.4%, respectively. Systemic reactions occurring at 1-1.3% include diarrhea, nausea and/or vomiting and rash. 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. 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 50 mg/kg every 6 hours.
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.
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.
AZACTAM should be used during pregnancy only if clearly needed.