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US Full Prescribing Information
 
AZACTAM® (aztreonam for injection, USP) delivers proven efficacy in the management of certain Gram-negative infections.1
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AZACTAM is available in single-dose vials for intravenous or intramuscular injection.
  • AZACTAM is available in 15 mL, single-dose-capacity vials,
    • 1 g/vial and 2 g/vial, which should be constituted.
 

AZACTAM, a monobactam, is structurally different from other beta-lactam antibiotics, including penicillins, cephalosporins, and cephamycins.

 

It is indicated for the treatment of the following infections caused by susceptible Gram-negative organisms*:
  • Urinary Tract Infections
  • Lower Respiratory Tract Infections
  • Septicemia
  • Skin and Skin-Structure Infections
  • Intra-abdominal Infections
  • Gynecologic Infections

*Please click the Infections Treated with AZACTAM tab on this page or click Indications for a full description.

IMPORTANT SAFETY INFORMATION FOR AZACTAM® (aztreonam for injection, USP)

CONTRAINDICATIONS

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

WARNINGS 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.

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 renal function for potential nephrotoxicity and ototoxicity of aminoglycosides.

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 such as phlebitis/thrombophlebitis following IV administration and discomfort/swelling at the injection site following intramuscular administration occurred at rates of approximately 1.9% and 2.4%, respectively.

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 (≥1% of treated patients) 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.

SPECIAL POPULATIONS:

Pediatric Use: The safety and effectiveness of intravenous AZACTAM have been established in the age groups 9 months to 16 years. Sufficient data are not available for pediatric patients under 9 months of age or those with septicemia and skin and skin-structure infections (when skin infection is due to H. influenzae type b). Higher doses may be warranted in pediatric cystic fibrosis patients.

Pregnancy/Nursing mothers: AZACTAM should be used during pregnancy only if clearly needed. Aztreonam crosses the placenta and enters the fetal circulation. Aztreonam is excreted in human milk so consideration should be given to temporary discontinuation of nursing and use of formula feedings.

Please see Full Prescribing Information.

Reference: 1. AZACTAM (aztreonam for injection, USP) [package insert]. Princeton, NJ: Bristol-Myers Squibb Company.