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

Systemic reactions (considered to be related to therapy or of uncertain etiology) occurring at an incidence of 1 to 1.3 percent include diarrhea, nausea and/or vomiting, and rash. Reactions occurring at an incidence of less than 1 percent 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; rare cases of C. difficile-associated diarrhea, including pseudomembraneous colitis, or gastrointestinal bleeding have been reported. Onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment. (See WARNINGS)

Dermatologic: toxic epidermal necrolysis (see WARNINGS), 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.

Pediatric Adverse Reactions

Of the 612 pediatric patients who were treated with AZACTAM (aztreonam for injection, USP) in clinical trials, less than 1% required discontinuation of therapy due to adverse events. The following systemic adverse events, regardless of drug relationship, occurred in at least 1% of treated patients in domestic clinical trials: rash (4.3%), diarrhea (1.4%), and fever (1.0%). These adverse events were comparable to those observed in adult clinical trials.

In 343 pediatric patients receiving intravenous 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 three local reactions had an incidence of 0.5%.

The following laboratory adverse events, regardless of drug relationship, occurred in at least 1% of treated patients: 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 (absolute neutrophil count less than 1000/mm³ ) occurred in 11.3% of patients (8/71) younger than 2 years receiving 30 mg/kg q.h. 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 q.h. The increased frequency of these reported laboratory adverse events may be due to either increased severity of illness treated or higher doses of AZACTAM (aztreonam for injection, USP) administered.

Adverse Laboratory Changes

Adverse laboratory changes without regard to drug relationship that were reported during clinical trials were:

Hepatic: elevations of AST (SGOT), ALT (SGPT), and alkaline phosphatase; signs or symptoms of hepatobiliary dysfunction occurred in less than 1 percent of recipients (see above).

Hematologic: increases in prothrombin and partial thromboplastin times, positive Coombs test.

Renal: increases in serum creatinine.

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