ADVERSE REACTIONS
Local reactions such as phlebitis/thrombophlebitis
following intravenous administration, and discomfort/swelling at the injection
site following intramuscular administration occurred at rates of approximately
1.9% and 2.4%, respectively.
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; rare cases
of C. difficile–associated diarrhea, including pseudomembranous
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 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 3 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 every 6 hours. AST and ALT elevations
to greater than 3 times the upper limit of normal were noted in 15% to 20%
of patients aged 2 years or above receiving 50 mg/kg every 6 hours. The increased
frequency of these reported laboratory adverse events may be due to either
increased severity of illness treated or higher doses of AZACTAM 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% of recipients (see above).
Hematologic—increases
in prothrombin and partial thromboplastin times, positive Coombs’ test.
Renal—increases in serum creatinine.
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