A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Azactam Side Effects, and Drug Interactions - Aztreonam
Azactam Side Effects, and Drug Interactions - Aztreonam
SIDE EFFECTS
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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