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
Zinacef Side Effects, and Drug Interactions - Cefuroxime
Zinacef Side Effects, and Drug Interactions - Cefuroxime
SIDE EFFECTS
ZINACEF is generally well tolerated. The most common adverse
effects have been local reactions following IV administration. Other adverse
reactions have been encountered only rarely.
Local Reactions
Thrombophlebitis has occurred with IV administration in 1 in
60 patients.
Gastrointestinal
Gastrointestinal symptoms occurred in 1 in 150 patients and
included diarrhea (1 in 220 patients) and nausea (1 in 440 patients). The onset
of pseudomembranous colitis may occur during or after antibacterial treatment
(see WARNINGS).
Hypersensitivity Reactions
Hypersensitivity reactions have been reported in fewer than
1% of the patients treated with ZINACEF and include rash (1 in 125). Pruritus,
urticaria, and positive Coombs' test each occurred in fewer than 1 in 250 patients,
and, as with other cephalosporins, rare cases of anaphylaxis, drug fever, erythema
multiforme, interstitial nephritis, toxic epidermal necrolysis, and Stevens-Johnson
syndrome have occurred.
Blood
A decrease in hemoglobin and hematocrit has been observed in
1 in 10 patients and transient eosinophilia in 1 in 14 patients. Less common
reactions seen were transient neutropenia (fewer than 1 in 100 patients) and
leukopenia (1 in 750 patients). A similar pattern and incidence were seen with
other cephalosporins used in controlled studies. As with other cephalosporins,
there have been rare reports of thrombocytopenia.
Hepatic
Transient rise in SGOT and SGPT (1 in 25 patients), alkaline
phosphatase (1 in 50 patients), LDH (1 in 75 patients), and bilirubin (1 in
500 patients) levels has been noted.
Kidney
Elevations in serum creatinine and/or blood urea nitrogen and
a decreased creatinine clearance have been observed, but their relationship
to cefuroxime is unknown.
Postmarketing Experience with ZINACEF Products
In addition to the adverse events reported during clinical
trials, the following events have been observed during clinical practice in
patients treated with ZINACEF and were reported spontaneously. Data are generally
insufficient to allow an estimate of incidence or to establish causation.
Neurologic: Seizure.
Non-site specific: Angioedema.
Cephalosporin-class Adverse Reactions
In addition to the adverse reactions listed above that have
been observed in patients treated with cefuroxime, the following adverse reactions
and altered laboratory tests have been reported for cephalosporin-class antibiotics:
SIDE EFFECTS
Vomiting, abdominal pain, colitis, vaginitis including vaginal
candidiasis, toxic nephropathy, hepatic dysfunction including cholestasis, aplastic
anemia, hemolytic anemia, hemorrhage.
Several cephalosporins, including ZINACEF, have been implicated
in triggering seizures, particularly in patients with renal impairment when
the dosage was not reduced (see DOSAGE
AND ADMINISTRATION). If seizures associated with drug therapy
should occur, the drug should be discontinued. Anticonvulsant therapy can be
given if clinically indicated.
Altered Laboratory Tests: Prolonged prothrombin
time, pancytopenia, agranulocytosis.
DRUG INTERACTIONS
No specific information available.
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