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
Ceptaz Side Effects, and Drug Interactions - Ceftazidime
Ceptaz Side Effects, and Drug Interactions - Ceftazidime
SIDE EFFECTS
The following adverse effects from clinical
trials were considered to be either related to ceftazidime therapy
or were of uncertain etiology. The most common were local
reactions following IV injection
and allergic and gastrointestinal
reactions. No disulfiramlike
reactions were reported.
Local Effects
Local effects reported in fewer than 2% of patients were phlebitis
and inflammation at the site
of injection (1 in
69 patients).
Hypersensitivity REACTIONS
Hypersensitivity reactions reported in 2% of patients, were pruritus,
rash, and fever. Immediate reactions, generally manifested by rash
and/or pruritus, occurred in 1 in 285 patients. Toxic epidermal
necrolysis, Stevens-Johnson
syndrome, and erythema
multiforme have also been reported with cephalosporin antibiotics,
including ceftazidime. Angioedema and anaphylaxis
(bronchospasm and/or hypotension) have been reported very rarely.
Gastrointestinal Symptoms
Gastrointestinal symptoms reported in fewer than 2% of patients,
were diarrhea (1 in 78), nausea
(1 in 156), vomiting
(1 in 500), and abdominal pain (1 in 416). The onset of pseudomembranous
colitis symptoms may
occur during or after treatment
(see WARNINGS ).
Central Nervous System REACTIONS
Central nervous system
reactions (fewer than 1%) included headache, dizziness, and paresthesia.
Seizures have been reported with several cephalosporins, including
ceftazidime. In addition,
encephalopathy,
asterixis, neuromuscular excitability, and myoclonia
have been reported in renally impaired patients treated with unadjusted
dosage regimens of ceftazidime
(see PRECAUTIONS: General).
Less Frequent Adverse Events
Adverse events (fewer than 1%) were candidiasis
(including oral thrush)
and vaginitis.
Hematologic: Rare cases of hemolytic
anemia have been reported.
Laboratory Test Changes
Laboratory test changes
noted during ceftazidime clinical
trials were transient and included: eosinophilia
(1 in 13), positive
Coombs' test without hemolysis
(1 in 23), thrombocytosis
(1 in 45), and slight elevations in one or more of the hepatic
enzymes, aspartate aminotransferase (AST, SGOT) (1 in 16), alanine
aminotransferase (ALT SGPT) (1 in 15), LDH
(1 in 18), GGT (1 in 19), and alkaline
phosphatase (1 in
23). As with some other cephalosporins,
transient elevations of blood
urea, blood
urea nitrogen, and/or serum
creatinine were observed occasionally. Transient leukopenia,
neutropenia, agranulocytosis,
thrombocytopenia, and lymphocytosis
were seen very rarely.
Observed During Clinical Practice
In addition to the
adverse events reported from clinical
trials, the following events have been identified during post-approval
use of CEPTAZ. Because they are reported voluntarily from a population
of unknown size, estimates of frequency
cannot be made. These events have been chosen for inclusion due
to a combination of their seriousness, frequency
of reporting, or potential
causal connection to CEPTAZ.
General: Anaphylactic or anaphylactoid reactions,
which, in rare instances, were severe (e.g., cardiopulmonary
arrest), including laryngeal edema,
stridor, and urticaria; pain
at injection site.
Hepatobiliary Tract and Pancreas: Hyperbilirubinemia.
Renal and Genitourinary: Renal impairment.
Cephalosporin-Class Adverse REACTIONS
In addition to the
adverse reactions listed above that have been observed in patients
treated with ceftazidime, the following adverse reactions and altered
laboratory tests
have been reported for cephalosporin-class antibiotics:
Adverse Reactions: Colitis, toxic
nephropathy, hepatic
dysfunction including cholestasis,
aplastic anemia, hemorrhage.
Altered Laboratory Tests: Prolonged prothrombin
time, false-positive test
for urinary glucose,
pancytopenia.
DRUG INTERACTIONS
Nephrotoxicity has been reported following concomitant
administration of cephalosporins with aminoglycoside
antibiotics or potent
diuretics such as furosemide. Renal function
should be carefully monitored, especially if higher dosages of the
aminoglycosides are to be administered or if therapy is prolonged,
because of the potential
nephrotoxicity and ototoxicity of aminoglycosidic antibiotics. Nephrotoxicity
and ototoxicity were not noted when ceftazidime was given alone
in clinical trials.
Chloramphenicol has been shown to be antagonistic to beta-lactam
antibiotics, including ceftazidime, based on in vitro studies
and time kill curves with
enteric gram-negative
bacilli. Due to the possibility of antagonism in vivo, particularly
when bactericidal
activity is desired,
this drug combination should be avoided.
Drug/Laboratory Test Interactions
The administration
of ceftazidime may result in a false-positive
reaction for glucose
in the urine when using
CLINITEST ® tablets, Benedict's
solution, or Fehling's
solution. It is recommended that glucose
tests based on enzymatic glucose
oxidase reactions (such
as CLINISTIX ® or TES-TAPE®)
be used.
top
