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
Maxipime Side Effects, and Drug Interactions - Cefepime
Maxipime Side Effects, and Drug Interactions - Cefepime
SIDE EFFECTS
Clinical Trials
In clinical trials
using multiple doses
of cefepime, 4137 patients were treated with the recommended dosages
of cefepime (500 mg to 2
g IV q12h). There were no
deaths or permanent
disabilities thought related to drug toxicity. Sixty-four (1.5%)
patients discontinued medication
due to adverse events thought by the investigators to be possibly,
probably, or almost certainly related to drug
toxicity. Thirty-three (51%) of these 64 patients who discontinued
therapy did so because
of rash. The percentage of cefepime-treated patients who discontinued
study drug because of drug-related
adverse events was very similar at daily doses of 500 mg, 1 g and
2 g q12h (0.8%, 1.1%, and 2.0%, respectively). However, the incidence
of discontinuation due to rash
increased with the higher recommended doses.
The following adverse events were thought to be probably related
to cefepime during evaluation
of the drug in clinical
trials conducted in North America (n=3125 cefepime-treated patients).
TABLE 10
Adverse Clinical Reactions Cefepime Multiple-Dose Dosing
Regimens Clinical Trials— North America
| INCIDENCE EQUAL TO
OR GREATER THAN
1% |
Local reactions (3.0%),
including phlebitis
(1.3%), pain and/or
inflammation (0.6%)*; rash
(1.1%) |
| INCIDENCE
LESS T.A. 1% BUT
GREATER T.A. 0.1%
|
Colitis
(including pseudomembranous colitis), diarrhea,
fever, headache,
nausea, oral moniliasis, pruritus,
urticaria, vaginitis,
vomiting |
*local reactions, irrespective of relationship to cefepime in those
patients who received intravenous
infusion (n=3048).
At the higher dose of
2 g q.h. the incidence
of probably-related adverse events was higher among the 795 patients
who received this dose
of cefepime. They consisted of rash
(4%), diarrhea (3%),
nausea (2%), vomiting
(1%), pruritus (1%), fever
(1%), and headache
(1%).
The following adverse laboratory
changes, irrespective of relationship to therapy
with cefepime, were seen during clinical
trials conducted in North America.
TABLE 11
Adverse Laboratory Changes Cefepime Multiple-Dose Dosing
Regimens Clinical Trials— North America
| INCIDENCE EQUAL TO
OR GREATER THAN
1% |
Positive Coombs’ test
(without hemolysis) (16.2%); decreased phosphorous (2.8%);
increased ALT/ SGPT
(2.8%), AST/SGOT (2.4%), eosinophils (1.7%); abnormal PTT
(1.6%), PT (1.4%) |
| INCIDENCE LESS THAN
1% BUT GREATER THAN
0.1% |
Increased alkaline
phosphatase, BUN, calcium,
creatinine,
phosphorous, potassium, total bilirubin; decreased calcium*,
hematocrit,
neutrophils, platelets, WBC |
*Hypocalcemia was more common among elderly patients. Clinical
consequences from changes in either calcium
or phosphorus were
not reported.
In Postmarketing Experience
In addition to the
events reported during North American clinical
trials with cefepime, the following adverse experiences have been
reported during worldwide postmarketing experience. Because of the
uncontrolled nature of spontaneous
reports, a causal relationship to MAXIPIME (cefepime hydrochloride)
treatment has not been determined.
Encephalopathy, myoclonus,
and seizures have been reported in renally impaired patients treated
with unadjusted dosing regimens of cefepime. Several cephalosporins
have been implicated in triggering seizures, particularly in patients
with renal impairment
when the dosage was
not reduced. (See DOSAGE AND ADMINISTRATION
and OVERDOSAGE.) If seizures
associated with drug
therapy occur, the
drug should be discontinued.
Anticonvulsant therapy
can be given if clinically indicated. Precautions should be taken
to adjust daily dosage
in patients with renal
insufficiency or other conditions that may compromise renal
function to reduce
antibiotic concentrations that can lead
or contribute to these and other serious adverse events, including
renal failure.
As with other cephalosporins, transient
leukopenia, neutropenia,
agranulocytosis and thrombocytopenia
have been reported.
Cephalosporin-class adverse reactions
In addition to the
adverse reactions listed above that have been observed in patients
treated with cefepime, the following adverse reactions and altered
laboratory tests
have been reported for cephalosporin-class antibiotics:
Stevens-Johnson syndrome,
erythema multiforme,
toxic epidermal necrolysis,
renal dysfunction, toxic
nephropathy, aplastic
anemia, hemolytic
anemia, hemorrhage, hepatic
dysfunction including
cholestasis, and
pancytopenia.
DRUG INTERACTIONS
Renal function should
be monitored carefully if high doses of aminoglycosides are to be
administered with MAXIPIME because of the increased potential of
nephrotoxicity and ototoxicity of aminoglycoside
antibiotics. Nephrotoxicity has been reported following concomitant
administration
of other cephalosporins with potent
diuretics such as furosemide.
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