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 Warnings, Precautions, Pregnancy, Nursing, Abuse - Cefepime
Maxipime Warnings, Precautions, Pregnancy, Nursing, Abuse - Cefepime
WARNINGS
BEFORE THERAPY WITH MAXIPIME (CEFEPIME HYDROCHLORIDE) FOR INJECTION
IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE
TO DETERMINE WHETHER THE
PATIENT HAS HAD PREVIOUS IMMEDIATE HYPERSENSITIVITY REACTIONS TO
CEFEPIME, CEPHALOSPORINS, PENICILLINS, OR
OTHER DRUGS. IF THIS PRODUCT IS TO
BE GIVEN TO PENICILLIN-SENSITIVE PATIENTS, CAUTION SHOULD BE EXERCISED
BECAUSE CROSS-HYPERSENSITIVITY AMONG BETA-LACTAM ANTIBIOTICS HAS
BEEN CLEARLY DOCUMENTED
AND MAY OCCUR IN UP TO 10%
OF PATIENTS WITH A HISTORY OF PENICILLIN ALLERGY. IF AN ALLERGIC
REACTION TO MAXIPIME OCCURS,
DISCONTINUE THE DRUG. SERIOUS ACUTE HYPERSENSITIVITY REACTIONS MAY
REQUIRE TREATMENT WITH EPINEPHRINE AND OTHER EMERGENCY MEASURES
INCLUDING OXYGEN, CORTICOSTEROIDS, INTRAVENOUS FLUIDS, INTRAVENOUS
ANTIHISTAMINES, PRESSOR AMINES, AND AIRWAY MANAGEMENT, AS
CLINICALLY INDICATED.
Pseudomembranous colitis
has been reported with nearly all antibacterial agents, including
MAXIPIME, and may range
in severity from mild to life-threatening. Therefore, it is important
to consider this diagnosis
in patients who present with diarrhea
subsequent to the administration
of antibacterial
agents.
Treatment with antibacterial
agents alters the normal
flora of the colon and
may permit overgrowth
of clostridia. Studies indicate that a toxin produced by Clostridium
difficileis a primary
cause of "antibiotic-associated
colitis".
After the diagnosis
of pseudomembranous colitis
has been established, therapeutic measures should be initiated.
Mild cases of pseudomembranous colitis usually respond to drug
discontinuation alone. In
moderate-to-severe cases, consideration should be given to management
with fluids and electrolytes, protein supplementation, and treatment
with an antibacterial
drug clinically effective
against Clostridium difficile colitis.
PRECAUTIONS
General
As with other antimicrobials, prolonged use of MAXIPIME may result
in overgrowth of nonsusceptible microorganisms. Repeated evaluation
of the patient’s condition
is essential. Should superinfection
occur during therapy, appropriate measures should be taken.
Many cephalosporins, including cefepime, have been associated with
a fall in prothrombin
activity. Those at risk
include patients with renal or hepatic
impairment, or p.o.
nutritional state, as well as patients receiving a protracted course
of antimicrobial
therapy. Prothrombin time
should be monitored in patients at risk, and exogenous
vitamin K administered
as indicated.
Positive direct Coombs’ tests have been reported during treatment
with MAXIPIME. In hematologic
studies or in transfusion
cross-matching procedures when antiglobulin
tests are performed on the minor
side or in Coombs’ testing
of newborns whose mothers have received cephalosporin
antibiotics before parturition, it should be recognized that a positive
Coombs’ test may be due
to the drug.
MAXIPIME should be prescribed with caution in individuals with
a history of gastrointestinal
disease, particularly
colitis. Arginine has been shown to alter glucose
metabolism and elevate
serum potassium
transiently when administered at 33 times the amount provided by
the maximum recommended
human dose of MAXIPIME.
The effect of lower doses
is not presently known.
In patients with impaired renal
function (creatinine
clearance </=60
mL/min), the dose of MAXIPIME
should be adjusted to compensate for the slower rate
of renal elimination.
Because high and prolonged serum
antibiotic concentrations can occur from usual dosages in patients
with renal insufficiency
or other conditions that may compromise renal
function, the maintenance dosage should be reduced when cefepime
is administered to such
patients. Serious adverse events including encephalopathy,
myoclonus, seizures,
and/or renal failure
have been reported postmarketing in patients with renal
impairment treated with unadjusted doses of cefepime (see ADVERSE
REACTIONS: In Postmarketing Experience and OVERDOSAGE).
Continued dosage should
be determined by degree
of renal impairment,
severity of infection,
and susceptibility
of the causative organisms. (See specific recommendations for dosing
adjustment in DOSAGE
AND ADMINISTRATION.)
Drug/Laboratory Test Interactions
The administration
of cefepime may result in a false-positive
reaction for glucose
in the urine when using
Clinitest® tablets. It is recommended that glucose
tests based on enzymatic glucose
oxidase reactions (such
as Clinistix® or Tes-Tape® ) be used.
Carcinogenesis, Mutagenesis, and Impairment of Fertility
No long-term animal
carcinogenicity studies have been conducted with cefepime. A battery
of in vivo and in vitro genetic toxicity tests, including
the Ames Salmonella
reverse mutation assay,
CHO/HGPRT mammalian cell
forward gene mutation
assay, chromosomal aberration
and sister chromatid
exchange assays in
human lymphocytes, CHO
fibroblast clastogenesis
assay, and cytogenetic and micronucleus
assays in mice were conducted. The overall conclusion of these tests
indicated no definitive
evidence of genotoxic
potential. No untoward effects
on fertility or reproduction
have been observed in rats, mice, and rabbits when cefepime is administered
subcutaneously at 1 to 4 times the recommended maximum
human dose
calculated on a mg/m2 basis.
Usage in Pregnancy
Teratogenic Effects— Pregnancy Category B: Cefepime
was not teratogenic
or embryocidal when
administered during the period
of organogenesis
to rats at doses up to 1000 mg/kg/day (4 times the recommended maximum
human dose
calculated on a mg/m
2 basis) or to mice at doses up to
1200 mg/kg (2 times the recommended maximum
human dose calculated on a mg/m
2 basis) or to rabbits at
a dose level of 100 mg/kg
(approximately equal to the recommended maximum
human dose calculated on
a mg/m
2 basis).
There are, however, no adequate
and well-controlled studies of cefepime use in pregnant
women. Because animal
reproduction studies
are not always predictive of human
response, this drug should
be used during pregnancy only if clearly needed.
Nursing Mothers
Cefepime is excreted in human
breast milk
in very low concentrations [0.5 mcg/mL].
Caution should be exercised when cefepime is administered to a nursing
woman.
Labor and Delivery
Cefepime has not been studied for use during labor
and delivery. Treatment should only be given if clearly indicated.
Pediatric Use
The safety and efficacy
of MAXIPIME (cefepime hydrochloride) in pediatric patients below
the age of 12 years have
not been established. This product is intended for use in patients
12 years of age and older.
Geriatric Use
In clinical studies,
when geriatric patients received the usual recommended adult dose,
clinical efficacy
and safety were comparable to clinical
efficacy and safety in non-geriatric adult
patients. In elderly patients,
dosage and administration
of cefepime should be adjusted in the presence of renal insufficiency.
(See DOSAGE AND ADMINISTRATION.)
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