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
Cefizox Warnings, Precautions, Pregnancy, Nursing, Abuse - Ceftizoxime
Cefizox Warnings, Precautions, Pregnancy, Nursing, Abuse - Ceftizoxime
WARNINGS
BEFORE THERAPYWITH CEFIZOX IS INSTITUTED, CAREFUL INQUIRY SHOULD
BE MADE TO DETERMINE WHETHER
THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO
CEFJZOX, OTHER 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 CEFIZOX OCCURS,
DISCONTINUE THE DRUG. SERIOUS ACUTE HYPERSENSITIVITY REACTIONS MAY
REQUIRE TREATMENT WITH EPINEPHRINE AND OTHER EMERGENCY MEASURES,
INCLUDING OXYGEN, IV FLUIDS, IV
ANTIHISTA MINES, CORTICOSTEROIDS, PRESSOR AMINES, AND AIRWAY MANAGEMENT,
AS CLINICALLY INDICATED.
Pseudomembranous colitis
has been reported with nearly all antibacterial agents, including
ceftizoxime, 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 theadministration of antibacterial agents.
Treatment with antibacterial
agents alters the normal
flora of the colon and
may permit overgrowth
of clostridia. Studies indicate that atoxin produced by Clostridium
difficile is a primary
cause of “ antibiotic-associated
“ colitis.
After the diagnosis
of pseudomembranous colitis
has been established, appropriate 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 all broad-spectrum antibiotics, Cefizox (ceftizoxime for
injection, USP) should be prescribed with caution in individuals
with a history of gastrointestinal
disease, particularly
colitis.
Although Cefizox has not been shown to produce an alteration in
renal function, renal
status should be evaluated,
especially in seriously ill patients receiving
maximum dose therapy. As
with any antibiotic,
prolonged use may result in overgrowth
of nonsusceptible organisms. Careful observation is essential; appropriate
measures should be taken if superinfection
occurs.
Drug Interactions
Althoughthe occurrence has not been reported with Cefizox, nephrotoxicity
has been reported following concomitant
administration
of other cephalosporins and
aminoglycosides.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term studies in animals to evaluate the carcinogenic
potential of ceftizoxime have not been conducted.
In an in vitro bacterial cell
assay (i.e., Ames test),
there was no evidence of
mutagenicity at ceftizoxime concentrations of 0.001-0.5 mcg/plate.
Ceftizoxime did not produce increases in micronuclei in the in vivo
mouse micronucleus test
when given to animals at doses up to 7500 mg/kg, approximately six
times greater than the maximum
human daily dose
on a mg/M 2 basis.
Ceftizoxime had no effect
on fertility when
administered subcutaneously to rats at daily doses of up to 1000
mg/kg/day, approximately two times the maximum
human daily dose
on a mg/M2 basis.
Ceftizoxime produced no histological
changes in the sexual
organs of male and female
dogs when given intravenously for thirteen weeks at a dose
of 1000 mg/kg/day, approximately five times greater than the maximum
human daily dose on a mg/M2
basis.
Pregnancy
Teratogenic Effects: Pregnancy Category B. Reproduction
studies performed in rats and rabbits have revealed no
evidence of impaired
fertility or harm to the fetus
due to Cefizox. There are, however, no
adequate and wellcontrolled studies in pregnant
women. Because animal
reproduction studies are not always predictive of human
effects, this drug should
be used
during pregnancy only
if clearly needed.
Labor and Delivery
Safety of Cefizox use during labor
and delivery has not
been established.
Nursing Mothers
Cefizox is excreted in human
milk in low concentrations.
Caution should be exercised when Cefizox is administered to a nursing
woman.
Pediatric Use
Safety and efficacy
in pediatric patients
from birth to six months
of age have not been established. In
pediatric patients
six months of age and older, treatment
with Cefizox has been associated with transient
elevated levels of eosinophils, AST
(SGOT), ALT (SGPT), and
CPK (creatine phosphokinase).
The CPKelevation may be related to IM administration.
The potential for
the toxic effect
in pediatric patients
from chemicalsthat may leachfrom the single-dose IV
preparation in plastic
has not been determined.
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