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 Warnings, Precautions, Pregnancy, Nursing, Abuse - Ceftazidime
Ceptaz Warnings, Precautions, Pregnancy, Nursing, Abuse - Ceftazidime
WARNINGS
BEFORE THERAPY WITH C.P.A.
IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO
DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY
REACTIONS TO CEFTAZIDIME,
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 C.P.A.
OCCURS, DISCONTINUE THE DRUG. SERIOUS ACUTE HYPERSENSITIVITY REACTIONS
MAY REQUIRE TREATMENT WITH EPINEPHRINE AND OTHER EMERGENCY MEASURES,
INCLUDING OXYGEN, IV FLUIDS, IV
ANTIHISTAMINES, CORTICOSTEROIDS, PRESSOR AMINES, AND AIRWAY MANAGEMENT,
AS CLINICALLY INDICATED.
Pseudomembranous colitis
has been reported with nearly all antibacterial agents, including
ceftazidime, 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
difficile is one 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.
Elevated levels of ceftazidime in patients with renal
insufficiency can lead
to seizures, encephalopathy,
asterixis, neuromuscular
excitability, and myoclonia
(see PRECAUTIONS
).
PRECAUTIONS
General
High and prolonged serum
ceftazidime concentrations can occur from usual dosages in patients
with transient or
persistent reduction
of urinary output because
of renal insufficiency.
The total daily dosage
should be reduced when ceftazidime is administered to patients with
renal insufficiency
(see DOSAGE AND ADMINISTRATION
). Elevated levels of ceftazidime in these patients can lead
to seizures, encephalopathy, asterixis, neuromuscular
excitability, and myoclonia. Continued dosage should be determined
by degree of renal
impairment, severity
of infection, and susceptibility
of the causative organisms.
As with other antibiotics, prolonged use of C.P.A.
may result in overgrowth of nonsusceptible organisms. Repeated evaluation
of the patient's condition is essential. If superinfection
occurs during therapy,
appropriate measures
should be taken.
Inducible type I beta-lactamase
resistance has been
noted with some organisms (e.g., Enterobacter spp., Pseudomonas
spp., and Serratia spp.). As
with other extended-spectrum beta-lactam antibiotics, resistance
can develop during therapy,
leading to clinical
failure in some cases.
When treating infections caused by these organisms, periodic
susceptibility testing should be performed when clinically appropriate.
If patients fail to respond to monotherapy, an aminoglycoside
or similar agent should
be considered.
Cephalosporins may be associated with a fall
in prothrombin activity.
Those at risk include patients
with renal or hepatic
impairment, or poor
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.
CEPTAZ 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 50 times the recommended
dose. The effect of lower
dosing is not known.
Distal necrosis can
occur after inadvertent intra-arterial
administration of ceftazidime.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term studies in animals have not been performed to evaluate
carcinogenic potential. However, a mouse
Micronucleus test and an
Ames test were both negative
for mutagenic effects.
Pregnancy
Teratogenic Effects: Pregnancy Category B: Reproduction
studies have been performed in mice and rats at doses up to 40 times
the human dose and have
revealed no evidence
of impaired fertility
or harm to the fetus due
to ceftazidime. C.P.A.
at 23 times the human
dose was not teratogenic
or embryotoxic in a rat
reproduction study.
There are, however, no adequate
and well controlled studies 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
Ceftazidime is excreted in human
milk in low concentrations.
It is not known whether the arginine
component of this
product is excreted
in human milk. Because many drugs are excreted in human
milk and because safety
of the arginine component
of C.P.A. in nursing
infants has not been established, a decision should be made whether
to discontinue nursing
or to discontinue the drug,
taking into account the importance of the drug
to the mother.
Pediatric Use
Safety of the arginine
component of C.P.A.
in neonates, infants, and children has not been established. This
product is for use in
patients 12 years and older. If treatment
with ceftazidime is indicated for neonates, infants, or children
a sodium carbonate
formulation should be used.
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