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
Claforan Warnings, Precautions, Pregnancy, Nursing, Abuse - Cefotaxime
Claforan Warnings, Precautions, Pregnancy, Nursing, Abuse - Cefotaxime
WARNINGS
BEFORE THERAPY WITH CLAFORAN IS INSTITUTED, CAREFUL INQUIRY SHOULD BE
MADE TO DETERMINE WHETHER THE PATIENT
HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO
CEFOTAXIME SODIUM, CEPHALOSPORINS, PENICILLINS, OR OTHER DRUGS. THIS PRODUCT
SHOULD BE GIVEN WITH CAUTION TO
PATIENTS WITH TYPE I HYPERSENSITIVITY REACTIONS TO
PENICILLIN. ANTIBIOTICS SHOULD BE ADMINISTERED WITH CAUTION TO
ANY PATIENT WHO HAS DEMONSTRATED
SOME FORM OF ALLERGY, PARTICULARLY TO
DRUGS. IF AN ALLERGIC REACTION TO
CLAFORAN OCCURS, DISCONTINUE TREATMENT WITH THE DRUG. SERIOUS HYPERSENSITIVITY
REACTIONS MAY REQUIRE EPINEPHRINE AND OTHER EMERGENCY MEASURES.
During post-marketing surveillance, a potentially life-threatening arrhythmia
was reported in each of six patients who received a rapid (less than 60
seconds) bolus injection
of cefotaxime through a central
venous catheter. Therefore,
cefotaxime should only be administered as instructed in the DOSAGE
AND ADMINISTRATION section.
Pseudomembranous colitis
has been reported with nearly all antibacterial agents, including cefotaxime,
and may range from mild to life
threatening. Therefore, it is important to consider its diagnosis
in patients 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 colitis
may respond to drug discontinuance
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.
When the colitis is not relieved
by drug discontinuance or when
it is severe, oral vancomycin is the treatment
of choice for antibiotic-associated pseudomembranous colitis produced
by C. difficile. Other causes of colitis
should also be considered.
PRECAUTIONS
CLAFORAN should be prescribed with caution in individuals with a history
of gastrointestinal
disease, particularly colitis.
Because high and prolonged serum
antibiotic concentrations
can occur from usual doses in patients with transient
or persistent reduction of urinary
output because of renal
insufficiency, the total daily dosage should be reduced when CLAFORAN
is administered to such patients. Continued dosage should be determined
by degree of renal
impairment, severity of
infection, and susceptibility
of the causative organism.
Although there is no clinical
evidence supporting the necessity
of changing the dosage of cefotaxime
sodium in patients with even
profound renal dysfunction,
it is suggested that, until further data are obtained, the dose
of cefotaxime sodium be halved
in patients with estimated creatinine
clearances of less than 20 mL/min/1.73 m2.
When only serum creatinine
is available, the following formula2 (based on sex,
weight, and age of the patient)
may be used to convert this value into creatinine
clearance. The serum creatinine
should represent a steady state
of renal function.
| |
Weight (kg) x (140 - age) |
| Males: |
72 x serum
creatinine |
| Females: |
0.85 x above value |
As with other antibiotics, prolonged use of CLAFORAN 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.
As with other beta-lactam antibiotics, granulocytopenia and, more rarely,
agranulocytosis may
develop during treatment
with CLAFORAN, particularly if given over long periods. For courses of
treatment lasting longer
than 10 days, blood counts should
therefore be monitored.
CLAFORAN, like other parenteral
anti-infective drugs, may be locally irritating to tissues. In
most cases, perivascular extravasation of CLAFORAN responds to changing
of the infusion site. In
rare instances, extensive perivascular
extravasation of CLAFORAN
may result in tissue damage
and require surgical treatment.
To minimize the potential for tissue
inflammation, infusion
sites should be monitored regularly and changed when appropriate.
Drug Interactions
Increased nephrotoxicity has been reported following concomitant administration
of cephalosporins and aminoglycoside
antibiotics.
Carcinogenesis, Mutagenesis
Long-term studies in animals have not been performed to evaluate carcinogenic
potential. Mutagenic tests included a micronucleus
and an Ames test. Both tests were negative
for mutagenic effects.
Pregnancy
Pregnancy (Category B): Reproduction studies
have been performed in mice and rats at doses up to 30 times the usual
human dose
and have revealed no evidence
of impaired fertility or
harm to the fetus because of
cefotaxime sodium. However, there are no
well-controlled studies in pregnant women. Because animal
reproductive studies
are not always predictive of human
response, this drug should be
used during pregnancy only
if clearly needed.
Nonteratogenic Effects: Use of the drug
in women of child-bearing potential requires that the anticipated benefit
be weighed against the possible risks.
In perinatal and postnatal
studies with rats, the pigs in the group
given 1200 mg/kg of CLAFORAN were significantly lighter in weight
at birth and remained smaller
than pigs in the control group
during the 21 days of nursing.
Nursing Mothers
CLAFORAN is excreted in human
milk in low concentrations. Caution
should be exercised when CLAFORAN is administered to a nursing woman.
Pediatric Use
See Precautions above regarding perivascular
extravasation. The potential
for toxic effects in pediatric
patients from chemicals that may leach from the plastic
in single dose Galaxy® containers
(premixed CLAFORAN Injection) has not been determined.
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