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C2,
D,
E,
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Chloromycetin Warnings, Precautions, Pregnancy, Nursing, Abuse - Chloramphenicol
Chloromycetin Warnings, Precautions, Pregnancy, Nursing, Abuse - Chloramphenicol
WARNINGS
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WARNING
Serious and fatal
blood dyscrasias
(aplastic anemia,
hypoplastic anemia, thrombocytopenia and granulocytopenia)
are known to occur after the administration of chioramphenicol.
In addition, there
have been reports of aplastic anemia attributed to chloramphenicol
which later terminated in leukemia. Blood dyscrasias have
occurred after both short term
and prolonged therapy
with this drug. Chioramphenicol must not be used when less
potentially dangerous agents will
be effective, as described in the INDICATIONS
section. It must not be used in the treatment
of trivial infections or where it is not indicated, as in
colds, influenza,
infections of the throat; or as a prophylactic
agent to prevent
bacterial infections.
Precautions: It is essential
that adequate blood
studies be made during treatment
with the drug. While blood
studies may detect early peripheral blood changes, such
as leukopenia,
reticulocytopenia
or granulocytopenia, before they become irreversible, such
studies cannot be relied on to detect bone marrow
depression
prior to development
of aplastic anemia. To facilitate appropriate studies and
observation during therapy,
it is desirable that patients be hospitalized.
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IMPORTANT CONSIDERATIONS IN PRESCRIBING INJECTABLE CHLORAMPHENICOL
SODIUM SUCCINATE:
Chloramphenicol sodium
succinate is intended
for IV use only. It has been
demonstrated to be ineffective when given intramuscularly.
- Chloramphenicol sodium
succinate must be
hydrolyzed to its microbiologically active form
and there is a big lag
in achieving adequate blood
levels compared with the base
given IV.
- The oral form
of chloramphenicol
is readily absorbed and adequate blood levels are achieved and
maintained on the recommended dosage.
- Patients started on IV
chloramphenicol
sodium succinate
should be changed to the oral
form as soon as practicable.
PRECAUTIONS
Baseline blood studies
should be followed by periodic
blood studies approximately
every two days during therapy. The drug
should be discontinued upon appearance
of reticulocytopenia, leukopenia,
thrombocytopenia,
anemia or any other blood
study findings attributable to chloramphenicol. However, it should
be noted that such studies
do not exclude the possible later appearance of the irreversible
type of bone
marrow depression.
Repeated courses of the drug
should be avoided if at all possible. Treatment should not be continued
longer than required to produce a cure
with little or no risk
or relapse of the disease.
Concurrent therapy
with other drugs that may cause
bone marrow
depression should be avoided.
Excessive blood levels
may result from administration
of the recommended dose to patients with impaired liver
or kidney function, including
that due to immature
metabolic processes in the infant. The dosage
should be adjusted accordingly or, preferably, the blood
concentration
should be determined at appropriate
intervals.
There are no studies to
establish the safety of this drug
in pregnancy.
Since chloramphenicol
readily crosses the placental
barrier, caution in use of the drug
is particularly important during pregnancy
at term or during labor
because of potential
toxic effects on the fetus
(gray syndrome).
Precaution should be used in therapy
of premature and full-term
infants to avoid “gray syndrome” toxicity
(see ADVERSE REACTIONS).
Serum drug levels should
be carefully followed during therapy of the newborn
infant.
Precaution should be used in therapy
during lactation because
of the possibility of toxic
effects on the nursing
infant.
The use of this antibiotic,
as with other antibiotics, may result in an overgrowth
of nonsusceptible organisms, including fungi. If infections caused
by nonsusceptible organisms appear during therapy,
appropriate measures
should be taken.
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