Chloramphenicol warnings and precautions

Chloramphenicol
CHLORAMPHENICOL SODIUM SUCCINATE® FDA Package Insert
Description
Clinical Pharmacology
Indications and Usage
Contraindications
Warnings and Precautions
Adverse Reactions
Dosage and Administration
How Supplied
Labels and Packages

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1];Associate Editor(s)-in-Chief: Abdurahman Khalil, M.D. [2]

IMPORTANT CONSIDERATIONS IN PRESCRIBING CHLORAMPHENICOL SODIUM SUCCINATE FOR INJECTION Chloramphenicol sodium succinate for injection is intended for IV use only. It has been demonstrated to be ineffective when given intramuscularly.

• Chloramphenicol sodium succinate for injection 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 for injection 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.

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• In the treatment of typhoid fever some authorities recommended that chloramphenicol be administered at therapeutic levels for 8 to 10 days after the patient has become afebrile to lessen the possibility of relapse.

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

References

http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=aed29594-211d-49ef-813f-131975a8d0e3