Chloramphenicol
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From MedlinePlus, U.S. National Library of Medicine
Boxed warning
Boxed Warning WARNING Serious and fatal blood dyscrasias (aplastic anemia, hypoplastic anemia, thrombocytopenia, and granulocytopenia) are known to occur after the administration of chloramphenicol. 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. Chloramphenicol must not be used when less potentially dangerous agents will be effective, as described in the INDICATIONS AND USAGE 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.
Handling and access
NIOSH hazardous drug
Table 1NIOSH lists chloramphenicol as a hazardous drug. AHFS class: 8:12.08 chloramphenicol.
- Listed in Table 1 because it meets the NIOSH definition of a hazardous drug and is classified as a carcinogen.
- Carcinogen classification: IARC Group 2A carcinogen; NTP “reasonably anticipated to be a human carcinogen”.
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Amphenicol-class Antibacterial
Dosing in kidney impairment
In exceptional cases patients with infections due to moderately resistant organisms may require increased dosage up to 100 mg/kg/day to achieve blood levels inhibiting the pathogen, but these high doses should be decreased as soon as possible. Adults with impairment of hepatic or renal function or both may have reduced ability to metabolize and excrete the drug.
Children with impaired liver or kidney function may retain excessive amounts of the drug. Newborn Infants (See section titled “Gray Syndrome” under ADVERSE REACTIONS.) A total of 25 mg/kg/day in 4 equal doses at 6-hour intervals usually produces and maintains concentrations in blood and tissues adequate to control most infections for which the drug is indicated.
These dosage recommendations are extremely important because blood concentration in all premature and full-term neonates under two weeks of age differs from that of other infants neonates. This difference is due to variations in the maturity of the metabolic functions of the liver and the kidneys. When these functions are immature (or seriously impaired in adults), high concentrations of the drug are found which tend to increase with succeeding doses.
Preparation and administration
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The following method of administration is recommended: Intravenously as a 10% (100 mg/mL) solution to be injected over at least a one-minute interval. This is prepared by the addition of 10 mL of an aqueous diluent such as water for injection or 5% dextrose injection. Adults Adults should receive 50 mg/kg/day in divided doses at 6-hour intervals.
Drug interactions
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- Chloramphenicol
Contraindications
Contraindications Chloramphenicol is contraindicated in individuals with a history of previous hypersensitivity and/or toxic reaction to it. 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.
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
BLikelihood score B: Highly likely cause of clinically apparent liver injury, now rarely seen.
Chloramphenicol is a broad spectrum antibiotic introduced into clinical practice in 1948, but which was subsequently shown to cause serious and fatal aplastic anemia and is now used rarely and reserved for severe, life-threatening infections for which other antibiotics are not available. Chloramphenicol has also been linked to cases of acute, clinically apparent liver injury with jaundice, largely in association with aplastic anemia.
ABCDEA: well known cause; E: unlikely cause. [HD]: high doses only.
Pregnancy and lactation
Pregnancy
pregnancy. Since chloramphenicol readily crosses the placental barrier, caution in use of the drug is particularly imporant during pregnancy at term or during labor because of the 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 non-susceptible organisms, including fungi. If infections caused by non-susceptible organisms appear during therapy, appropriate measures should be taken.
Breastfeeding (LactMed)
Adverse reactions such as vomiting, excessive intestinal gas and falling asleep at the breast have been reported in breastfed infants whose mothers were taking oral chloramphenicol. Milk concentrations are not sufficient to induce "gray baby" syndrome, but since chloramphenicol-induced aplastic anemia is not dose-related, this might occur, but has not been reported. An alternate drug is preferred to chloramphenicol during breastfeeding, especially while nursing a newborn or preterm infant. If the mother must receive chloramphenicol during nursing, monitor the infant for gastrointestinal disturbances and adequacy of nursing. Monitoring of the infant's complete blood count and differential is advisable. In some cases, discontinuation of breastfeeding might be preferred.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
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