(klor am FEN i kole)
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Reconstituted, Intravenous:
Generic: 1 g (1 ea)
- Antibiotic, Miscellaneous
Reversibly binds to 50S ribosomal subunits of susceptible organisms preventing amino acids from being transferred to growing peptide chains thus inhibiting protein synthesis
To most tissues and body fluids; good CSF and brain penetration
CSF concentration with uninflamed meninges: 21% to 50% of plasma concentration
CSF concentration with inflamed meninges: 45% to 89% of plasma concentration
Vd: Chloramphenicol: 0.5-1 L/kg; Chloramphenicol succinate: 0.2-3.1 L/kg; decreased with hepatic or renal dysfunction
Chloramphenicol: Hepatic to metabolites (inactive); Chloramphenicol succinate: Hydrolyzed in the liver, kidney and lungs to chloramphenicol (active)
Urine (~30% as unchanged chloramphenicol succinate in adults, 6% to 80% in children; 5% to 15% as chloramphenicol)
Neonates: 1-2 days: 24 hours; 10-16 days: 10 hours
Normal renal function:
Chloramphenicol: Infants: Significantly prolonged; Children 4-6 hours; Adults: ~4 hours
Chloramphenicol succinate: Adults: ~3 hours
End-stage renal disease: Chloramphenicol: 3-7 hours
Hepatic disease: Prolonged
Chloramphenicol: ~60%; decreased with hepatic or renal dysfunction and 30% to 40% in newborn infants
Use: Labeled Indications
Treatment of serious infections due to organisms resistant to other less toxic antibiotics or when its penetrability into the site of infection is clinically superior to other antibiotics to which the organism is sensitive; useful in infections caused by Bacteroides, H. influenzae, Neisseria meningitidis, Salmonella, and Rickettsia; active against many vancomycin-resistant enterococci
Hypersensitivity to chloramphenicol or any component of the formulation; treatment of trivial or viral infections; bacterial prophylaxis
Children: Usual dosing range: IV: 50-100 mg/kg/day in divided doses every 6 hours; maximum daily dose: 4 g/day
Meningitis: IV: Infants >30 days and Children: 75-100 mg/kg/day divided every 6 hours
Adults: 50-100 mg/kg/day in divided doses every 6 hours; maximum daily dose: 4 g/day
Dosing adjustment in renal impairment: Use with caution; monitor serum concentrations
Dosing adjustment/comments in hepatic impairment: Use with caution; monitor serum concentrations.
Do not administer IM; can be administered IVP over at least 1 minute at a concentration of 100 mg/mL, or IV intermittent infusion over 15-30 minutes at a final concentration for administration of ≤20 mg/mL.
Hazardous agent; use appropriate precautions for handling and disposal (NIOSH 2014 [group 2]).
May have increased dietary need for riboflavin, pyridoxine, and vitamin B12. Some products may contain sodium.
Stable in dextran 6% in dextrose, dextran 6% in NS, D5LR, D51/4NS, D51/2NS, D5NS, D5W, D10W, fat emulsion 10%, LR, 1/2NS, NS.
Y-site administration: Incompatible with fluconazole.
Compatibility in syringe: Incompatible with glycopyrrolate, metoclopramide.
Store at room temperature prior to reconstitution. Reconstituted solutions remain stable for 30 days. Use only clear solutions. Frozen solutions remain stable for 6 months.
Alcohol (Ethyl): Chloramphenicol may enhance the adverse/toxic effect of Alcohol (Ethyl). Monitor therapy
Barbiturates: Chloramphenicol may decrease the metabolism of Barbiturates. Barbiturates may increase the metabolism of Chloramphenicol. Consider therapy modification
BCG (Intravesical): Antibiotics may diminish the therapeutic effect of BCG (Intravesical). Avoid combination
BCG (Intravesical): Myelosuppressive Agents may diminish the therapeutic effect of BCG (Intravesical). Avoid combination
BCG Vaccine (Immunization): Antibiotics may diminish the therapeutic effect of BCG Vaccine (Immunization). Monitor therapy
Carbocisteine: Chloramphenicol may enhance the adverse/toxic effect of Carbocisteine. Specifically, chloramphenicol may enhance adverse effects of alcohol that is present in liquid formulations of carbocisteine-containing products. Monitor therapy
CefTAZidime: Chloramphenicol may diminish the therapeutic effect of CefTAZidime. Management: Consider using a different combination of antimicrobials, especially if bactericidal activity is desired. If these agents are combined, monitor for reduced antimicrobial effectiveness and/or therapeutic failure. Consider therapy modification
Cilostazol: CYP2C19 Inhibitors may increase the serum concentration of Cilostazol. Management: Consider reducing the cilostazol dose to 50 mg twice daily in patients who are also receiving inhibitors of CYP2C19. Consider therapy modification
Citalopram: CYP2C19 Inhibitors (Strong) may increase the serum concentration of Citalopram. Management: Limit citalopram dose to a maximum of 20 mg/day if used with a strong CYP2C19 inhibitor. Patients using this combination should be monitored closely for evidence of citalopram toxicity (e.g., serotonin syndrome, QT prolongation, etc.). Consider therapy modification
Clopidogrel: CYP2C19 Inhibitors (Strong) may decrease serum concentrations of the active metabolite(s) of Clopidogrel. Management: Due to a risk for impaired clopidogrel effectiveness with such a combination, carefully consider the need for a strong CYP2C19 inhibitor in patients receiving clopidogrel. Monitor patients closely for evidence of a diminished response to clopidogrel. Consider therapy modification
CloZAPine: Myelosuppressive Agents may enhance the adverse/toxic effect of CloZAPine. Specifically, the risk for neutropenia may be increased. Monitor therapy
CycloSPORINE (Systemic): Chloramphenicol may increase the serum concentration of CycloSPORINE (Systemic). Management: Cyclosporine dose reductions will likely be required with initiation of concurrent chloramphenicol. Monitor cyclosporine concentrations and response closely following initiation and/or discontinuation of chloramphenicol. Consider therapy modification
CYP2C19 Substrates: CYP2C19 Inhibitors (Strong) may decrease the metabolism of CYP2C19 Substrates. Consider therapy modification
Deferiprone: Myelosuppressive Agents may enhance the neutropenic effect of Deferiprone. Avoid combination
Dipyrone: May enhance the adverse/toxic effect of Myelosuppressive Agents. Specifically, the risk for agranulocytosis and pancytopenia may be increased Avoid combination
Flibanserin: CYP2C19 Inhibitors (Strong) may increase the serum concentration of Flibanserin. Monitor therapy
Fosphenytoin: May decrease the serum concentration of Chloramphenicol. Fosphenytoin may increase the serum concentration of Chloramphenicol. Chloramphenicol may increase the serum concentration of Fosphenytoin. Monitor therapy
Phenytoin: May decrease the serum concentration of Chloramphenicol. Phenytoin may increase the serum concentration of Chloramphenicol. Chloramphenicol may increase the serum concentration of Phenytoin. Monitor therapy
Rifampin: May increase the metabolism of Chloramphenicol. Consider therapy modification
Sodium Picosulfate: Antibiotics may diminish the therapeutic effect of Sodium Picosulfate. Management: Consider using an alternative product for bowel cleansing prior to a colonoscopy in patients who have recently used or are concurrently using an antibiotic. Consider therapy modification
Sulfonylureas: Chloramphenicol may decrease the metabolism of Sulfonylureas. Monitor therapy
Tacrolimus (Systemic): Chloramphenicol may increase the serum concentration of Tacrolimus (Systemic). Management: Tacrolimus dose reductions will likely be required with initiation of concurrent chloramphenicol. Monitor tacrolimus concentrations and response closely following initiation and/or discontinuation of chloramphenicol. Consider therapy modification
Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Vaccination with live attenuated typhoid vaccine (Ty21a) should be avoided in patients being treated with systemic antibacterial agents. Use of this vaccine should be postponed until at least 3 days after cessation of antibacterial agents. Consider therapy modification
Vitamin B12: Chloramphenicol may diminish the therapeutic effect of Vitamin B12. Monitor therapy
Vitamin K Antagonists (eg, warfarin): Chloramphenicol may enhance the anticoagulant effect of Vitamin K Antagonists. Chloramphenicol may increase the serum concentration of Vitamin K Antagonists. Monitor therapy
Voriconazole: Chloramphenicol may increase the serum concentration of Voriconazole. Monitor therapy
May cause false-positive results in urine glucose tests when using cupric sulfate (Benedict's solution, Clinitest®).
Frequency not defined.
Central nervous system: Confusion, delirium, depression, fever, headache
Dermatologic: Angioedema, rash, urticaria
Gastrointestinal: Diarrhea, enterocolitis, glossitis, nausea, stomatitis, vomiting
Hematologic: Aplastic anemia, bone marrow suppression, granulocytopenia, hypoplastic anemia, pancytopenia, thrombocytopenia
Ocular: Optic neuritis
Miscellaneous: Anaphylaxis, hypersensitivity reactions, Gray syndrome
Concerns related to adverse effects:
• Blood dyscrasias: [U.S. Boxed Warning]: Serious and fatal blood dyscrasias (aplastic anemia, hypoplastic anemia, thrombocytopenia, and granulocytopenia) have occurred after both short-term and prolonged therapy. Monitor CBC frequently in all patients; discontinue if evidence of myelosuppression. Irreversible bone marrow suppression may occur weeks or months after therapy. Avoid repeated courses of treatment. Should not be used for minor infections or when less potentially toxic agents are effective.
• Gray syndrome: Characterized by circulatory collapse, cyanosis, acidosis, abdominal distention, myocardial depression, coma, and death. Reaction appears to be associated with serum levels ≥50 mcg/mL. May result from drug accumulation in patients with impaired hepatic or renal function.
• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C. difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2 months postantibiotic treatment.
• Hepatic impairment: Use with caution in patients with hepatic impairment; reduced dosage recommended.
• Renal impairment: Use with caution in patients with renal impairment
• Glucose 6-phosphate dehydrogenase deficiency: Use with caution in patients with glucose 6-phosphate dehydrogenase deficiency.
• Neonates: Use in neonates (including premature) has resulted in “gray-baby syndrome" characterized by circulatory collapse, cyanosis, acidosis, abdominal distention (with or without emesis), myocardial depression, coma, and death; progression of symptoms is rapid; prompt termination of therapy required. Reaction result from drug accumulation possibly caused by the impaired neonatal hepatic or renal function.
• Hazardous agent: Use appropriate precautions for handling and disposal (NIOSH 2014 [group 2]).
CBC with differential (baseline and every 2 days during therapy), periodic liver and renal function tests, serum drug concentration
Chloramphenicol crosses the placenta producing cord concentrations approaching maternal serum concentrations. An increased risk of teratogenic effects has not been associated with the use of chloramphenicol in pregnancy (Czeizel, 2000; Heinonen, 1977). "Gray Syndrome" has occurred in premature infants and newborns receiving chloramphenicol. The manufacturer recommends caution if used in a pregnant patient near term or during labor. Chloramphenicol may be used for the treatment of Rocky Mountain spotted fever in pregnant women although caution should be used when administration occurs during the third trimester (CDC, 2006).
• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
• Patient may experience headache. Have patient report immediately to prescriber signs of infection, impaired wound healing, severe dizziness, passing out, loss of strength and energy, bruising, bleeding, illogical thinking, mood changes, vision changes, burning or numbness feeling, or signs of Clostridium difficile (C. diff)-associated diarrhea (stomach pain or cramps, very loose or watery stools, or bloody stools) (HCAHPS).
• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.
More about chloramphenicol
- Chloramphenicol (AHFS Monograph)
- Chloramphenicol Sodium Succinate (AHFS Monograph)
- Chloramphenicol Injection (FDA)