CHLORAMPHENICOL SODIUM SUCCINATE 
Pronounciation
Trade Name(s)
- Chloromycetin
For all age levels, determine baseline blood studies before administration. See Monitor and Precautions.
Avoid repeated courses of this drug if at all possible. Treatment should not be continued longer than the time required to produce a cure with little or no risk of relapse of disease.
Adults and pediatric patients with mature metabolic processes (e.g., normal kidney and liver function):
12.5 mg/kg every 6 hours. In exceptional cases, infections due to moderately resistant organisms may require up to 25 mg/kg every 6 hours. Severe infections (e.g., bacteremia or meningitis), especially when adequate cerebrospinal fluid concentrations are desired, may require up to 25 mg/kg every 6 hours. These increased doses must be reduced to 12.5 mg/kg every 6 hours as soon as possible. Maximum dose is 4 Gm/24 hr for all ages. Change to oral form as soon as practical.
NEONATAL DOSE
When kidney or liver function is immature in infants (or seriously impaired in adults), high concentrations of chloromycetin are found and tend to increase with succeeding doses. See Maternal/Child.
Infants under 2 weeks of age or older infants with immature metabolic processes (e.g., premature infants):
6.25 mg/kg every 6 hours. Increased doses demanded by severe infections should be given only to maintain the blood concentration within a therapeutically effective range. Close monitoring of blood concentrations by microtechniques is recommended (information available from manufacturer).
Infants 2 weeks of age or older with mature metabolic processes:
12.5 mg/kg every 6 hours may ordinarily be administered. See comments under Usual Dose.
Another source suggests a loading dose followed by maintenance doses based on age and weight.
20 mg/kg.
Administer the first maintenance dose 12 hours after the loading dose. 7 days of age or younger and over 7 days of age if weight is 2 kg or less: 25 mg/kg of body weight once daily.
Over 7 days of age and over 2 kg:
25 mg/kg every 12 hours.
Reduce dose and/or initiate oral therapy as soon as feasible.
■ Reduce dose and/or extend intervals in infants and children with immature metabolic processes. See specific dose recommendations. Close monitoring of blood concentrations by microtechniques is recommended.
■ In patients with immature or impaired hepatic or renal function, dose reduction may be required.
■ Dosing should be cautious in the elderly. Consider decreased organ function and concomitant disease or drug therapy.
Each 1 Gm should be reconstituted with 10 mL of SWFI or D5W to prepare a 10% solution (100 mg/mL). May be further diluted in 50 to 100 mL of D5W for intermittent infusion. Give through Y-tube, or additive infusion set.
Store at CRT. Administer within 24 hours of preparation.
Compatibility information not available from manufacturer. Other sources suggest specific compatibilities dependent on concentration and manufacturer; consult a pharmacist.
Effective against a wide range of gram-positive and gram-negative bacteria. Primarily bacteriostatic. May be bactericidal at high concentrations or against highly susceptible organisms. Acts by inhibiting protein synthesis. Well distributed in therapeutic doses throughout the body, especially in the liver and kidneys. Lowest concentrations are found in the brain and spinal fluid; however, chloramphenicol enters cerebrospinal fluid even in the absence of meningeal inflammation, appearing in concentrations about half of those found in the blood. Partially metabolized. Excreted in urine, bile, and feces. Crosses the placental barrier. Secreted in breast milk.
Only in serious infections in which potentially less dangerous drugs are ineffective or contraindicated; acute Salmonella typhi infections, meningeal infections (e.g., Haemophilus influenzae), bacteremia, rickettsia, lymphogranuloma psittacosis, and other serious gram-negative infections.
■ Cystic fibrosis regimens.
Serious blood dyscrasias (e.g., aplastic anemia, hypoplastic anemia, thrombocytopenia, and granulocytopenia) resulting in irreversible bone marrow suppression and death are known to occur. Aplastic anemia resulting in leukemia has been reported. Blood dyscrasias have occurred after both short-term and longer-term therapy. Do not use if potentially less dangerous agents would be effective.
■ Administration in a hospital with facilities for monitoring the patient and responding to any medical emergency is preferred.
■ Sensitivity studies mandatory to determine susceptibility of the causative organism not only to chloramphenicol but also to other less dangerous drugs.
■ Superinfection caused by overgrowth of nonsusceptible organisms, including fungi, is possible. Treatment should not be continued longer than required to produce a cure with little or no risk of relapse of the disease.
■ For IV use only.
■ A reversible type of bone marrow suppression characterized by vacuolization of the erythroid cells, reduction of reticulocytes, and leukopenia is dose related and usually responds to withdrawal of chloramphenicol.
■ Clostridium difficile–associated diarrhea (CDAD) has been reported. May range from mild diarrhea to fatal colitis. Consider in patients who present with diarrhea during or after treatment with chloramphenicol.
■ Use caution in patients with impaired hepatic and/or renal function.
Obtain blood studies (CBC) before initiating therapy and approximately every 2 days during therapy; discontinue drug if blood studies show any indication of anemia, leukopenia, reticulocytopenia, thrombocytopenia, or any blood study findings attributable to chloramphenicol.
■ Monitor chloramphenicol serum levels at least weekly, and more often if indicated (e.g., impaired liver or kidney function, immature metabolic processes, suspicion of beginning blood dyscrasias).
■ Therapeutic levels range between 15 and 25 mcg/mL for meningitis; 10 and 20 mcg/mL for other infections. Trough levels should range between 5 and 15 mcg/mL for meningitis; 5 and 10 mcg/mL for other infections.
■ Monitor hepatic and renal function as indicated; see Dose Adjustments.
■ See Drug/Lab Interactions.
Promptly report fever, sore throat, tiredness, unusual bleeding, or bruising.
■ Promptly report diarrhea or bloody stools that occur during treatment or up to several months after an antibiotic has been discontinued; may indicate CDAD and require treatment.
Category C: no studies documented. Use during pregnancy with extreme caution; may have toxic effects on fetus.
■ Discontinue breast-feeding.
■ Blood concentration in all premature and full-term neonates under 2 weeks of age differs from that of other neonates. Use caution, lower doses, and/or extended intervals in premature infants and newborns. May cause gray syndrome (e.g., abdominal distension with or without emesis, progressive pallid cyanosis, vasomotor collapse, irregular respiration, death within a few hours of onset of symptoms); monitor serum levels; see Precautions/Monitor.
See Dose Adjustments.
■ Response similar to that seen in younger patients.
■ Monitor renal function.
May cause irreversible bone marrow suppression. Avoid concurrent therapy with drugs that cause blood dyscrasias (e.g., penicillins, hydantoins [phenytoin]), other bone marrow suppressants (e.g., cytotoxic drugs, radiation therapy).
■ Increases serum levels of oral antidiabetics (e.g., chlorpropamide) and increases hypoglycemic effects; dose reduction may be required.
■ May be synergistic with or antagonize effects of aminoglycosides, cephalosporins, and penicillins. (Is used with ampicillin in pediatric patients.)
■ Chloramphenicol can inhibit specific P450 enzymes; reduced metabolism and increased serum levels may occur in agents also metabolized by that route (e.g., chlorpropamide [Diabinese], phenobarbital, phenytoin, tolbutamide, warfarin).
■ Concurrent use with hydantoins (e.g., phenytoin) may decrease or increase the effectiveness of chloramphenicol. Hydantoin levels may be increased, resulting in toxicity.
■ Concurrent use with phenobarbital may decrease chloramphenicol serum levels and increase phenobarbital serum levels, resulting in phenobarbital toxicity. Monitor serum levels of both drugs if concurrent use is indicated.
■ Concurrent administration with anticoagulants (e.g., heparin, warfarin) may prolong PT.
■ May increase serum iron levels.
■ May delay response to antianemia drugs (e.g., iron preparations, vitamin B12, folic acid). Avoid concurrent use in patients with anemia if possible.
■ Rifampin increases chloramphenicol metabolism and decreases its effects.
Blood dyscrasias (e.g., aplastic anemia, hypoplastic anemia, granulocytopenia, thrombocytopenia) may result in irreversible bone marrow suppression and death. CDAD, confusion, depression, diarrhea, fever, gray syndrome of newborns and infants, headache, hypersensitivity reactions (e.g., angioedema, anaphylaxis, fever, rashes, urticaria), leukemia, nausea, optic and peripheral neuritis, paroxysmal nocturnal hemoglobinuria, pseudomembranous colitis, rashes, stomatitis, vomiting, and many others. May be fatal.
Notify the physician immediately of any adverse symptoms. Discontinue the drug upon appearance of anemia, leukopenia, reticulocytopenia, thrombocytopenia, or any other blood study findings attributable to chloramphenicol. Discontinue the drug for symptoms of optic and peripheral neuritis. Monitoring of plasma levels is imperative in all patients and especially in neonates. Treat hypersensitivity reactions as indicated. Treat CDAD with fluids, electrolytes, protein supplements, and appropriate antibiotics (e.g., oral vancomycin) as indicated. In severe cases, surgical evaluation may be indicated. Resuscitate as necessary.