Class: Antibiotic, Anti-infective agent
Chloromycetin Sodium Succinate
- Powder for Injection 100 mg/mL (as base) when reconstituted
Interferes with or inhibits microbial protein synthesis.
Chloramphenicol is rapidly absorbed and 75% to 90% bioavailable. C max is 11.2 mcg/mL. T max is 1 h. Therapeutic concentrations are 10 to 20 mcg/mL (peak) and 5 to 10 mcg/mL (trough).
Chloramphenicol diffuses rapidly; highest concentrations are found in the liver and kidney and lowest concentrations are found in the brain and CSF. It also is found in pleural and ascitic fluid, saliva, milk, and aqueous and vitreous humors. It crosses the placenta and is about 60% protein bound.
Chloramphenicol or sodium succinate is hydrolyzed to active chloramphenicol base.
68% to 99% is excreted in the urine. 8% to 12% is excreted as free chloramphenicol; the remainder is excreted as inactive metabolites. Small amounts are found in bile and feces. The t ½ is about 1.5 to 4 h.
Special PopulationsRenal Function Impairment
Metabolism and excretion may be reduced. Dosage adjustment is recommended.Hepatic Function Impairment
Metabolism and excretion may be reduced. Dosage adjustment is recommended.
Indications and Usage
Treatment of infections caused by susceptible strains of specific microorganisms; serious systemic infections for which less potentially dangerous drugs are ineffective or contraindicated.
Trivial infections (eg, colds, influenza, throat infections) or infections other than indicated; prophylaxis of systemic bacterial infections; hypersensitivity to product.
Dosage and AdministrationSystemic Infections
IV 50 mg/kg/day in divided doses every 6 h; may require up to 100 mg/kg/day initially for infections caused by moderately resistant organisms.Children
IV 50 mg/kg/day in 4 doses every 6 h; 50 to 100 mg/kg/day for severe infections (eg, bacteremia, meningitis).Infants and Children with immature metabolic processes
IV 25 mg/kg/day.Newborns
IV Usually 25 mg/kg/day in 4 doses every 6 h.Newborns over 14 days (over 2 kg)
IV up to 50 mg/kg/day in 4 doses every 6 h.Newborns under 2 kg and birth to 14 days (over 2 kg)
IV 25 mg/kg every day.
- For IV use only; it is less effective when given via IM route.
- Give direct IV as 10% solution in water for injection or 5% dextrose injection over at least 1 min. Do not administer if cloudy.
Store reconstituted solution below 30°C (86°F). Prior to reconstitution, refrigerate at 2° to 8°C (36° to 46°F). Protect from light. Remove from refrigerator for dispensing; discard after 21 days.
Drug InteractionsAgents that suppress bone marrow
Risk or severity of bone marrow suppression may be increased.Anticoagulants
May enhance anticoagulation action.Barbiturates
May reduce effectiveness of chloramphenicol while barbiturate effects may be enhanced; effects may last days after barbiturates are withdrawn.Ferrous salts
May increase serum iron levels.Hydantoins (eg, phenytoin)
May increase serum hydantoin levels, with possible toxicity; chloramphenicol levels may increase or decrease.Rifampin
May reduce chloramphenicol serum levels; effect may last days after rifampin is withdrawn.Sulfonylureas
May cause clinical manifestations of hypoglycemia.Vitamin B 12
May decrease hematologic effects of vitamin B 12 in patients with pernicious anemia.
Laboratory Test Interactions
None well documented.
Headache; mental confusion; delirium; mild depression; optic neuritis; peripheral neuritis.
Diarrhea; nausea; vomiting; glossitis; stomatitis; enterocolitis.
Bone marrow depression; aplastic anemia; hypoplastic anemia; thrombocytopenia; granulocytopenia.
Hypersensitivity reactions (eg, fever, rash, angioedema, urticaria, anaphylaxis); Gray syndrome.
Probably mutagenic and teratogenic in humans.
Determine baseline CBC and platelet count and monitor every 2 days.Bone marrow syndrome/Gray syndrome
Observe patient daily for signs of bone marrow depression (eg, fatigue, sore throat, bleeding, aplastic anemia, hypoplastic anemia, thrombocytopenia, agranulocytosis) and Gray syndrome in infants.Serum levels
Monitor serum levels of medication weekly. Therapeutic level peak is 10 to 20 mcg/mL; if level is higher, notify health care provider.
Category C .
Excreted in breast milk.
Use drug with caution and in reduced dosages in premature and term infants and children with immature metabolic functions to avoid Gray syndrome toxicity (eg, toxic and potentially fatal reaction in premature infants and newborns). Symptoms of Gray syndrome generally appear in this sequence: abdominal distention with or without emesis; progressive pallid cyanosis; vasomotor collapse, frequently accompanied by irregular respiration; death within a few hours of onset (death occurs in 40% of patients within 2 days of initial symptoms). Other initial symptoms of Gray syndrome may include refusal to suck, loose green stools, flaccidity, ashen gray color, decreased temperature, and refractory lactic acidosis.
Excessive blood levels of drug may occur; dosage adjustment may be required.
Excessive blood levels of drug may occur; dosage adjustment may be required. Preexisting liver dysfunction may be significant risk factor for Gray syndrome.
Special Risk Patients
Use drug with caution in patients with acute intermittent porphyria or G-6-PD deficiency.
Use of antibiotics may result in bacterial or fungal overgrowth.
Serious and fatal blood dyscrasias can occur.
Nausea, vomiting, unpleasant taste, diarrhea, bone marrow suppression.
- Emphasize importance of follow-up examinations because of possible complications from drug that can occur up to months after therapy is completed.
- Instruct patient that bitter taste that occurs after IV administration will subside 2 to 3 min after injection.
- Instruct patient to report these symptoms to health care provider: bleeding, fever, sore throat, itching, nausea, vomiting, diarrhea, bruising, numbness, weakness of hands or feet.
- Advise parents to report these symptoms to health care provider if they occur in infants: failure to feed, abdominal distention, drowsiness, blue or gray skin color, any problems in breathing.
- Instruct patient to report signs of further infection or worsening of current infection to health care provider.