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Chloramphenicol information from DrugsUpdate  

See Available Brands of Chloramphenicol in India

P - Contraindicated in pregnancy
L - Contraindicated in lactation

Chloramphenicol is a bacteriostatic antimicrobial. It is considered a prototypical broad-spectrum antibiotic, alongside the tetracyclines.

Chloramphenicol is effective against a wide variety of Gram-positive and Gram-negative bacteria, including most anaerobic organisms. Due to resistance and safety concerns, it is no longer a first-line agent for any indication in developed nations, although it is sometimes used topically for eye infections; nevertheless, the global problem of advancing bacterial resistance to newer drugs has led to renewed interest in its use. In low-income countries, chloramphenicol is still widely used because it is exceedingly inexpensive and readily available.

The most serious adverse effect associated with chloramphenicol treatment is bone marrow toxicity, which may occur in two distinct forms: bone marrow suppression, which is a direct toxic effect of the drug and is usually reversible, and aplastic anemia, which is idiosyncratic (rare, unpredictable, and unrelated to dose) and generally fatal.

Pharmacodynamics

Interferes with or inhibits microbial protein synthesis

Pharmacokinetics

Chloramphenicol inhibits bacterial protein synthesis by binding to 50s subunit of the bacterial ribosome, thus preventing peptide bond formation by peptidyl transferase. It has both bacteriostatic and bactericidal action against H. influenzae, N. meningitidis and S. pneumoniae.

Duration
Typhoid: 8-10 days; meningitis: 7-10 days; brain abscess: Up to 4 weeks

Absorption
Readily absorbed with peak plasma concentrations after 1 or 2 hours (oral)

Distribution
Distributed widely into tissues and fluids, CSF (up to 50% even in the absence of meningitis), eye (aqueous and vitreous humours); crosses the placenta and enters the breast milk. Protein-binding: 60%.

Metabolism
Hydrolysed to the free drug in the GI tract (palmitate); liver by conjugation with glucuronic acid,lungs and kidneys after parenteral admin (sodium succinate).

Excretion

Via the urine (30% as unchanged before hydrolysis, 5-10% of an oral dose), via the bile (3%), via the faeces (1% as inactive form); 1.5-4 hours (elimination half-life).

Chloramphenicol Indications / Chloramphenicol Uses

Information Not Available

Chloramphenicol Adverse Reactions / Chloramphenicol Side Effects

GI symptoms; bleeding; peripheral and optic neuritis, visual impairment, blindness; encephalopathy, confusion, delirium, mental depression, headache. Haemolysis in patients with G6PD deficiency. ophthalmic application: Hypersensitivity reactions including rashes, fever and angioedema. Ear drops: Ototoxicity.

Potentially Fatal: Bone marrow suppression and irreversible aplastic anaemia. Neutropenia, thrombocytopenia. Grey baby syndrome. Rarely, anaphylaxis.

Precautions

Probably mutagenic and teratogenic in humans.

Monitor
CBC/Platelet count
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, its should be notified.

Special Precautions

Impaired renal or hepatic function; premature and full-term neonates. Monitor plasma concentrations to avoid toxicity.

Other Drug Interactions

Decreased effects of iron  and vitamin B12 in anaemic patients. Phenobarbitone  and rifampin  reduce efficacy of chloramphenicol. Impairs the action of oral contraceptives.

Potentially Fatal: Increases the effect of oral anticoagulants, oral hypoglycaemic agents, phenytoin. Avoid concomitant administration with drugs that depress bone marrow function.

Other Interactions

Information Not Available

Dosage

Oral
Bacterial meningitis
Adult: 50 mg/kg/day in 4 divided doses increased to 100 mg/kg/day for meningitis or severe infections due to moderately resistant organisms. Continue treatment after the patient's temperature has normalised for a further 4 days in rickettsial disease and 8-10 days in typhoid fever.
Child: Premature and full-term neonates: 25 mg/kg/day in 4 divided doses. Full-term infants >2 weeks: 50 mg/kg/day in 4 divided doses. Children: 50 mg/kg/day in 4 divided doses increased to 100 mg/kg/day for meningitis or severe infections.
Elderly:
Renal impairment: Dose reduction may be required.
Hepatic impairment: Dose reduction may be required.

Oral
Whipple's Disease
Adult: 50 mg/kg/day in 4 divided doses increased to 100 mg/kg/day for meningitis or severe infections due to moderately resistant organisms. Continue treatment after the patient's temperature has normalised for a further 4 days in rickettsial disease and 8-10 days in typhoid fever.
Child: Premature and full-term neonates: 25 mg/kg/day in 4 divided doses. Full-term infants >2 weeks: 50 mg/kg/day in 4 divided doses. Children: 50 mg/kg/day in 4 divided doses increased to 100 mg/kg/day for meningitis or severe infections.
Elderly:
Renal impairment: Dose reduction may be required.
Hepatic impairment: Dose reduction may be required.

Oral
Severe systemic infections with Camphylobacter fetus
Adult: 50 mg/kg/day in 4 divided doses increased to 100 mg/kg/day for meningitis or severe infections due to moderately resistant organisms. Continue treatment after the patient's temperature has normalised for a further 4 days in rickettsial disease and 8-10 days in typhoid fever.
Child: Premature and full-term neonates: 25 mg/kg/day in 4 divided doses. Full-term infants >2 weeks: 50 mg/kg/day in 4 divided doses. Children: 50 mg/kg/day in 4 divided doses increased to 100 mg/kg/day for meningitis or severe infections.
Elderly:
Renal impairment: Dose reduction may be required.
Hepatic impairment: Dose reduction may be required.

Oral
Infections caused by H. influenzae
Adult: 50 mg/kg/day in 4 divided doses increased to 100 mg/kg/day for meningitis or severe infections due to moderately resistant organisms. Continue treatment after the patient's temperature has normalised for a further 4 days in rickettsial disease and 8-10 days in typhoid fever.
Child: Premature and full-term neonates: 25 mg/kg/day in 4 divided doses. Full-term infants >2 weeks: 50 mg/kg/day in 4 divided doses. Children: 50 mg/kg/day in 4 divided doses increased to 100 mg/kg/day for meningitis or severe infections.
Elderly:
Renal impairment: Dose reduction may be required.
Hepatic impairment: Dose reduction may be required.

Oral
Ehrlichiosis
Adult: 50 mg/kg/day in 4 divided doses increased to 100 mg/kg/day for meningitis or severe infections due to moderately resistant organisms. Continue treatment after the patient's temperature has normalised for a further 4 days in rickettsial disease and 8-10 days in typhoid fever.
Child: Premature and full-term neonates: 25 mg/kg/day in 4 divided doses. Full-term infants >2 weeks: 50 mg/kg/day in 4 divided doses. Children: 50 mg/kg/day in 4 divided doses increased to 100 mg/kg/day for meningitis or severe infections.
Elderly:
Renal impairment: Dose reduction may be required.
Hepatic impairment: Dose reduction may be required.

Oral
Severe gastroenteritis
Adult: 50 mg/kg/day in 4 divided doses increased to 100 mg/kg/day for meningitis or severe infections due to moderately resistant organisms. Continue treatment after the patient's temperature has normalised for a further 4 days in rickettsial disease and 8-10 days in typhoid fever.
Child: Premature and full-term neonates: 25 mg/kg/day in 4 divided doses. Full-term infants >2 weeks: 50 mg/kg/day in 4 divided doses. Children: 50 mg/kg/day in 4 divided doses increased to 100 mg/kg/day for meningitis or severe infections.
Elderly:
Renal impairment: Dose reduction may be required.
Hepatic impairment: Dose reduction may be required.

Oral
Severe melioidosis
Adult: 50 mg/kg/day in 4 divided doses increased to 100 mg/kg/day for meningitis or severe infections due to moderately resistant organisms. Continue treatment after the patient's temperature has normalised for a further 4 days in rickettsial disease and 8-10 days in typhoid fever.
Child: Premature and full-term neonates: 25 mg/kg/day in 4 divided doses. Full-term infants >2 weeks: 50 mg/kg/day in 4 divided doses. Children: 50 mg/kg/day in 4 divided doses increased to 100 mg/kg/day for meningitis or severe infections.
Elderly:
Renal impairment: Dose reduction may be required.
Hepatic impairment: Dose reduction may be required.

Oral
Plague
Adult: 50 mg/kg/day in 4 divided doses increased to 100 mg/kg/day for meningitis or severe infections due to moderately resistant organisms. Continue treatment after the patient's temperature has normalised for a further 4 days in rickettsial disease and 8-10 days in typhoid fever.
Child: Premature and full-term neonates: 25 mg/kg/day in 4 divided doses. Full-term infants >2 weeks: 50 mg/kg/day in 4 divided doses. Children: 50 mg/kg/day in 4 divided doses increased to 100 mg/kg/day for meningitis or severe infections.
Elderly:
Renal impairment: Dose reduction may be required.
Hepatic impairment: Dose reduction may be required.

Oral
Granuloma inguinale
Adult: 50 mg/kg/day in 4 divided doses increased to 100 mg/kg/day for meningitis or severe infections due to moderately resistant organisms. Continue treatment after the patient's temperature has normalised for a further 4 days in rickettsial disease and 8-10 days in typhoid fever.
Child: Premature and full-term neonates: 25 mg/kg/day in 4 divided doses. Full-term infants >2 weeks: 50 mg/kg/day in 4 divided doses. Children: 50 mg/kg/day in 4 divided doses increased to 100 mg/kg/day for meningitis or severe infections.
Elderly:
Renal impairment: Dose reduction may be required.
Hepatic impairment: Dose reduction may be required.

Oral
Brain abscess
Adult: 50 mg/kg/day in 4 divided doses increased to 100 mg/kg/day for meningitis or severe infections due to moderately resistant organisms. Continue treatment after the patient's temperature has normalised for a further 4 days in rickettsial disease and 8-10 days in typhoid fever.
Child: Premature and full-term neonates: 25 mg/kg/day in 4 divided doses. Full-term infants >2 weeks: 50 mg/kg/day in 4 divided doses. Children: 50 mg/kg/day in 4 divided doses increased to 100 mg/kg/day for meningitis or severe infections.
Elderly:
Renal impairment: Dose reduction may be required.
Hepatic impairment: Dose reduction may be required.

Oral
Anthrax
Adult: 50 mg/kg/day in 4 divided doses increased to 100 mg/kg/day for meningitis or severe infections due to moderately resistant organisms. Continue treatment after the patient's temperature has normalised for a further 4 days in rickettsial disease and 8-10 days in typhoid fever.
Child: Premature and full-term neonates: 25 mg/kg/day in 4 divided doses. Full-term infants >2 weeks: 50 mg/kg/day in 4 divided doses. Children: 50 mg/kg/day in 4 divided doses increased to 100 mg/kg/day for meningitis or severe infections.
Elderly:
Renal impairment: Dose reduction may be required.
Hepatic impairment: Dose reduction may be required.

Oral
Gas Gangrene
Adult: 50 mg/kg/day in 4 divided doses increased to 100 mg/kg/day for meningitis or severe infections due to moderately resistant organisms. Continue treatment after the patient's temperature has normalised for a further 4 days in rickettsial disease and 8-10 days in typhoid fever.
Child: Premature and full-term neonates: 25 mg/kg/day in 4 divided doses. Full-term infants >2 weeks: 50 mg/kg/day in 4 divided doses. Children: 50 mg/kg/day in 4 divided doses increased to 100 mg/kg/day for meningitis or severe infections.
Elderly:
Renal impairment: Dose reduction may be required.
Hepatic impairment: Dose reduction may be required.

Oral
Listeriosis
Adult: 50 mg/kg/day in 4 divided doses increased to 100 mg/kg/day for meningitis or severe infections due to moderately resistant organisms. Continue treatment after the patient's temperature has normalised for a further 4 days in rickettsial disease and 8-10 days in typhoid fever.
Child: Premature and full-term neonates: 25 mg/kg/day in 4 divided doses. Full-term infants >2 weeks: 50 mg/kg/day in 4 divided doses. Children: 50 mg/kg/day in 4 divided doses increased to 100 mg/kg/day for meningitis or severe infections.
Elderly:
Renal impairment: Dose reduction may be required.
Hepatic impairment: Dose reduction may be required.

Oral
Anaerobic bacterial infections
Adult: 50 mg/kg/day in 4 divided doses increased to 100 mg/kg/day for meningitis or severe infections due to moderately resistant organisms. Continue treatment after the patient's temperature has normalised for a further 4 days in rickettsial disease and 8-10 days in typhoid fever.
Child: Premature and full-term neonates: 25 mg/kg/day in 4 divided doses. Full-term infants >2 weeks: 50 mg/kg/day in 4 divided doses. Children: 50 mg/kg/day in 4 divided doses increased to 100 mg/kg/day for meningitis or severe infections.
Elderly:
Renal impairment: Dose reduction may be required.
Hepatic impairment: Dose reduction may be required.

Oral
Q fever
Adult: 50 mg/kg/day in 4 divided doses increased to 100 mg/kg/day for meningitis or severe infections due to moderately resistant organisms. Continue treatment after the patient's temperature has normalised for a further 4 days in rickettsial disease and 8-10 days in typhoid fever.
Child: Premature and full-term neonates: 25 mg/kg/day in 4 divided doses. Full-term infants >2 weeks: 50 mg/kg/day in 4 divided doses. Children: 50 mg/kg/day in 4 divided doses increased to 100 mg/kg/day for meningitis or severe infections.
Elderly:
Renal impairment: Dose reduction may be required.
Hepatic impairment: Dose reduction may be required.

Oral
Psittacosis
Adult: 50 mg/kg/day in 4 divided doses increased to 100 mg/kg/day for meningitis or severe infections due to moderately resistant organisms. Continue treatment after the patient's temperature has normalised for a further 4 days in rickettsial disease and 8-10 days in typhoid fever.
Child: Premature and full-term neonates: 25 mg/kg/day in 4 divided doses. Full-term infants >2 weeks: 50 mg/kg/day in 4 divided doses. Children: 50 mg/kg/day in 4 divided doses increased to 100 mg/kg/day for meningitis or severe infections.
Elderly:
Renal impairment: Dose reduction may be required.
Hepatic impairment: Dose reduction may be required.

Oral
Tularaemia
Adult: 50 mg/kg/day in 4 divided doses increased to 100 mg/kg/day for meningitis or severe infections due to moderately resistant organisms. Continue treatment after the patient's temperature has normalised for a further 4 days in rickettsial disease and 8-10 days in typhoid fever.
Child: Premature and full-term neonates: 25 mg/kg/day in 4 divided doses. Full-term infants >2 weeks: 50 mg/kg/day in 4 divided doses. Children: 50 mg/kg/day in 4 divided doses increased to 100 mg/kg/day for meningitis or severe infections.
Elderly:
Renal impairment: Dose reduction may be required.
Hepatic impairment: Dose reduction may be required.

Ophthalmic
Ocular infections
Adult: Instill 1 drop of a 0.5% solution every 2 hours. Increase dosage interval upon improvement. To continue treatment for at least 48 hours after complete healing. Reduce dose once symptoms are controlled or apply a 1% ointment 3-4 times daily.
Renal impairment: Dose reduction may be required.
Hepatic impairment: Dose reduction may be required.

Otic/Aural
Otitis Externa
Adult: Instill 2-3 drops of a 5% solution into the ear bid-tid.
Renal impairment: Dose reduction may be required.
Hepatic impairment: Dose reduction may be required.

Food(before/after)

Should be taken on an empty stomach. (Take on an empty stomach 1 hour before or 2 hours after meals.)

List of Contraindications

Chloramphenicol and Pregnancy

Contraindicated in pregnancy

Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.

Chloramphenicol and Lactation

Contraindicated in lactation

Chloramphenicol and Children

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.

Chloramphenicol and Geriatic

Information Not Available

Chloramphenicol and Other Contraindications

History of hypersensitivity or toxic reaction to the drug; pregnancy, lactation; porphyria; parenteral admin for minor infections or as prophylaxis; preexisting bone marrow depression or blood dyscrasias.

Storage

Ophthalmic
Refrigerate at 2-8°C. Do not freeze

Oral
Store at 15-25°C

Otic/Aural
Refrigerate at 2-8°C. Do not freeze

Lab interference

Ophthalmic
Refrigerate at 2-8°C. Do not freeze

Oral
Store at 15-25°C

Otic/Aural
Refrigerate at 2-8°C. Do not freeze

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