Dosage/Direction for Use
Oral Bacterial meningitis Adult: 50 mg/kg daily in 4 divided doses. Meningitis or severe infections due to moderately resistant organisms: Up to 100 mg/kg daily in 4 divided doses, reduced as soon as clinically indicated. Continue treatment after the patient's temperature has normalised for a further 2-4 days in rickettsial disease and 8-10 days in typhoid fever. Elderly: Renal impairment: Dose reduction may be required. Hepatic impairment: Dose reduction may be required. Oral Brain abscess Adult: 50 mg/kg daily in 4 divided doses. Meningitis or severe infections due to moderately resistant organisms: Up to 100 mg/kg daily in 4 divided doses, reduced as soon as clinically indicated. Continue treatment after the patient's temperature has normalised for a further 2-4 days in rickettsial disease and 8-10 days in typhoid fever. Elderly: Renal impairment: Dose reduction may be required. Hepatic impairment: Dose reduction may be required. Oral Cystic fibrosis Adult: 50 mg/kg daily in 4 divided doses. Meningitis or severe infections due to moderately resistant organisms: Up to 100 mg/kg daily in 4 divided doses, reduced as soon as clinically indicated. Continue treatment after the patient's temperature has normalised for a further 2-4 days in rickettsial disease and 8-10 days in typhoid fever. Elderly: Renal impairment: Dose reduction may be required. Hepatic impairment: Dose reduction may be required. Oral Granuloma inguinale Adult: 50 mg/kg daily in 4 divided doses. Meningitis or severe infections due to moderately resistant organisms: Up to 100 mg/kg daily in 4 divided doses, reduced as soon as clinically indicated. Continue treatment after the patient's temperature has normalised for a further 2-4 days in rickettsial disease and 8-10 days in typhoid fever. Elderly: Renal impairment: Dose reduction may be required. Hepatic impairment: Dose reduction may be required. Oral Pelvic inflammatory disease Adult: 50 mg/kg daily in 4 divided doses. Meningitis or severe infections due to moderately resistant organisms: Up to 100 mg/kg daily in 4 divided doses, reduced as soon as clinically indicated. Continue treatment after the patient's temperature has normalised for a further 2-4 days in rickettsial disease and 8-10 days in typhoid fever. Elderly: Renal impairment: Dose reduction may be required. Hepatic impairment: Dose reduction may be required. Oral Anaerobic bacterial infections Adult: 50 mg/kg daily in 4 divided doses. Meningitis or severe infections due to moderately resistant organisms: Up to 100 mg/kg daily in 4 divided doses, reduced as soon as clinically indicated. Continue treatment after the patient's temperature has normalised for a further 2-4 days in rickettsial disease and 8-10 days in typhoid fever. Elderly: Renal impairment: Dose reduction may be required. Hepatic impairment: Dose reduction may be required. Oral Psittacosis Adult: 50 mg/kg daily in 4 divided doses. Meningitis or severe infections due to moderately resistant organisms: Up to 100 mg/kg daily in 4 divided doses, reduced as soon as clinically indicated. Continue treatment after the patient's temperature has normalised for a further 2-4 days in rickettsial disease and 8-10 days in typhoid fever. Elderly: Renal impairment: Dose reduction may be required. Hepatic impairment: Dose reduction may be required. Oral Whipple's disease Adult: 50 mg/kg daily in 4 divided doses. Meningitis or severe infections due to moderately resistant organisms: Up to 100 mg/kg daily in 4 divided doses, reduced as soon as clinically indicated. Continue treatment after the patient's temperature has normalised for a further 2-4 days in rickettsial disease and 8-10 days in typhoid fever. 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 daily in 4 divided doses. Meningitis or severe infections due to moderately resistant organisms: Up to 100 mg/kg daily in 4 divided doses, reduced as soon as clinically indicated. Continue treatment after the patient's temperature has normalised for a further 2-4 days in rickettsial disease and 8-10 days in typhoid fever. Elderly: Renal impairment: Dose reduction may be required. Hepatic impairment: Dose reduction may be required. Oral Ehrlichiosis Adult: 50 mg/kg daily in 4 divided doses. Meningitis or severe infections due to moderately resistant organisms: Up to 100 mg/kg daily in 4 divided doses, reduced as soon as clinically indicated. Continue treatment after the patient's temperature has normalised for a further 2-4 days in rickettsial disease and 8-10 days in typhoid fever. Elderly: Renal impairment: Dose reduction may be required. Hepatic impairment: Dose reduction may be required. Oral Severe gastroenteritis Adult: 50 mg/kg daily in 4 divided doses. Meningitis or severe infections due to moderately resistant organisms: Up to 100 mg/kg daily in 4 divided doses, reduced as soon as clinically indicated. Continue treatment after the patient's temperature has normalised for a further 2-4 days in rickettsial disease and 8-10 days in typhoid fever. Elderly: Renal impairment: Dose reduction may be required. Hepatic impairment: Dose reduction may be required. Oral Severe melioidosis Adult: 50 mg/kg daily in 4 divided doses. Meningitis or severe infections due to moderately resistant organisms: Up to 100 mg/kg daily in 4 divided doses, reduced as soon as clinically indicated. Continue treatment after the patient's temperature has normalised for a further 2-4 days in rickettsial disease and 8-10 days in typhoid fever. Elderly: Renal impairment: Dose reduction may be required. Hepatic impairment: Dose reduction may be required. Oral Plague Adult: 50 mg/kg daily in 4 divided doses. Meningitis or severe infections due to moderately resistant organisms: Up to 100 mg/kg daily in 4 divided doses, reduced as soon as clinically indicated. Continue treatment after the patient's temperature has normalised for a further 2-4 days in rickettsial disease and 8-10 days in typhoid fever. Elderly: Renal impairment: Dose reduction may be required. Hepatic impairment: Dose reduction may be required. Oral Q fever Adult: 50 mg/kg daily in 4 divided doses. Meningitis or severe infections due to moderately resistant organisms: Up to 100 mg/kg daily in 4 divided doses, reduced as soon as clinically indicated. Continue treatment after the patient's temperature has normalised for a further 2-4 days in rickettsial disease and 8-10 days in typhoid fever. Elderly: Renal impairment: Dose reduction may be required. Hepatic impairment: Dose reduction may be required. Oral Gas gangrene Adult: 50 mg/kg daily in 4 divided doses. Meningitis or severe infections due to moderately resistant organisms: Up to 100 mg/kg daily in 4 divided doses, reduced as soon as clinically indicated. Continue treatment after the patient's temperature has normalised for a further 2-4 days in rickettsial disease and 8-10 days in typhoid fever. Elderly: Renal impairment: Dose reduction may be required. Hepatic impairment: Dose reduction may be required. Oral Anthrax Adult: 50 mg/kg daily in 4 divided doses. Meningitis or severe infections due to moderately resistant organisms: Up to 100 mg/kg daily in 4 divided doses, reduced as soon as clinically indicated. Continue treatment after the patient's temperature has normalised for a further 2-4 days in rickettsial disease and 8-10 days in typhoid fever. Elderly: Renal impairment: Dose reduction may be required. Hepatic impairment: Dose reduction may be required. Oral Actinomycosis Adult: 50 mg/kg daily in 4 divided doses. Meningitis or severe infections due to moderately resistant organisms: Up to 100 mg/kg daily in 4 divided doses, reduced as soon as clinically indicated. Continue treatment after the patient's temperature has normalised for a further 2-4 days in rickettsial disease and 8-10 days in typhoid fever. Elderly: Renal impairment: Dose reduction may be required. Hepatic impairment: Dose reduction may be required. Oral Listeriosis Adult: 50 mg/kg daily in 4 divided doses. Meningitis or severe infections due to moderately resistant organisms: Up to 100 mg/kg daily in 4 divided doses, reduced as soon as clinically indicated. Continue treatment after the patient's temperature has normalised for a further 2-4 days in rickettsial disease and 8-10 days in typhoid fever. Elderly: Renal impairment: Dose reduction may be required. Hepatic impairment: Dose reduction may be required. Oral Tularaemia Adult: 50 mg/kg daily in 4 divided doses. Meningitis or severe infections due to moderately resistant organisms: Up to 100 mg/kg daily in 4 divided doses, reduced as soon as clinically indicated. Continue treatment after the patient's temperature has normalised for a further 2-4 days in rickettsial disease and 8-10 days in typhoid fever. Elderly: Renal impairment: Dose reduction may be required. Hepatic impairment: Dose reduction may be required. Intravenous Typhoid fever Adult: 50 mg/kg daily in divided doses at 6 hourly intervals. Severe infections (e.g. meningitis) or infections due to moderately resistant organisms: Up to 100 mg/kg daily, decreased as soon as possible. Child: Premature newborn infants and children with premature metabolic processes 25 mg/kg daily in 4 divided doses at 6 hourly intervals; Full-term neonates after 2 weeks of life 50 mg/kg daily in 4 divided doses at 6 hourly intervals. Renal impairment: Dose reduction may be required. Hepatic impairment: Dose reduction may be required. Reconstitution: IV: Reconstitute vial with 10 mL of sterile water for inj or 5% dextrose inj to a final concentration of 100 mg/mL. Intravenous Meningitis Adult: 50 mg/kg daily in divided doses at 6 hourly intervals. Severe infections (e.g. meningitis) or infections due to moderately resistant organisms: Up to 100 mg/kg daily, decreased as soon as possible. Child: Premature newborn infants and children with premature metabolic processes 25 mg/kg daily in 4 divided doses at 6 hourly intervals; Full-term neonates after 2 weeks of life 50 mg/kg daily in 4 divided doses at 6 hourly intervals. Renal impairment: Dose reduction may be required. Hepatic impairment: Dose reduction may be required. Reconstitution: IV: Reconstitute vial with 10 mL of sterile water for inj or 5% dextrose inj to a final concentration of 100 mg/mL. Intravenous Septicaemia Adult: 50 mg/kg daily in divided doses at 6 hourly intervals. Severe infections (e.g. meningitis) or infections due to moderately resistant organisms: Up to 100 mg/kg daily, decreased as soon as possible. Child: Premature newborn infants and children with premature metabolic processes 25 mg/kg daily in 4 divided doses at 6 hourly intervals; Full-term neonates after 2 weeks of life 50 mg/kg daily in 4 divided doses at 6 hourly intervals. Renal impairment: Dose reduction may be required. Hepatic impairment: Dose reduction may be required. Reconstitution: IV: Reconstitute vial with 10 mL of sterile water for inj or 5% dextrose inj to a final concentration of 100 mg/mL. Ophthalmic Bacterial conjunctivitis Adult: As 0.5% solution: Instill 1-2 drops to the affected eye(s) 6 times daily or more frequently as necessary. As 1% ointment: Apply approx 1 cm of ointment to the affected eye(s) 3-4 hourly, or more frequently as required. Continue treatment for at least 48 hours after complete healing. Treatment duration: 5 days. Child: ≥2 years Same as adult dose. Otic/Aural Otitis externa Adult: As 5% or 10% solution: Instill 3-4 drops into the affected ear(s) bid-tid for up to 1 week. Child: Same as adult dose. |
Administration
Should be taken on an empty stomach. Take on an empty stomach 1 hr before or 2 hr after meals.
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Contraindications
Hypersensitivity. Known or family history of blood dyscrasias (e.g. aplastic anaemia), acute porphyria, active immunisation. Perforated eardrum (otic). Pregnancy and lactation (oral, IV). Concomitant administration of drugs that cause bone marrow depression.
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Special Precautions
Avoid prolonged use. Not indicated for treatment of viral infections or for prophylaxis of bacterial infections. Renal and hepatic impairment. Children. Pregnancy and lactation (ophthalmic, otic). Patient Counselling Eye drops may cause transient blurred vision, if affected do not drive or operate machinery. Monitoring Parameters Monitor chloramphenicol plasma concentration, hepatic and renal functions periodically. Check CBC with differential at baseline and every 2 days during treatment. Perform culture and susceptibility tests; consult local recommendations before treatment initiation due to antibiotic resistance risks.
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Adverse Reactions
Ear and labyrinth disorders: Ototoxicity.
Eye disorders: Transient stinging and irritation (ophthalmic), optic neuritis (prolonged use).
Gastrointestinal disorders: Nausea, vomiting, glossitis, stomatitis, diarrhoea, enterocolitis.
Nervous system disorders: Headache, peripheral neuritis (prolonged use).
Psychiatric disorders: Delirium, mental confusion, mild depression.
Potentially Fatal: Blood dyscrasias (e.g. aplastic anaemia, hypoplastic anaemia, thrombocytopenia, granulocytopenia), Grey baby syndrome, hypersensitivity reactions (e.g. angioedema, anaphylaxis, urticaria, fever, vesicular and maculopapular dermatitis), superinfection (e.g. C. difficile-associated diarrhoea and pseudomembranous colitis). |
Overdosage
Symptoms: IV: Aplastic anaemia, thrombocytopenia, leucopenia, increased Fe levels, nausea, vomiting, diarrhoea. Management: IV: Consider charcoal haemoperfusion to remove chloramphenicol from plasma.
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Drug Interactions
Enhances the effects of coumarin anticoagulants (e.g. dicoumarol, warfarin), certain hypoglycaemics (e.g. chlorpropamide, tolbutamide) and antiepileptics (e.g. phenytoin). Hepatic enzyme inducers (e.g. phenobarbital, rifampicin) may decrease chloramphenicol plasma concentrations. May decrease the effects of Fe and vit B12 in anaemic patients. Prolonged treatment may reduce the efficacy of oestrogen-containing oral contraceptives. May increase the plasma levels of calcineurin inhibitors (e.g. tacrolimus, ciclosporin).
Potentially Fatal: Increased haematologic toxicity with drugs that cause bone marrow depression (e.g. cytotoxic agents, sulfonamides). |
Action
Chloramphenicol inhibits bacterial protein synthesis by binding to 50S subunit of the bacterial ribosome, thus preventing amino acid transfer to growing peptide chains thereby inhibiting protein synthesis.
Absorption: Rapidly and readily absorbed from the gastrointestinal tract. May be absorbed systemically after ophthalmic and otic administration. Bioavailability: Approx 80% (oral); approx 70% (IV). Distribution: Widely distributed to most tissues and body fluids including CSF. Enters the brain. Crosses the placenta and enters the breastmilk. Enters the aqueous and vitreous humours of the eye. Volume of distribution: 0.6-1 L/kg. Plasma protein binding: Approx 60%. Metabolism: As chloramphenicol palmitate: Hydrolysed to chloramphenicol in the gastrointestinal tract. As chloramphenicol succinate: Hydrolysed in the liver, kidney and lungs to chloramphenicol (active). Chloramphenicol is then metabolised in the liver into inactive metabolites. Excretion: Via urine (approx 30% as unchanged chloramphenicol succinate, 5-15% as chloramphenicol). Elimination half-life: 1.5-4 hours. |
Storage
Intravenous: IV inj: Store below 25°C. Protect from light. Reconstituted IV inj: Store between 2-8°C; stable for 24 hours. Ophthalmic: Eye drops solution: Store between 2-8°C. Do not freeze. Protect from light. Eye ointment: Store below 25°C. Protect from light. Oral: Store below 25°C. Protect from light. Otic/Aural: Ear drops solution: Store between 2-8°C. Do not freeze. Protect from light.
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ATC Classification
S01AA01 - chloramphenicol ; Belongs to the class of antibiotics. Used in the treatment of eye infections.
D06AX02 - chloramphenicol ; Belongs to the class of other topical antibiotics used in the treatment of dermatological diseases. S03AA08 - chloramphenicol ; Belongs to the class of antiinfectives used in ophthalmologic and otologic preparations. J01BA01 - chloramphenicol ; Belongs to the class of amphenicols. Used in the systemic treatment of infections. S02AA01 - chloramphenicol ; Belongs to the class of antiinfectives used in the treatment of ear infections. G01AA05 - chloramphenicol ; Belongs to the class of antibiotics. Used in the treatment of gynecological infections. D10AF03 - chloramphenicol ; Belongs to the class of topical antiinfective preparations used in the treatment of acne. |