Chloramphenicol


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : PO Susceptible infections 50 mg/kg/day in 4 divided doses; up to 100 mg/kg/day for meningitis or severe infections due to moderately resistant organisms. IV Typhoid fever; Septicaemia; Meningitis 50 mg/kg/day in divided doses at 6 hourly intervals. Severe infections (e.g. meningitis) or infections due to moderately resistant organisms: Up to 100 mg/kg/day, decreased as soon as possible. Ophthalmic Bacterial conjunctivitis As 0.5% solution: Instill 1-2 drops to the affected eye(s) 6 times/day 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. Treatment duration: 5 days. Otic Otitis externa As 5% or 10% solution: Instill 3-4 drops into the affected ear(s) bid-tid for up to 1 week.
Dosage Details
Intravenous
Meningitis, Septicaemia, 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.

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.

Oral
Actinomycosis, Anaerobic bacterial infections, Anthrax, Bacterial meningitis, Brain abscess, Cystic fibrosis, Ehrlichiosis, Gas gangrene, Granuloma inguinale, Infections caused by H. influenzae, Listeriosis, Pelvic inflammatory disease, Plague, Psittacosis, Q fever, Severe gastroenteritis, Severe melioidosis, Tularaemia, 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.

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.
Renal Impairment
Oral/Intravenous:
Dose reduction may be required.
Hepatic Impairment
Oral/Intravenous:
Dose reduction may be required.
Administration
Should be taken on an empty stomach. Take 1 hr before or 2 hr after meals.
Reconstitution
IV: Reconstitute vial with 10 mL of sterile water for inj or 5% dextrose inj to a final concentration of 100 mg/mL.
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.
Special Precautions
Avoid prolonged use. Not indicated for the treatment of viral infections or for prophylaxis of bacterial infections. Renal and hepatic impairment. Children. Pregnancy and lactation (ophthalmic, otic).
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).
IM/IV/Ophth/Parenteral/PO/Topical: C
Patient Counseling Information
Eye drops may cause transient blurred vision, if affected do not drive or operate machinery.
MonitoringParameters
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.
Overdosage
Symptoms: IV: Aplastic anaemia, thrombocytopenia, leucopenia, increased Fe levels, nausea, vomiting, diarrhoea. Management: IV: Consider charcoal haemoperfusion to remove chloramphenicol from plasma.
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
Description: 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.
Pharmacokinetics:
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.
Chemical Structure

Chemical Structure Image
Chloramphenicol

Source: National Center for Biotechnology Information. PubChem Database. Chloramphenicol, CID=5959, https://pubchem.ncbi.nlm.nih.gov/compound/Chloramphenicol (accessed on Jan. 21, 2020)

Storage
Eye/ear drops solution: Store between 2-8°C. Do not freeze. Protect from light. Cap/Eye ointment/IV inj: Store below 25°C. Protect from light. Reconstituted IV inj: Store between 2-8°C; stable for 24 hours.
ATC Classification
S01AA01 - chloramphenicol ; Belongs to the class of antibiotics. Used in the treatment of eye infections.
S02AA01 - chloramphenicol ; Belongs to the class of antiinfectives used in the treatment of ear infections.
J01BA01 - chloramphenicol ; Belongs to the class of amphenicols. Used in the systemic treatment of infections.
References
Anon. Chloramphenicol (Systemic). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 03/12/2019.

Bausch & Lomb (NZ) Ltd. Minims Chloramphenicol, Eye Drops Solution 0.5% w/v data sheet 16 August 2019. Medsafe. http://www.medsafe.govt.nz/. Accessed 03/12/2019.

Buckingham R (ed). Chloramphenicol. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 03/12/2019.

Chloramphenicol 250 mg Capsules (Chelonia Healthcare Limited). MHRA. https://products.mhra.gov.uk/. Accessed 04/12/2019.

Devatis Limited. Chloramphenicol 1% w/w Eye Ointment data sheet 25 July 2019. Medsafe. http://www.medsafe.govt.nz/. Accessed 03/12/2019.

Joint Formulary Committee. Chloramphenicol. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 03/12/2019.

Kemicetine Injection (Essential Pharma Ltd). MHRA. https://products.mhra.gov.uk/. Accessed 03/12/2019.

Link Pharmaceuticals Ltd. Chloramphenicol Link 1g Powder for Injection data sheet 26 July 2018. Medsafe. http://www.medsafe.govt.nz/. Accessed 03/12/2019.

RiteMed Chloramphenicol (Am-Europharma Corporation). MIMS Philippines. http://www.mims.com/philippines. Accessed 04/12/2019.

Disclaimer: This information is independently developed by MIMS based on Chloramphenicol from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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