Chloramphenicol


Generic Medicine Info
Indications and Dosage
Intravenous
Bacterial meningitis, Disease caused by Rickettsiales, Infections caused by Haemophilus influenzae, Infections caused by Lymphogranuloma-psittacosis group, Septicaemia, Severe Gram-negative infections, Typhoid fever
Adult: 50 mg/kg daily in divided doses 6 hourly. For severe infections (e.g. meningitis, septicaemia): Doses may be increased up to 100 mg/kg daily in divided doses 6 hourly; reduce dose as soon as clinically indicated. Doses are given via IV inj as a 10% (100 mg/mL) solution over 1 minute. Dosage and treatment recommendations may vary among countries and individual products (refer to specific product guidelines).
Child: Same as adult dose. Dosage and treatment recommendations may vary among countries and individual products (refer to specific product guidelines).

Ophthalmic
Superficial ocular infections
Adult: As 0.5% solution: Instil 1-2 drops to the affected eye(s) up to 6 times daily or more frequently as necessary. Alternatively, instil 1-2 drops to the affected eye(s) every 2-6 hours. As 1% ointment: Apply approx 1 cm of ointment to the affected eye(s) 3-4 times daily. Alternatively, apply approx 1 cm of ointment into the affected eye(s) at night if using eye solution in the morning. Continue treatment for at least 48 hours after complete healing. Treatment duration: 5 days.
Child: ≥2 years Same as adult dose.

Oral
Bacterial meningitis, Disease caused by Rickettsiales, Infections caused by Haemophilus influenzae, Infections caused by Lymphogranuloma-psittacosis group, Septicaemia, Severe Gram-negative infections, Typhoid fever
Adult: 50 mg/kg daily in divided doses 6 hourly. For severe infections (e.g. meningitis, septicaemia): Doses may be increased up to 100 mg/kg daily in divided doses 6 hourly; reduce dose as soon as clinically indicated. Dosage and treatment recommendations may vary among countries and individual products (refer to specific product guidelines).

Otic/Aural
Acute otitis externa
Adult: As 5% or 10% solution: Instil 3-4 drops into the affected ear(s) bid-tid for up to 1 week.
Child: As 5% solution: Instil 2-3 drops into the affected ear(s) bid-tid.
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.
Reconstitution
IV: Dilute vial with 9.2 mL of sterile water for inj, dextrose 5% in water, or NaCl 0.9% up to a concentration of 10% (100 mg/mL) or lower.
Contraindications
Hypersensitivity. Treatment of trivial or minor infections (e.g. viral infections, infections of the throat); for use as prophylaxis of bacterial infections. Known or family history of blood dyscrasias including aplastic anaemia. History of myelosuppression with previous use of chloramphenicol. Perforated tympanic membrane (otic). Acute porphyria. Not for use during active immunisation. Pregnancy and lactation (oral, IV). Concomitant administration of drugs known to cause bone marrow depression.
Special Precautions
The use of chloramphenicol should only be reserved if other treatments are ineffective, and its use should always be accompanied by monitoring. Avoid prolonged use and repeated courses. Chloramphenicol may be administered via IM inj in certain patients, however, its effectivity remains to be determined; refer to specific country guidelines prior to administration. Renal and hepatic impairment. Neonates, children, and elderly. Pregnancy and lactation (ophthalmic, otic).
Adverse Reactions
Significant: Delayed corneal healing (ophthalmic ointment).
Blood and lymphatic system disorders: Increased bleeding time.
Ear and labyrinth disorders: Ototoxicity.
Eye disorders: Optic neuritis leading to blindness, blurred vision, transient blindness.
Gastrointestinal disorders: Nausea, vomiting, dry mouth, diarrhoea, glossitis, stomatitis, enterocolitis.
General disorders and administration site conditions: Fever.
Nervous system disorders: Headache, peripheral neuritis.
Psychiatric disorders: Mental depression, confusion.
Skin and subcutaneous tissue disorders: Macular and vesicular rash, urticaria.
Vascular disorders: Acidotic CV collapse.
Potentially Fatal: Serious blood dyscrasias (e.g. aplastic anaemia, hypoplastic anaemia, thrombocytopenia, granulocytopenia), grey baby syndrome, severe hypersensitivity reactions (e.g. angioedema, anaphylaxis, urticaria, fever, vesicular and maculopapular dermatitis); superinfection (e.g. overgrowth of nonsusceptible organisms, including fungi; Clostridioides difficile-associated diarrhoea and pseudomembranous colitis).
IM/IV/Ophth/Parenteral/PO/Topical: C
Patient Counseling Information
Ophthalmic: Chloramphenicol ophthalmic solution may cause transient blurred vision, if affected, do not drive or operate machinery. Do not use contact lenses during treatment.
Monitoring Parameters
Perform culture and susceptibility tests; consult local recommendations before treatment initiation due to antibiotic resistance risks. Monitor serum drug concentrations (particularly in neonates and infants); hepatic and renal functions; CBC with differential (at baseline and every 2 days during treatment).
Overdosage
Symptoms: IV: Nausea, vomiting, diarrhoea, increased serum Fe levels; aplastic anaemia, thrombocytopenia, leucopenia. Management: Charcoal haemoperfusion may be considered to remove chloramphenicol from plasma.
Drug Interactions
Prolonged elimination thereby causing increased serum levels of warfarin, phenytoin, tolbutamide, and sulfonylureas. Reduced or increased plasma levels with rifampicin. Prolonged half-life with paracetamol. May increase the plasma levels of calcineurin inhibitors (e.g. ciclosporin, tacrolimus). Decreased serum levels with barbiturates; may decrease the metabolism of phenobarbitone. May attenuate (small chance) the therapeutic effect of oral estrogen-containing contraceptives. Reduced response to vitamin B12 (hydroxocobalamin).
Potentially Fatal: Increased haematologic toxicity with drugs that cause bone marrow depression (e.g. cytotoxic agents, sulfonamides, carbamazepine, phenylbutazone, penicillamine, procainamide, propylthiouracil, nucleoside reverse transcriptase inhibitors; certain antipsychotics [e.g. clozapine, depot antipsychotics]).
Action
Description:
Mechanism of Action: Chloramphenicol, a broad-spectrum potent antibiotic which reversibly binds to the 50S ribosomal subunit of susceptible organisms, prevents amino acid transfer to growing peptide chains thereby inhibiting bacterial protein synthesis.
Pharmacokinetics:
Absorption: Readily and rapidly absorbed from the gastrointestinal tract. May be absorbed systemically after ophthalmic and otic administration. Bioavailability: Approx 80% (oral); approx 70% (IV).
Distribution: Widely distributed in body tissues and fluids. Enters CSF and brain. Diffuses to aqueous and vitreous humours of the eye. Crosses the placenta and enters breast milk. Volume of distribution: 0.6-1 L/kg (chloramphenicol); 0.2-3.1 L/kg (chloramphenicol succinate). Plasma protein binding: Approx 60%.
Metabolism: As chloramphenicol palmitate: Hydrolysed to chloramphenicol in the gastrointestinal tract. As chloramphenicol succinate: Partially and variably hydrolysed in the liver, kidneys, and lungs to chloramphenicol (active); further metabolised into inactive metabolites.
Excretion: Via urine (approx 30% as unchanged chloramphenicol succinate, 5-15% as chloramphenicol); bile (approx 3%). Elimination half-life: 2-5 hours.
Chemical Structure

Chemical Structure Image
Chloramphenicol

Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 5959, Chloramphenicol. https://pubchem.ncbi.nlm.nih.gov/compound/Chloramphenicol. Accessed Aug. 25, 2023.

Storage
Cap/Ophthalmic ointment: Store below 30°C. Protect from light and moisture. Intact vials: Store between 20-25°C. Protect from light. Reconstituted solution for inj: Store between 2-8°C for 24 hours. Ophthalmic/Otic solution: Store between 2-8<248>C. Do not freeze. Protect from light. Storage recommendations may vary among countries and individual products. Refer to specific product guidelines.
MIMS Class
Chloramphenicols / Ear Anti-Infectives & Antiseptics / Eye Anti-Infectives & Antiseptics
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
Committee on Infectious Diseases, American Academy of Pediatrics, Kimberlin DW, Barnett ED, Lynfield R, Sawyer MH. "Tables of Antibacterial Drug Dosages", Red Book: 2021-2024 Report of the Committee on Infectious Diseases. American Academy of Pediatrics [online]. Accessed 19/06/2023.

Anon. Chloramphenicol (Ophthalmic). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 19/06/2023.

Anon. Chloramphenicol (Otic). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 19/06/2023.

Anon. Chloramphenicol (Systemic) (Pediatric and Neonatal Lexi-Drugs). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 19/06/2023.

Anon. Chloramphenicol (Systemic). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 19/06/2023.

Anon. Chloramphenicol. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 12/07/2023.

Buckingham R (ed). Chloramphenicol. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 19/06/2023.

Chloramphenicol 10% w/v Ear Drops (Martindale Pharmaceuticals Ltd). MHRA. https://products.mhra.gov.uk. Accessed 22/06/2023.

Chloramphenicol 5% w/v Ear Drops (Martindale Pharmaceuticals Ltd). MHRA. https://products.mhra.gov.uk. Accessed 19/06/2023.

Chloramphenicol Capsules BP 250 mg (Chemidex Pharma Ltd). MHRA. https://products.mhra.gov.uk. Accessed 12/07/2023.

Chloramphenicol Sodium Succinate Injection, Powder, Lyophilized, for Solution (Fresenius Kabi USA, LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 19/06/2023.

Chloramphenicol. Gold Standard Drug Database in ClinicalKey [online]. Elsevier Inc. https://www.clinicalkey.com. Accessed 12/07/2023.

Enclor Capsule 250 mg (Idaman Pharma Manufacturing Sdn Bhd). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 19/06/2023.

Joint Formulary Committee. Chloramphenicol. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 19/06/2023.

Kemicetine Injection (Essential Pharma Ltd). MHRA. https://products.mhra.gov.uk. Accessed 19/06/2023.

Klorazin Eye Ointment 1% w/w (Galentic Pharma [India] Pvt. Ltd). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 12/07/2023.

Link Pharmaceuticals Ltd. Chloramphenicol Link 1 g Powder for Injection data sheet 14 April 2023. Medsafe. http://www.medsafe.govt.nz. Accessed 22/06/2023.

Minims Chloramphenicol 0.5% w/v, Eye Drops, Solution (Bausch & Lomb UK Limited). MHRA. https://products.mhra.gov.uk. Accessed 19/06/2023.

Paediatric Formulary Committee. Chloramphenicol. BNF for Children [online]. London. BMJ Group, Pharmaceutical Press, and RCPCH Publications. https://www.medicinescomplete.com. Accessed 19/06/2023.

Pharmacy Retailing (NZ) Limited Trading as Healthcare Logistics. Chlorsig Eye Drops 0.5% and Eye Ointment 1% data sheet 05 October 2021. Medsafe. http://www.medsafe.govt.nz. Accessed 12/07/2023.

Xepanicol Ear Drops 5% w/v (Xepa-Soul Pattinson [Malaysia] Sdn Bhd). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 22/06/2023.

Xepanicol Eye Drops (Xepa-Soul Pattinson [Malaysia] Sdn Bhd). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 12/07/2023.

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 © 2024 MIMS. All rights reserved. Powered by MIMS.com
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