Chloramphenicol (NA)

Clinical Pharmacologist's Monograph

⚠️ Prescription Only: This medicine is Schedule H/H1. Do not self-medicate.

1. Clinical Overview

Chloramphenicol is a broad-spectrum bacteriostatic antibiotic originally derived from *Streptomyces venezuelae*. It is a potent inhibitor of bacterial protein synthesis. Due to its association with serious and potentially fatal hematological toxicities (aplastic anemia, gray baby syndrome), its systemic use is now highly restricted in India and globally. It is primarily reserved for severe, life-threatening infections where safer alternatives are ineffective or contraindicated. Its topical use (ophthalmic, otic) remains common and is considered relatively safe.

OnsetDurationBioavailability
Oral/IV: Peak serum concentrations reached in 1-3 hours. Topical (Ophthalmic): Onset of action within hours.Approximately 4-8 hours, necessitating multiple daily doses for systemic therapy.Oral: 75-90% (well absorbed). IV: 100% (bioequivalent).

2. Mechanism of Action

Chloramphenicol binds reversibly to the 50S subunit of the bacterial 70S ribosome. This binding inhibits the peptidyl transferase step of protein synthesis, preventing the transfer of the growing peptide chain to the newly attached aminoacyl-tRNA. This results in bacteriostatic inhibition of bacterial growth.

3. Indications & Uses

  • Severe Typhoid Fever (Salmonella Typhi) resistant to fluoroquinolones and 3rd gen cephalosporins
  • Bacterial Meningitis (as an alternative in penicillin/cephalosporin-allergic patients, especially for H. influenzae, N. meningitidis, S. pneumoniae)
  • Rickettsial infections (e.g., Scrub typhus, Rocky Mountain spotted fever) where tetracyclines are contraindicated
  • Topical: Bacterial Conjunctivitis, Bacterial Keratitis, External Otitis (Otitis Externa)

4. Dosage & Administration

Adult Dosage: Systemic (Severe infections): 50 mg/kg/day in divided doses every 6 hours (IV/Oral). Max: 4 g/day. Typhoid Fever: 500 mg every 6 hours for 14 days. Topical (Eye): 1-2 drops in affected eye(s) every 2-6 hours. Ointment: Apply small amount 3-4 times daily.

Administration: Oral: Can be taken with or without food. IV: Administer as a slow intravenous infusion over 15-30 minutes. Topical Ophthalmic: Wash hands, avoid touching dropper tip, apply pressure to lacrimal sac (nasolacrimal duct) for 1 minute to minimize systemic absorption. Do not share eye/ear drops.

5. Side Effects

Common side effects may include:

  • Nausea, vomiting, diarrhea
  • Bitter or metallic taste
  • Headache, mild depression
  • Topical: Transient stinging/burning, blurred vision (ophthalmic)

6. Drug Interactions

DrugEffectSeverity
Warfarin, AcenocoumarolChloramphenicol inhibits metabolism, increasing anticoagulant effect and risk of bleeding.Major
Phenytoin, PhenobarbitalChloramphenicol inhibits metabolism, increasing phenytoin/phenobarbital levels (toxicity). Conversely, these drugs may decrease chloramphenicol levels.Major
Sulfonylureas (Glibenclamide)Increased hypoglycemic effect.Moderate
Vitamin B12, Folic Acid, IronChloramphenicol antagonizes the hematopoietic response to these agents.Moderate
Penicillins, CephalosporinsPotential antagonism of bactericidal activity in some situations.Moderate
RifampicinDecreases chloramphenicol serum levels by inducing metabolism.Moderate
Paracetamol (Acetaminophen)May increase risk of bone marrow suppression and prolong half-life of chloramphenicol.Moderate

7. Patient Counselling

  • DO complete the full course as prescribed, even if you feel better.
  • DO inform all your doctors and dentists you are taking chloramphenicol.
  • DO get regular blood tests (CBC) as advised by your doctor during systemic therapy.
  • DONT use leftover medication for a new infection.
  • DONT share your eye/ear drops with anyone else.
  • DONT use systemic chloramphenicol for colds, flu, or viral infections.

8. Toxicology & Storage

Overdose: Nausea, vomiting, acidosis, hypothermia ('Gray' appearance in infants), cardiovascular collapse, bone marrow hypoplasia leading to pancytopenia, confusion, peripheral neuropathy.

Storage: Store at room temperature (15-25°C), protected from light and moisture. Do not freeze. Keep oral and injectable forms out of reach of children. For eye/ear drops: Once opened, most solutions should be discarded after 28 days (check package insert). Do not use if solution is discolored or contains particles.