Chloramphenicol (5% w/v) + Prednisolone (0.5% w/v) + Acetic acid (2% w/v) + Benzocaine (3% w/v) (Medical Monograph)

Overview

A fixed-dose combination topical otic/otic-sterile solution designed for the treatment of acute otitis externa and infected otitis media with perforation. It combines a broad-spectrum bacteriostatic antibiotic (Chloramphenicol), a potent corticosteroid (Prednisolone) for anti-inflammatory and anti-pruritic action, an acidifying/antimicrobial agent (Acetic acid), and a local anesthetic (Benzocaine) for symptomatic pain relief. This combination addresses infection, inflammation, and pain simultaneously, commonly used in Indian clinical practice for 'swimmer's ear' and other acute ear infections.

Uses

  • Acute Otitis Externa (Swimmer's Ear)
  • Infected Otitis Media with perforation of the tympanic membrane (where topical treatment is indicated)
  • Superficial bacterial infections of the external auditory canal with associated inflammation and pain

Side Effects

  • Transient mild stinging or burning sensation upon instillation (due to Acetic acid)
  • Local irritation or itching in the ear canal
  • Dryness or flaking of skin in the ear

Detailed Pharmacology

This combination exerts a multi-pronged therapeutic action. Chloramphenicol inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit. Prednisolone induces phospholipase A2 inhibitory proteins (lipocortins), suppressing prostaglandin and leukotriene synthesis, thereby reducing inflammation, edema, and itching. Acetic acid creates an acidic environment (lowers pH) hostile to bacterial and fungal growth, particularly Pseudomonas aeruginosa and Candida. Benzocaine blocks sodium ion channels in neuronal membranes, preventing the initiation and conduction of nerve impulses, providing local analgesia.

Available Brands in India

BrandManufacturerPrice
Otocin Cipla Ltd. ₹80 - ₹150 (approx.)
Oticin Sun Pharmaceutical Industries Ltd. ₹70 - ₹130 (approx.)
Earcort FDC Limited ₹65 - ₹120 (approx.)
Otosporin GlaxoSmithKline Pharmaceuticals Ltd. (GSK) ₹90 - ₹160 (approx.)