Prednisolone + Neomycin Sulphate + Polymixin B Sulphate

A. Ophthalmic (Eye) Indications

• Bacterial conjunctivitis with associated inflammation
• Blepharitis and blepharoconjunctivitis
• Bacterial keratitis and keratoconjunctivitis (non-viral origin)
• Anterior uveitis with suspected bacterial contamination
• Post-operative ocular inflammation at risk of bacterial infection
• Allergic conjunctivitis with secondary bacterial involvement

B. Otic (Ear) Indications

• Acute and chronic otitis externa with inflammation and bacterial infection
• Post-surgical ear canal inflammation with superimposed infection
• Infected eczema or dermatitis of the external auditory canal
• Otitis media (with intact tympanic membrane and confirmed external canal involvement)

This combination is used when both anti-inflammatory and antibacterial actions are required in the eye or ear.

Ophthalmic Use (Eye Drops/Ointment)

• Adults and Children ≥2 years:
• Drops: Instill 1–2 drops into the conjunctival sac every 2 to 4 hours during the acute phase; reduce frequency as improvement occurs.
• Ointment: Apply a thin ribbon into the affected eye(s) 2 to 4 times daily.
• Maximum Duration: 7–10 days unless under strict medical supervision.

Otic Use (Ear Drops)

• Adults and Children ≥2 years:
• Instill 3–4 drops into the affected ear canal 2 to 4 times daily.
• A wick may be inserted and saturated with solution for deeper penetration.
• Maximum Duration: 7 days

Special Populations:

• Elderly: No specific dose adjustment, but monitor closely for local or systemic adverse effects.
• Renal/Hepatic Impairment: Not usually relevant due to low systemic absorption, but prolonged use may increase risk of toxicity. Use caution in compromised patients.

Administration Tips:

• Shake well before use (for suspension).
• Avoid contamination of the dropper tip.
• Do not wear contact lenses during ophthalmic treatment.
• Do not administer in the presence of a perforated tympanic membrane unless directed.

This fixed-dose combination exerts both anti-inflammatory and antibacterial actions:

• Prednisolone is a synthetic glucocorticoid that binds to intracellular corticosteroid receptors, modulating gene expression to suppress inflammatory mediators such as prostaglandins, leukotrienes, and cytokines. It reduces ocular and auditory inflammation, vascular permeability, and immune cell infiltration.
• Neomycin Sulphate is an aminoglycoside antibiotic that irreversibly binds to the 30S subunit of bacterial ribosomes, inhibiting protein synthesis and leading to bacterial cell death. It is primarily active against Gram-positive organisms.
• Polymyxin B Sulphate binds to the phospholipids of Gram-negative bacterial cell membranes, disrupting membrane integrity and leading to leakage of intracellular contents and cell death.

Together, these agents provide effective localized treatment for bacterial infections with associated inflammation in the eye or ear.

• Absorption: Minimal systemic absorption via topical (eye/ear) application when epithelium is intact. Increased absorption may occur if the mucosal barrier is damaged or used for prolonged periods.
• Distribution: Acts locally in conjunctival, corneal, or auditory tissues; negligible systemic distribution under normal conditions.
• Metabolism:
• Prednisolone: If absorbed, metabolized hepatically via CYP3A4.
• Neomycin & Polymyxin B: Not significantly metabolized; primarily remain at the site of application.
• Elimination:
• Prednisolone: Renally excreted as metabolites.
• Neomycin & Polymyxin B: Excreted unchanged in urine if systemically absorbed.
• Onset of Action: Anti-inflammatory and antibacterial effects begin within a few hours of administration.

• Pregnancy:
• Prednisolone (topical): Low systemic absorption; generally considered safe for short-term use.
• Neomycin/Polymyxin B: Animal studies suggest potential risk with systemic exposure; ototoxicity is a theoretical risk.
• Recommendation: Use only when clearly needed. Avoid prolonged use or use on large areas.
• Lactation:
• Topical ophthalmic and otic use unlikely to result in significant systemic levels in the mother or exposure to the nursing infant.
• Caution advised during prolonged use or if epithelial integrity is compromised. Monitor infants if prolonged maternal use is expected.

• Primary Class: Topical Corticosteroid + Antibiotic Combination
• Subclasses:
• Corticosteroid (Prednisolone)
• Aminoglycoside Antibiotic (Neomycin Sulphate)
• Polypeptide Antibiotic (Polymyxin B Sulphate)

• Known hypersensitivity to prednisolone, neomycin, polymyxin B, or any formulation components
• Viral infections of the eye (e.g., herpes simplex keratitis, varicella, vaccinia)
• Fungal infections of the eye or ear
• Untreated ocular tuberculosis
• Perforated tympanic membrane (for otic use)
• Use in children under 2 years (unless under specialist supervision)

• Prolonged use of corticosteroids may increase intraocular pressure and lead to glaucoma or posterior subcapsular cataracts.
• Risk of ototoxicity with neomycin if tympanic membrane is perforated or systemic absorption occurs.
• Superinfections (fungal or resistant bacterial) may occur with extended use.
• Allergic sensitization is possible, especially to neomycin.
• Avoid in viral eye diseases or undiagnosed red eye.
• Pediatric use: Caution advised; systemic absorption risk is higher in infants and young children.
• Discontinue immediately if hypersensitivity or irritation develops.

Common (local and mild):

• Temporary eye or ear irritation, stinging, or burning
• Blurred vision after ophthalmic use
• Local redness or discomfort
• Eyelid itching or swelling

Less Common but Serious:

• Elevated intraocular pressure and optic nerve damage (with prolonged use)
• Posterior subcapsular cataract
• Superinfections (bacterial or fungal)
• Ototoxicity: Hearing loss, tinnitus (especially with tympanic perforation)
• Hypersensitivity reactions, including contact dermatitis (neomycin-related)

Note: Risk increases with prolonged or excessive use.

• Systemic drug interactions are unlikely due to minimal absorption via eye/ear.
• Avoid concurrent topical products in the same area unless prescribed (may alter pH, increase irritation, or interfere with absorption).
• Avoid live vaccines during prolonged corticosteroid use, due to potential immunosuppressive effects.
• Increased risk of ototoxicity when combined with systemic aminoglycosides or loop diuretics.

• Ophthalmic and Otologic societies have updated recommendations advising that corticosteroid-antibiotic combinations should be used for the shortest possible duration to prevent complications such as elevated intraocular pressure and superinfections.
• Neomycin-containing topical products have updated labeling highlighting the risk of contact sensitization and ototoxicity.
• Monitoring intraocular pressure is recommended for patients requiring treatment beyond 10 days.

• Store at: 15°C to 25°C (59°F to 77°F)
• Protect from light and moisture
• Do not freeze
• Shake well before use (for suspensions)
• Use within 28 days of opening (ophthalmic products)
• Keep out of reach of children
• Do not use beyond expiration date