Neomycin (0.35% w/v) + Fluorometholone (0.1% w/v)

Clinical Pharmacologist's Monograph

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

1. Clinical Overview

A fixed-dose combination ophthalmic suspension containing an aminoglycoside antibiotic (Neomycin) and a potent corticosteroid (Fluorometholone). It is primarily indicated for the treatment of steroid-responsive inflammatory ocular conditions where a risk of bacterial infection exists or where such infection is present. The combination provides anti-inflammatory, anti-allergic, and antibacterial coverage.

OnsetDurationBioavailability
Anti-inflammatory effects of Fluorometholone typically begin within hours, with noticeable improvement in symptoms like redness and swelling often seen within 1-2 days. The antibacterial effect of Neomycin begins upon contact with susceptible organisms.Topical ocular duration is approximately 4-6 hours per instillation, necessitating multiple daily doses. The anti-inflammatory effect is sustained with regular dosing.Topical ocular bioavailability is low (<5%) due to minimal systemic absorption from the eye. The drug acts locally.

2. Mechanism of Action

The combination exerts a dual action: Neomycin binds to the 30S ribosomal subunit of susceptible bacteria, inhibiting protein synthesis and causing bacterial cell death. Fluorometholone binds to cytoplasmic glucocorticoid receptors, triggering anti-inflammatory and immunosuppressive effects by inhibiting phospholipase A2 (reducing prostaglandin/leukotriene synthesis), stabilizing lysosomal membranes, and inhibiting migration of inflammatory cells.

3. Indications & Uses

  • Steroid-responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe (e.g., allergic conjunctivitis, non-infectious keratitis)
  • Inflammatory conditions where the risk of ocular bacterial infection is high or where such infection is present

4. Dosage & Administration

Adult Dosage: One or two drops instilled into the conjunctival sac of the affected eye(s) every 4 to 6 hours. In severe conditions, may be used hourly for the first 1-2 days as directed by the physician.

Administration: 1. Wash hands. 2. Shake the suspension well before use. 3. Tilt head back, pull lower eyelid down to form a pouch. 4. Instill prescribed drops without touching the dropper tip to eye or any surface. 5. Close eyes gently for 1-2 minutes, applying gentle pressure to the nasolacrimal duct (inner corner of eye) to minimize systemic absorption. 6. Wait at least 5-10 minutes before instilling any other eye medication.

5. Side Effects

Common side effects may include:

  • Transient stinging or burning upon instillation
  • Blurred vision temporarily after application
  • Mild ocular irritation or itching
  • Watery eyes

6. Drug Interactions

DrugEffectSeverity
Other topical ophthalmic corticosteroidsAdditive risk of elevated IOP, cataract, and infection.Major
Topical ophthalmic NSAIDs (e.g., Ketorolac, Nepafenac)May increase risk of corneal healing complications.Moderate
Systemic aminoglycosides (e.g., Gentamicin, Amikacin)Theoretical additive ototoxicity and nephrotoxicity if significant systemic absorption occurs.Moderate
Neuromuscular blocking agents (e.g., Succinylcholine)Neomycin may potentiate neuromuscular blockade, risk is extremely low with topical use.Theoretical

7. Patient Counselling

  • DO shake the bottle well before each use.
  • DO wash hands before and after use.
  • DO apply gentle pressure on the inner corner of the eye (nasolacrimal duct) for 1-2 minutes after instillation.
  • DO wait at least 5-10 minutes before using other eye drops.
  • DO NOT touch the dropper tip to your eye, fingers, or any surface.
  • DO NOT wear contact lenses during treatment unless specifically advised by your doctor (preservative may be absorbed by lenses).
  • DO NOT share your eye drops with anyone.
  • DO NOT stop the medication abruptly if used for more than a week; taper as directed.

8. Toxicology & Storage

Overdose: Topical overdose is unlikely to cause acute systemic toxicity. Symptoms would be an extension of side effects: severe ocular irritation, corneal damage, markedly elevated IOP, and if ingested accidentally (from nasolacrimal drainage), possible ototoxicity, nephrotoxicity, and neuromuscular blockade (symptoms: hearing loss, dizziness, respiratory depression).

Storage: Store at controlled room temperature (15°C to 25°C). Protect from light and excessive heat. Do not freeze. Keep the bottle tightly closed when not in use. Discard the bottle 4 weeks after opening to prevent contamination. Keep out of reach and sight of children.