Fluormetholone + Neomycin Sulphate

Approved Indications:

• Ocular Inflammatory Conditions with Suspected or Confirmed Bacterial Infection, such as:
• Allergic conjunctivitis with secondary bacterial infection
• Chronic or acute bacterial blepharitis
• Bacterial keratitis or keratoconjunctivitis (non-viral)
• Post-operative ocular inflammation where infection risk is present
• Bacterial uveitis involving anterior segment

Important Off-Label / Clinically Accepted Uses:

• Sterile inflammatory ocular conditions with high risk of secondary bacterial infection, where combined corticosteroid-antibiotic therapy is justified.

Adults (including elderly):

• Instill 1 to 2 drops into the affected eye(s) 2 to 4 times daily.
• In severe cases, dosage may be increased to 1 drop every 1–2 hours, then gradually reduced as symptoms improve.
• Duration should generally not exceed 7–10 days without medical reassessment.

Pediatric Use:

• Use with extreme caution. Safety and efficacy in children under 2 years not established.
• Dosing similar to adults in children ≥2 years, with short-term use only.

Special Populations:

• Renal or Hepatic Impairment: No specific dose adjustment due to minimal systemic absorption; however, use cautiously.
• Contact Lens Wearers: Should discontinue lens use during therapy due to potential for contamination and irritation.

Route of Administration:
Topical (ophthalmic) only. Not for injection or oral use.

Fluorometholone is a synthetic glucocorticoid that inhibits multiple inflammatory cytokines, stabilizes lysosomal membranes, suppresses leukocyte infiltration, and reduces prostaglandin synthesis in ocular tissues, thereby relieving inflammation, edema, and irritation. Neomycin Sulphate is an aminoglycoside antibiotic that binds irreversibly to the 30S subunit of bacterial ribosomes, inhibiting protein synthesis and leading to cell death. Combined, they offer both anti-inflammatory and broad-spectrum antibacterial effects, particularly against gram-negative and some gram-positive organisms.

• Absorption: Minimal systemic absorption when applied topically to the eye.
• Distribution: Primarily local ocular tissue distribution; systemic exposure negligible.
• Metabolism: Fluorometholone undergoes hepatic metabolism if absorbed. Neomycin is not significantly metabolized.
• Excretion: Neomycin is excreted renally if systemically absorbed; fluorometholone metabolites are excreted in urine.
• Onset of Action: Within hours for inflammation and microbial load reduction.
• Half-life: Not clinically relevant for topical use.
• Bioavailability: Low systemic bioavailability due to limited absorption from conjunctival sac.

• Pregnancy:
  Classified as Pregnancy Category C. Animal reproduction studies have shown an adverse effect on the fetus. Use only if the potential benefit justifies the potential risk.
• Lactation:
  It is unknown whether topical ophthalmic use results in significant excretion into breast milk. Use with caution during breastfeeding, especially with prolonged therapy or damaged ocular epithelium.

• Primary Class: Corticosteroid + Antibiotic (Ophthalmic Combination)
• Subclasses:
• Corticosteroid – Glucocorticoid (Fluorometholone)
• Antibiotic – Aminoglycoside (Neomycin Sulphate)

• Hypersensitivity to fluorometholone, neomycin, or any component of the formulation.
• Viral eye infections, especially herpes simplex keratitis (dendritic keratitis).
• Fungal or mycobacterial infections of the eye.
• Vaccinia, varicella, or other viral infections involving the cornea or conjunctiva.
• Perforated ocular globe or suspected epithelial damage, which increases systemic absorption.

• Prolonged use may increase intraocular pressure (IOP), leading to glaucoma or optic nerve damage.
• Risk of secondary ocular infections, especially fungal, due to corticosteroid-induced immunosuppression.
• Delayed wound healing and corneal thinning in predisposed patients.
• Monitor for signs of hypersensitivity or allergic reactions; discontinue if present.
• Not recommended for undifferentiated red eye or without bacterial infection confirmation.
• Use with caution in pediatric patients, as corticosteroids may affect ocular development.
• Neomycin may cause contact sensitization or ototoxicity if absorbed systemically in large amounts.

Common (≥1%):

• Eye discomfort or irritation
• Transient burning or stinging
• Blurred vision after instillation
• Dryness or foreign body sensation

Less Common:

• Increased intraocular pressure
• Superficial punctate keratitis
• Eyelid swelling or erythema

Serious / Rare:

• Secondary fungal or viral eye infections
• Cataract formation (with prolonged use)
• Optic nerve damage
• Anaphylactic reaction (rare but possible)
• Hypersensitivity to neomycin, manifesting as swelling, itching, or erythema

• Avoid concurrent topical ocular NSAIDs: May increase risk of corneal complications.
• Systemic aminoglycosides (e.g., gentamicin): Potential for cumulative toxicity if neomycin is absorbed.
• Live vaccines (e.g., varicella): Avoid during systemic corticosteroid exposure.
• CYP450: Fluorometholone does not significantly affect CYP enzymes due to limited systemic exposure.
• No significant food or alcohol interactions with ophthalmic use.

• FDA & EMA emphasize limiting duration of combination corticosteroid-antibiotic eye preparations to prevent microbial resistance and steroid-related complications.
• Recent clinical guidelines recommend avoiding empirical use of steroid-antibiotic combos in undiagnosed red eyes.
• Emphasis on routine IOP monitoring in patients receiving treatment longer than 10 days.

• Store below 25°C (77°F).
• Do not freeze.
• Protect from light and moisture.
• Shake well before use.
• Discard 28 days after opening the bottle to avoid contamination.
• Keep out of reach of children.