FML

Fluorometholone (0.1% w/w)
Price: ₹180 - ₹220 for 5ml
Mfr: Allergan (now AbbVie) | Form: Ophthalmic Suspension

📋 Clinical Overview

Fluorometholone (0.1% w/w) is a potent, medium-strength synthetic glucocorticoid (corticosteroid) formulated for topical ophthalmic use. It is a fluorinated derivative of prednisolone, designed to provide anti-inflammatory, anti-allergic, and anti-proliferative effects on the ocular surface and anterior segment of the eye. Its fluorination enhances its lipophilicity, allowing for better corneal penetration compared to some non-fluorinated steroids, while its esterification (typically as acetate) contributes to its potency. It is a mainstay in Indian ophthalmology for managing a variety of inflammatory and allergic conditions, offering a favorable balance between efficacy and a relatively lower propensity to raise intraocular pressure (IOP) compared to more potent steroids like dexamethasone or prednisolone acetate, though it is not devoid of this risk.

💊 Dosage & Administration

Adult: One drop into the conjunctival sac of the affected eye(s) 2 to 4 times daily. In severe inflammation, dosing may be initiated every 1-2 hours during waking hours, then tapered. Do not discontinue abruptly; taper frequency over 7-14 days.

Note: 1. Wash hands. 2. Tilt head back. 3. Gently pull lower eyelid down to form a pouch. 4. Instill prescribed number of drops without touching the dropper tip to eye, fingers, 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.

⚠️ Contraindications

  • Active viral infections of the cornea and conjunctiva (e.g., Herpes Simplex Keratitis, Varicella, Vaccinia)
  • Active fungal infections of the eye
  • Active mycobacterial (tubercular) ocular infections
  • Hypersensitivity to Fluorometholone or any component of the formulation

🔬 Mechanism of Action

Fluorometholone binds to cytoplasmic glucocorticoid receptors (GR) in target ocular cells (conjunctival, corneal, and anterior uveal tissues). The drug-receptor complex translocates to the nucleus, where it modulates gene transcription. It induces the synthesis of anti-inflammatory proteins (lipocortins) while inhibiting the transcription of genes encoding for pro-inflammatory mediators such as phospholipase A2, cyclooxygenase-2 (COX-2), various cytokines (IL-1, IL-2, IL-6, TNF-α), and adhesion molecules. This results in stabilization of lysosomal membranes, inhibition of leukocyte migration, and suppression of capillary dilation and permeability.

🤕 Side Effects

  • Transient Ocular Stinging/Burning upon instillation
  • Blurred Vision temporarily after application
  • Watery Eyes
  • Mild Ocular Discomfort

🤰 Special Populations

Pregnancy: Pregnancy Category C (US FDA). Animal studies show fetal harm. No adequate, well-controlled studies in pregnant women. Should be used only if the potential benefit justifies the potential risk to the fetus. Topical use minimizes systemic exposure.

Driving: May cause temporary blurred vision after instillation. Patients should not drive or operate machinery until vision clears.

🔄 Drug Interactions

Other Ocular CorticosteroidsAdditive risk of IOP elevation, cataract, and infection.Major
Acetazolamide, Dorzolamide, Timolol (Antiglaucoma drugs)Fluorometholone may counteract IOP-lowering effect, requiring dose adjustment.Moderate
Cyclosporine (ophthalmic)Potential additive immunosuppression; may be used together under supervision for specific conditions.Moderate
NSAIDs (e.g., Ketorolac tromethamine eye drops)Increased risk of corneal adverse events (ulceration, perforation), especially post-surgery.Major
Systemic CYP3A4 Inducers (e.g., Rifampicin, Phenytoin, Carbamazepine)May increase metabolism of systemically absorbed fluorometholone, potentially reducing efficacy.Minor

🔁 Alternatives to FML

Same composition (Fluorometholone (0.1% w/w)), different brands:

Flarex Flumet Flucon Ocu-Metholone Flurone