FML Forte (fluorometholone ophthalmic suspension) 0.25% is a high-potency topical corticosteroid formulated for the management of significant inflammatory conditions of the eye. It is specifically indicated for steroid-responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe. This formulation provides a concentrated anti-inflammatory effect, targeting severe ocular surface diseases where a standard potency steroid may be insufficient. Its use is reserved for cases demanding robust control of the inflammatory cascade to prevent tissue damage and preserve vision.

Features

• Active Ingredient: Fluorometholone 0.25% (2.5 mg/mL)
• Dosage Form: Sterile, preserved ophthalmic suspension
• Potency: High-potency corticosteroid
• Presentation: Typically supplied in a 5 mL or 10 mL dropper bottle
• Mechanism: Inhibits the inflammatory response to a variety of agents by suppressing edema, fibrin deposition, capillary dilation, and phagocytic migration.

Benefits

• Delivers potent anti-inflammatory action to rapidly control severe ocular surface and anterior segment inflammation.
• Helps reduce the risk of sight-threatening complications associated with unchecked intraocular inflammation, such as synechiae formation or macular edema.
• Aids in alleviating patient symptoms of pain, photophobia, redness, and blurred vision caused by significant inflammatory processes.
• Provides a critical tool for ophthalmologists in managing postoperative inflammation following complex ocular surgeries.
• Formulated as a suspension for enhanced corneal contact time, promoting sustained therapeutic effect at the site of action.

Common use

FML Forte is prescribed for the short-term treatment of severe steroid-responsive inflammatory conditions of the eye. Its primary applications include the management of significant corneal injury from chemical burns or trauma, severe allergic conjunctivitis unresponsive to milder agents, and intense anterior uveitis (iritis). It is also a cornerstone in managing postoperative inflammation following intraocular surgery, such as cataract extraction or glaucoma filtering procedures, where controlling the inflammatory response is critical for surgical success and visual recovery. Its use is typically initiated by an ophthalmologist following a comprehensive slit-lamp examination to confirm a diagnosis warranting such potent therapy.

Dosage and direction

The dosage of FML Forte may vary significantly based on the severity of the inflammatory condition. It is imperative to use this medication exactly as prescribed by an ophthalmologist.

1. Shake the bottle well for at least 10 seconds before each use to ensure a uniform suspension.
2. Instill 1 drop into the conjunctival sac of the affected eye(s) 2 to 4 times daily. In cases of extremely severe inflammation, dosing may be initiated as frequently as every hour during waking hours, under strict medical supervision, with a rapid taper.
3. To avoid contamination, do not touch the dropper tip to any surface, including the eye, fingers, or eyelid.
4. If using more than one type of ophthalmic medication, administer them at least 5 to 10 minutes apart. Ointments should always be administered last.
5. Duration of therapy is strictly determined by the prescribing physician. Treatment should not be abruptly discontinued; a gradual tapering of the dose is often necessary to prevent rebound inflammation.

Precautions

• Ophthalmologist Supervision Required: FML Forte is a potent medication that must be used under the close supervision of an ophthalmologist. Intraocular pressure (IOP) should be monitored frequently (e.g., every 2-4 weeks initially) during treatment.
• Prolonged Use: Extended use may lead to glaucoma, damage to the optic nerve, defects in visual acuity and fields of vision, or posterior subcapsular cataract formation.
• Infection: Use in the presence of viral diseases of the cornea and conjunctiva (e.g., epithelial herpes simplex keratitis, vaccinia, varicella) is contraindicated. Corticosteroids may mask signs of infection or enhance existing infection. Fungal infections of the cornea are particularly prone to develop coincidentally with long-term local steroid application.
• Perforation: In those diseases causing thinning of the cornea or sclera, perforation has been known to occur with the use of topical steroids.
• Contact Lenses: Soft contact lenses should not be worn during treatment with this preserved suspension.

Contraindications

FML Forte is contraindicated in patients with:

• Most viral diseases of the cornea and conjunctiva, including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella.
• Mycobacterial infection of the eye.
• Fungal diseases of the ocular structures.
• Known hypersensitivity to any component of this medication (fluorometholone, benzalkonium chloride, etc.).

Possible side effect

The following adverse reactions may occur, with the risk increasing with duration of use:

• Increased intraocular pressure (IOP): This is the most common serious side effect, which may lead to glaucoma and optic nerve damage.
• Posterior subcapsular cataract formation.
• Delayed wound healing.
• Secondary ocular infections from pathogens including viruses, fungi, and bacteria.
• Ocular: Transient burning or stinging upon instillation, blurred vision, ptosis, conjunctival erythema, punctate keratitis, and mydriasis.
• Systemic effects are rare but possible with significant absorption.

Drug interaction

• While formal interaction studies are limited, systemic effects, though rare, could theoretically interact with other corticosteroid therapies a patient may be receiving.
• Inform your ophthalmologist of all medications you are using, including prescription, over-the-counter, vitamins, and herbal products.

Missed dose

If a dose is missed, instill it as soon as you remember. However, if it is almost time for the next scheduled dose, skip the missed dose and resume the regular dosing schedule. Do not instill a double dose to make up for a missed one.

Overdose

Topical overdose is unlikely to cause life-threatening systemic effects. Ocular overdose may be flushed from the eye(s) with warm tap water. In case of accidental ingestion, seek medical attention or contact a Poison Control center immediately.

Storage

• Store at controlled room temperature, 20°-25°C (68°-77°F).
• Protect from light and freezing.
• Keep the bottle tightly closed when not in use.
• Discard the medication within 28 days of first opening the bottle to prevent contamination and loss of potency.

Disclaimer

This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your ophthalmologist or other qualified health provider with any questions you may have regarding a medical condition or medication. Never disregard professional medical advice or delay in seeking it because of something you have read here. The prescribing information provided by the manufacturer is the ultimate authority on the safe and effective use of this product.

Reviews

• “As a corneal specialist, FML Forte is an indispensable tool in my arsenal for managing severe chemical burns and recalcitrant anterior uveitis. Its potency allows for rapid control of inflammation, which is often sight-saving. IOP monitoring is, of course, non-negotiable.” – Dr. A. Reynolds, MD
• “Prescribing this medication requires a strong doctor-patient relationship built on trust and adherence to follow-up. The results in controlling post-operative inflammation after complex vitreoretinal surgery are excellent, but the risks mandate extreme vigilance.” – Dr. M. Ito, FACS
• “For patients with severe allergic eye disease that does not respond to standard treatments, a short, sharp course of FML Forte under close supervision can break the cycle of inflammation and provide immense relief. The key is the ‘short course’ and ‘close supervision’.” – Dr. S. Chen, OD