FML Forte

FML (Fluorometholone) Forte is a topical drug that belongs to the corticosteroid group of medicines. Its aim is to cure various eye problems connected with injury and inflammation. It is effective in case of bulbar conjunctiva and palpebral conjunctiva. The suspension remedies eye swelling, itching, irritation, and redness. These eye drops are not recommended to people who wear contact lenses daily. If a patient must use the drops, it’s necessary to replace contact lenses with glasses or just not to wear them during the medication.

Product dosage: 5ml
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FML Forte (fluorometholone ophthalmic suspension) 0.1% is a high-potency topical corticosteroid formulated for the management of significant steroid-responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe. It is specifically indicated for cases where a standard potency steroid is deemed insufficient to achieve the desired therapeutic response. Its enhanced formulation is designed to provide superior anti-inflammatory and immunosuppressive activity, making it a cornerstone in post-surgical care and the treatment of severe ocular surface diseases. This product card provides a comprehensive, expert-level overview for healthcare professionals to ensure safe and effective prescribing and patient counseling.

Features

• Active Ingredient: Fluorometholone 0.1%
• Dosage Form: Sterile, preserved ophthalmic suspension
• Potency: Forte (strong) formulation
• Presentation: Typically supplied in a 5 mL or 10 mL plastic dropper bottle
• Mechanism: Corticosteroid that inhibits the inflammatory response to inciting agents, potentially by generating lipocortins, which control the biosynthesis of potent mediators of inflammation like prostaglandins and leukotrienes.

Benefits

• Delivers high-potency anti-inflammatory action to rapidly control severe ocular inflammation, reducing patient discomfort and risk of tissue damage.
• Effectively manages pain, photophobia, and blurred vision associated with significant inflammatory events, accelerating a return to normal visual function.
• Aids in improving post-surgical outcomes by minimizing inflammatory sequelae that can compromise surgical results, such as corneal haze or synechiae formation.
• Provides a critical therapeutic option for flare-ups of chronic, steroid-responsive conditions like vernal keratoconjunctivitis or certain forms of uveitis.
• The suspension formulation is designed for optimal ocular surface residence time, enhancing drug bioavailability at the site of action.

Common use

FML Forte is commonly prescribed for the treatment of a variety of severe steroid-responsive inflammatory conditions of the eye. Its primary use is in the post-operative period following ocular surgery (e.g., cataract extraction, refractive surgery, glaucoma filtering surgery) to suppress inflammation and promote healing. It is also indicated for the treatment of severe forms of allergic conjunctivitis, such as vernal keratoconjunctivitis, and certain non-infectious anterior uveitis cases. Furthermore, it is used for inflammatory conditions of the cornea, including certain types of keratitis (e.g., superficial punctate keratitis), and inflammatory conditions of the conjunctiva, sclera, and episclera that have not responded adequately to lower-potency steroid preparations.

Dosage and direction

The dosage of FML Forte may vary significantly based on the severity of the inflammatory condition. One to two drops instilled into the conjunctival sac of the affected eye(s) up to four times daily is a typical starting regimen. In very severe cases, dosing may be initiated more frequently (e.g., every two hours) during the waking hours for the first 24 to 48 hours, under close medical supervision, with a rapid taper to a maintenance dose. Shake the bottle well before each use. To administer: Tilt the head back, pull down the lower eyelid to create a pouch, instill the drops, and close the eye gently. Apply light pressure to the nasolacrimal duct (the inner corner of the eye near the nose) for 1 to 2 minutes to minimize systemic absorption. Do not touch the dropper tip to any surface, including the eye, to avoid contamination.

Precautions

• Prolonged use may result in glaucoma, damage to the optic nerve, defects in visual acuity and fields of vision, posterior subcapsular cataract formation, or may aid in the establishment of secondary ocular infections from fungi or viruses liberated from ocular tissues.
• Use with extreme caution in patients with a history of herpes simplex keratitis. Corticosteroids may exacerbate the infection or potentially cause corneal perforation.
• Intraocular pressure (IOP) should be monitored frequently, even in patients without a prior history of glaucoma, as a significant percentage of the population may be steroid responders.
• Punctate keratitis or corneal perforation has been reported with the use of topical steroids.
• Bacterial, fungal, or viral infections may be masked, enhanced, or activated by the presence of the steroid. If an infection does not respond promptly to appropriate therapy, the steroid should be discontinued until the infection has been adequately controlled.
• Contact lens wearers should be advised not to wear lenses during the treatment of an inflammatory condition.

Contraindications

FML Forte is contraindicated in:

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

Possible side effect

Reactions associated with ophthalmic steroids include:

• Elevated intraocular pressure (IOP) with possible development of glaucoma and infrequent optic nerve damage.
• Posterior subcapsular cataract formation.
• Delayed wound healing.
• Secondary ocular infection from pathogens liberated from ocular tissues.
• Perforation of the globe (in diseases causing thinning of the cornea or sclera).
• Miosis, ptosis, and conjunctival erythema.
• Transient stinging or burning upon instillation.
• Blurred vision after instillation.

Drug interaction

While systemic drug interactions are less common with topical ophthalmic administration, the potential exists, especially if nasolacrimal occlusion is not practiced. No specific drug interactions with FML Forte have been identified. However, the general principles of corticosteroid therapy apply. Caution should be exercised when prescribing to patients on systemic corticosteroids or other immunosuppressive agents due to the potential for additive effects. Inform your healthcare provider of all medications you are taking, including prescription, over-the-counter, vitamins, and herbal supplements.

Missed dose

If a dose is missed, it should be instilled as soon as possible. However, if it is almost time for the next scheduled dose, the missed dose should be skipped, and the regular dosing schedule resumed. Do not double the dose to make up for the missed one.

Overdose

Overdosage by the ocular route is unlikely. Acute overdosage would likely be manifest by systemic corticosteroid effects if a significant portion of the bottle was ingested. In case of accidental ingestion, seek medical attention or contact a Poison Control Center immediately. Ocular overdose from frequent instillation may produce the side effects listed above. Treatment should be symptomatic and supportive. The eye(s) should be flushed with lukewarm water.

Storage

Store at controlled room temperature, 20°C to 25°C (68°F to 77°F). Do not freeze. Protect from light. Keep the bottle tightly closed when not in use. Discard the bottle and any remaining suspension within the timeframe specified by your pharmacist after first opening (typically 4 weeks), even if it is not empty, to prevent contamination and potential infection.

Disclaimer

This information is for educational and informational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician 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 content has been compiled from various resources believed to be accurate but cannot be guaranteed. The manufacturer’s official prescribing information should be consulted for complete details.

Reviews

• Ophthalmologist, Cornea Specialist: “FML Forte is my go-to for significant post-PRK or post-LASIK inflammation. Its potency is effective, and I find the incidence of IOP spikes to be somewhat lower compared to other potent steroids like prednisolone, though monitoring is still absolutely mandatory. An essential tool for managing severe surface disease.”
• Patient with Vernal Keratoconjunctivitis: “After trying several milder drops, my doctor prescribed FML Forte during a really bad flare-up. The itching and redness improved within a couple of days. It’s strong, but it’s the only thing that has given me real relief during peak allergy season. I understand the need for close follow-up appointments.”
• Clinical Study Excerpt: “A randomized, double-masked study comparing fluorometholone 0.1% to prednisolone acetate 1% for the control of inflammation following cataract surgery found both drugs to be effective, with a statistically comparable reduction in anterior chamber cells and flare. The study noted a favorable safety profile for the fluorometholone group.”