FLURONE

Fluorometholone USP 0.1%

Sterile Ophthalmic Suspension

Composition

• Each ml contains Fluorometholone USP 1 mg.
• Preservative: Benzalkonium Chloride BP 0.1 mg.

Description

• It is a sterile ophthalmic suspension containing Fluorometholone - a corticosteroid for topical administration to the eyes.

Clinical Pharmacology

Fluorometholone is a corticosteroid with an excellent anti-inflammatory action with no significant influence on intraocular pressure. The anti-inflammatory activity of Fluorometholone is at least 40 times stronger than that of Hydrocortisone. Corticosteroids are thought to act by the introduction of phospholipase A2 inhibitory proteins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandin and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2. In comparison with other corticosteroids, Fluorometholone is more rapidly degraded in tissue and therefore has less effect on intraocular pressure. The immunosuppressive action of Fluorometholone is less pronounced than that of Dexamethasone.

Indications and Uses

This ophthalmic suspension is indicated for the treatment of

- Acute and chronic non-infectious conjunctivitis and keratitis of allergic origin.

- Non-infectious inflammation of the anterior chamber of the eye (including anterior uveitis, episcleritis, and scleritis).

- Post-operative irritative conditions after strabismus, cataract, and glaucoma surgery.

Dosage and Administration

• 1 drop 2-4 times daily in the conjunctival sac(s).
• During the first 24-48 hours the dosage can be increased to 1 drop hourly.

Precautions

• Corticosteroids may mask, activate, or aggravate an infection of the eye. If no improvement is seen after a few days of application, other forms of treatment should be used. Do not touch the dropper tip to any surface as this may contaminate this preparation.

Side-Effects

Elevation of intraocular pressure (IOP) with possible development of glaucoma and optic nerve damage, loss of visual acuity or defects in fields of vision, posterior subcapsular cataract formation, and delayed wound healing. The following adverse reactions may also occur - secondary ocular infection from pathogens liberated from ocular tissues and perforation of the globe where there is thinning of the cornea or sclera.

Use in Pregnancy & Lactation

• Animal experiments with Fluorometholone have shown adverse effects on the fetus. However, Fluorometholone ophthalmic suspension should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Drug Interactions

• Specific drug interaction studies have not been conducted with Fluorometholone ophthalmic suspension.

Overdosage

• Overdose through local administration is not known and not likely.

Pharmaceutical Precautions

• Store at room temperature, and protect from light and freezing. It is desirable that the contents should not be used more than one month after the first opening of the bottle. Shake well before use.

Commercial Pack

• Plastic dropper bottle of 5 ml.

Biopharma Ltd. Produces FLURONE 5 ML EYE DROPS it is a trusted product for alleviating various discomforts, and it's commonly found in pharmacies and stores.