Metalone0.1%

Fluorometholone acetate ophthalmic suspension is a topical corticosteroid used for the treatment of steroid-responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the eye.

Contains Metalone 0.1% 0.1% as the active ingredient in a sterile ophthalmic suspension.

Fluorometholone acetate is a topical corticosteroid eye drop used to reduce inflammation of the surface and front part of the eye, such as after eye surgery or injury, or in inflammatory eye conditions where a steroid is appropriate. It is for ophthalmic use only and is not for injection. As with all topical eye steroids, it should only be used under a doctor's diagnosis and supervision, since steroids can worsen certain eye infections.

Therapeutic Class: Ophthalmic Corticosteroid

Fluorometholone acetate is formulated to enhance corneal penetration compared to some other fluorometholone preparations. Corticosteroids inhibit the inflammatory response to a variety of inciting agents, suppressing oedema, fibrin deposition, capillary dilation, leukocyte migration, capillary proliferation, fibroblast proliferation, and scar formation associated with inflammation, but may also delay or slow healing.

• Shake the suspension well immediately before each use
• Wash hands before use
• Tilt the head back, gently pull down the lower eyelid to form a pocket, and instill the prescribed number of drops
• Avoid touching the dropper tip to the eye or any surface, to prevent contamination
• Remove contact lenses before instillation, if applicable, per your doctor's advice

Systemic absorption from topical ophthalmic use is generally limited, so significant systemic drug interactions are uncommon with normal use. If other eye medicines are used at the same time, doses should be spaced apart, and any concerns should be discussed with a doctor or pharmacist.

Common side effects

• Eye stinging or burning on instillation
• Blurred vision (transient)
• Eye discomfort or foreign body sensation
• Altered taste (dysgeusia), reported post-marketing

Serious side effects with prolonged use

• Raised intraocular pressure, which can lead to glaucoma and optic nerve damage
• Posterior subcapsular cataract formation
• Defects in visual acuity and visual field
• Delayed wound healing and increased risk of secondary ocular infection, including fungal infection
• Cushing's syndrome and adrenal suppression, reported rarely with very frequent use, particularly in young children

Pregnancy

There are limited data on the use of Metalone 0.1% ophthalmic suspension in pregnant women. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus, as advised by a doctor.

Breastfeeding

Systemically administered corticosteroids appear in human milk, but it is not established whether topical ophthalmic use results in clinically significant amounts in breast milk. Caution is advised, and use should be discussed with a healthcare professional.

• Prolonged use may result in raised intraocular pressure and glaucoma with optic nerve damage; intraocular pressure should be checked frequently if this product is used for 10 days or longer.
• Prolonged use may also increase the risk of posterior subcapsular cataract formation.
• Use of ocular steroids may prolong the course and worsen the severity of many viral eye infections, including herpes simplex; use in the treatment of herpes simplex keratitis requires great caution.
• Corticosteroids can suppress the host immune response, increasing the risk of secondary ocular infection, including fungal infection, particularly with extended use; fungal infection should be suspected in any persistent corneal ulceration where a steroid has been used.
• Not more than the initial prescribed quantity should be used without further examination of the patient by a physician.

Topical ophthalmic overdose is uncommon but excessive or prolonged use increases the risk of steroid-related eye effects described above. If the medicine is accidentally swallowed, or a large amount is applied, seek medical advice. Stop use and consult a doctor if irritation or symptoms worsen.

Store as directed on the product label, typically at controlled room temperature, tightly closed when not in use. Do not use after the labeled expiry date; discard any unused portion after the manufacturer's specified in-use period once opened.

• Elderly: No specific dose adjustment is generally required, but monitor for intraocular pressure changes with prolonged use, as in any patient.
• Young children: Cushing's syndrome and adrenal suppression have been reported rarely with very frequent use of topical ophthalmic corticosteroids, particularly in young children; use the lowest effective dose and duration.

Treatment duration depends on clinical response and is determined by the prescribing doctor. Because prolonged corticosteroid use increases the risk of raised eye pressure and cataract, this medicine is generally not intended for extended, uninterrupted use, and intraocular pressure should be checked if treatment continues for 10 days or longer. In chronic conditions, withdrawal of treatment should be carried out gradually rather than stopped abruptly.

Drug Class: Topical ophthalmic glucocorticoid

Fluorometholone acetate works by suppressing the local inflammatory response in ocular tissue, reducing swelling, redness, and discomfort caused by inflammation. There is no single, fully accepted explanation for how ocular corticosteroids achieve this effect, but their action is broadly similar to corticosteroids used elsewhere in the body.

Fluorometholone acetate is used in children 2 years and older, generally following the same dosing pattern as adults, with the lowest effective dose and duration used under a doctor's supervision, given the reported (rare) risk of adrenal suppression with very frequent use in young children.