FML^®

MIMS Revision Date: 01 August 2024

1 Name of Medicine

FML - fluorometholone 1 mg/mL eye drops.

2 Qualitative and Quantitative Composition

FML eye drops contain fluorometholone 1 mg/mL (0.1%).
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

A topical anti-inflammatory glucosteroid eye drop.

4 Clinical Particulars

4.1 Therapeutic Indications

For steroid responsive inflammation of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe.

4.2 Dose and Method of Administration

Bottle should be shaken before use.
1 to 2 drops instilled into the conjunctival sac two to four times daily. During the initial 24 to 48 hours, the dosage may be safely increased to 2 drops every hour. Care should be taken not to discontinue therapy prematurely.
In order to minimise systemic absorption of FML eye drops, apply pressure to the tear duct immediately following administration of the drug.

4.3 Contraindications

FML is contraindicated in patients with:
acute superficial (or epithelial) herpes simplex keratitis (dendritic keratitis);
fungal diseases of ocular structures;
vaccinia, varicella, mycobacterial infection of the eye and most other viral diseases of the cornea and conjunctiva;
tuberculosis of the eye;
hypersensitivity to the constituents of this medication.

4.4 Special Warnings and Precautions for Use

Steroid medication in the treatment of patients with a history of herpes simplex keratitis requires great caution. Frequent slit lamp microscopy is mandatory (see Section 4.3 Contraindications).
Eye drops containing a corticosteroid should not be used for more than 10 days except under strict ophthalmic supervision with regular checks for intraocular pressure.
Prolonged use may cause increased intraocular pressure in susceptible individuals, resulting in glaucoma, with damage to the optic nerve, defects in visual acuity and fields of vision; posterior subcapsular cataract formation and delayed wound healing; or may aid in the establishment of secondary ocular infections from fungi or viruses liberated from ocular tissues. Steroids should be used with caution in the presence of glaucoma; intraocular pressure should be checked frequently.
Various ocular diseases and long-term use of topical corticosteroids have been known to cause corneal and scleral thinning. Use of topical corticosteroids in the presence of thin corneal or scleral tissue may lead to perforation.
Acute purulent untreated infection of the eye may be masked or activity enhanced by the presence of steroid medication.
As fungal infections of the cornea are particularly prone to develop coincidentally with long-term local steroid application, fungal invasion must be suspected in any persistent corneal ulceration where a steroid has been used or is in use. Fungal cultures should be taken when appropriate.
Intraocular pressure should be checked frequently.
Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, consider evaluating for possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.
Information for patients. To prevent eye injury or contamination, care should be taken to avoid touching the bottle tip to the eye or to any other surface. The use of the bottle by more than one person may spread infection. Keep the bottle tightly closed when not in use. Keep out of the reach of children.
The preservative in FML, benzalkonium chloride, may be absorbed by and cause discolouration of soft contact lenses. Patients wearing soft contact lenses should be instructed to remove contact lenses prior to administration of the solution and wait at least 15 minutes after instilling FML before reinserting soft contact lenses.
Use in the elderly. No data available.
Paediatric use. Safety and effectiveness have not been demonstrated in children under 2 years of age.
Effects on laboratory tests. No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Although the systemic exposure is expected to be low with topical ophthalmic corticosteroid administration, co-treatment with CYP3A inhibitors may increase the risk of systemic corticosteroid-related side-effects.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility. No data available.
Use in pregnancy. (Category B3)
There are no adequate well-controlled studies in pregnant women. Fluorometholone has been shown to be teratogenic, fetotoxic and embryocidal in rabbits when given in doses approximating the human dose and above. Safety of the use of topical steroids during pregnancy has not been established. Fluorometholone was ocularly applied to both eyes of pregnant rabbits on days 6 to 18 of gestation. A significant dose-related increase in foetal abnormalities and in foetal loss was observed.
FML should be used with caution during pregnancy only if the potential benefit outweighs the potential risk to the foetus.
Use in lactation. It is not known whether topical ophthalmic administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Because of the potential for serious adverse reactions in nursing infants from fluorometholone, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

4.7 Effects on Ability to Drive and Use Machines

As with any ocular medication, if transient blurred vision occurs at instillation, the patient should wait until the vision clears before driving or using machinery.

4.8 Adverse Effects (Undesirable Effects)

Immune system disorders. Hypersensitivity.
Gastro-intestinal disorders. Dysgeusia.
Eye disorders. Elevation of intraocular pressure (IOP) with possible development of glaucoma, and optic nerve damage, loss of visual acuity or defects in fields of vision, eye irritation, conjunctival/ocular hyperaemia, eye pain, visual disturbances, foreign body sensation, eyelid oedema, eyelid ptosis, blurred vision, eye discharge, eye pruritus, lacrimation increased, eye oedema/eye swelling, mydriasis, cataract (including posterior subcapsular cataract formation), ulcerative keratitis, ocular infection (including bacterial, fungal and viral infections) and punctate keratitis. The following have also been reported after the use of topical corticosteroids: secondary ocular infection from pathogens liberated from ocular tissues, perforation of the globe where there is thinning of the cornea or sclera.
Cases of corneal calcification have been reported very rarely in association with the phosphate component of FML in some patients with significantly damaged corneas.
Skin and subcutaneous tissue disorders. Rash and delayed wound healing.
General disorders and administrative site disorders. Rare occurrences of systemic hypercorticoidism.
Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.9 Overdose

Should an excess amount of drops be inadvertently administered, flush the eyes with water.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action. Inhibition of the inflammatory response to inciting agents of mechanical, chemical or immunological nature. No generally accepted explanation of this steroid property has been advanced. However, corticosteroids are thought to act by the induction of phospholipase A₂ inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A₂. Corticosteroids are capable of producing a rise in intraocular pressure. In clinical studies on patient's eyes treated with both dexamethasone and fluorometholone suspensions, fluorometholone demonstrated a lower propensity to increase intraocular pressure than dexamethasone.
Clinical trials. No data available.

5.2 Pharmacokinetic Properties

No data available.

5.3 Preclinical Safety Data

Genotoxicity. No data available.
Carcinogenicity. No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Liquifilm (polyvinyl alcohol) 1.4%, benzalkonium chloride 0.004%, disodium edetate, sodium chloride, monobasic sodium phosphate, dibasic sodium phosphate heptahydrate, polysorbate 80, purified water and sodium hydroxide if needed to adjust pH.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

18 months.
Discard unused contents 4 weeks after opening.
Contents are sterile if seal is intact.

6.4 Special Precautions for Storage

Store below 30°C. Protect from freezing. Store upright.

6.5 Nature and Contents of Container

A sterile suspension in 5 mL plastic dropper bottles.
AUST R 23212.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Chemical structure.

Chemical name: 9-fluoro-11β,17-dihydroxy-6α-methyl pregna-1,4-diene-3,20-dione.
Empirical formula: C₂₂H₂₉FO₄.
CAS number. 426-13-1.

7 Medicine Schedule (Poisons Standard)

S4: Prescription Only Medicine.

Date of First Approval

10 October 1991

Date of Revision

01 July 2024

Summary Table of Changes