FML

1. Name Of The Medicinal Product

FML Liquifilm Ophthalmic Suspension

2. Qualitative And Quantitative Composition

Fluorometholone 0.10% w/v

3. Pharmaceutical Form

Sterile Ophthalmic Suspension

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 Posology And Method Of Administration

Route of administration: topical ophthalmic administration.

Adults: One to two 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.

Children: Not recommended for children aged two and under.

4.3 Contraindications

Acute superficial herpes simplex (dendritic) keratitis, vaccinia, varicella and most other viral diseases of the conjunctiva and cornea. Ocular tuberculosis. Fungal diseases of the eye. Hypersensitivity to any of the constituents of the medication.

4.4 Special Warnings And Precautions For Use

Steroid medication in the treatment of herpes simplex keratitis (involving the stroma) requires great caution: frequent slit-lamp microscopy is mandatory. 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 tissue.

In those diseases causing thinning of the cornea or sclera, perforation has been known to occur with use of topical steroids.

Safety and effectiveness have not been demonstrated in children of the age group two years or below.

This preparation contains benzalkonium chloride and should not be used by patients continuing to wear soft (hydrophilic) contact lenses.

As fungal infections of the cornea are particularly prone to develop coincidentally with long term local steroid applications, fungus invasion must be suspected in any persistent corneal ulceration where a steroid has been or is in use.

Intraocular pressure should be checked frequently.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

There is inadequate evidence of safety in human pregnancy. Administration of corticosteroids to pregnant animals can cause abnormalities of foetal development including cleft palate and intra-uterine growth retardation. There may therefore be a very small risk of such effects in the human foetus.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Glaucoma with optic nerve damage, visual acuity or field defects, posterior subcapsular cataract formation, secondary ocular infection from pathogens liberated from ocular tissues, perforation of the globe.

Local side-effects of steroid therapy, i.e. skin atrophy, striae and telangiectasia, are especially likely to affect facial skin.

4.9 Overdose

Not likely to occur.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

FML is a synthetic adrenocorticosteroid (glucocorticoid), a derivative of desoxyprednisolone. It forms part of a well-known group of steroids used to treat ocular inflammation. Glucocorticosteroids complex with cytoplasmic receptors and subsequently stimulate synthesis of proteins with anti-inflammatory effects. They inhibit early phenomena of the inflammatory response (oedema, fibrin deposition, capillary dilation, phagocytic migration) as well as capillary proliferation, collagen deposition and scar formation.

Whilst topical corticosteroid therapy frequently increases intraocular pressure in normal eyes and in ocular hypertensive subjects, fluorometholone has a substantially lower propensity to elevate IOP than, for example, dexamethasone.

5.2 Pharmacokinetic Properties

Topical application of a 0.1% tritium-labelled-fluorometholone suspension gave rise to peak radioactivity levels in the aqueous humour 30 minutes post-instillation. A high concentration of rapidly-produced metabolite was found both in aqueous humour and corneal extracts, indicating that fluorometholone undergoes metabolic change as it penetrates into the cornea and aqueous humour.

5.3 Preclinical Safety Data

No information.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Polyvinyl alcohol

Benzalkonium chloride

Edetate Disodium

Sodium chloride

Sodium phosphate, dibasic, heptahydrate

Sodium phosphate, monobasic, monohydrate

Polysorbate 80

Sodium hydroxide to adjust pH

Purified water

6.2 Incompatibilities

None known.

6.3 Shelf Life

36 months unopened.

28 days after first opening.

6.4 Special Precautions For Storage

Do not store above 25°C. Do not freeze.

6.5 Nature And Contents Of Container

5 ml and 10 ml bottles and dropper tips composed of low density polyethylene. Caps are impact polystyrene.

6.6 Special Precautions For Disposal And Other Handling

No information.

7. Marketing Authorisation Holder

Allergan Ltd

The Parkway

Marlow International

Marlow

Bucks

SL7 1YL

UK

8. Marketing Authorisation Number(S)

PL 00426/0028

9. Date Of First Authorisation/Renewal Of The Authorisation

15^th July 2003

10. Date Of Revision Of The Text

20^th December 2007