INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo FML Liquifilm Sterile Eye Suspension
SCHEDULING STATUS:
Schedule 4

PROPRIETARY NAME
(and dosage form):

FML Liquifilm Sterile Eye Suspension

COMPOSITION
FML Liquifilm Sterile Eye Suspension contains:
        Fluorometholone 1,0 mg/mL
        Liquifilm® (polyvinyl alcohol) 14 mg/mL
Preservative:
        Benzalkonium chloride 0,004% m/v

PHARMACOLOGICAL CLASSIFICATION
A 15.2 Opthalmic preparations with corticosteroids.

PHARMACOLOGICAL ACTION
Fluorometholone is an anti-inflammatory steroid. Glucocorticoids inhibit the oedema, fibrin deposition, capillary dilation, and phagocytic migration of the acute inflammatory response as well as capillary proliferation, depostion of collagen and scar formation. Adrenocorticoids and their derivatives are capable of producing a rise in intraocular pressure.

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

CONTRA-INDICATIONS
Acute superficial herpes simplex keratitis. Fungal diseases of ocular structures. Vaccina, varicella and most other viral diseases of the cornea and conjunctiva. Tuberculosis of the eye. Hypersensitivity to the constituents of this medication.

WARNING
As the possibility of adverse effects on the corneal permeability and the danger of disruption of the corneal epithelium with prolonged or repeated usage of benzalkonium chloride preserved ophthalmologic preparations cannot be excluded, regular ophthalmologic examination is required.
Caution should be exercised in the use of benzalkonium chloride preserved topical medication over an extended period in patients with extensive ocular surface disease.

DOSAGE AND DIRECTIONS FOR 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.

SIDE EFFECTS AND SPECIAL PRECAUTIONS
Steroid medication in the treatment of herpes simplex (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 and 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. Acute purulent untreated infection of the eye may be masked or activity enhanced by presence of steroid medication.
Not to be used in children under 2 years. Safety of intensive or protracted use of topical steroids during pregnancy has not been established.
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 used or is in use. Intraocular pressure should be checked frequently.

KNOW SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
Refer to ‘Side Effects and Special Precautions’listed above.

IDENTIFICATION
A milky white, slightly viscous microfine suspension.

PRESENTATION
FML Sterile Eye Suspension is supplied in sterile dropper bottles containing 5 ml suspension.

STORAGE INSTRUCTIONS
Store below 25ºC. Do not freeze. Store in an upright position. Do not use for longer than 30 days after opening. KEEP OUT OF REACH OF CHILDREN. Shake well before use.

REGISTRATION NUMBER
J/15.2/327

NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION
Allergan Pharmaceuticals (Pty) Ltd.
30 New Road (entrance off Bavaria Road)
Randjespark Ext 11, Midrand, 1682
Johannesburg, Gauteng
SOUTH AFRICA

DATE OF PUBLICATION OF THIS PACKAGE INSERT
5 August 1977

Updated on this site: July 2008
Source: Pharmaceutical Industry

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