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

Logo FLUCON® ophthalmic suspension

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

FLUCON® ophthalmic suspension

COMPOSITION:
Each mL of the suspension contains:
Fluorometholone 1 mg
Preservative: Benzalkonium chloride 0,01%

PHARMACOLOGICAL CLASSIFICATION:
A.15.2 Ophthalmic preparations with corticosteroids.

PHARMACOLOGICAL ACTION:
Fluorometholone is a synthetic glucocorticoid with a local anti-inflammatory action approximately 40 times greater than that of hydrocortisone. It inhibits the inflammatory response to inciting agents of mechanical; chemical or immunological nature. No generally accepted explanation of this steroid property has been advanced.
Corticosteroids and their derivatives are capable of producing a rise in intraocular pressure. In clinical studies on patient's eyes treated with both dexamethasone and fluorometholone, fluorometholone demonstrated a lower propensity to increase intraocular pressure than did dexamethasone.

INDICATIONS:
Flucon is indicated for steroid responsive non-infective 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.
Vaccinia, varicella and most other viral diseases of the cornea and conjunctiva.
Tuberculosis of the eye.
Bacterial infections.
Mechanical lacerations and abrasions of the eye.
Do not use in children under 2 years.
Glaucoma.

WARNINGS:
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 ophthalmological preparations cannot be excluded, regular ophthalmological 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.
SHAKE WELL BEFORE USE.
STORE UPRIGHT.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Corticosteroids delay wound healing, promote development and spread of infection and may mask evidence of its progression until sight is lost.
Perforation has been known to occur with the use of topical steroids in those diseases of the eye which cause thinning of the cornea or sclera.
Employment of steroid medication in the treatment of stromal herpes simplex requires great caution: frequent slit lamp microscopy is mandatory. Steroid medication may give rise to serious exacerbations of herpes infections of the eye. 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 infection from pathogens liberated from ocular tissue.
As fungal infections of the cornea are particularly prone to develop coincidentally with long-term topical steroid applications, fungus invasion must be suspected in any persistent corneal ulceration where a steroid has been used or is in use.
Prolonged use may give rise to the development of iatrogenic glaucoma. Intraocular pressure should be monitored frequently.
If the eye has not responded within 48 hours; the patient should be referred to an ophthalmologist because of the possiblity of inducing corneal abscess, fungal keratopathy or glaucoma.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
As for Side-effects and Special precautions above.
Discontinue use immediately.
Appropriate antimicrobial therapy should be instituted in the presence of infection.

IDENTIFICATION:
White to slight amber suspension.

PRESENTATION:
Plastic dropper bottle containing 5 mL.

STORAGE INSTRUCTIONS:
Keep in a cool place below 25°C, protect from light.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
N/15.2/16

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Alcon Laboratories (S.A.) (Pty) Ltd.
Surrey Avenue
RANDBURG 2194

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
20 July 1981
34351-F

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