- ANTI-INFLAMMATORY AGENTS
- OPHTHALMOLOGICAL DRUGS
- Pharmaceutical Form : Sterile Ophthalmic Suspension
- Composition : Each 1 mL contains 1mg of Fluorometholone.
- Active Substance : Sterile Ophthalmic Suspension
Fluorometholone is a synthetic corticosteroid (glucocorticoid), a derivative of desoxyprednisolone. It is a member of the group of universally known steroids used for the treatment of eye inflammation.
When tritium-labelled FLORA 0.1% suspension was administered locally, the peak concentration of the radioactive substance in aqueous humour was achieved 30 minutes after administration. A rapidly forming metabolite occurred at high concentrations both in aqueous humour and corneal extracts, which shows that fluorometholone is metabolised to a certain extent while penetrating the cornea and aqueous humour.
For corticosteroid responsive inflammation of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe.
Hypersensitivity to the active substance or to any of the excipients.
Fluorometholone is contraindicated in most viral diseases of the cornea and conjunctiva, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, as well as mycobacterial and untreated bacterial infection of the eye and fungal diseases of ocular structures, and any undiagnosed ‘red eye’ as this may indicate a viral infection.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
- Acute purulent infections of the eye may be masked or enhanced by the use of topical steroids. FLORA 0.1% contains no antimicrobial agent. If infection is present, appropriate measures must be taken to counteract the infective organisms.
- Prolonged use may also suppress the host immune response and thus increase the hazard of secondary ocular infections.
- Fungal infections of the cornea have been reported coincidentally with long-term steroid application and fungal invasion may be suspected in any persistent corneal ulceration where a steroid has been used, or is in use.
- Various ocular diseases and long-term use of topical corticosteroids have been known to cause corneal or scleral thinning. Use of topical corticosteroids in the presence of thin corneal or scleral tissue may lead to perforation.
- The preservative in the product, benzalkonium chloride, may be absorbed by and cause discoloration 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 Fluorometholone before reinserting soft contact lenses.
- Use of intraocular steroids may prolong the course and may exacerbate the severity of many viral infections on the eye (including herpes simplex). Patients with a history of herpes simplex keratitis should be treated with caution. Use of steroid medication in the presence of stromal herpes simplex requires caution and should be followed by frequent, mandatory, slitlamp microscopy.
- Prolonged use of topical corticosteroids may cause an increase in intraocular pressure in certain individuals. This may result in glaucoma with damage to the optic nerve with resultant defects in visual acuity and visual fields. Steroids should be used with caution in the presence of glaucoma. It is advisable that intraocular pressure be checked frequently during treatment with Fluorometholone.
- Eye drops containing corticosteroids should not be used for more than 10 days except under strict ophthalmic supervision with regular checks for intraocular pressure.
- Posterior subcapsular cataract formation has been reported after heavy or protracted use of topical ophthalmic corticosteroids.
- The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation.
- Systemic adverse events may occur with extensive use of topical steroids; punctal occlusion may be recommended.
- The possibility of adrenal suppression should be considered with prolonged, frequent, use of high dose topical steroids, particularly in infants and children.
- To prevent eye injury or contamination, care should be taken to avoid touching the bottle tip to the eye or to any other surface.
No interaction studies have been performed.
Co-treatment with CYP3A inhibitors, including cobicistat-containing products, is expected to increase the risk of systemic side-effects. The combination should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side-effects, in which case patients should be monitored for systemic corticosteroid side-effects.
There are no or limited amount of data from the use of fluorometholone in pregnant women.
Studies in animals have shown reproductive toxicity.
Fluorometholone is not recommended during pregnancy.
It is unknown whether fluorometholone is excreted in human milk. Fluorometholone should not be used during breast-feeding.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES:
Fluorometholone has no influence on the ability to drive or use machines. However, instillation of any eye drop could result in transient blurring of vision. If this occurs, the patient should wait for the blurring to subside before driving or operating machinery or taking part in any activity where this could put themselves or others at risk.
- Immune system disorders: Hypersensitivity, Urticaria.
- Nervous system disorders:
- Eye disorders: Intraocular pressure increased, Cataract (including subcapsular), Eye penetration (scleral or corneal perforation), Foreign body sensation, Ocular infection (including bacterial, fungal, and viral infections), Ocular stinging, Eye irritation, Ocular hyperemia, Vision blurred/Visual impairment, Mydriasis.
- Gastrointestinal disorders:
- Skin and subcutaneous tissue disorder: Pruritus, Rash.
- Systemic: extensive topical use of corticosteroids may lead to systemic side effects.
DOSAGE AND ADMINISTRATION:
FLORA 0.1% is for topical ophthalmic use only, applied as drops into the conjunctival sac.
Shake FLORA 0.1% well before use.
Instil 1 – 2 drops into the conjunctival sac 2 – 4 times daily. During the first 24 to 48 hours of treatment, the dose may be safely increased to 2 drops at one hour intervals.
The treatment should not be withdrawn too early.
In chronic conditions, withdrawal of treatment should be carried out by gradually decreasing the frequency of applications.
The safety and efficacy in children aged 2 years or less has not been established.
Overdosage by the topical ophthalmic route will not ordinarily cause acute problems.
If accidental overdosage occurs in the eye, the eye should be flushed with water or normal saline. If accidentally ingested, the patient should drink fluids to dilute.
Store at 2°-25°C, protect from freezing
10 ml Plastic Bottle