FML Eye Drop
Composition (Each mL Contains)
- Fluorometholone 1mg
- Benzalkonium Chloride IP 0.04mg
- Purified Water IP q.s
Fluorometholone Liquifilm Sterile Ophthalmic Solution
Action
Corticosteroids such as Fluorometholone, inhibit the inflammatory response to a variety of inciting agents. They inhibits the edema, fibrin deposition, capillary dilation, leukocyte migration, phagocytic activity, capillary proliferation, fibroblast proliferation, deposition of collagen, and scar formation associated with inflammation Corticosteroids inhibits the synthesis histamine within mast cells by blocking the action of histidine decarboxylase. Corticosteroids also decrease prostaglandin synthesis and retard epithelial regeneration Corticosteroids and their derivatives are capable of producing a rise in intraocular pressure. In clinical studies on patient’s eyes treated with both Dexamethasone 0.1% and Fluoromethalone 0.1% luorometholone demonstrated a propensity to increase intraocular pressure than did Dexamethasone.
Indication of FML Eye Drop
- For steroid responsive inflammation of conjunctiva, cornea and anterior segment of the eye.
Contraindication
- Superficial (or epithelial) herpes simplex keratitis (dendritic keratitis)
- Fungal disease of ocular structure
- Vaccinia, Varicella and most other viral disease of conjunctiva and cornea.
- Mycobacterial infection of an eye
- Hypersensitivity to any component of this drug.
WARNINGS AND PRECAUTIONS
Prolonged use may result in glaucoma, damage to the optic nerve, defects in visual acuity and fields of vision, posterior sub-capsular cataract formation, and delayed wound healing. Steroids should be used with caution in the presence of glaucoma; intraocular pressure should be checked frequently or may aid in the establishment of secondary ocular infections from fungi or viruses liberated from ocular tissue.
Eye drops containing corticosteroids should not be used for more than 10 days except under strict ophthalmic supervision with regular checks for intraocular pressure.
Use of topical corticosteroids in the presence of thin corneal or scleral tissue may lead to perforation. Prolonged use may also suppress the host immune response and thus increase the hazard of secondary ocular infections. As fungal infections of the cornea are particularly prone to develop coincidentally with long-term local steroid applications, 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.
Use of intraocular steroids may prolong the course and may exacerbate the severity of many viral infections on the eye (including herpes simplex). Use of a corticosteroid medication in the treatment of the patients with a history of herpes simplex requires great caution; frequent slit lamp microscopy is recommended.
The preservative in FML , 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 FML before reinserting soft contact lenses.
To prevent eye injury or contamination, care should be taken to avoid touching the bottle or tube tip to the eye or to any other surface. The use of the bottle or tube by more than one person may spread infection. Keep bottle or tube tightly closed when not in use. Keep out of the reach of children.
Acute purulent untreated infection of the eye may be masked or activity enhanced by presence of steroid medication. 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 corticosteroid.
Pediatric Use
Safety and effectiveness have not been demonstrated in children of the age group 2 years or below.
FML Eye Drop Use in Pregnancy
Safety of the use of topical steroids during pregnancy has not been established. Administration of corticosteroids to pregnant animals has been associated with abnormalities of foetal development. Fluorometholone has been shown to be embryocidal, fetotoxic, and teratogenic in rabbits when administered by ocular instillation. FML should be used with caution during pregnancy only if the potential benefit outweighs the potential risk to the fetus..
Lactation
It is not known whether topical ophthalmic administration of FML could result in sufficient systemic absorption to produce detectable quantities in human 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.
Effects on ability to drive and use machine
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. Use the solution within one month after opening the container. Do not touch the nozzle tip to any surface since this may contaminate solution. If irritation persist or increases discontinue use and consult physician.
Indiscriminate and prolonged use of the preparation may lead to glaucoma, cataract and fungal infections.
Dosage
As prescribed by an Ophthalmologist.
Bottle Size: FML Eye Drop 5 ml Plastic Dropper Bottle.
Note: Store in Cool Place. Protect from freezing. On prescription only. Discard any unused product 1 month after first opening.
Shake Well before use. Keep this medicine out of reach of the children.
