Sterile Ophthalmic Suspension
Each mL contains: fluorometholone 1 mg with: LIQUIFILM (polyvinyl
alcohol) 14 mg, benzalkonium chloride 0.04 mg, edetate disodium, sodium
chloride, sodium phosphate monobasic, sodium phosphate dibasic, polysorbate
80, and purified water.
Inhibition of the inflammatory response to inciting agents of mechanical,
chemical or immunological nature. No generally accepted explanation of this
steroid property has been advanced. However, corticosteroids are thought to
act by the induction of phospholipase A2 inhibitory proteins,
collectively called lipocortins. It is postulated that these proteins
control the biosynthesis of potent mediators of inflammation such as
prostaglandins and leukotrienes by inhibiting the release of their common
precursor arachidonic acid. Arachidonic acid is released from membrane
phospholipids by phospholipase A2. Adrenocorticosteroids and
their-derivatives are capable of producing a rise in intraocular pressure.
In clinical studies on patients' eyes treated with both dexamethasone and
fluorometholone, fluorometholone demonstrated a lower propensity to increase
intraocular pressure than did dexamethasone.
For steroid responsive inflammation of the palpebral and bulbar conjunctiva,
cornea and anterior segment of the globe.
Acute superficial (or epithelial) herpes simplex keratitis (dendritic
Fungal diseases of ocular structures.
Vaccinia, varicella and most other viral diseases of the cornea and
Mycobacterial infection such as tuberculosis of the eye.
Hypersensitivity to the constituents of this medication.
Employment of a corticosteroid medication in the treatment of patients with
a history of herpes simplex requires great caution.
Prolonged use may cause increased intraocular pressure in susceptible
individuals resulting in glaucoma, and infrequent damage to the optic nerve,
defects in visual acuity and fields of vision; posterior subcapsular
cataract formation and delayed wound healing; or may aid in the
establishment of secondary ocular infections from fungi or viruses liberated
from ocular tissues.
Steroids should be used with caution in the presence of glaucoma;
intraocular pressure should be checked frequently. Eye drops containing
corticosteroids should not be used for more than 10 days except under strict
ophthalmic supervision with regular checks for intraocular pressure.
Various ocular diseases and long-term use of topical corticosteroids have
been known to cause corneal and scleral thinning. Use of topical
corticosteroids in the presence of thin corneal or scleral tissue may lead
Acute purulent untreated infection of the eye may be masked or activity
enhanced by presence of steroid medication.
Pediatric Use: Safety and effectiveness have not been demonstrated
in children of the age group 2 years or below.
Geriatric Use: No overall differences in safety or effectiveness have
been observed between elderly and younger patients.
Use in Pregnancy and Lactation: There are no adequate and well
controlled studies in pregnant women. Administration of corticosteroids to
pregnant animals has been associated with abnormalities of fetal
development. Fluorometholone has been shown to be embryocidal, fetotoxic,
and teratogenic in rabbits when administered by ocular instillation. FML
LIQUIFILM should be used with caution during pregnancy only if the potential
benefit outweighs the potential risk to the fetus. It is not known whether
topical ophthalmic administration of FML LIQUIFILM 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 Machines: 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.
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.
Intraocular pressure should be checked frequently.
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.
Use with Contact Lenses: The preservative in FML LIQUIFILM,
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 LIQUIFILM before reinserting soft
Potential for Eye Injury and Contamination: 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.
Elevation of intraocular pressure (IOP) with possible development of
glaucoma, and infrequent optic nerve damage, posterior subcapsular cataract
formation, secondary ocular infection from pathogens liberated from ocular
tissues, perforation of the globe and delayed wound healing.
Class Effects. Although systemic effects are extremely uncommon,
there have been rare occurrences of systemic hypercorticoidism after use of
Postmarketing Experience. The following adverse reactions have been
identified during postmarketing use of FML LIQUIFILM. Because postmarketing
reporting is voluntary and from a population of uncertain size, it is not
possible to reliably estimate the frequency of these reactions:
Investigations: Intraocular pressure increased
Eye disorders: Eye irritation, Conjunctival/Ocular hyperemia, Eye
pain, Visual disturbance, Foreign body sensation, Eyelid edema, Blurred
vision, Eye discharge, Eye pruritis, Lacrimation increased, Eye edema/Eye
swelling, Mydriasis, Cataract (including subcapsular), Ulcerative keratitis,
Ocular infection (including bacterial, fungal, and viral infections), Visual
field defect, Punctate keratitis, Erythema of eyelid (ointment only).
Immune system disorders: Hypersensitivity
Nervous system disorders: Dysgeusia
Skin and subcutaneous tissue disorders: Rash
Overdose by the topical ophthalmic route will not ordinarily cause acute
problems. If accidentally ingested, drink fluids to dilute.
DOSAGE AND ADMINISTRATION
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
As a sterile suspension in 5 mL and 10 mL plastic dropper bottles.
Note: Store below 25°C. Protect from freezing. Store upright. On
Keep out of the reach of children. Shake well before use.