The initial prescription and renewal of the medication
order beyond 20 milliliters of FML® suspension should be made by a
physician only after examination of the patient with the aid of magnification,
such as slit lamp biomicroscopy and, where appropriate, fluorescein staining.
If signs and symptoms fail to improve after two days, the patient should be
As fungal infections of the cornea are particularly prone
to develop coincidentally with long-term local corticosteroid applications,
fungal invasion should be suspected in any persistent corneal ulceration where
a corticosteroid has been used or is in use. Fungal cultures should be taken when
If this product is used for 10 days or longer,
intraocular pressure should be monitored (see WARNINGS).
Carcinogenesis, Mutagenesis, Impairment of Fertility
No studies have been conducted in animals or in humans to
evaluate the possibility of these effects with fluorometholone.
Teratogenic effects - Pregnancy Category C
Fluorometholone has been shown to be embryocidal and
teratogenic in rabbits when administered at low multiples of the human ocular
dose. Fluorometholone was applied ocularly to rabbits daily on days 6-18 of
gestation, and dose-related fetal loss and fetal abnormalities including cleft
palate, deformed rib cage, anomalous limbs and neural abnormalities such as
encephalocele, craniorachischisis, and spina bifida were observed. There are no
adequate and well-controlled studies of fluorometholone in pregnant women, and
it is not known whether fluorometholone can cause fetal harm when administered
to a pregnant woman. Fluorometholone should be used during pregnancy only if
the potential benefit justifies the potential risk to the fetus.
It is not known whether topical ophthalmic administration
of corticosteroids could result in sufficient systemic absorption to produce
detectable quantities in human 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
Safety and effectiveness in infants below the age of two
years have not been established.
No overall differences in safety or effectiveness have
been observed between elderly and younger patients.