WARNINGS
Not for injection. Use in the treatment of herpes simplex infection requires great caution. Prolonged use may result in glaucoma, damage to the optic nerve, defect in visual acuity and visual field, cataract formation and/or may aid in the establishment of secondary ocular infections from pathogens due to suppression of host response. Acute purulent infections of the eye may be masked or exacerbated by presence of steroid medication. In those diseases causing thinning of the cornea or sclera, perforation has been known to occur with chronic use of topical steroids. It is advisable that the intraocular pressure be checked frequently.
PRECAUTIONS
General
Fungal infections of the cornea are particularly prone to develop coincidentally with long-term local steroid application. Fungus invasion must be considered in any persistent corneal ulceration where a steroid has been used or is in use.
Information for Patients
Do not touch dropper tip to any surface, as this may contaminate the suspension. The preservative in Flarex®, benzalkonium chloride, may be absorbed by soft contact lenses. Flarex should not be administered while wearing soft contact lenses.
Carcinogenesis, mutagenesis, impairment of fertility
No studies have been conducted in animals or in humans to evaluate the possibility of these effects with fluorometholone.
Pregnancy
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.
Nursing Mothers
Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when FLAREX® Ophthalmic Suspension is administered to a nursing woman.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
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