The initial prescription and renewal of the medication order 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 appropriate.
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 potential of these effects.
Pregnancy: Teratogenic effects. Pregnancy Category C.
Prednisolone has been shown to be teratogenic in mice when given in doses 1-10
times the human dose.
Dexamethasone, hydrocortisone and prednisolone were ocularly applied to both
eyes of pregnant mice five times per day on days 10 through 13 of gestation.
A significant increase in the incidence of cleft palate was observed in the
fetuses of the treated mice. There are no adequate and well controlled studies
in pregnant women. Omnipred (prednisolone acetate ophthalmic suspension)
should be used during pregnancy only if the potential benefit justifies the
potential risk to the fetus.
Nursing Mothers: It is not known whether topical 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 prednisolone acetate, 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.
Pediatric Use: Safety and effectiveness in pediatric patients
have not been established.
Geriatric Use: No overall differences in safety or effectiveness
have been observed between elderly and younger patients.