Included as part of the PRECAUTIONS section.
Intraocular Pressure (IOP) Increase
Prolonged use of corticosteroids may result in glaucoma
with damage to the optic nerve, defects in visual acuity and fields of vision.
Steroids should be used with caution in the presence of glaucoma. If this
product is used for 10 days or longer, intraocular pressure should be monitored.
Use of corticosteroids may result in posterior
subcapsular cataract formation.
The use of steroids after cataract surgery may delay
healing and increase the incidence of bleb formation. In those diseases causing
thinning of the cornea or sclera, perforations have been known to occur with
the use of topical steroids. 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.
Prolonged use of corticosteroids may suppress the host
response and thus increase the hazard of secondary ocular infections. In acute
purulent conditions of the eye, steroids may mask infection or enhance existing
Employment of a corticosteroid medication in the
treatment of patients with a history of herpes simplex requires great caution.
Use of ocular steroids may prolong the course and may exacerbate the severity
of many viral infections of the eye (including herpes simplex).
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. Fungal cultures should be taken when
Contact Lens Wear
Patients should not wear contact lenses during their
course of therapy with LOTEMAX.
Carcinogenesis, Mutagenesis, Impairment Of Fertility
Long-term animal studies have not been conducted to
evaluate the carcinogenic potential of loteprednol etabonate. Loteprednol
etabonate was not genotoxic in vitro in the Ames test, the mouse lymphoma tk
assay, or in a chromosome aberration test in human lymphocytes, or in vivo in
the single dose mouse micronucleus assay. Treatment of male and female rats
with up to 50 mg/kg/day and 25 mg/kg/day of loteprednol etabonate,
respectively, (600 and 300 times the maximum clinical dose, respectively) prior
to and during mating did not impair fertility in either gender.
Use In Specific Populations
Pregnancy Category C
Loteprednol etabonate has been shown to be embryotoxic
(delayed ossification) and teratogenic (increased incidence of meningocele,
abnormal left common carotid artery, and limb flexures) when administered
orally to rabbits during organogenesis at a dose of 3 mg/kg/day (35 times the
maximum daily clinical dose), a dose which caused no maternal toxicity. The
no-observed-effect-level (NOEL) for these effects was 0.5 mg/kg/day (6 times
the maximum daily clinical dose). Oral treatment of rats during organogenesis
resulted in teratogenicity (absent innominate artery at ≥5 mg/kg/day
doses, and cleft palate and umbilical hernia at ≥50 mg/kg/day) and
embryotoxicity (increased post-implantation losses at 100 mg/kg/day and
decreased fetal body weight and skeletal ossification with ≥50 mg/kg/day).
Treatment of rats with 0.5 mg/kg/day (6 times the maximum clinical dose) during
organogenesis did not result in any reproductive toxicity. Loteprednol
etabonate was maternally toxic (significantly reduced body weight gain during treatment)
when administered to pregnant rats during organogenesis at doses of ≥5
Oral exposure of female rats to 50 mg/kg/day of
loteprednol etabonate from the start of the fetal period through the end of
lactation, a maternally toxic treatment regimen (significantly decreased body
weight gain), gave rise to decreased growth and survival, and retarded
development in the offspring during lactation; the NOEL for these effects was 5
mg/kg/day. Loteprednol etabonate had no effect on the duration of gestation or
parturition when administered orally to pregnant rats at doses up to 50
mg/kg/day during the fetal period.
There are no adequate and well controlled studies in
pregnant women. LOTEMAX 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. Systemic steroids appear in human milk and
could suppress growth, interfere with endogenous corticosteroid production, or
cause other untoward effects. Caution should be exercised when LOTEMAX is
administered to a nursing woman.
Safety and effectiveness in pediatric patients have not
No overall differences in safety and effectiveness have
been observed between elderly and younger patients.