Included as part of the PRECAUTIONS section.
Prolonged use of corticosteroids may result in glaucoma with damage to the
optic nerve, defects in visual acuity and fields of vision. If this product
is used for 10 days or longer, IOP should be monitored.
Sensitivity to topically applied
aminoglycosides may occur.
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, steroids
may mask infection or enhance existing infection. If signs and symptoms fail
to improve after 2 days, the patient should be re-evaluated.
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 with systemic aminoglycosides
If product is used in combination with systemic aminoglycoside antibiotics
the patient should be monitored for total serum concentration.
Carcinogenesis, Mutagenesis, Impairment of Fertility
No studies have been conducted to evaluate the carcinogenic or mutagenic potential.
No impairment of fertility was noted in studies of subcutaneous tobramycin
in rats at doses of 50 and 100 mg/kg/day (equivalent to human doses of 8 and
16 mg/kg/day, at least 2 orders of magnitude greater than the topical ocular
Use In Specific Populations
Pregnanacy Category C. Corticosteroids have been shown to be teratogenic in
animal studies. Ocular administration of 0.1% dexamethasone resulted in 15.6%
and 32.3% incidence of fetal anomalies in two groups of pregnant rabbits. Fetal
growth retardation and increased mortality rates have been observed in rats
with chronic dexamethasone therapy. Reproduction studies have been performed
in rats and rabbits with tobramycin at doses up to 100 mg/kg/day (equivalent
to human doses of 16 and 32 mg/kg/day, respectively) and have revealed no evidence
of impaired fertility or harm to the fetus. There are no adequate and well controlled
studies in pregnant women. TOBRADEX® ST (tobramycin / dexamethasone ophthalmic suspension 0.3%/0.05%) ophthalmic suspension should be
used during pregnancy only if the potential benefit justifies the potential
risk to the fetus.
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 TOBRADEX® ST (tobramycin / dexamethasone ophthalmic suspension 0.3%/0.05%) is administered to a nursing woman.
Safety and effectiveness in pediatric patients below the age of 2 years have
not been established.
No overall differences in safety or effectiveness have been observed between
elderly and younger patients.