General. The possibility of fungal infections of the cornea should be
considered after long-term steroid dosing. As with other antibiotic preparations,
prolonged use may result in overgrowth of nonsusceptible organisms, including
fungi. If superinfection occurs, appropriate therapy should be initiated. When
multiple prescriptions are required, or whenever clinical judgment dictates,
the patient should be examined with the aid of magnification, such as slit lamp
biomicroscopy and, where appropriate, fluorescein staining.
Cross-sensitivity to other aminoglycoside antibiotics may occur; if hypersensitivity develops with this product, discontinue use and institute appropriate therapy.
Ophthalmic ointment may retard corneal wound healing.
Patients should be advised not to wear contact lenses if they have signs and symptoms of bacterial ocular infection.
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.
Pregnancy Category C. Corticosteroids have been found 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 parenterally
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®
(tobramycin and dexamethasone ophthalmic ointment) 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 TOBRADEX® (tobramycin and dexamethasone opthalmic ointment) (tobramycin and
dexamethasone ophthalmic ointment) is administered to a nursing woman.
Pediatric Use: Safety and effectiveness in pediatric patients below
the age of 2 years have not been established.
Geriatric Use: No overall clinical differences in safety or effectiveness
have been observed between the elderly and the other adult patients.