A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Tobradex Warnings, Precautions, Pregnancy, Nursing, Abuse - Tobramycin and Dexamethasone
Tobradex Warnings, Precautions, Pregnancy, Nursing, Abuse - Tobramycin and Dexamethasone
WARNINGS
NOT FOR INJECTION INTO THE EYE Sensitivity to topically
applied aminoglycosides may occur in some patients. If a sensitivity
does occur, discontinue use.
Prolonged use of steroids may result in glaucoma, with damage to
the optic nerve, defects in visual
acuity and fields of vision, and posterior subcapsular cataract
formation. Intraocular pressure
should be routinely monitored even though it may be difficult in
children and uncooperative patients. Prolonged use may suppress
the host response
and thus increase the hazard of secondary ocular
infections. In those diseases,
causing thinning of the cornea
or sclera, perforations have been known to occur with the use of
topical steroids. In
acute purulent
conditions of the eye, steroids may mask
infection or enhance
existing infection.
PRECAUTIONS
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.
Information for the Patient: Do not touch
dropper tip to any surface,
as this may contaminate
the contents.
Carcinogenesis, Mutagenesis, and 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
dexamthasone therapy. Reproduction studies have been performed in
rats and rabbits with tobramycin
at doses of 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. Dexamethasone and tobramycin
ophthalmic suspension
and 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 dexamethasone and tobramycin
ophthalmic suspension
is administered to a nursing woman.
Pediatric Use: Safety and effectiveness
in children have not yet been established.
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