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
Neodecadron Warnings, Precautions, Pregnancy, Nursing, Abuse - Neomycin and Dexamethasone
Neodecadron Warnings, Precautions, Pregnancy, Nursing, Abuse - Neomycin and Dexamethasone
WARNINGS
NOT FOR INJECTION INTO THE EYE
Prolonged use of corticosteroids may result in ocular hypertension and/or glaucoma
with damage to the optic nerve, defects in visual acuity and fields of vision,
and in posterior subcapsular cataract formation.
Prolonged use of corticosteroids 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 corticosteroids. In acute purulent conditions of the eye, corticosteroids
may mask infection or enhance existing infection.
If this product is used for 10 days or longer, intraocular pressure should
be routinely monitored even though it may be difficult in children and uncooperative
patients. Corticosteroids should be used with caution in the presence of ocular
hypertension and/or glaucoma. Intraocular pressure should be checked frequently.
The use of corticosteroids after cataract surgery may delay healing and increase
the incidence of filtering blebs.
Use of ocular corticosteroids may prolong the course and may exacerbate the
severity of many viral infections of the eye (including herpes simplex). Employment
of a corticosteroid medication in the treatment of patients with a history of
herpes simplex requires great caution; periodic slit lamp microscopy is essential.
(See CONTRAINDICATIONS.)
Neomycin sulfate may occasionally cause cutaneous sensitization. If any reaction
indicating such sensitivity is observed, discontinue use.
Ophthalmic Solution NEODECADRON contains sodium bisulfite, a sulfite that may
cause allergic-type reactions including anaphylactic symptoms and life-threatening
or less severe asthmatic episodes in certain susceptible people. The overall
prevalence of sulfite sensitivity in the general population is unknown and probably
low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic
people.
PRECAUTIONS
General
The initial prescription and renewal of the medication order beyond 20 milliliters
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 re-evaluated.
The possibility of fungal infections of the cornea should be considered after
prolonged corticosteroid dosing. Fungal cultures should be taken when appropriate.
If this product is used for 10 days or longer, intraocular pressure should
be monitored (see WARNINGS
).
There have been reports of bacterial keratitis associated with the use of multiple
dose containers of topical ophthalmic products. These containers had been inadvertently
contaminated by patients who, in most cases, had a concurrent corneal disease
or a disruption of the ocular epithelial surface. (See PRECAUTIONS
, Information
for Patients . )
Information for Patients
Patients should be instructed to avoid allowing the tip of the dispensing container
to contact the eye, eyelid, fingers, or any other surface. The use of this product
by more than one person may spread infection. Keep tightly closed when not in
use.
Patients should also be instructed that ocular preparations, if handled improperly,
can become contaminated by common bacteria known to cause ocular infections.
Serious damage to the eye and subsequent loss of vision may result from using
contaminated preparations (see PRECAUTIONS
, General ).
If redness, irritation, swelling or pain persists or becomes aggravated, the
patient should be advised to consult a physician. Patients should also be advised
that if they have ocular surgery or develop an intercurrent ocular condition
(e.g., trauma or infection), they should immediately seek their physician's
advice.
One of the preservatives in Ophthalmic Solution NEODECADRON, benzalkonium chloride,
may be absobed by soft contact lenses. Patients wearing soft contact lenses
should be instructed to wait at least 15 minutes after instilling Ophthalmic
Solution NEODECADRON before they insert their lenses.
Keep out of the reach of children.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long term animal studies have not been performed to evaluate the carcinogenic
potential or the effect on fertility of Ophthalmic Solution NEODECADRON. Treatment
of human lymphocytes in-vitro with neomycin increased the frequency of
chromosome aberrations at the highest concentration (80 µg/mL) tested; however,
the effects of neomycin on carcinogenesis and mutagenesis in humans are unknown.
Pregnancy
Teratogenic effects
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. There are no adequate and well-controlled studies in pregnant women.
Ophthalmic Solution NEODECADRON should be used during pregnancy only if the
potential benefit justifies the potential risk to the fetus. Infants born of
mothers who have received substantial doses of corticosteroids during pregnancy
should be observed carefully for signs of hypoadrenalism.
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 Ophthalmic Solution NEODECADRON, 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.
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