||Neomycin and Polymyxin B
Sulfates and Dexamethasone Ophthalmic Ointment USP ®
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Neomycin and Polymyxin B Sulfates and
Dexamethasone Ophthalmic Suspension USP is a multiple dose anti-infective
steroid combination in a sterile suspension for topical application.
Neomycin Sulfate is the sulfate
salt of neomycin B and C which are produced by the growth of Streptomyces
fradiae Waksman. It has a potency equivalent to not less than 600 micrograms
of neomycin base per milligram, calculated on an anhydrous basis.
Polymyxin B Sulfate is the sulfate
salt of Polymyxin B1 and B2 which are produced by the growth of Bacillus
polymyxa Migula. It has a potency of not less than 6,000 Polymyxin B units
per milligram, calculated on an anhydrous basis.
Indications and Usage
For steroid-responsive inflammatory
ocular conditions for which a corticosteroid is indicated and where bacterial
infection or a risk of bacterial ocular infection exists.
Ocular steroids are indicated in
inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and
anterior segment of the globe where the inherent risk of steroid use in certain
cases of infective conjunctivitides is accepted to obtain a diminution in edema
and inflammation. They are also indicated in chronic anterior uveitis and
corneal injury from chemical radiation or thermal burns; or penetration of
The use of a combination drug with
an anti-infective component is indicated where the risk of infection is high or
where there is an expectation that potentially dangerous numbers of bacteria
will be present in the eye.
Epithelial herpes simplex keratitis,
vaccinia, varicella and many other viral diseases of the cornea and
conjunctiva. Mycobacterial infection of the eye. Fungal diseases of
ocular structures. Hypersensitivity to a component of the medication.
Pregnancy. Pregnancy C
Dexamethasone has been shown to be Teratogenic
in mice and rabbits following topical ophthalmic application in multiples of the
In the mouse, corticosteroids produce fetal resorptions and a specific
abnormality, cleft palate. In the rabbit, corticosteroids have produced
fetal resorptions and multiple abnormalities involving the head, ears, limbs,
There are no adequate or well-controlled studies in pregnant in women.
Neomycin, Polymyxin B Sulfates and Dexamethasone Ophthalmic Ointment should be
used during pregnancy only if the potential benefit to the mother justifies the
potential risk to the embryo or fetus. Infants born of mothers who have
received substantial doses of corticosteroids during pregnancy should be
observed carefully for signs of hypoadrenalism.
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 Neomycin, Polymyxin B Sulfates and Dexamethasone Ophthalmic
Ointment, is administered to a nursing woman.
Safety and effectiveness in pediatric
patients have not been established.
Adverse reactions have occurred with
steroid/anti-infective combination drugs which can be attributed to the steroid
component, the anti-infective component, or the combination. Exact
incidence figures are not available since no denominator of treated patients is
Reactions occurring most often from the presence fo the anti-infective
ingredients are allergic sensitizations. The reactions due to the steroid
component are; elevation of intraocular pressure with possible development of
glaucoma, and infrequent optic nerve damage; posterior sub capsular cataract
formation; and delayed wound healing.
The development of secondary infection
has occurred after use of combinations containing steroids and
antimicrobials. Fungal infections of the cornea are particularly prone to
develop coincidentally with long-term applications of steroids. The possibility
of fungal invasion must be considered in any persistent corneal ulceration where
steroid treatment has been used.
Secondary bacterial ocular infection following suppression of host responses
Product Information Provided by
Bausch and Lomb Pharmaceuticals.