Description:
Description
Neomycin and Polymyxin B Sulfates,
Bacitracin Zinc, and Hydrocortisone Ophthalmic Ointment, USP is a sterile
anitmicrobial and anti-inflammatory ointment for ophthalmic use.
Indications and Usage
Neomycin and Polymyxin B sulfates,
bacitracin zinc, and hydrocortisone ophthalmic ointment is indicated for
steroid-responsive inflammatory ocular conditions for which a corticosteroid is
indicated and where bacterial infection or a risk of bacterial infection exists.
Ocular corticosteroids are
indicated in inflammatory conditions of the palpebral and bulbar conjunctiva,
cornea, and anterior segment of the globe where the inherent risk of
corticosteroid use in certain 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 foreign bodies.
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.
The particular anti-infective drugs in this product are active against the
following common bacterial eye pathogens: Staphylococcus aureus,
streptococci, including Streptococcus pneumonia, Escherichia coli, Haemophilus
influenzae, Klebsiella-Enterobacter species, Neisseria species, and Pseudomonas
aeruginosa. The product does not provide adequate coverage against
Serratia marcescens.
Contraindications
Neomycin and Polymyxin B sulfates, Bacitracin,
and hydrocortisone ophthalmic ointment is contraindicated in most viral diseases
of the cornea an conjunctiva including: epithelial herpes simplex
keratitis, vaccinia and varicella, and also in mycobacterial infection of the
eye and fungal diseases of ocular structures.
This product is also contraindicated in individuals who have shown
hypersensitivity to any of its components. Hypersensitivity to the antibiotic
component occurs at a higher rate than for other components.
Carcinogenesis, Mutagenensis,
Impairment of Fertility
Long-term studies in animals to evaluate
carcinogenic or mutagenic potential have not been conducted with Polymyxin B
sulfate or bacitracin. Treatment of cultured human lymphocytes in vitro
with neomycin increased the frequency of chromosome aberrations at the highest
concentration tested; however, the effects of neomycin on carcinogenesis and
mutagenesis in humans are unknown.
Long-term studies in animals showed no evidence of carcinogenicity or
mutagenicity attributable to oral administration of corticosteroids.
Long-term animal studies have not been performed to evaluate the carcinogenic
potential of topical corticosteroids. Studies to determine mutagenicty
with hydrocortisone have revealed negative results.
Polymyxin B has been reported to impair the motility of equine sperm, but its
effects on male or female fertility are unknown. No adverse effects on
male or female fertility, litter size or survival were observed in rabbits given
bacitracin zinc 100gm/ton of diet. Long-term animal studies have not been
performed to evaluate the effect on fertility of topical corticosteroids.
Pregnancy; Teratogenic Effects
Pregnancy Category C.
Corticosteroids have been found to be teratogenic in rabbits when applied
topically at concentrations of 0.5% on days 6 to 18 of gestation and in mice
when applied topically at a concentration of 15% on days 10 to 13 of
gestation. There are no adequate and well-controlled studies in pregnant
women. Neomycin and Polymyxin B sulfates, bacitracin zinc, and
hydrocortisone ophthalmic ointment should be used during pregnancy only if the
potential benefit justifies the potential risk to the fetus.
Nursing Mothers
It is 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
neomycin and Polymyxin B sulfates, bacitracin zinc, and hydrocortisone
ophthalmic ointment, 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.
Adverse Reactions
Adverse reactions have occurred with
corticosteroid/anti-infective combination drugs which can be attributed to the
corticosteroid component, the anti-infective component, or the
combination. The exact incidence is not known.
Reactions occurring most often from the presence of the anti-infective
ingredient are allergic sensitization reactions including itching, swelling and
conjunctival erythema. More serious hypersensitivity reactions, including
anaphylaxis, have been reported rarely.
The reactions due to the corticosteroid component in decreasing order of
frequency are: elevation of intraocular pressure with possible development
of glaucoma, and infrequent optic nerve damage; posterior sub capsular cataract
formation; and delayed wound healing.
Secondary Infection
The development of secondary infection
has occurred after use of combinations containing corticosteroids and anitmicrobial.
Fungal and viral infections of the cornea are particularly prone to develop
coincidentally with long-term applications of a corticosteroid. The possibility
of fungal invasion must be considered in any persistent corneal ulceration where
corticosteroid treatment has been used.
Local irritation on instillation has also been reported.
Dosage and Administration
Apply the ointment in the affected eye
every 3 to 4 hours, depending on the severity of the condition.
Not more than 8 grams should be prescribed initially and the prescription should
not be refilled without further evaluation.
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