Document
DailyMed Label: Neomycin and Polymyxin B Sulfates and Bacitracin Zinc with Hydrocortisone Acetate
Title
DailyMed Label: Neomycin and Polymyxin B Sulfates and Bacitracin Zinc with Hydrocortisone Acetate
Date
2010
Document type
DailyMed Prescription
Name
Neomycin and Polymyxin B Sulfates and Bacitracin Zinc with Hydrocortisone Acetate
Generic name
Neomycin and Polymyxin B Sulfates and Bacitracin Zinc with Hydrocortisone Acetate
Manufacturer
Physicians Total Care, Inc.
Product information
NDC: 54868-6122
Product information
NDC: 54868-6122
Description
Neomycin and polymyxin B sulfates and bacitracin zinc with
hydrocortisone acetate ophthalmic ointment is a sterile antimicrobial and
anti-inflammatory ointment for ophthalmic use. Each gram contains: neomycin
sulfate equivalent to 3.5 mg neomycin base, polymyxin B sulfate equivalent to
10,000 polymyxin B units, bacitracin zinc equivalent to 400 bacitracin units,
hydrocortisone acetate 10 mg (1 %), in a white petrolatum and mineral oil base.
Bacitracin zinc is the zinc salt of bacitracin, a mixture of related cyclic
polypeptides (mainly bacitracin A) produced by the growth of an organism of the
licheniformis group of Bacillus
subtilis var Tracy. It has a potency of not less than 40 bacitracin units
per mg. The structural formula is:
Hydrocortisone acetate,
Pregn-4-ene-3,20-dione,21-(acetyloxy)-11,17-dihydroxy-,(11β)–, is an
anti-inflammatory hormone. Its structural formula is:
Neomycin sulfate is the sulfate salt of neomycin B and C, which are produced by
the growth of Streptomyces fradiae Waksman (Fam.
Streptomycetaceae ). It has a potency equivalent of not less than 600 ug of
neomycin standard per mg, calculated on an anhydrous basis. The structural
formulae are:
Polymyxin B sulfate is the sulfate salt of polymyxin B 1
and B 2 , which are produced by the growth of Bacillus polymyxa (Prazmowski) Migula (Fam. Bacillaceae).
It has a potency of not less than 6,000 polymyxin B units per mg, calculated on
an anhydrous basis. The structural formulae are:
image of bacitracin zinc chemical structure
image of hydrocortisone acetate chemical structure
image of neomycin sulfate chemical structure
image of polymyxinc b sulfate chemical structure
Indications
Neomycin and polymyxin B sulfates and bacitracin zinc with hydrocortisone
acetate 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 (see
CLINICAL
PHARMACOLOGY: Microbiology
). The particular anti-infective drugs in
this product are active against the following common bacterial eye pathogens:
Staphylococcus aureus, streptococci, including Streptococcus pneumoniae, Escherichia coli, Haemophilus
influenzae, Klebsiella/Enterobacter species, Neisseria species, and Pseudomonas
aeruginosa. The product does not provide adequate coverage against Serratia marcescens.
Dosage
Apply the ointment in the affected eye every 3 or 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 as
outlined in
PRECAUTIONS
above.
Contraindications
Neomycin and polymyxin B sulfates and bacitracin zinc with hydrocortisone
acetate ophthalmic ointment is contraindicated in most viral diseases of the
cornea and conjunctiva including: epithelial herpes simplex keratitis (dendritic
keratitis), vaccinia and varicella, and also in mycobacterial infection of the
eye and fungal diseases of ocular structures. Neomycin and polymyxin B sulfates
and bacitracin zinc with hydrocortisone acetate ophthalmic ointment 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.
Precautions
General: The initial prescription and renewal of the medication
order beyond 8 grams 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. As fungal infections of the
cornea are particularly prone to develop coincidentally with long-term
corticosteroid applications, fungal invasion should be suspected in any
persistent corneal ulceration where a corticosteroid has been used or is in use.
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 topical ophthalmic products in
multiple-dose containers which have been inadvertently contaminated by patients,
most of whom had a concurrent corneal disease or a disruption of the ocular
epithelial surface (see
PRECAUTIONS:
Information for Patients
). Allergic cross-reactions may occur which
could prevent the use of any or all of the following antibiotics for the
treatment of future infections: kanamycin, paromomycin, streptomycin, and
possibly gentamicin.
Information for Patients: If inflammation
or pain persists longer than 48 hours or becomes aggravated, the patient should
be advised to discontinue use of the medication and consult a physician. This
product is sterile when packaged. To prevent contamination, care should be taken
to avoid touching the tip of the tube to eyelids or to any other surface. The
use of this tube by more than one person may spread infection. Store at 15°-25°C
(59°-77°F). Keep out of the reach of children.
Carcinogenesis, Mutagenesis, 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 concentrations
(80 μg/mL) tested; however, the effects of neomycin on carcinogenesis and
mutagenesis in humans are unknown. Long-term studies in animals (rats, rabbits,
mice) 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 mutagenicity with hydrocortisone acetate 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 100 gm/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 and bacitracin zinc with hydrocortisone
acetate ophthalmic ointment should be used during pregnancy only if the
potential benefit justifies the potential risk to the fetus.
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 neomycin and polymyxin B sulfates and bacitracin zinc with
hydrocortisone acetate 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 children have not been established.
Geriatric Use: No overall differences in
safety or effectiveness have been observed in between elderly and younger
patients.
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 (see
How supplied
Neomycin and Polymyxin B Sulfates and Bacitracin Zinc with
Hydrocortisone Acetate Ophthalmic Ointment is supplied in 3.5 g (1/8 Oz) sterile
tamper proof tube with ophthalmic tip,
NDC 54868-6122-0.
Store at 15° to 25°C (59° to
77°F).
E. FOUGERA & CO.
a
division of Altana Inc.
MELVILLE, NEW YORK 11747
I22938E R8/04 #174
Relabeling of "Additional Barcode" by: Physicians Total Care, Inc. Tulsa, OK 74146
Clinical pharmacology
Corticosteroids suppress the inflammatory response to a variety
of agents and they probably delay or slow healing. Since corticosteroids may
inhibit the body's defense mechanism against infection, concomitant
antimicrobial drugs may be used when this inhibition is considered to be
clinically significant in a particular case. When a decision to administer both
a corticosteroid and antimicrobials is made, the administration of such drugs in
combination has the advantage of greater patient compliance and convenience,
with the added assurance that the appropriate dosage of all drugs is
administered. When each type of drug is in the same formulation, compatibility
of ingredients is assured and the correct volume of drug is delivered and
retained. The relative potency of corticosteroids depends on the molecular
structure, concentration, and release from the vehicle.
Microbiology The anti-infective components in neomycin and polymyxin B
sulfates and bacitracin zinc with hydrocortisone acetate ophthalmic ointment are
included to provide action against specific organisms susceptible to it.
Neomycin sulfate and polymyxin B sulfate are active in vitro against susceptible
strains of the following microorganisms: Staphylococcus
aureus , streptococci including Streptococcus
pneumoniae, Escherichia coli, Haemophilus influenzae,
Klebsiella/Enterobacter species, Neisseria
species, and Pseudomonas aeruginosa. The product does
not provide adequate coverage against Serratia
marcescens (see
INDICATIONS AND
USAGE
).
Package label
image of package label
2 organizations
1 product
Organization
Rebel Distributors Corp.Organization
Physicians Total Care, Inc.