Document
DailyMed Label: Neomycin and Polymyxin B Sulfates and Hydrocortisone
Title
DailyMed Label: NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE
Date
2010
Document type
DailyMed Prescription
Name
NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE
Generic name
NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE
Manufacturer
STAT RX USA LLC
Product information
NDC: 16590-347
Product information
NDC: 16590-347
Description
DESCRIPTION Neomycin and Polymyxin B Sulfates and Hydrocortisone Ophthalmic
Suspension is a sterile antimicrobial and anti-inflammatory suspension for
ophthalmic use.
Each mL contains: Actives: neomycin sulfate
(equivalent to 3.5 mg neomycin base), polymyxin B sulfate equivalent to 10,000
polymyxin B units, and hydrocortisone 10 mg (1%). Preservative:
thimerosal 0.001%. Inactives: cetyl alcohol,
glyceryl monostearate, mineral oil, polyoxyl 40 stearate, propylene glycol,
sulfuric acid (to adjust pH) and water for injection.
Neomycin sulfate is the sulfate salt of neomycin B and C, which are produced
by the growth of Streptomyces fradiae Waksman (Fam.
Streptomycetacae). It has a potency equivalent to not less than 600 μg of
neomycin standard per mg, calculated on an anhydrous basis. Its structural
formula are:
neomycin-01 IMAGE
Polymyxin B sulfate is the sulfate salt of Polymyxin, B1 and B2, 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. Its structural
formula are:
neomycin-02 IMAGE
Hydrocortisone, 11β, 17, 21-trihydroxypregn-4-ene-3, 20 dione, is an
anti-inflammatory hormone. Its structural formula is:
neomycin-03 IMAGE
neomycin-01 IMAGE
neomycin-02 IMAGE
neomycin-03 IMAGE
Indications
INDICATIONS AND USAGE Neomycin and Polymyxin B Sulfates and Hydrocortisone Ophthalmic
Suspension is indicated 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 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 , Escherichia coli , Haemophilus influenzae , Klebsiella/Enterobacter species, Neisseria species, and Pseudomonas
aeruginosa .
The product does not provide adequate coverage against Serratia marcescens and streptococci, including Streptococcus pneumoniae .
Dosage
DOSAGE AND ADMINISTRATION One or two drops in the affected eye every 3 or 4 hours,
depending on the severity of the condition. The suspension may be used more
frequently if necessary.
Not more than 20 mL should be prescribed initially and the prescription
should not be refilled without further evaluation as outlined in PRECAUTIONS
above.
Contraindications
CONTRAINDICATIONS Neomycin and Polymyxin B Sulfates and Hydrocortisone Ophthalmic
Suspension 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 Hydrocortisone Ophthalmic Suspension 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.
Warnings
WARNINGS NOT FOR INJECTION INTO THE EYE. Neomycin and Polymyxin B Sulfates
and Hydrocortisone Ophthalmic Suspension should never be directly introduced
into the anterior chamber of 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 posterior subcapsular cataract formation.
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
corticosteroids. In acute purulent conditions of the eye, corticosteroids may
mask infection or enhance existing infection.
If these products are used for 10 days or longer, intraocular pressure should
be routinely monitored even though it may be difficult in uncooperative
patients. Corticosteroids should be used with caution in the presence of
glaucoma.
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 corticosteroid medication in the treatment of herpes simplex
requires great caution.
Topical antibiotics, particularly, neomycin sulfate, may cause cutaneous
sensitization. A precise incidence of hypersensitivity reactions (primarily skin
rash) due to topical antibiotics is not known. The manifestations of
sensitization to topical antibiotics are usually itching, reddening, and edema
of the conjunctiva and eyelid. A sensitization reaction may manifest simply as a
failure to heal. During long-term use of topical antibiotic products, periodic
examination for such signs is advisable, and the patient should be told to
discontinue the product if they are observed. Symptoms usually subside quickly
on withdrawing the medication. Application of products containing these
ingredients should be avoided for the patient thereafter (see
PRECAUTIONS:
General
).
PRECAUTIONS
General The initial prescription and renewal of the medication order
beyond 20 mL 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 2
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
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.
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.
How supplied
HOW SUPPLIED Neomycin and Polymyxin B Sulfates and Hydrocortisone Ophthalmic
Suspension is available in a DROP-TAINER* bottle containing 7.5 mL. NDC
61314-641-75
SHAKE WELL BEFORE USING.
Store at 20°-25°C (68°-77°F).
Rx Only
*DROP-TAINER is a Registered trademark of Alcon Manufacturing Ltd.
9002784-0707
Mfd. For:
FALCON Pharmaceuticals, Ltd.
For t Worth, Texas 76134 USA
Mfd. By:
ALCON LABORATORIES, INC.
Fort Worth, Texas 76134 USA
Printed in USA
Clinical pharmacology
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
intended 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 Hydrocortisone Ophthalmic Suspension 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 , Escherichia
coli , Haemophilus influenzae , Klebsiella/Enterbacter species, Neisseria species, and Pseudomonas
aeruginosa . The product does not provide adequate coverage against Serratia marcescens and streptococci, including Streptococcus pneumoniae (see
INDICATIONS AND USAGE
).
Package label
NEO-POLY-B 3-5MG-10KU LABEL IMAGE
NEO-POLY-B 3-5MG-10KU LABEL IMAGE
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