Document
DailyMed Label: NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE
Title
DailyMed Label: NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE
Date
2010
Document type
DailyMed Prescription
Name
NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE
Generic name
NEOMYCIN, POLYMYXIN B AND DEXAMETHASONE
Manufacturer
STAT RX LLC USA
Product information
NDC: 16590-167
Product information
NDC: 16590-167
Description
DESCRIPTION
Neomycin and polymyxin B sulfates and dexamethasone ophthalmic
suspension is a multiple dose anti-infective steroid combination in sterile
suspension form for topical application. The chemical structure for the active
ingredient, dexamethasone, is: DEX STRUCTURE IMAGE
Established Name:
dexamethasone
Chemical Name:
pregna-1, 4-diene-3, 20-dione, 9-fluoro-11,17, 21-trihydroxy-16-methyl-,
(11β, 16α)-.
The other active ingredients are neomycin sulfate and polymyxin B
sulfate.
Each mL contains: Actives: neomycin sulfate
equivalent to neomycin 3.5 mg, polymyxin B sulfate 10,000 units, dexamethasone
0.1%. Preservative: benzalkonium chloride 0.004%. Vehicle: hypromellose 2910 0.5%. Inactives:
sodium chloride, polysorbate 20, hydrochloric acid and/or sodium
hydroxide (to adjust pH), purified water.
DEX STRUCTURE IMAGE
Indications
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 corticosteroids are indicated in inflammatory conditions of the
palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe
where the inherent risk of corticosteroids 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 drug in this product is active against the
following common bacterial eye pathogens: Staphylococcus
aureus, Escherichia coli, Haemophilus influenzae, Klebsiella/Enterobacter
species, Neisseria species, and Pseudomonas aeruginosa.
This product does not provide adequate coverage against: Serratia marcescens and streptococci, including Streptococcus pneumoniae.
Dosage
DOSAGE AND ADMINISTRATION
One to two drops topically in the conjunctival sac(s). In severe
disease, drops may be used hourly, being tapered to discontinuation as the
inflammation subsides. In mild disease, drops may be used up to four to six
times daily.
Not more than 20 mL should be prescribed initially and the prescription
should not be refilled without further evaluation as outlined in PRECAUTIONS
above.
FOR TOPICAL OPHTHALMIC USE ONLY.
Contraindications
CONTRAINDICATIONS
Epithelial herpes simplex keratitis (dendritic 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. (Hypersensitivity
to the antibiotic component occurs at a higher rate than for other
components.)
Precautions
PRECAUTIONS
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 a slit lamp biomicroscopy and, where
appropriate, fluorescein staining.
The possibility of persistent fungal infections of the cornea should be
considered after prolonged corticosteroid dosing.
Pregnancy
Pregnancy Category C. Dexamethasone has been shown to be
teratogenic in mice and rabbits following topical ophthalmic application in
multiples of the therapeutic dose.
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, palate,
etc.
There are no adequate or well-controlled studies in pregnant women. Neomycin
and polymyxin B sulfates and dexamethasone ophthalmic suspension 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.
Nursing Mothers
Systemically administered 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 and polymyxin B sulfates and
dexamethasone ophthalmic suspension is administered to a nursing woman.
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.
How supplied
HOW SUPPLIED
Sterile ophthalmic suspension in 5 mL plastic DROP-TAINER*
dispenser ( NDC 61314-630-06).
STORAGE: Store at 8°-27°C (46°-80°F).
Rx Only
*DROP-TAINER is a registered trademark of Alcon Manufacturing, Ltd.
FALCON LOGO IMAGE
Dist. by:
FALCON Pharmaceuticals, Ltd.
Fort
Worth, Texas 76134 USA
Mfd by:
ALCON LABORATORIES, INC.
Fort Worth,
Texas 76134 USA
Printed in USA
340905-0803
FALCON LOGO IMAGE
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, a concomitant
antimicrobial drug 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 an antimicrobial 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 both drugs is administered, plus assured compatibility of
ingredients when both types of drugs are in the same formulation and,
particularly, that 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.
Package label
NEO POLYB DEX LABEL IMAGE
NEO POLYB DEX LABEL IMAGE
1 organization
1 product
Organization
STAT RX LLC USA