Shop Online : Neo/Poly/Dex Ophthalmic Ointment

DESCRIPTION:

Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Ointment is a multiple dose anti-infective steroid

combination in sterile ointment form for topical application.

The chemical structure for the active ingredient Neomycin Sulfate is:

The chemical structure for the active ingredient Polymyxin B Sulfate is :

The chemical structure for the active ingredient Dexamethasone is:

Established Name:

Dexamethasone

Chemical Name:

Pregna-1, 4-diene-3, 20-dione,

9-fluoro-11,17, 21-trihydroxy-16-

methyl-, (11

Each gram contains: Actives:

CLINICAL PHARMACOLOGY:

Corticoids suppress the inflammatory response to a variety of agents and they probably delay or slow healing. Since

corticoids 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 corticoid 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.

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 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

Pseudomonas aeruginosa.

This product does not provide adequate coverage against:

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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.)

WARNINGS:

NOT FOR INJECTION. Do not touch tube tip to any surface, as this may contaminate the contents. Prolonged use may

result in 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 steroids. In acute purulent conditions of the eye, steroids may mask infection or enhance existing infection.

If this product is used for 10 days or longer, intraocular pressure should be routinely monitored even though it may be

difficult in children and uncooperative patients.

Products containing neomycin sulfate may cause cutaneous sensitization.

Employment of steroid medication in the treatment of herpes simplex requires great caution.

PRECAUTIONS:

The initial prescription and renewal of the medication order beyond 8 g 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 steroid dosing.

Patients should be advised not to wear contact lenses if they have signs and symptoms of bacterial ocular infection.

Do not use the product if the imprinted carton seals have been damaged, or removed.

Pregnancy:

Nursing Mothers:

Pediatrics:

Geriatrics:

ADVERSE REACTIONS:

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 available.

Reactions occurring most often from the presence of the anti-infective ingredient are allergic sensitizations. The reactions

due to the steroid component are: elevation of intraocular pressure (IOP) with possible development of glaucoma, and

infrequent optic nerve damage; posterior subcapsular cataract formation; and delayed wound healing.

Secondary Infection:

DOSAGE AND ADMINISTRATION:

Apply a small amount into the conjunctival sac(s) up to three or four times daily.

How to Apply Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Ointment:

1. Tilt your head back.

2. Place a finger on your cheek just under your eye and gently pull down until a “V” pocket is formed between your

eyeball and your lower lid.

3. Place a small amount (about 1/2 inch) of Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Ointment

in the “V” pocket. Do not let the tip of the tube touch your eye.

4. Look downward before closing your eye.

Not more than 8 g should be prescribed initially and the prescription should not be refilled without further evaluation as

outlined in PRECAUTIONS above.

HOW SUPPLIED:

3.5 g STERILE Ointment supplied in an aluminum tube with a white polyethylene tip and white polyethylene cap.

(

STORAGE:

Store at 2°- 25°C (36°- 77°F).

Rx Only

Revised: October 2003

Distributed by :

FALCON Pharmaceuticals, Ltd.

Fort Worth, Texas 76134 USA

Manufactured by:

S.A. ALCON-COUVREUR N.V.

Puurs, Belgium