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NEO-POLY-DEX
Overview
What is NEO-POLY-DEX?
Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Ointment USP is a multiple dose anti-infective steroid combination in a sterile ointment for topical application. The active ingredient dexamethasone, is represented by the following structural formula:
CHFO Mol. Wt. 392.47
Chemical Name: Pregna-1,4-diene-3,20-dione, 9-fluoro-11,17,21-trihydroxy-16-methyl-, (11β,16α)-.
Neomycin Sulfate is the sulfate salt of neomycin B and C which are produced by the growth of Waksman (Fam. Streptomycetaceae). It has a potency equivalent to not less than 600 micrograms of neomycin base per milligram, calculated on an anhydrous basis. The structural formulae are:
Polymyxin B Sulfate is the sulfate salt of polymyxin B and B which are produced by the growth of (Prazmowski) Migula (Fam. Bacillaceae). It has a potency of not less than 6,000 polymyxin B units per milligram, calculated on an anhydrous basis.
The structural formulae are:
Each Gram Contains:
PRESERVATIVES ADDED: Methylparaben 0.05%, Propylparaben 0.01%.
What does NEO-POLY-DEX look like?
What are the available doses of NEO-POLY-DEX?
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What should I talk to my health care provider before I take NEO-POLY-DEX?
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How should I use NEO-POLY-DEX?
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 cases of 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 is active against the following common bacterial eye pathogens:
species.
This product does not provide adequate coverage against Serratia marcescens, and Streptococci, including .
Apply a small amount into the conjunctival sac(s) up to three or four times daily, or may be used adjunctively with Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension at bedtime.
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 grams should be prescribed initially and the prescription should not be refilled without further evaluation as outlined in above.
What interacts with NEO-POLY-DEX?
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What are the warnings of NEO-POLY-DEX?
Sorry No Records found
What are the precautions of NEO-POLY-DEX?
Sorry No Records found
What are the side effects of NEO-POLY-DEX?
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 ingredients 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:
Secondary bacterial ocular infection following suppression of host responses also occurs.
What should I look out for while using NEO-POLY-DEX?
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.)
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 these products are 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.
What might happen if I take too much NEO-POLY-DEX?
Sorry No Records found
How should I store and handle NEO-POLY-DEX?
Store at 20 - 25° C (68 - 77° F) [See USP Controlled Room Temperature].See the FDA-approved Medication Guide.Store at 20 - 25° C (68 - 77° F) [See USP Controlled Room Temperature].See the FDA-approved Medication Guide.Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Ointment USP is supplied in an ophthalmic tube in the following size:3.5 gram tube – Prod. No. 04034Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Ointment USP is supplied in an ophthalmic tube in the following size:3.5 gram tube – Prod. No. 04034
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Corticoids suppress the inflammatory response to a variety of agents and they probably delay or slow the healing. Since corticoids may inhibit the body's defense mechanism against infections, 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.
Non-Clinical Toxicology
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.)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 these products are 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.
Drug Interactions:
Cimetidine (400 mg twice daily) increased the mean Cmax and AUC of orally administered azelastine hydrochloride (4 mg twice daily) by approximately 65%. Ranitidine hydrochloride (150 mg twice daily) had no effect on azelastine pharmacokinetics.
Interaction studies investigating the cardiac effects, as measured by the corrected QT interval (QTc), of concomitantly administered oral azelastine hydrochloride and erythromycin or ketoconazole were conducted. Oral erythromycin (500 mg three times daily for seven days) had no effect on azelastine pharmacokinetics or QTc based on analyses of serial electrocardiograms. Ketoconazole (200 mg twice daily for seven days) interfered with the measurement of azelastine plasma concentrations; however, no effects on QTc were observed.
No significant pharmacokinetic interaction was observed with the coadministration of an oral 4 mg dose of azelastine hydrochloride twice daily and theophylline 300 mg or 400 mg twice daily.
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.
The possibility of persistent fungal infections of the cornea should be considered after prolonged steroid dosing.
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 ingredients 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:
Secondary bacterial ocular infection following suppression of host responses also occurs.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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