![Neomycin and Polymyxin B Sulfates and Dexamethasone 3.5 mg/g; 10000 [iU]/g; 1 mg/g Ointment, 3.5 g — NDC 61314-0631-36 package photo](https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=7f2e3c46-9f39-45e7-99a9-64cc4f6f649d&name=carton.jpg)
Neomycin and Polymyxin B Sulfates and Dexamethasone 3.5 mg/g; 10000 [iU]/g; 1 mg/g Ointment, 3.5 g
Past resolved recalls for this product (1)
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Corticosteroid class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Dexamethasone reduces the irritation, redness, burning, and swelling of eye caused by chemicals, heat, radiation, infection, allergy, or foreign bodies in the eye. It is sometimes used after eye surgery.
Read the full MedlinePlus article ↗- It's actually treating both at once. This product combines a steroid (dexamethasone) to calm inflammation in your eye and two antibiotics (neomycin and polymyxin B) to fight or pre...
- What exactly is this eye medication treating — is it for an infection or for inflammation?
- Shake the bottle well before each use — the medication is a suspension and settles if left still. Tilt your head back, pull down your lower lid slightly, and place the drops into t...
- Tilt your head back and place a finger gently under your eye to pull the lower lid down, forming a small 'V' pocket. Squeeze a small ribbon of ointment — about half an inch — into...
Patient education
Supplement & herbal interactions
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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Lanolin is a waxy substance derived from sheep's wool. It's used in medicines as an emollient and skin-conditioning agent to soften formulations and improve spreadability in topical products like creams and ointments.
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Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
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Petrolatum is a purified mineral oil-based jelly derived from petroleum. In medicines, it acts as an emollient, lubricant, and moisture barrier to soften skin, reduce friction, and help prevent water loss from formulations.
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Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
4 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per g | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $2.687 | $9.41 / 3.5 g |
| Medicaid paysCMS SDUD · 12 mo | $4.75 | $16.62 / 3.5 g |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
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🔁 Therapeutic equivalents
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⏳ Availability & generic status
The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.
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🗺️ Medicaid utilization & spend
🔬 Reported adverse events (FAERS)
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 61314-0631-36 You're viewing this | 3.5 g in 1 TUBE (61314-631-36) | 1996-02-21 | Active |
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
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 species, Neisseria species, and Pseudomonas aeruginosa. This product does not provide adequate coverage against: Serratia marcescens and Streptococci , including Streptococcus pneumoniae.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION 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 g 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 dexamethasone ophthalmic ointment is contraindicated in 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.
Neomycin and polymyxin B sulfates and dexamethasone ophthalmic ointment is also contraindicated in individuals with known or suspected hypersensitivity to a component of the medication. (Hypersensitivity to the antibiotic component occurs at a higher rate than for other components.)
⚠️ Warnings ▾
WARNINGS NOT FOR INJECTION. Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). Employment of steroid medication in the treatment of herpes simplex requires great caution; frequent slit lamp microscopy is recommended.
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 acute purulent conditions or parasitic infections of the eye, steroids may mask infection or enhance existing infection.
In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids. If this product is used for 10 days or longer, intraocular pressure (IOP) should be routinely monitored even though it may be difficult in children and uncooperative patients. Steroids should be used with caution in the presence of glaucoma.
IOP should be checked frequently. The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation. Products containing neomycin sulfate may cause cutaneous sensitization.
Sensitivity to topically administered aminoglycosides, such as neomycin, may occur in some patients. Severity of hypersensitivity reactions may vary from local effects to generalized reactions such as erythema, itching, urticaria, skin rash, anaphylaxis, anaphylactoid reactions, or bullous reactions. If hypersensitivity develops during use of the product, treatment should be discontinued.
Cross-hypersensitivity to other aminoglycosides can occur, and the possibility that patients who become sensitized to topical neomycin may also be sensitive to other topical and/or systemic aminoglycosides should be considered.
🤒 Adverse Reactions ▾
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 IOP with possible development of glaucoma, and infrequent optic nerve damage; posterior subcapsular cataract formation; and delayed wound healing. Secondary Infection: The development of secondary infection has occurred after use of combinations containing steroids and antimicrobials. Fungal infections of the cornea are particularly prone to develop coincidentally with long-term applications of steroid.
The possibility of fungal invasion must be considered in any persistent corneal ulceration where steroid treatment has been used. Keratitis, conjunctivitis, corneal ulcers, and conjunctival hyperemia have occasionally been reported following use of steroids. Secondary bacterial ocular infection following suppression of host responses also occurs.
Additional adverse reactions identified from post marketing use include ulcerative keratitis, headache, and Stevens-Johnson syndrome. The following additional adverse reactions have been reported with dexamethasone use: Cushing’s syndrome and adrenal suppression may occur after use of dexamethasone in excess of the listed dosing instructions in predisposed patients, including children and patients treated with CYP3A4 inhibitors.
🧬 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.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Neomycin and polymyxin B sulfates and dexamethasone ophthalmic ointment is supplied as a STERILE ointment in an aluminum tube with a white polyethylene tip and white polyethylene cap as follows: 3.5 g in an aluminum tube NDC 61314-631-36 Storage: Store at 2°C to 25°C (36°F to 77°F). After opening, neomycin and polymyxin B sulfates and dexamethasone ophthalmic ointment can be used until the expiration date on the tube. Manufactured by Novartis Manufacturing NV Puurs-Sint-Amands, Belgium for Sandoz Inc., Princeton, NJ 08540 Rev.
07/2024 9103458 US
📋 Description ▾
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: Neomycin B (R 1 =H, R 2 =CH 2 NH 2 ) Neomycin C (R 1 =CH 2 NH 2 , R 2 =H) The chemical structure for the active ingredient Polymyxin B Sulfate is: The chemical structure for the active ingredient Dexamethasone is: C 22 H 29 FO 5 Molecular Weight = 392.47 g/mol Established name: dexamethasone Chemical name: pregna-1, 4-diene-3, 20-dione,9-fluoro-11,17, 21-trihydroxy-16-methyl-, (11β, 16α)-.
Each gram of neomycin and polymyxin B sulfates and dexamethasone ophthalmic ointment contains: Active: neomycin sulfate equivalent to neomycin 3.5 mg, polymyxin B sulfate 10,000 units, dexamethasone 0.1%. Preservatives: methylparaben 0.05%, propylparaben 0.01%. Inactives: anhydrous liquid lanolin and white petrolatum. neomycin-chemical polymyxin-chemical polymyxin-text dexamethasone-chemical