neomycin and polymyxin b sulfates and dexamethasone
Pharmaranks rates Neomycin and Polymyxin B Sulfates and Dexamethasone 3.5/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Neomycin and Polymyxin B Sulfates and Dexamethasone is a combination medicine containing Dexamethasone, Neomycin Sulfate, and Polymyxin B Sulfate.
Dexamethasone and Neomycin Sulfate and Polymyxin B Sulfate · by Padagis US
Generic of Maxitrol
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Dexamethasone and Neomycin Sulfate and Polymyxin B Sulfate
- Form
- Topical
- Strength
- Dexamethasone 0.1%; Neomycin Sulfate EQ 3.5MG BASE/GM; Polymyxin B Sulfate 10,000 UNITS/GM
- Type
- Prescription (Rx)
- Brand or generic
- Generic
- Manufacturer
- Padagis US
- Half-life
- about 4 hours (how long it stays in your system)
- What the pharmacy pays
- ~$0.23 per ml — not your price
- FDA application
- ANDA062938
- Availability
- Discontinued (per FDA)
What is Neomycin and Polymyxin B Sulfates and Dexamethasone?
From the FDA label: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: C 22 H 29 FO 5 Mol. Wt. 392.47 Chemical Name: Pregna-1,4-diene-3,20-dione, 9-fluoro-11, 17,21-trihydroxy-16-methyl-, (11ß, 16α)-. Neomycin Sulfate is the sulfate salt of neomycin B and C which are produced by the growth of Streptomyces fradiae 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 formula are: Polymyxin B Sulfate is the sulfate salt of polymyxin B 1 and B 2 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 milligram, calculated on an anhydrous basis. The structural formula are: Each gram of ointment contains: ACTIVES: Dexamethasone 1 mg (0.1%), Neomycin Sulfate equivalent to Neomycin 3.5 mg base, Polymyxin B Sulfate 10,000 units in a base containing INACTIVES: White Petrolatum and Mineral Oil. Structural Formula Image 1 Structural Formula Image 2 Structural Formula Image 3
How to use
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.
Side effects
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: The development of the secondary infection has occurred after use of combination containing steroids and antimicrobials. Fungal infections of the cornea are particularly prone to develop coincidentally with long-term applications of steroids. The possibility of fungal invasion must be considered in any persistent corneal ulceration where steroid treatment has been used. Secondary bacterial ocular infection following suppression of host responses also occurs. To report SUSPECTED ADVERSE REACTIONS, contact Perrigo at 1-866-634-9120, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Warnings
Important safety information
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.
Who should not take Neomycin and Polymyxin B Sulfates and Dexamethasone
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 the other components.) The use of these combinations is always contraindicated after uncomplicated removal of a corneal foreign body.
How long does Dexamethasone and Neomycin Sulfate and Polymyxin B Sulfate stay in your body?
The elimination half-life of dexamethasone and neomycin sulfate and polymyxin b sulfate is about 4 hours — the time it takes the body to clear about half of it. As a rule of thumb, a medicine is mostly gone after roughly 4 to 5 half-lives, though this varies from person to person with age and kidney or liver function. This is the plasma (terminal) elimination half-life — the label states the mean terminal half-life is 4 hours. Dexamethasone's anti-inflammatory/biologic effect lasts far longer than its blood levels (commonly cited biologic half-life ~36-54 hours), which is why it is dosed less often than the short plasma half-life implies; the drug is largely cleared from the blood within about a day (roughly 4-5 half-lives, ~1 day), but this clearance window is not the same as a drug-test detection window. Dexamethasone is ~77% protein-bound and metabolized by CYP3A4 (renal excretion is less than 10% of clearance), so strong CYP3A4 inhibitors/inducers can lengthen or shorten exposure. The manufacturer notes the effect of renal or hepatic impairment on its pharmacokinetics has not been formally studied.
This is general information, not medical advice. It doesn’t tell you when a drug test would read negative (tests detect substances for different, often longer, windows) or when it’s safe to take another dose — ask your pharmacist or prescriber. Source: HEMADY (dexamethasone) tablets — FDA label, Clinical Pharmacology (DailyMed).
Dosage forms
Topical
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
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Frequently asked questions
- How is Neomycin and Polymyxin B Sulfates and Dexamethasone rated?
- pharmaranks gives Neomycin and Polymyxin B Sulfates and Dexamethasone a composite score of 3.5 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- How much does Neomycin and Polymyxin B Sulfates and Dexamethasone cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $0.23 per ml, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.
- Is there a coupon or discount for Neomycin and Polymyxin B Sulfates and Dexamethasone?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Neomycin and Polymyxin B Sulfates and Dexamethasone. To pay less, Neomycin and Polymyxin B Sulfates and Dexamethasone is already a generic — usually the lowest-cost version — so the main levers are comparing cash prices between pharmacies and using a pharmacy discount-card service. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Neomycin and Polymyxin B Sulfates and Dexamethasone?
- Neomycin and Polymyxin B Sulfates and Dexamethasone is marketed by Padagis US. You can see Padagis US's full profile, rating, and other products on pharmaranks.
- Is Neomycin and Polymyxin B Sulfates and Dexamethasone a brand-name or generic drug?
- Neomycin and Polymyxin B Sulfates and Dexamethasone is a generic medication; its active ingredient is Dexamethasone and Neomycin Sulfate and Polymyxin B Sulfate. Generics contain the same active ingredient as the brand-name original and are usually lower cost.
- Is Neomycin and Polymyxin B Sulfates and Dexamethasone available over the counter?
- No. Neomycin and Polymyxin B Sulfates and Dexamethasone is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Neomycin and Polymyxin B Sulfates and Dexamethasone come in?
- Neomycin and Polymyxin B Sulfates and Dexamethasone is currently marketed as topical, per the FDA's National Drug Code Directory.
- Is Neomycin and Polymyxin B Sulfates and Dexamethasone FDA-registered?
- Neomycin and Polymyxin B Sulfates and Dexamethasone is on record with the U.S. FDA under application number ANDA062938. You can verify this on its official FDA label.
- Has Neomycin and Polymyxin B Sulfates and Dexamethasone been recalled by the FDA?
- Neomycin and Polymyxin B Sulfates and Dexamethasone has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Neomycin and Polymyxin B Sulfates and Dexamethasone safe?
- There's no single safe-or-not verdict. pharmaranks gives Neomycin and Polymyxin B Sulfates and Dexamethasone a recall-safety score of 70/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Neomycin and Polymyxin B Sulfates and Dexamethasone?
- Neomycin and Polymyxin B Sulfates and Dexamethasone's side effects are taken directly from its FDA label. From the label: 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.… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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neomycin and polymyxin b sulfates and dexamethasone
70/100