maxitrol
Pharmaranks rates Maxitrol 3.5/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Maxitrol is a combination medicine containing Dexamethasone, Neomycin Sulfate, and Polymyxin B Sulfate.
Dexamethasone and Neomycin Sulfate and Polymyxin B Sulfate · by Harrow Eye
Available as a generic: Neomycin and Polymyxin B Sulfates and Dexamethasone
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, Suspension
- Strength
- Dexamethasone 0.1%; Neomycin Sulfate EQ 3.5MG BASE/ML; Polymyxin B Sulfate 10,000 UNITS/ML
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Harrow Eye
- 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
- NDA050023
What is Maxitrol?
From the FDA label: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: Molecular Weight = 392.45 g/mol C 22 H 29 FO 5 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. The structural formula for 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 structural formula for polymyxin B sulfate is: Each mL of Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension contains: Actives: neomycin sulfate equivalent to neomycin 3.5 mg, polymyxin B sulfate 10,000 units, dexamethasone 0.1%. Inactives: benzalkonium chloride 0.004% (preservative), hydrochloric acid and/or sodium hydroxide (to adjust pH), hypromellose 2910 0.5%, polysorbate 20, purified water, sodium chloride. NEOMYCIN SULFATE The structural formula for neomycin sulfate The structural formula for polymyxin B sulfate
How to use
Maxitrol is sold in more than one form (Topical and Suspension), and each is dosed differently. The instructions below come from the FDA label for application NDA050023 — follow the label that came with the product you were actually prescribed.
One to two drops 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.
Side effects
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. 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 corticosteroid component are: elevation of IOP with possible development of glaucoma, and infrequent optic nerve damage; posterior subcapsular cataract formation; and delayed wound healing. Corticosteroid-containing preparations have also been reported to cause perforation of the globe. Keratitis, conjunctivitis, corneal ulcers, and conjunctival hyperemia have occasionally been reported following use of steroids. 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.
Warnings
Important safety information
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 a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution; frequent slit lamp microscopy is recommended. Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision, and in posterior subcapsular cataract formation. Prolonged use may also suppress the host immune response and thus increase the hazard of secondary ocular infections. Acute purulent or parasitic infections of the eye may be masked or activity enhanced by the presence of corticosteroid medication. Various ocular diseases and long-term use of topical corticosteroids have been known to cause corneal and scleral thinning. Use of topical corticosteroids in the presence of thin corneal or scleral tissue may lead to perforation. 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. Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension is not for injection. It should never be injected subconjunctivally, nor should it be directly introduced into the anterior chamber of the eye. 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.
Who should not take Maxitrol
Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension is contraindicated in most viral diseases of the cornea and conjunctiva, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures. Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.
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 and Suspension
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- How is Maxitrol rated?
- pharmaranks gives Maxitrol 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 Maxitrol 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 Maxitrol?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Maxitrol. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Maxitrol?
- Maxitrol is marketed by Harrow Eye. You can see Harrow Eye's full profile, rating, and other products on pharmaranks.
- Is Maxitrol a brand-name or generic drug?
- Maxitrol is a brand-name product with the active ingredient Dexamethasone and Neomycin Sulfate and Polymyxin B Sulfate. Lower-cost generic equivalents containing Dexamethasone and Neomycin Sulfate and Polymyxin B Sulfate are available — ask your pharmacist.
- Is Maxitrol available over the counter?
- No. Maxitrol 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 Maxitrol come in?
- Maxitrol is currently marketed as topical and suspension, per the FDA's National Drug Code Directory.
- Is Maxitrol FDA-registered?
- Maxitrol is on record with the U.S. FDA under application number NDA050023. You can verify this on its official FDA label.
- Has Maxitrol been recalled by the FDA?
- Maxitrol 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 Maxitrol safe?
- There's no single safe-or-not verdict. pharmaranks gives Maxitrol 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 Maxitrol?
- Maxitrol's side effects are taken directly from its FDA label. From the label: 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. 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.
Reviews
No reviews yet. Be the first to write one.
People also viewed
abiraterone acetate
Abiraterone Acetate
acular
Ketorolac Tromethamine
acular ls
Ketorolac Tromethamine
aimovig
Erenumab-Aooe
albendazole
Albendazole
alphagan p
Brimonidine Tartrate
Compare Maxitrol head-to-head
Browse medications A–Z
Research products from A to Z, compare independent ratings, and find alternatives.
maxitrol
70/100