DailyMed Label: MAXITROL

DailyMed Label: Maxitrol

2023

DailyMed Prescription

Maxitrol

neomycin sulfate, polymyxin b sulfate and dexamethasone

Harrow Eye, LLC

NDC: 82667-100

NDC: 82667-100

MAXITROL ® (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 MAXITROL ® (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. maxitrol-suspension-01.jpg The structural formula for neomycin sulfate The structural formula for polymyxin B sulfate

For steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial infection exists. Ocular corticosteroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of corticosteroids 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 S treptococci , including Streptococcus pneumoniae .

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.

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. MAXITROL is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.

The initial prescription and renewal of the medication order beyond 20 mL of MAXITROL ® (neomycin and polymyxin B sulfates and dexamethasone ophthalmic suspension) 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. If signs and symptoms fail to improve after two days, the patient should be reevaluated. As fungal infections of the cornea are particularly prone to develop coincidentally with long-term corticosteroid applications, fungal invasion should be suspected in any persistent corneal ulceration where a corticosteroid has been used or is in use. Fungal cultures should be taken when appropriate. If this product is used for 10 days or longer, IOP should be monitored ( see WARNINGS ). Prolonged use of topical anti-bacterial agents may give rise to overgrowth of non-susceptible organisms including fungi. If inflammation or pain persists longer than 48 hours or becomes aggravated, the patient should be advised to discontinue use of the medication and consult a physician. This product is sterile when packaged. To prevent contamination, care should be taken to avoid touching the bottle tip to eyelids or to any other surface. The use of this bottle by more than one person may spread infection. Keep bottle tightly closed when not in use. Keep out of reach of children. Patients should be advised that their vision may be temporarily blurred following dosing with MAXITROL ® (neomycin and polymyxin B sulfates and dexamethasone ophthalmic suspension). Care should be exercised in operating machinery or driving a motor vehicle. Long-term studies in animals to evaluate carcinogenic or mutagenic potential have not been conducted with polymyxin B sulfate. Treatment of cultured human lymphocytes in vitro with neomycin increased the frequency of chromosome aberrations at the highest concentration (80 mcg/mL) tested. However, the effects of neomycin on carcinogenesis and mutagenesis in humans are unknown. Polymyxin B has been reported to impair the motility of equine sperm, but its effects on male or female fertility are unknown. Dexamethasone has been shown to be teratogenic in mice and rabbits following topical ophthalmic application in multiples of the therapeutic dose. In the mouse, corticosteroids produce fetal resorptions and a specific abnormality, cleft palate. In the rabbit, corticosteroids have produced fetal resorptions and multiple abnormalities involving the head, ears, limbs, palate, etc. There are no adequate or well-controlled studies in pregnant women. However, prolonged or repeated corticoid use during pregnancy has been associated with an increased risk of intra-uterine growth retardation. MAXITROL ® (neomycin and polymyxin B sulfates and dexamethasone ophthalmic suspension) should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the embryo or fetus. Infants born of mothers who have received substantial doses of corticosteroids during pregnancy should be observed carefully for signs of hypoadrenalism. Systemically administered corticosteroids appear in human milk, could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when MAXITROL ® (neomycin and polymyxin B sulfates and dexamethasone ophthalmic suspension) is administered to a nursing woman. Safety and effectiveness in pediatric patients below the age of 2 years have not been established. No overall differences in safety or effectiveness have been observed between elderly and younger patients.

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.

MAXITROL ® (neomycin and polymyxin B sulfates and dexamethasone ophthalmic suspension) is supplied as a sterile ophthalmic suspension in a white, low density polyethylene dispenser with a pink, polypropylene cap as follows: 5 mL in 8 mL bottle………………………………………………………. NDC 82667-100-05 Storage : Store upright at 8°C to 27°C (46°F to 80°F). After opening, MAXITROL (neomycin and polymyxin B sulfates and dexamethasone ophthalmic suspension) can be used until the expiration date on the bottle.

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.

NDC 82667-100-05 Maxitrol® (neomycin and polymyxin B sulfates and dexamethasone ophthalmic suspension) 5 mL Sterile HARROW ® maxitrol-suspension-04.jpg