Neomycin Sulfate / Polymyxin B Sulfate / Dexamethasone

What it is and how it works

Mechanism class: Corticosteroid Hormone Receptor Agonists

Indications

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.

Dosage and administration (summary)

DOSAGE AND ADMINISTRATION Apply a small amount into the conjunctival sac(s) up to three or four times daily. How to Apply MAXITROL ® (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 ½ inch) of MAXITROL (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.

Contraindications

CONTRAINDICATIONS MAXITROL ® (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.

Warnings and precautions

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.

Pregnancy

Pregnancy 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.

Storage and supply

HOW SUPPLIED MAXITROL ® (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 0078-0771-01 Storage : Store at 2°C to 25°C (36°F to 77°F).

Source: Neomycin Sulfate, Polymyxin B Sulfate And Dexamethasone (Maxitrol) — US FDA prescribing information, 2023-06-27, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.