Dexamethasone, neomycin, polymyxin B (as sulfate).
Eye Suspension: Each mL of solution contains active dexamethasone 1 mg, neomycin sulfate equivalent to neomycin 3.5 mg/mL, polymyxin B sulfate 1.25 mg (10,000 units/mL).
Eye Ointment: Each gram contains active dexamethasone 1 mg, neomycin sulfate equivalent to 3.5 mg/g, polymyxin B sulfate 750 mcg (6,000 units/g).
Excipients/Inactive Ingredients: Eye Suspension: Benzalkonium chloride (preservative) 40 mcg, methocel E 4M HPMC 2910 5 mg, sodium chloride, polysorbate 20, hydrochloric acid and/or sodium hydroxide (to adjust pH), purified water.
Eye Ointment: Methylparaben 500 mcg, propylparaben 100 mcg, white petrolatum, anhydrous liquid lanolin.
Pharmacology: Polymyxin is bactericidal and most effective against Pseudomonas aeruginosa. Development of resistant strains is rare. The following gram negative organisms are highly susceptible to polymyxin: Aerobacter aerogenes, Escherichia coli, Klebsiella pneumoniae, Koch-Weeks bacillus.
Neomycin sulfate is a broad spectrum antibiotic. Some organisms which are sensitive of this antibiotic are: Staphylococcus aureus, Corynebacterium diptheriae, E. coli, Klebsiella pneumoniae, Proteus vulgaris, Aerobacter aerogenes and Haemophilus influenzae.
Dexamethasone is the most potent of a series of 16-methyl substituted hydrocortisone analogs and readily penetrates the cornea. It causes inhibition of the inflammatory response to inciting agents of a mechanical, chemical or immunological nature. No generally accepted explanation of this steroid property has been advanced.
In the management of infectious ocular inflammations produced by organisms which are sensitive to the antibiotics neomycin sulfate and polymyxin B sulfate.
Acute or chronic non-purulent conjunctivitis and keratojunctivitis, non-specific superficial keratitis, deep keratitis, acnerosacea keratitis, iridocyclitis, mild acute iritis, recurrent marginal ulceration and corneal ulcer (use with care in those disease causing thinning of the cornea because of the danger of perforation), non-purulent blepharitis, scleritis, episcleritis scleroconjunctivitis, herpes zoster opthalmicus (do not use in herpes simplex) and post-operatively to aid in the prevention of ophthalmic cases of infections.
Eye Suspension: One to two drops topically in the conjunctival sac(s). In severe disease, drops may be used up to four to six times daily.
Eye Ointment: Apply a small amount into the conjunctival sac(s) up to three to four times daily or may be used adjunctively with drops at bedtime or as prescribed by the physician.
This preparation is contraindicated in epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella and most other viral diseases of the cornea and conjunctiva, tuberculosis of the eye, fungal diseases of ocular structures and in those persons who have shown hypersensitivity to any component of this operation.
This product should not be used after uncomplicated removal of a cornea foreign body.
Prolonged use in susceptible individuals may result in increased intraocular pressure (glaucoma) with damage of the optic nerve, defects in visual acuity and fields of vision, posterior subcapsular cataract formation or may increase the hazard of secondary ocular infections from pathogens due to suppression of host response. In those diseases causing thinning of the cornea or sclera, perforation has been known to occur with the use of topical steroids. In acute purulent infections of the eye, infections appear to be enhanced with the presence of steroids. Frequent observations of patients are essential for monitoring potential adverse reactions.
As fungal infections of the cornea re particularly prone to develop coincidentally with long term topical steroid application, fungus invasion must be considered in any persistent corneal ulceration where a steroid has been used or is in use. Rarely, filtering blebs have been reported when topical steroids have been used following cataract surgery.
Use in Pregnancy: The safety protracted use of topical steroids in pregnancy has not been studied. Therefore, it is advisable not to use this product for long term treatment of pregnant patients.
The safety protracted use of topical steroids in pregnancy has not been studied. Therefore, it is advisable not to use this product for long term treatment of pregnant patients.
Glaucoma with optic nerve damage, visual acuity and field defect; cataract formation; secondary ocular infection following suppression of host response and perforation of the globe may occur.
Keep tightly closed every after use. Store in cool place.
S01CA01 - dexamethasone and antiinfectives ; Belongs to the class of corticosteroids in combination with antiinfectives. Used in the treatment of eye diseases.
Postop eye oint
3.5 g x 1's
Postop eye susp
5 mL x 1's
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