Cortisporin (Neomy) Ophthalmic Ointment (neomycin and polymyxin B sulfates, bacitracin zinc, and hydrocortisone ophthalmic ointment) is a sterile antimicrobial and anti-inflammatory ointment for ophthalmic use. Each gram contains: neomycin sulfate equivalent to 3.5 mg neomycin base, polymyxin B sulfate equivalent to 10,000 polymyxin B units, bacitracin zinc equivalent to 400 bacitracin units, hydrocortisone 10 mg (1%), and white petrolatum, q.s.
Neomycin sulfate is the sulfate salt of neomycin B and C, which are produced by the growth of Waksman (Fam. Streptomycetaceae). It has a potency equivalent of not less than 600 µg of neomycin standard per mg, calculated on an anhydrous basis. The structural formulae are:
Polymyxin B sulfate is the sulfate salt of polymyxin B and B, which are produced by the growth of (Prazmowski) Migula (Fam. Bacillaceae). It has a potency of not less than 6,000 polymyxin B units per mg, calculated on an anhydrous basis. The structural formulae are:
Bacitracin zinc is the zinc salt of bacitracin, a mixture of related cyclic polypeptides (mainly bacitracin A) produced by the growth of an organism of the group of var Tracy. It has a potency of not less than 40 bacitracin units per mg. The structural formula is:
Hydrocortisone, 11β, 17, 21-trihydroxypregn-4-ene-3, 20-dione, is an anti-inflammatory hormone. Its structural formula is:
Cortisporin (Neomy) Ophthalmic Ointment is contraindicated in most viral diseases of the cornea and conjunctiva including: epithelial herpes simplex keratitis (dendritic keratitis), vaccinia and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures.
Cortisporin (Neomy) Ophthalmic Ointment is also contraindicated in individuals who have shown hypersensitivity to any of its components. Hypersensitivity to the antibiotic component occurs at a higher rate than for other components.
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. The exact incidence is not known.
Reactions occurring most often from the presence of the anti-infective ingredient are allergic sensitization reactions including itching, swelling, and conjunctival erythema (see ). More serious hypersensitivity reactions, including anaphylaxis, have been reported rarely.
The reactions due to the corticosteroid component in decreasing order of frequency are: elevation of intraocular pressure (IOP) with possible development of glaucoma, and infrequent optic nerve damage; posterior subcapsular cataract formation; and delayed wound healing.
Local irritation on installation has been reported.
Apply the ointment in the affected eye every 3 or 4 hours, depending on the severity of the condition.
Not more than 8 grams should be prescribed initially and the prescription should not be refilled without further evaluation as outlined in above.
Tube of 1/8 oz. (3.5 g) with ophthalmic tip (NDC 61570-035-35).
Store at 15° to 25°C (59° to 77°F).
Rev. 9/98
Distributed by: Monarch Pharmaceuticals, Inc., Bristol, TN 37620
Manufactured by: Draxis Pharma, Inc., Kirkland, Quebec H9H 4J4
