Cortomycin Eye Ointment

Name: Cortomycin Eye Ointment

Clinical pharmacology

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, concomitant antimicrobial drugs 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 antimicrobials 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 all drugs is administered. When each type of drug is in the same formulation, compatibility of ingredients is assured and 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.

Microbiology:

The anti-infective components in neomycin and polymyxin B sulfates, bacitracin zinc and hydrocortisone ophthalmic ointment are included to provide action against specific organisms susceptible to it. Neomycin sulfate and polymyxin B sulfate are active in vitro against susceptible strains of the following microorganisms: Staphylococcus aureus, streptococci, including Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae, Klebsiella-Enterobacter species, Neisseria species, and Pseudomonas aeruginosa. This product does not provide adequate coverage against Serratia marcescens (see INDICATIONS AND USAGE).

Contraindications

Neomycin and polymyxin B sulfates, bacitracin zinc and hydrocortisone 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.

This product 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

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 WARNINGS). 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.

Secondary Infection:

The development of secondary infection has occurred after use of combinations containing corticosteroids and antimicrobials. Fungal and viral infections of the cornea are particularly prone to develop coincidentally with long-term applications of a corticosteroid. The possibility of fungal invasion must be considered in any persistent corneal ulceration where corticosteroid treatment has been used.

Local irritation on instillation has also been reported.

Dosage and administration

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 PRECAUTIONS: above.

How supplied

Neomycin and Polymyxin B Sulfates, Bacitracin Zinc and Hydrocortisone Ophthalmic Ointment, USP is supplied in a tube with ophthalmic tip applicator in the following size:

3.5 g - Prod. No. 03934.

DO NOT USE IF CAP AND NECKRING ARE NOT INTACT.

FOR OPHTHALMIC USE ONLY

Storage:

Store between 15° - 30°C (59°- 86°F).

KEEP OUT OF REACH OF CHILDREN.

Rx only

Revised November 2007

Bausch & Lomb Incorporated
Tampa, FL 33637

©Bausch & Lomb Incorporated

9113800 (Folded)
9113900 (Flat)

For Healthcare Professionals

Applies to bacitracin / hydrocortisone / neomycin / polymyxin b ophthalmic: ophthalmic ointment

Hypersensitivity

Hypersensitivity reactions have included itching, swelling and conjunctival erythema. More serious reactions including anaphylaxis have been reported rarely.[Ref]

Ocular

Ocular side effects associated with the corticosteroid component have included with elevated intraocular pressure with possible development of glaucoma, optic nerve damage, posterior subcapsular cataract formation and delayed wound healing. In addition, perforation of the cornea and sclera have occurred when administering topical steroids to patients with diseases that cause thinning of the cornea or sclera.[Ref]

Other

The development of a secondary infection has been reported in patients treated with antimicrobial and corticosteroid combinations. Fungal and viral infections of the cornea can develop with long-term application of corticosteroids.[Ref]

Some side effects of Cortomycin Eye Ointment may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

(web3)