NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE

Adverse Reactions Adverse reactions have occurred with steroid/anti-infective combination drugs which can be attributed to the steroid component, the anti-infective component, or the combination. Exact incidence figures are not available since no denominator of treated patients is available. Reactions occurring most often from the presence of the anti-infective ingredients are allergic sensitizations. The reactions due to the steroid component are: elevation of 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 steroids and antimicrobials. Fungal infections of the cornea are particularly prone to develop coincidentally with long-term applications of steroid. The possibility of fungal invasion must be considered in any persistent corneal ulceration where steroid treatment has been used. Keratitis, conjunctivitis, corneal ulcers, and conjunctival hyperemia have occasionally been reported following use of steroids. Secondary bacterial ocular infection following suppression of host responses also occurs. Additional adverse reactions identified from post marketing use include ulcerative keratitis, headache, and Stevens-Johnson syndrome. To report SUSPECTED ADVERSE REACTIONS, contact Bausch + Lomb, a division of Valeant Pharmaceuticals North America LLC, at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Contraindications 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. Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Ointment is also contraindicated in individuals with known or suspected hypersensitivity to a component of the medication. (Hypersensitivity to the antibiotic component occurs at a higher rate than for other components.)

Description Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Ointment, USP is a multiple dose anti-infective steroid combination in sterile ointment form for topical application. The chemical structure for the active ingredient Neomycin Sulfate is: The chemical structure for the active ingredient Polymyxin B Sulfate is: The chemical structure for the active ingredient Dexamethasone is: Established Name: Dexamethasone Chemical Name: pregna-1, 4-diene-3, 20-dione, 9-fluoro-11, 17, 21-trihydroxy-16-methyl-, (11β, 16α) - Each gram contains: Actives: neomycin sulfate equivalent to neomycin 3.5 mg, polymyxin B sulfate 10,000 units, dexamethasone 0.1%. Preservatives: methylparaben 0.05%, propylparaben 0.01%. Inactives: white petrolatum, lanolin, mineral oil. Desc Desc 1 Desc 2 Desc 3

Dosage and Administration Apply a small amount into the conjunctival sac(s) up to three or four times daily. How to Apply Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Ointment: Tilt your head back. 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. Place a small amount (about 1/2 inch) of Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Ointment in the "V" pocket. Do not let the tip of the tube touch your eye. Look downward before closing your eye. Not more than 8 g should be prescribed initially and the prescription should not be refilled without further evaluation as outlined in PRECAUTIONS above.

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. 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 Streptococci, including Streptococcus pneumoniae.

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, 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.

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NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE NEOMYCIN SULFATE NEOMYCIN POLYMYXIN B SULFATE POLYMYXIN B DEXAMETHASONE DEXAMETHASONE

ANDA064063

NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE

NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE

80425-0229

HUMAN PRESCRIPTION DRUG

OPHTHALMIC

Principal Display Panel label 1

Sterile Rx only

How Supplied/Storage and Handling Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Ointment is supplied as a STERILE ointment in a pre-printed aluminum tube with a natural HDPE cannula and a white HDPE cap. 3.5 g in an aluminum tube NDC: 80425-0229-01 Storage: Store between 15°-25°C (59°-77°F). KEEP OUT OF REACH OF CHILDREN. FOR OPHTHALMIC USE ONLY Bausch + Lomb, a division of Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA © 2018 Bausch & Lomb Incorporated Revised September 2018 9114006 (Folded) 9114106 (Flat)