Neomycin Polymyxin B Sulfates and Dexamethasone

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 corticosteroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of corticosteroids 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.

DOSAGE AND ADMINISTRATION: One or two drops in the conjunctival sac(s). In severe disease, drops may be used hourly, being tapered to discontinuation as the inflammation subsides. In mild disease, drops may be used up to four to six times daily. Not more than 20 mL should be prescribed initially and the prescription should not be refilled without further evaluation as outlined in PRECAUTIONS above. FOR TOPICAL OPHTHALMIC USE ONLY. SHAKE WELL BEFORE USING.

CONTRAINDICATIONS: Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension is contraindicated in most viral diseases of the cornea and conjunctiva, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures. Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.

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. 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 ingredient are allergic sensitizations. The reactions due to the corticosteroid component are: elevation of IOP with possible development of glaucoma, and infrequent optic nerve damage; posterior subcapsular cataract formation; and delayed wound healing. Corticosteroid-containing preparations have also been reported to cause perforation of the globe. Keratitis, conjunctivitis, corneal ulcers, and conjunctival hyperemia have occasionally been reported following use of steroids. Additional adverse reactions identified from post marketing use include ulcerative keratitis, headache, and Stevens-Johnson syndrome. The following additional adverse reactions have been reported with dexamethasone use: Cushing’s syndrome and adrenal suppression may occur after use of dexamethasone in excess of the listed dosing instructions in predisposed patients, including children and patients treated with CYP3A4 inhibitors. To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb Incorporated at 1-800-553-5340 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DESCRIPTION: Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension, USP is a multiple dose anti-infective steroid combination in a sterile suspension for topical application. The active ingredient, Dexamethasone, is represented by the following structural formula: C 22 H 29 FO 5 Mol. Wt. 392.47 Chemical Name: Pregna-1,4-diene-3,20-dione, 9-fluoro-11,17,21-trihydroxy-16-methyl-, (11β,16α)-. Neomycin Sulfate is the sulfate salt of neomycin B and C which are produced by the growth of Streptomyces fradiae Waksman (Fam. Streptomycetaceae). It has a potency equivalent to not less than 600 micrograms of neomycin base per milligram, calculated on an anhydrous basis. The structural formula is: Polymyxin B Sulfate is the sulfate salt of polymyxin B 1 and B 2 which are produced by the growth of Bacillus polymyxa (Prazmowski) Migula (Fam. Bacillaceae). It has a potency of not less than 6,000 polymyxin B units per milligram, calculated on an anhydrous basis. The structural formula is: Each mL contains: ACTIVES: Neomycin Sulfate (equivalent to 3.5 mg neomycin), Polymyxin B Sulfate equal to 10,000 polymyxin B units, Dexamethasone 1 mg (0.1%); INACTIVES: Sodium Chloride, Hypromellose, Polysorbate 20, Purified Water. Hydrochloric Acid and/or Sodium Hydroxide may be added to adjust pH (3.5 – 6.0). PRESERVATIVE ADDED: Benzalkonium Chloride 0.004% Dexamethasone (structural formula) Neomycin Sulfate (structural formula) Polymyxin B Sulfate (structural formula)

HOW SUPPLIED Neomycin and polymyxin B sulfates and dexamethasone ophthalmic suspension, USP is supplied as a sterile ophthalmic suspension in a white, low-density polyethylene (LDPE) bottle with a linear low-density polyethylene (LLDPE) extended controlled drop tip and polypropylene cap: NDC 68788-9720-5- 5 mL in 10 mL bottle Relabeled By: Preferred Pharmaceuticals Inc. Storage: Store between 15°C to 25°C (59°F to 77°F). Store upright. KEEP OUT OF REACH OF CHILDREN. Distributed by: Bausch & Lomb Americas Inc. Bridgewater, NJ 08807 USA Manufactured by: Bausch & Lomb Incorporated Tampa, FL 33637 USA © 2022 Bausch & Lomb Incorporated or its affiliates Relabeled By: Preferred Pharmaceuticals Inc. Rev. 12/2022 9114306 (Flat)