Polymyxin B Sulfate and Trimethoprim

INDICATIONS AND USAGE Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution is indicated in the treatment of surface ocular bacterial infections, including acute bacterial conjunctivitis, and blepharoconjunctivitis, caused by susceptible strains of the following microorganisms: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus viridans, Haemophilus influenzae and Pseudomonas aeruginosa. * *Efficacy for this organism in this organ system was studied in fewer than 10 infections.

DOSAGE AND ADMINISTRATION In mild to moderate infections, instill one drop in the affected eye(s) every three hours (maximum of 6 doses per day) for a period of 7 to 10 days.

CONTRAINDICATIONS Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution is contraindicated in patients with known hypersensitivity to any of its components.

ADVERSE REACTIONS The most frequent adverse reaction to Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution is local irritation consisting of increased redness, burning, stinging, and/or itching. This may occur on instillation, within 48 hours, or at any time with extended use. There are also multiple reports of hypersensitivity reactions consisting of lid edema, itching, increased redness, tearing, and/or circumocular rash. Stevens- Johnson Syndrome/Toxic Epidermal Necrolysis (SJS/TEN) and anaphylaxis have been reported. Photosensitivity has been reported in patients taking oral trimethoprim. To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc., at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DESCRIPTION Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution is a sterile antimicrobial solution for topical ophthalmic use. It has a pH of 4.0 to 6.2 and osmolality of 270 to 310 mOsm/kg. Chemical Names: Trimethoprim sulfate, 2,4-diamino-5-(3,4,5-trimethoxybenzyl)pyrimidine sulfate (2:1), is a white, odorless, crystalline powder with a molecular weight of 678.72 and the following structural formula: 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 mg, calculated on an anhydrous basis. The structural formula are: Contains: Actives: polymyxin B sulfate 10,000 units/mL; trimethoprim sulfate equivalent to trimethoprim 1mg/mL. Preservative: benzalkonium chloride 0.04 mg/mL. Inactives: sodium chloride; sulfuric acid and purified water. May also contain sodium hydroxide for pH adjustment. trimethoprim-chemical polymyxin-chemical polymyxin-text

HOW SUPPLIED Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution, USP is a sterile solution. Each mL contains trimethoprim sulfate equivalent to 1 mg trimethoprim and polymyxin B sulfate 10,000 units in NDC: 70518-1735-00 PACKAGING: 10 mL in 1 BOTTLE PLASTIC TYPE 0 Storage: Store at 15° to 25°C (59° to 77°F) and protect from light. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762