polymyxin b sulfate and trimethoprim sulfate

INDICATIONS AND USAGE Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution, USP 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. Photosensitivity has been reported in patients taking oral trimethoprim. To report SUSPECTED ADVERSE REACTIONS, contact Somerset Therapeutics, LLC at 1-800-417-9175 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

DESCRIPTION Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution, USP is a sterile antimicrobial solution for topical ophthalmic use. It has pH of 4.0 to 6.2 and osmolality of 270 to 310 mOsm/kg. Chemical Names: Trimethoprim, 5-(3,4,5-Trimethoxybenzyl)pyrimidine-2,4-,diamine, is a white, odorless, crystalline powder with a molecular weight of 290.3 and the following structural formula: Structure 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 formulae are: Structure Contains: Actives: polymyxin B sulfate 10,000 units/mL; trimethoprim sulfate equivalent to trimethoprim 1 mg/mL. Preservative: benzalkonium chloride 0.04 mg/mL. Inactives: water for injection; sodium chloride; and sulfuric acid. May also contain sodium hydroxide to adjust the pH. Molecular Structure Molecular Structure

HOW SUPPLIED Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution, USP is supplied sterile in natural low density polyethylene (LDPE) ophthalmic bottles and natural low density polyethylene (LDPE) nozzle with white high density polyethylene (HDPE) caps as follows: 10 mL in 10 mL bottle - NDC 70069- 311 -01 Note: Store at 15° to 25°C (59° to 77°F) and protect from light. Rx only For Product Inquiry call +1-800-417-9175 Revised: May, 2024 Manufactured for: Somerset Therapeutics, LLC. Somerset, NJ 08873 Made in India Code No.: KR/DRUGS/KTK/28/289/97 ST-PST11/P/01 1200824