Polymyxin B Sulfate And Trimethoprim Sulfate

Polymyxin B Sulfate And Trimethoprim Sulfate

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Questions & Answers

Side Effects & Adverse Reactions

NOT FOR INJECTION INTO THE EYE. If a sensitivity reaction to polymyxin B sulfate and trimethoprim ophthalmic solution, USP occurs discontinue use. Polymyxin B sulfate and trimethoprim ophthalmic solution, USP is not indicated for the prophylaxis or treatment of ophthalmia neonatorum.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

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.

History

There is currently no drug history available for this drug.

Other Information

Polymyxin B sulfate and trimethoprim ophthalmic solution, USP is a sterile antimicrobial solution for topical ophthalmic use.

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:

structural formula

Polymyxin B sulfate is the sulfate salt of polymyxin B1 and B2 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:

structural formulae

Contains: Actives: polymyxin B sulfate 10,000 units/mL; trimethoprim sulfate equivalent to 1 mg/mL. Preservative: benzalkonium chloride 0.04 mg/mL. Inactives: purified water; sodium chloride; and sulfuric acid. May also contain sodium hydroxide for pH adjustment. It has pH of 4.0 to 6.2 and osmolality of 270 to 310 mOsm/kg.

Polymyxin B Sulfate And Trimethoprim Sulfate Manufacturers


  • Lake Erie Medical Dba Quality Care Products Llc
    Polymyxin B Sulfate And Trimethoprim Sulfate (Polymyxin B Sulfate, Trimethoprim Sulfate) Solution/ Drops [Lake Erie Medical Dba Quality Care Products Llc]
  • H.j. Harkins Company, Inc.
    Polymyxin B Sulfate And Trimethoprim Sulfate (Polymyxin B Sulfate, Trimethoprim Sulfate) Solution/ Drops [H.j. Harkins Company, Inc.]
  • Preferred Pharmaceuticals, Inc
    Polymyxin B Sulfate And Trimethoprim Sulfate (Polymyxin B Sulfate, Trimethoprim Sulfate) Solution/ Drops [Preferred Pharmaceuticals, Inc]
  • Clinical Solutions Wholesale
    Polymyxin B Sulfate And Trimethoprim Sulfate (Polymyxin B Sulfate, Trimethoprim Sulfate) Solution/ Drops [Clinical Solutions Wholesale]
  • Pacific Pharma, Inc.
    Polymyxin B Sulfate And Trimethoprim Sulfate (Polymyxin B Sulfate, Trimethoprim Sulfate) Solution/ Drops [Pacific Pharma, Inc.]
  • Medsource Pharmaceuticals
    Polymyxin B Sulfate And Trimethoprim Sulfate (Polymyxin B Sulfate, Trimethoprim Sulfate) Solution/ Drops [Medsource Pharmaceuticals]

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