Polymyxin B Sulfate And Trimethoprim

Polymyxin B Sulfate And Trimethoprim

Polymyxin B Sulfate And Trimethoprim Recall

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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 occurs, discontinue use.

Polymyxin B sulfate and trimethoprim ophthalmic solution 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 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 Pseudomonasaeruginosa.**

**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. It has a pH of 4.0 to 6.2 and osmolality of 270 to 310 mOsm/kg. Trimethoprim sulfate, a white, odorless, crystalline powder, is represented by the following structural formula:

Trimethoprim sulfate (Structural formula)

C28H38N8O10S
Mol. Wt. 678.72

Chemical Name: Trimethoprim sulfate, 2,4-diamino-5-(3,4 5-trimethoxybenzyl)pyrimidine sulfate (2:1)

Polymyxin B sulfate is the sulfate salt of polymyxin B1 and B2 which are produced by the growth of Bacilluspolymyxa (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 is:

Polymyxin B Sulfate, the sulfate salt of polymyxin Bl and B2 (Structural formula)

Each mL Contains: ACTIVES: Polymyxin B Sulfate equal to 10,000 polymyxin B units, Trimethoprim Sulfate (equivalent to trimethoprim 1 mg); INACTIVES: Sodium Chloride, Purified Water. Sulfuric acid and, if necessary, sodium hydroxide may be added to adjust pH (4.0 – 6.2). PRESERVATIVE ADDED: Benzalkonium Chloride 0.004%.

Polymyxin B Sulfate And Trimethoprim Manufacturers


  • Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
    Polymyxin B Sulfate And Trimethoprim (Polymyxin B Sulfate And Trimethoprim Sulfate) Solution/ Drops [Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc]
  • Bausch & Lomb Incorporated
    Polymyxin B Sulfate And Trimethoprim (Polymyxin B Sulfate And Trimethoprim Sulfate) Solution/ Drops [Bausch & Lomb Incorporated]
  • Physicians Total Care, Inc.
    Polymyxin B Sulfate And Trimethoprim (Polymyxin B Sulfate And Trimethoprim Sulfate) Solution/ Drops [Physicians Total Care, Inc.]

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