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Polymyxin B and Trimethoprim Ophthalmic (Polymyxin B Sulfate / Trimethoprim Sulfate Ophthalmic) - Summary



Polymyxin B Sulfate and
Trimethoprim Ophthalmic Solution, USP

Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution is a sterile antimicrobial solution for topical ophthalmic use.

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.

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Published Studies Related to Polymyxin B and Trimethoprim Ophthalmic (Polymyxin B / Trimethoprim Ophthalmic)

A multicenter comparison of polymyxin B sulfate/trimethoprim ophthalmic solution and moxifloxacin in the speed of clinical efficacy for the treatment of bacterial conjunctivitis. [2008.11]
PURPOSE: To compare the speed of clinical efficacy for two currently available topical antibiotics: polymyxin B sulfate/trimethoprim (polymyxin/trimethoprim) and 0.5% moxifloxacin ophthalmic solution... CONCLUSION: Moxifloxacin 0.5% administered three times daily is safe and cures bacterial conjunctivitis more effectively and significantly faster than polymyxin/trimethoprim dosed four times daily. The majority of patients were cured and symptom-free by 48 hours. Therefore, moxifloxacin is cost-effective and significantly more efficacious than polymyxin/trimethoprim in the speed by which it reduces the symptoms and disease transmission.

Antimicrobial efficacy and aqueous humor concentration of preoperative and postoperative topical trimethoprim/polymyxin B sulfate versus tobramycin. [1994.01]
We compared trimethoprim sulfate 0.1%/polymyxin B sulfate 10,000 units/mL with tobramycin 0.3% for preoperative sterilization of the ocular surface, aqueous humor concentration, and ocular safety and comfort in 99 patients who had cataract extraction and intraocular lens implantation... No significant differences were found in ocular safety and comfort.

Trimethoprim-polymyxin B sulphate ophthalmic ointment in the treatment of bacterial conjunctivitis: a double-blind study versus chloramphenicol ophthalmic ointment. [1988]
Forty-two patients with a clinical diagnosis of bacterial conjunctivitis were enrolled in a randomized, double-blind trial. Patients were treated with either trimethoprim-polymyxin B sulphate or chloramphenicol ophthalmic ointments 4-times a day for 7 days.Analysis of clinical evaluation data showed that both treatments were effective and well tolerated, and that there were no statistically significant differences between them with regard to eradication of organisms or clinical improvement.

The effect of trimethoprim-polymyxin B sulphate ophthalmic ointment and chloramphenicol ophthalmic ointment on the bacterial flora of the eye when administered to the operated and unoperated eyes of patients undergoing cataract surgery. [1988]
Both eyes of patients undergoing cataract surgery were treated with an ointment preparation containing either trimethoprim 5 mg/g and polymyxin B sulphate 10,000 units/g, or chloramphenicol 1%. The antibiotic preparations were administered four times daily on the day prior to surgery, once in the morning prior to surgery and twice daily for fourteen days post-operatively...

Results of a survey of children with acute bacterial conjunctivitis treated with trimethoprim-polymyxin B ophthalmic solution. [1995.09]
Acute conjunctivitis, one of the most frequently seen eye diseases in infants and children, is associated with a shorter duration of clinical disease when antimicrobial agents are used.The pediatricians in our survey who prescribed trimethoprim-polymyxin B ophthalmic solution for children with presumed acute bacterial conjunctivitis reported that this medication was effective and well tolerated.

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Clinical Trials Related to Polymyxin B and Trimethoprim Ophthalmic (Polymyxin B / Trimethoprim Ophthalmic)

Efficacy of Polymyxin B Against Infections Caused by Extensively Drug-resistant (XDR) Gram-Negative Bacteria [Recruiting]
The objective of the study is to evaluate the efficacy of Polymyxin B for treatment Gram negative bacterial infection. The hypothesis of study is Polymyxin B would be the new antibacterial agents for Thai Gram negative infected patients in case of desirable outcomes and minimal side effects.

The Effects of Polymyxin-B Protects on Sepsis Induced Kidney Dysfunction: a Randomized Clinical Trial [Completed]
Aim of the study is to verify whether Polymyxin-B hemoperfusion protects from renal dysfunction in patients with severe sepsis from gram negative infection.

Impact of Early Peri-operative Use of Polymyxin-B Hemoperfusion in Septic Patients Undergoing Emergent Abdominal Surgery [Recruiting]
Septic shock of intra-abdominal origin is likely due to Gram-negative bacteria or mixed pathogens and associated with high levels of endotoxin. The injury to the endothelium results in an increase of endothelial permeability, interstitial edema and release of nitric oxide (NO) that is a very potent vasodilatator. [6] Polymyxins obtained from the Gram-positive bacterium Bacillus polymyxa are antibiotics known for their ability to bind LPS in the outer membrane of the Gram-negative bacterial cell wall as well as free endotoxins with high affinity. Polymyxin-B has been shown to block the activation of cells by a wide variety of LPS. Studies converged to show an improvement in the treatment of septic shock by removing circulating endotoxin. Starting Polymyxin-B hemoperfusion during the operative time is to block the initiation of various deleterious biological cascades induced by endotoxemia such as systemic inflammation, disseminated coagulation disorders, and shock, leading to organ dysfunction and death.

Randomized-controlled Trial (RCT) on Combination Antibiotic for Infections Caused by Gram-negative Bacteria [Not yet recruiting]
Background and rationale: Antimicrobial resistance is a global public health threat. An increasing number of Gram-negative bacteria isolates worldwide are resistant to virtually all antibiotics including carbapenems. Although polymyxins are the current gold standard antibiotic for

treatment of severe extensively drug-resistant Gram-negative bacteria (XDR-GNB - defined in

Appendix I) infections, resistance development on therapy and treatment failures are common. Combination antibiotics therapy have better in vitro efficacy, but have not been formally tested in a prospective trial. We will conduct a Phase IIB, prospective, open-label, randomized-controlled trial in 4 major Singaporean hospitals, with balanced treatment assignments achieved by permuted block randomization, stratified by hospital. There will be 75 subjects per arm, with the subjects in the comparator arm receiving standard-dose polymyxin B while the intervention arm will receive a second antibiotic, doripenem, with polymyxin B against the bacterial isolate in question. Subjects with ventilator-associated pneumonia (VAP) will additionally receive nebulized colistin. The primary outcome is 30-day mortality while secondary outcomes include microbiological clearance, time to defervescence, and toxicity of therapy, presence of secondary infections due to new multi-drug resistant bacteria and length of ICU stay. Plasma drug levels will be measured by liquid chromatography-mass spectrometry. Hypothesis: The underlying primary hypothesis is that combination antibiotic therapy (IV polymyxin B + IV doripenem) is superior to mono-antibiotics therapy (IV polymyxin B) in reducing 30-day mortality from XDR-GNB infections.

The Pilot Study of the Efficacy of Polymyxin-B Hemoperfusion in Critically Ill Patients With Severe Sepsis [Recruiting]
This research project is a study to immunology changes in critically ill patients with severe sepsis by using Endotoxin Activity Assay (EAA) combined with Polymyxin-B Hemoperfusion.

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Page last updated: 2009-02-08

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