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

 
 



SUMMARY

Polymyxin B Sulfate and
Trimethoprim Ophthalmic Solution, USP
Sterile

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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NEWS HIGHLIGHTS

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)

Early Use of Polymyxin B Hemoperfusion in Abdominal Sepsis [Enrolling by invitation]
This clinical study designed as a prospective, open labelled, multi-centre, RCT will be carried out to evaluate if direct hemoperfusion with polymyxin B immobilized fiber column (PMX) is superior to conventional medical therapy for sepsis, for patients with sepsis arising from abdominal cavity infection, accompanied by the failure of one or more organs. 120 patients (60 treatment/60 control) will be considered in this study. Those patients fulfilling inclusion criteria and not having exclusion criteria will be randomly allocated to one of two study groups. One group will be treated with PMX (PMX group) and the other will receive a "standard therapy" for sepsis (control group). All patients will receive full intensive care management, including fluid resuscitation, vasopressors, antimicrobial chemotherapy, ventilatory support, and renal replacement therapy, if required. Each patient will be followed up for 28 days after study entry.

Effectiveness of Polymixin B Sulphate + Prednisolone + Benzoacaine + Clioquinol in Acute and Sub-acute Dermatitis Eczematous [Not yet recruiting]
Dermatitis eczematous is a recurrent pruritic skin disorder which has a significant morbidity and impaired quality of life due specially pruritus and physical visible skin lesions. The propose of this trial is evaluate the effectiveness of two differents topic associations of drugs.

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

Selective Digestive Decontamination in Carriers of Carbapenem-Resistant Klebsiella Pneumoniae [Not yet recruiting]
There is an urgent need to control our current national outbreak of carbapenem-resistant Klebsiella pneumoniae (CRKP). The purpose of this study is to eradicate CRKP gastrointestinal carriage using selective digestive decontamination (SDD); with buccal and oral gentamicin and polymyxin E administration. This will reduce infections and hopefully mortality caused by CRKP.

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.

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Page last updated: 2009-02-08

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