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.

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.

Treatment of Acyclovir-Resistant Mucocutaneous Herpes Simplex Disease in Patients With AIDS: Open Label Pilot Study of Topical Trifluridine [Completed]
To determine the safety, effectiveness, and toxicity of topical (local) trifluridine in treating mucocutaneous (at the nasal, oral, vaginal, and anal openings) Herpes simplex virus ( HSV ) disease that has shown resistance to acyclovir in HIV-infected patients. HSV infection in patients with AIDS is often associated with skin sores and frequent recurrences. Treatment with the drug acyclovir results in healing for most patients, but repeated treatment sometimes results in resistance of the virus to acyclovir. Thus, when this happens, other treatments need to be used. Trifluridine is an antiviral drug that is used for the treatment of Herpes infections that occur in the eye. This study attempts to determine if trifluridine is useful for treating HSV sores that have not healed after treatment with acyclovir.

Comparison of Combination Antibiotics Eyedrop to Artificial Tear in Hordeolum After Incision and Curettage [Recruiting]
To compare the effectiveness of combined antibiotic ophthalmic solution (neomycin sulfate, polymyxin B sulfate and gramicidin) with placebo (artificial tear) in the treatment of hordeolum after incision and curettage

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