Penetration of Orally Administered Prulifloxacin into Human Prostate Tissue

Giberti, Claudio; Gallo, Fabrizio; Rosignoli, Maria Teresa; Barattè, S.; Picollo, Rossella; Dionisio, Paolo

doi:10.2165/0044011-200929010-00003

Cited by 8 publications

(8 citation statements)

References 19 publications

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“…Prulifloxacin, a third generation fluoroquinolone, has been approved for the treatment of lower urinary tract infection. Furthermore, it has demonstrated its ability to better penetrate into prostatic tissue compared to other quinolones, thus confirming a potential therapeutic role in the treatment of bacterial prostatic infections [21]. Giannarini et al, comparing a 4-weeks course of prulifoxacin in comparison with levofloxacin in the treatment of chronic bacterial prostatitis, report, at 6 months, a microbiological eradication of 72.73% and 71.11%, repectively, and a reduction in the NIH-CPSI of 10.75 and 10.73.…”

Section: Discussionmentioning

confidence: 99%

Chronic bacterial prostatitis: efficacy of short-lasting antibiotic therapy with prulifloxacin (Unidrox®) in association with saw palmetto extract, lactobacillus sporogens and arbutin (Lactorepens®)

et al. 2014

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BackgroundBacterial prostatitis (BP) is a common condition accounting responsible for about 5-10% of all prostatitis cases; chronic bacterial prostatitis (CBP) classified as type II, are less common but is a condition that significantly hampers the quality of life, (QoL) because not only is it a physical condition but also a psychological distress. Commonly patients are treated with antibiotics alone, and in particular fluoroquinolones are suggested by the European Urology guidelines. This approach, although recommended, may not be enough. Thus, a multimodal approach to the prolonged antibiotic therapy may be helpful.Methods210 patients affected by chronic bacterial prostatitis were enrolled in the study. All patients were positive to Meares-Stamey test and symptoms duration was > 3 months. The purpose of the study was to evaluate the efficacy of a long lasting therapy with a fluoroquinolone in association with a nutraceutical supplement (prulifloxacin 600 mg for 21 days and an association of Serenoa repens 320 mg, Lactobacillus Sporogens 200 mg, Arbutin 100 mg for 30 days). Patients were randomized in two groups (A and B) receiving respectively antibiotic alone and an association of antibiotic plus supplement.ResultsBiological recurrence at 2 months in Group A was observed in 21 patients (27.6%) and in Group B in 6 patients (7.8%). Uropathogens found at the first follow-up were for the majority Gram – (E. coli and Enterobacter spp.). A statistically significant difference was found at the time of the follow-up between Group A and B in the NIH-CPSI questionnaire score, symptoms evidence and serum PSA.ConclusionsBroad band, short-lasting antibiotic therapy in association with a nutritional supplement (serenoa repens, lactobacillus sporogens and arbutin) show better control and recurrence rate on patients affected by chronic bacterial prostatitits in comparison with antibiotic treatment alone.Trial registrationNCT02130713Date of trial Registration: 30/04/2014

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Section: Discussionmentioning

confidence: 99%

Chronic bacterial prostatitis: efficacy of short-lasting antibiotic therapy with prulifloxacin (Unidrox®) in association with saw palmetto extract, lactobacillus sporogens and arbutin (Lactorepens®)

et al. 2014

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“…[2][3][4] Differently from other antibacterial agents, fluoroquinolones have excellent pharmacokinetic properties which give high concentrations in various body tissues, including sinus mucosa. After 1-3 hours from a single 500 mg levofloxacin administration, average paranasal sinus mucosa-to-plasma ratios ranged approximately between 1.5 and 2.5.…”

Section: Discussionmentioning

confidence: 99%

“…1 It has the aptitude to penetrate several target tissues, [2][3][4] particularly lung tissue with a mean ratio of 6.9 between tissue and plasma concentrations, observed over a 24-hour period. 2 Following a single 600 mg oral administration of prulifloxacin, ulifloxacin reaches the maximum plasma concentration of 1.6 mg/ ml after 1 hour, with an AUC 0-' value of 7.3 mg/ml*h. 5 After 10-day repeated once daily administrations of prulifloxacin, the ulifloxacin C max was 2 mg/ml, with 0.75 hours and 7.6 mg/ml*h of t max and AUC ss corresponding values.…”

Section: Introductionmentioning

confidence: 99%

Penetration of prulifloxacin into sinus mucosa of patients undergoing paranasal sinus elective endoscopic surgery

Benedetto

Passàli

Tomacelli

et al. 2012

Journal of Chemotherapy

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The aim of this study was to assess the concentration of ulifloxacin, the active metabolite of prulifloxacin, in sinuses mucosa and plasma of patients with chronic rhinosinusitis, requiring sinus elective endoscopic surgery. Thirty-nine patients (30 males, 9 females; age range 22-77 years) with chronic sinusitis were enrolled, 35 were treated with the investigational medication. Samples from four untreated patients were used to validate the analytical method, while four treated patients dropped out before surgery. One 600 mg prulifloxacin tablet once daily was administered for 5 days before surgery. The last dosing was scheduled from 2 to 12 hours from tissue and plasma sampling. In each patient, two samples of paranasal sinus mucosa (from ethmoid and turbinate, respectively) and one blood sample were collected. Concentrations of ulifloxacin in plasma and sinuses mucosa were measured using validated bioanalytical LC/MS/MS methods. Individual and mean ulifloxacin concentrations in tissues were always higher than the relevant plasma levels. The highest concentrations were observed between 2.5 and 4.5 hours after the last dosing in all districts. The mean tissue/plasma ratios were 2.5 and 3.0 for ethmoid and turbinate, respectively. Data expressed as Area Under the Curves (AUC±SD) showed that ulifloxacin concentrations in the ethmoid were slightly higher (18.68±6.48 μg/g*h) than in turbinate (15.00±2.89 μg/g*h), and definitely higher than in plasma (6.32±1.14 μg/ml*h). The AUC ratios between tissues and plasma were 3.0 for ethmoides and 2.4 for turbinates. One patient reported two treatment-related episodes of diarrhea, which spontaneously resolved after the drug suspension. Results from this study seem to suggest that prulifloxacin showed good distribution in sinus tissues, where it reaches concentrations significantly higher than in plasma. These findings strongly call for confirmatory clinical trials in patients with bacterial rhinosinusitis.

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“…Mean prostate tissue/plasma concentration ratios following antibiotic administration ranged from 3.8 to 9.5 [36]. In addition, ulifloxacin is not only highly active against commonly involved Gram-negative pathogens (E. coli, K. pneumoniae, P. mirabilis) but also displays some activity against Grampositive bacteria, including Enterococcus and Staphylococcus spp., which have recently been found to play an important role in CBP [37,38].…”

Section: Discussionmentioning

confidence: 99%

Prulifloxacin: a review focusing on its use beyond respiratory and urinary tract infections

Rafailidis

Polyzos

Sgouros

et al. 2011

International Journal of Antimicrobial Agents

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To cite this version:Petros I. Rafailidis, Konstantinos A. Polyzos, Konstantinos Sgouros, Matthew E. Falagas.Prulifloxacin: a review focusing on its use beyond respiratory and urinary tract infections.International Journal of Antimicrobial Agents, Elsevier, 2011, 37 (4) This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. In summary, prulifloxacin appears to be a promising agent for the treatment of bacterial prostatitis and traveller's diarrhoea.

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Penetration of Orally Administered Prulifloxacin into Human Prostate Tissue

Abstract: These findings confirm the ability of prulifloxacin to penetrate prostatic tissues, indicating high exposure of the target tissue to ulifloxacin and, therefore, a potential therapeutic role for prulifloxacin in the treatment of bacterial prostatic infections.

Cited by 8 publications

References 19 publications

Chronic bacterial prostatitis: efficacy of short-lasting antibiotic therapy with prulifloxacin (Unidrox®) in association with saw palmetto extract, lactobacillus sporogens and arbutin (Lactorepens®)

Chronic bacterial prostatitis: efficacy of short-lasting antibiotic therapy with prulifloxacin (Unidrox®) in association with saw palmetto extract, lactobacillus sporogens and arbutin (Lactorepens®)

Penetration of prulifloxacin into sinus mucosa of patients undergoing paranasal sinus elective endoscopic surgery

Prulifloxacin: a review focusing on its use beyond respiratory and urinary tract infections

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