Prulifloxacin 600mg Tablets Prulifloxacin: Efficacy in Respiratory and Urinary tract infections Introduction Exacerbations of chronic bronchitis (AECB) are a major cause of morbidity and mortality in patients with chronic obstructive 1 pulmonary disease (COPD), and their impact on public health is increasing. Urinary tract infections (UTIs) are considered to be the most common bacterial infection. In non-institutionalized elderly populations, UTIs are the second most common form of 2 infection, accounting for nearly 25% of all infections. There are important medical and financial implications associated with UTIs. In the last few years, the antimicrobial activity, efficacy and relative safety of fluoroquinolones have made them attractive for the treatment of community-acquired and nosocomial infections. Prulifloxacin, the prodrug of ulifloxacin, is a new fluoroquinolone antibacterial agent with a broad spectrum of activity against Gram-positive and Gram-negative bacteria. Prulifloxacin is available for oral use, and after absorption is metabolized in to the active form, ulifloxacin. It exhibits good penetration in target tissues and 3 a long elimination half-life, allowing once-daily administration. Prulifloxacin has been successfully tested in Phase III randomized, controlled trials including patients with acute exacerbations of chronic bronchitis, uncomplicated and complicated 4 urinary tract infections and chronic bacterial prostatitis. This article highlights the role of Prulifloxacin in treatment of Respiratory and Urinary Tract infections. Efficacy in Respiratory Tract Infections Prulifloxacin is effective in treatment of AECOPD in cigarette smokers Pasqua and co-workers conducted a study to evaluate the efficacy of prulifloxacin in the treatment of AECOPD (acute exacerbations of chronic obstructive pulmonary disease) in cigarette smokers. The study recruited 61 consecutive smokers of either sex having signs and symptoms for AECOPD. The most common bacterial species isolated in the sputum was Haemophilus influenzae (in 42.6% of the total sample), followed by S. pneumoniae (16.5%), S. aureus (14.7%), M. catarrhalis (11.5%), and others (14.7%). The patients were assigned to receive prulifloxacin 600 mg orally once daily for 10 days. The results of the study showed clinical success in 91.8% of patients (67.2% cured and 24.6% improved). Bacteriological eradication rate of H. influenzae was 100%. S. pneumoniae (2 out of 10), S. aureus (1 out of 8), M. catarrhalis (1 out of 7), and P. aeruginosa (1 out of 3) were some of the persistent pathogens. The study concluded that prulifloxacin was effective in the treatment of AECOPD in cigarette smokers. 5 Prulifloxacin is as effective and safe as Ciprofloxacin in the treatment of patients with AECB A randomized, multicenter, double-blind, double-dummy study was conducted to assess the efficacy and safety of prulifloxacin vs. ciprofloxacin in patients with acute exacerbations of chronic bronchitis (AECB). The study included 235 patients. A dose of 600 mg prulifloxacin once daily, 500 mg ciprofloxacin twice a day (n=118) was administered for a duration of 10 days. The efficacy evaluations were performed by comparing pretreatment and post-treatment assessments. INTRA LABS Patients (%) The results of the study showed clinical success in 84.7 and 85% (Figure 1) of patients in the prulifloxacin and ciprofloxacin groups, respectively, proving the equivalence of treatments. The most commonly isolated strains like Haemophilus influenzae, Str e ptococcus pneumoniae, Klebsiella pneumoniae and Pseudomonas aeruginosa were successfully eradicated by 100 85 84.7 b o t h t h e d r u g s. B o t h 80 treatments were well 60 tolerated and in this study. 40 Adverse drug reactions were 20 of mild or moderate intensity. The researchers opined that a 10-day course of prulifloxacin was as effective and safe as ciprofloxacin in the treatment of patients with 6 AECB. 0 Prulifoxacin Ciprofloxacin Figure 1. Clinical success of Prulifloxacin and Ciprofloxacin in patients with AECB Efficacy in Urinary Tract Infections Prulifloxacin is effective and well-tolerated as Levofloxacin in the treatment of respiratory and urinary tract infections Chen and co-workers conducted a multicentre, double-blind, randomized controlled clinical trial to evaluate the efficacy and safety of prulifloxacin compared to levofloxacin for the treatment of respiratory and urinary infections in Chinese patients. The study recruited 267 patients and they were randomly assigned to either the treatment or the control group. Based on patient's condition prulifloxacin 264.2 mg (equivalent to ulifloxacin 200 mg) b.i.d. or levofloxacin hydrochloride 200 mg b.i.d. was administered orally for 5-14 days. The clinical response, bacterial eradication and incidence of adverse events were evaluated. Patients (%) According to study results, 243 patients completed the study. The cure and effective rates for the modified intention-to-treat population were 45.53% and 82.93% in the prulifloxacin group and 49.18% and 83.61% in the levofloxacin group. The cure and effective rates for the per-protocol analysis population were 45.90% and 83.61% in the prulifloxacin group and 49.59% and 83.47% in the levofloxacin group. The bacterial eradication rates were 96.59% and 95.35% (Figure 2), and the drug-related Prulifloxacin adverse event rates were 7.87% and 5.51% in the prulifloxacin Levofloxacin 96.59 95.35 100 83.61 83.47 82.93 83.61 and levofloxacin group, 80 respectively. The difference in 60 cure rates and efficacy rates 45.9 49.59 45.53 49.18 between the 2 groups was not 40 statistically significant (p > 0.05). 20 The researchers opined that prulifloxacin was as effective a n d we l l t o l e r a t e d a s levofloxacin in the treatment of respiratory and urinary tract infections.7 7.87 5.51 0 Cure rates Effective rates Modified intention to treat population Cure rates Effective rates Bacterial eradication Adverse event rates Per-protocol analysis population Figure 2. Efficacy of Prulifloxacin vs. Levofloxacin on various parameters Prulifloxacin 600mg Tablets Prulifloxacin is a safe and well-tolerated and effective treatment for the management of UTI A prospective, open-label, pilot trial with 6-month follow-up was conducted by Cai et al., to evaluate the tolerability and efficacy of Prulifloxacin in young female patients with symptoms of cystitis, with a history of recurrent UTI and urine culture positive for uropathogens. The study enrolled 51 female patients and they were administered with 14-day course of prulifloxacin orally and once daily. Microbiological and clinical efficacy was tested over three follow-up visits at 1, 3 and 6 months. Quality of life (QoL) was measured and the impact of prulifloxacin in modifying the Lactobacillus vaginal flora was also evaluated. The results of the pilot trial were as follows. The microbiological results at follow-up examinations were as follows: after 1 month, 47 patients were recurrence-free and 4 had recurrence; after 3 months, 41 were recurrence-free, while 6 reported recurrence; finally, after 6 months, 36 were recurrence-free and 5 had recurrence. The study concluded that 14-day administration of prulifloxacin 600 mg was a safe, well-tolerated and effective treatment for 8 the management of UTI in young women. Prulifloxacin can be used as empiric therapy of complicated urinary tract infections Carmignani and co-workers conducted a randomized, double-blind, double-dummy, controlled clinical trial to compare the efficacy and safety of a 10-day regimen of prulifloxacin 600 mg once daily with ciprofloxacin 500 mg twice daily in the treatment of patients with complicated urinary tract infections (UTIs). The study recruited 257 patients and the patients were orally treated with prulifloxacin (127 patients) or ciprofloxacin (130 patients). The eradication of infecting strains (<103 cfu/ml) was the primary efficacy parameter. The clinical outcome and tolerability were also assessed. The study concluded that high urinary concentrations of prulifloxacin, combined with a broad-spectrum antimicrobial activity can be used in the empiric therapy of UTIs.9 Patients (%) The results of the study showed that the successful treatment rate was 90.8% in the prulifloxacin group, and 77.8% in the ciprofloxacin group (p=0.008) during early follow-up period. In 94.8% and 93.3% (Figure 3) of prulifloxacin- and c i p r o f l ox a c i n - t r e a t e d patients a positive clinical outcome was observed. 100 94.8 93.3 90.8 Both drugs were well77.8 tolerated. 80 60 Prulifloxacin group 40 Ciprofloxacin group 20 0 Successful treatment rate Positive clinical outcome Figure 3. Efficacy of Prulifloxacin vs. Ciprofloxacin in complicated UTI Summary Prulifloxacin is a fluoroquinolone with indications in the treatment of urinary tract infection and acute exacerbations of chronic bronchitis. The antibacterial spectrum is similar to that of ciprofloxacin with clear advantages in terms of antipseudomonal in vitro activity. Evidenced clinical data reveal the equivalent efficacy of Prulifloxacin to levofloxacin and ciprofloxacin in treatment of AECB and complicated UTI. However, more clinical studies are warranted to better evaluate the role of this new fluoroquinolone in the panorama of antibiotics. Prulifloxacin 600mg Tablet For the use of registered medical practitioner. References 1.Blasi F, Aliberti S, Tarsia P et al. Prulifloxacin: a brief review of its potential in the treatment of acute exacerbation of chronic bronchitis. Int J Chron Obstruct Pulmon Dis. 2007;2(1):27-31. 2.Foxman B. Epidemiology of urinary tract infections: incidence, morbidity, and economic costs. Dis Mon. 2003;49(2):53-70. 3.Prats G, Rossi V, Salvatori E, Mirelis B. Prulifloxacin: a new antibacterial fluoroquinolone. Expert Rev Anti Infect Ther. 2006;4(1):27-41. 4.Giannarini G, Tascini C, Selli C.Prulifloxacin: clinical studies of a broad-spectrum quinolone agent. Future Microbiol. 2009;4(1):13-24. 5.Pasqua F, Biscione G, Crigna G et al. Prulifloxacin in the treatment of acute exacerbations of COPD in cigarette smokers. Ther Adv Respir Dis. 2008;2(4):209-214. 6.Grassi C, Salvatori E, Rosignoli MT et al. Randomized, double-blind study of prulifloxacin versus ciprofloxacin in patients with acute exacerbations of chronic bronchitis. Respiration. 2002;69(3):217-222. 7.Chen Y, Yang H, Lu G et al. Prulifloxacin versus levofloxacin in the treatment of respiratory and urinary tract infections: a multicentre, double-blind, randomized controlled clinical trial. Chemotherapy. 2012;58(3):249-256. 8.Cai T, Mazzoli S, Nesi G et al. 14-day prulifloxacin treatment of acute uncomplicated cystitis in women with recurrent urinary tract infections: a prospective, open-label, pilot trial with 6-month follow-up. J Chemother. 2009;21(5):535-541. 9.Carmignani G, De Rose AF, Olivieri L et al. Prulifloxacin versus ciprofloxacin in the treatment of adults with complicated urinary tract infections. Urol Int. 2005;74(4):326-331. Prulifloxacin 600mg Tablets Indications and Dosage: Oral Uncomplicated lower urinary tract infections Adults: In acute cases (simple cystitis): Single dose of 600 mg. Oral Acute Exacerbations of Chronic Bronchitis Adults: 600 mg daily up to 10 days. Oral Complicated lower urinary tract infections Adults: 600 mg daily up to 10 days. Corporate Office : # 36/37, Annipura Main Road, Sudhama Nagar, (Off Double Road) Bangalore - 560 027. Ph: 080-22114892/93, E-mail : [email protected] www.intralabsindia.com INTRA LABS 2013 The information provided on these pages remains, unless otherwise stated, the copyright of Insperel Meditech Pvt. Ltd. All layout, design, original artwork, concepts and other Intellectual Properties, remain the property and copyright of Insperel Meditech Pvt. 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