7-day regimen of faropenem for the treatment of cystitis 11Hamasuna R, Tanaka K, Hayami H, et al . Treatment of acute uncomplicated cystitis with faropenem for 3 days versus 7 days: Multicentre, randomized, open-label, controlled trial. J Antimicrob Chemother. 2014;69(6):1675–1680.
Acute uncomplicated cystitis is a common disease in women, and the increasing prevalence of resistant bacteria including ESBL-producing strains in pathogens causing acute uncomplicated cystitis has been of concern. Hamasuna, et al ., evaluated the efficacy of faropenem against cystitis, and compared 3- and 7-day administration regimens in a multicenter, randomized, controlled, open-label study. Women aged ≥20 years, with any cystitis symptoms, such as micturition pain, urinary frequency, urge to urinate, or lower abdominal pain with pyuria and bacteriuria were included in this study. The target bacteria wereStaphylococcus spp., Enterococcus faecalis ,Streptococcus agalactiae and Enterobacteriaceae. Faropenem sodium was administered three times daily (600 mg/day) for 3 days (n=97) or 7 days (n=103).
Clinical efficacy in the two groups was not significantly different when evaluated at 5–9 days after treatment completion, and at 4–6 weeks after treatment completion. The microbiological non-recurrence rate was 80.8% (21/26) in the 3-day treatment group and 79.4% (27/34) in the 7-day treatment group (p=1.0). The MIC90 for E. coli, K. pneumoniae, Staphylococcus and Enterococcus was 1, 0.5, 1 and 0.03 mg/L, respectively. Adverse events (AEs) were reported in 9.5% of patients (19/200) and there was no significant difference between the 3- and 7-day treatment groups. The most common AE was diarrhea (7.5%, 15/200). AE severity was mild-to-moderate.
The 7-day regimen of faropenem showed a superior rate of microbiological response. E. coli strains were, in general, susceptible to faropenem, including fluoroquinolone- and cephalosporin-resistant strains.
Faropenem for patients with acute cystitis caused by ESBL-producing E.coli
Fujino et al retrospectively reviewed the medical charts of patients with acute cystitis caused by ESBL-producing E. coli who were treated with the oral antimicrobial agent faropenem (FRPM) in their institution from June 2011 to May 2015.22Fujino, Keiko et al. The efficacy of faropenem for patients with acute cystitis caused by extended-spectrum β-lactamase producing Escherichia coli. Journal of Infection and Chemotherapy, Volume 23, Issue 5, 336 - 338 Ten patients with acute cystitis caused by ESBL-producing E.coli were treated with FRPM. Although a clinical cure was achieved in 9 of them, it reoccurred in 3. This study revealed that the treatment regimen with FRPM for patients with acute cystitis caused by ESBL-producing E.coli is promising. However, a non-negligible number of recurrences were caused by ESBL-producing E.coli
because of the nature of underlying diseases or pathologies in the urinary tract.
Faropenem for the management of urinary tract infection: Real-world experience from India. 33Shah A, Sharma S, Unnikrishnan TK. Experience of Faropenem for the management of urinary tract infection: Real-world experience from India. IP J Urol Nephrol Hepatol Sci 2020;3(4):
To record the real-world evidence on the use of faropenem in the management of UTIs, the responses of Indian urologists were obtained on the usage of faropenem in the management of complicated urinary tract infection (cUTI) after providing a set of eight questions having both multiple-choice responses and open-ended answers. Results : Responses from 391 participants were collected. In the majority of the urology clinics prevalence of cUTI was 5-10% whereas others found it to be 10-20%. A majority believed that faropenem was an effective pharmacotherapy for the management of UTIs (66.4%) including cUTI as a step-down therapy (66.4%). Faropenem 300 mg provided more compliance. The overall perception of the use of faropenem in their practice was that (out of 391 responses) the majority found it to be effective (72.7%) and 4.6% of participants have used faropenem as an alternative for cUTI. The majority found it safe (68.5) to be used in cUTI. It was shown that faropenem was preferred for the treatment of urinary tract infections due to its effectiveness, ability to cause less resistance and safety profile.
A faropenem regimen of 200–300 mg twice daily is recommended by Medindia for treating genitourinary infections.44Gandra S, Takahashi S, Mitrani-Gold FS, Mulgirigama A, Ferrinho DA. A systematic scoping review of faropenem and other oral penems: treatment of Enterobacterales infections, development of resistance and cross-resistance to carbapenems. JAC-Antimicrobial Resistance. 2022 Dec;4(6):dlac125.
Farpenem as an alternative to cefuroxime for the treatment of acute bacterial sinusitis
Siegert, et al ., compared the efficacy and safety of 7-day courses of faropenem medoxomil (300 mg twice daily; n=228) and cefuroxime axetil (250 mg twice daily; n=224) in adult patients with acute bacterial sinusitis in a prospective, multinational, multicenter, double-blind, comparative study.55Siegert R, Berg O, Gehanno P,et al . Comparison of the efficacy and safety of faropenem daloxate and cefuroxime axetil for the treatment of acute bacterial maxillary sinusitis in adults. Eur Arch Otorhinolaryngol. 2003;260(4):186–194.
S. pneumoniae , H. influenzae , S. aureus andM. catarrhalis were the most common organisms isolated at baseline. Four out of 36 H. influenzae , 9 out of 10 M. catarrhalis and 11 out of 19 S. aureus strains were β-lactamase producers. At 7–16 days post-therapy, clinical cure was reported in 89.0% of faropenem medoxomil- and 88.4% of cefuroxime axetil-treated patients, while the corresponding rates for bacteriological success were 91.5% and 90.8%. Eradication or presumed eradication (bacteriological response) is described in Figure 5. AEs were reported by 46 (16.8%) of the faropenem medoxomil-treated patients and 49 (17.9%) of the cefuroxime axetil-treated patients.
In a study by Upchurch, et al ., the efficacy and safety of faropenem medoxomil was compared with cefuroxime axetil in adults with acute bacterial sinusitis. This phase III, prospective, randomized, double-blind, multicenter trial included patients aged ≥18 years with a clinical diagnosis of acute sinusitis and duration of signs and symptoms >7 days but <28 days. Patients were randomly assigned in a 1:1:1 proportion to faropenem medoxomil 300 mg twice daily for 7 days (n=366) or 10 days (n=363) or cefuroxime axetil 250 mg twice daily for 10 days (n=370).66Upchurch J, Rosemore M, Tosiello R,et al . Randomized double-blind study comparing 7- and 10-day regimens of faropenem medoxomil with a 10-day cefuroxime axetil regimen for treatment of acute bacterial sinusitis. Otolaryngol Head Neck Surg. 2006;135(4):511–517.
Clinical cure rates for the 7-day and 10-day faropenem medoxomil regimens were non-inferior to that of the 10-day cefuroxime axetil regimen for the efficacy-valid population. The continued cure rates at the late follow-up visit showed that both faropenem medoxomil regimens had higher success rates than cefuroxime axetil. At least one AE was reported by 39%, 34% and 41% of patients in the faropenem medoxomil 7-day and 10-day groups and the cefuroxime axetil group, respectively. The majority of the AEs were mild or moderate in severity (∼87%) and improved or resolved after treatment.