Secnidazole 2g granules sachets

Objective: Bacterial vaginosis is a disease caused by vaginal microecology disorder, which seriously affects female health. At present, there are many drugs to treat BV, and this study aims to compare the efficacy and safety of multiple drugs for BV through a network meta-analysis (NMA). Methods: All studies were sourced from PubMed and Embase databases from the establishment date to April 13, 2023. We evaluated the clinical cure success rate and adverse effects (abnormal increase in vaginal discharge, external genital irritation, and vulvar itching) and performed subgroup analyses of the clinical cure success rate for different modes of administration. All statistical analyses were performed using R and STATA 14.0 software for network meta-analysis. Results: We included 42 studies that met the criteria, involving a total of 8382 patients. Network meta-analysis results showed that metronidazole and secnidazole had a higher rate of adverse reactions than placebo (RR 7.06; 95%-CI 2.61-19.10, RR 4.03; 95%-CI 1.63-9.98), the adverse reaction rate of probiotics group was lower than that of metronidazole group (RR 0.44; 95%-CI 0.21-0.93). The clinical cure rate of oral ornidazole was better than clindamycin (RR 16.08; 95%-CI 1.72-150.47), Secnidazole (RR 8.17; 95%-CI 1.66-40.25) and probiotics. Direct meta-analysis results showed that ornidazole had a better clinical cure rate than Secnidazole (RR 1.22; 95%-CI 1.10-1.34), oral ornidazole had a better clinical cure rate than Secnidazole (RR 1.23; 95%-CI 1.11-1.36). The clinical cure rate of vaginal application of sucrose was better than metronidazole (RR 1.12; 95%-CI 1.03-1.21) and metronidazole had a lower clinical cure rate than probiotics (RR 0.68; 95%-CI 0.52-0.88). Conclusions: The results of this systematic review and network meta-analysis suggest that ornidazole may be an effective alternative for the treatment of BV, and that sucrose and probiotics are potential BV treatments that need to be validated by more high-quality clinical studies in the future.

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Bacterial vaginosis (BV), Candida, and Trichomonas vaginalis (TV) are the most common causes of vaginitis. These infections are associated with various untoward consequences including increased risk of acquisition of the others, transmission of HIV, Neisseria gonorrhoeae, Chlamydia trachomatis, and herpes simplex virus-2 as well as adverse reproductive and mental health outcomes, and cervical cancer risk.1 Vaginitis disproportionately affects ethnic minorities and those with lower formal educational attainment and/or experiencing poverty, the very groups most likely to seek episodic care in emergency departments (EDs).2-4 Current U.S. Centers for Disease Control and Prevention (CDC) sexually transmitted infections (STIs) treatment guidelines for vaginitis do not provide an effective approach for many of these women, resulting in missed and delayed diagnoses and treatment.1 We propose an empirical, single-dose, point-of-care treatment strategy, novel to the U.S. but evidence-based and consistent with international guidelines, to address existing deficiencies in availability of inexpensive and accurate point-of-care diagnosis, and substantial barriers to medication adherence and follow-up commonly faced by women from disadvantaged groups who frequently seek help in EDs.5-7 Vaginitis is clinically diagnosed by complaints of itching, burning, and odor accompanied by vaginal discharge. However, providing effective treatment is challenging because of limitations to accurately diagnose the cause of vaginitis at the time of a woman's visit. Conventional microscopy (Gram stain and wet mount), which is typically available in EDs, in addition to being time-consuming, is strikingly insensitive for the diagnosis of BV, TV, and Candida, particularly with coinfections.8-12 For example, one study of 1740 women with vaginitis (BV, 783; Candida, 523; TV, 122; and mixed BV/Candida, 185) comparing standard microscopy to nucleic acid amplification testing (NAAT; using reference standards of culture for TV and Candida and Nugent criteria for BV) reported sensitivities for microscopy to detect BV, TV, and Candida were 76.8%, 68.6%, and 56.9%, respectively.8 For NAAT, sensitivities were 92.8%, 96.5%, and 90.2%, respectively. Specificities for both microscopy and NAAT were generally >90%. For microscopy detection of coinfections, sensitivities dropped to 10%–20%. Considering single and multiple infections, using microscopy, as many as one-quarter to one-half of infections are missed overall. CDC STI guidelines currently acknowledge microscopy's very poor sensitivity, recommending NAAT TV and Candida culture testing (or empirical treatment for Candida) if microscopy is negative.1 Currently, the only point-of-care NAAT for BV, Candida, and TV, the Cepheid Xpert Express MVP PCR test, with a minimum laboratory assay turnaround time of 60 min but longer in practice, is not generally available in U.S. EDs (based on a survey of 12 U.S. EDs in our EMERGEncy ID NET research network [https://www.emergencyidnet.org/] and communication with Cepheid Company). Urgent care facilities likely have even less laboratory support. Use of microscopy testing leads to missed diagnoses and inadequate or delayed treatment, with persistence of symptoms additionally contributing to these women's disabilities as well as risks of adverse health outcomes. In many centers, NAATs can be ordered as send-out tests; however, they are expensive, covered by most but not all insurance, and require follow-up, which pose real obstacles for many women who are uninsured or underinsured, are unhoused, and lack a telephone and transportation. Further, follow-up of send-out test results, counseling, and prescriptions take time, which has a potential operational impact on ED workflow. The consequences of inadequate treatment and inefficient testing approaches could be mitigated in these circumstances by an affordable, single-dose, empirical point-of-care treatment strategy. The 2021 U.S. CDC STI guidelines primarily recommend a 7-day 500-mg twice-daily oral metronidazole regimen to treat BV and TV in women and 150-mg single-dose oral fluconazole to treat candidal infection (Table 1).1 For treatment of women with TV, a 7-day 500 mg twice daily metronidazole regimen has been found to be associated with higher proportion of patients achieving 4-week cure than the 2-g single dose.13 Adherence is difficult due to this regimen's long duration and metronidazole's unpleasant metallic taste and frequent gastrointestinal side effects.14 As opposed to sexual health clinics, regulatory barriers obviate point-of-care ED medication dispensing, thus requiring the patient to go to a pharmacy to fill their prescription. One study found that patient adherence to multidose oral metronidazole treatment of BV was 50%–68%.15 Women of ethnic minorities and low socioeconomic status are at greatest risk of medication nonadherence.16 Metronidazole 500 mg orally BID × 7 days; or Metronidazole gel 0.75% 5 g intravaginally daily × 5 days; or Clindamycin cream 2% 5 g intravaginally daily × 7 days Tinidazole 2 g orally single dose QD × 2 days; or Tinidazole 1 g orally QD × 5 days or Secnidazole 2 g orally single dose; or Clindamycin 300 mg orally BID × 7 days; or Clindamycin 100 mg intravaginally QD × 3 days Metronidazole 400–500 mg orally BID × 5–7 days; or Metronidazole 2 g orally single dose or Metronidazole gel 0.75% 5 g intravaginally QD × 5 days; or Clindamycin cream 2% 5 g intravaginally QD × 7 days Tinidazole 2 g orally single dose or Tinidazole 1 g orally QD × 5 days or Metronidazole 2 g orally single dose or Clindamycin 300 mg orally BID × 7 days Tinidazole 2 g orally single dose or Metronidazole 400–500 mg orally BID × 5–7 days; or Metronidazole 2 g orally single dose Metronidazole 400 mg orally BID × 5–7 days; or Metronidazole 2 g orally in a single dose or Metronidazole gel 0.75% 5 g intravaginally daily × 5 days; or Clindamycin cream 2% 5 g intravaginally daily × 7 days Tinidazole 2 g orally single dose or Clindamycin 300 mg orally BID × 7 days In light of these practical realities, empirical single-dose oral tinidazole treatment of both BV and TV (with single-dose fluconazole) would offer a patient-centered solution to optimize the chance for first-time cure, particularly for women challenged by medication adherence and follow-up capability. Currently, the 2021 U.S. CDC STI guidelines recommend 2-g single-dose tinidazole (as four 500-mg tablets) for TV treatment and 2 g on Days 1 and 2 as an alternative BV treatment option.1 Due to ED dispensing limitations, the next day's dose would require the patient to fill a prescription. However, 2-g single-dose tinidazole is already recommended as an alternative treatment of both BV and TV by the European International Union against Sexually Transmitted Infections (IUSTI) and World Health Organization (WHO) and the British Association for Sexual Health and HIV (BASHH) U.K. guidelines (Table 1).5-7 Tinidazole's plasma half-life is 12–14 h, which is longer than metronidazole's (~8 h), allowing for a shorter treatment course, and its safety profile is less adverse, with metallic taste, nausea, anorexia, and constipation associated with longer duration as opposed to single-dose treatment.17 TV also exhibits less resistance to tinidazole than metronidazole, demonstrating both lower in vitro minimum lethal concentrations and a high clinical efficacy rate for patients with metronidazole-refractory TV infection.18 In 2017, the U.S. Food and Drug Administration (FDA) approved 2-g single-dose oral secnidazole (two 1-g packets) for treatment of BV and TV, and this is currently listed as an alternative BV treatment option in U.S. CDC guidelines.1, 19 Table 2 shows the results of clinical trials among women with symptomatic vaginitis comparing metronidazole, tinidazole, and secnidazole, including single-dose regimens, to treat BV and TV.20-26 For BV, when compared with metronidazole 500 mg BID for 7 days, both 2-g single-dose tinidazole and 2-g single-dose secnidazole demonstrated similar cure rates to metronidazole.22, 25 Another trial comparing single doses of secnidazole, tinidazole, and metronidazole to treat BV found that tinidazole had a significantly greater clinical cure rate than metronidazole but secnidazole did not, further supporting the efficacy of single-dose tinidazole.26 Across all trials, for BV, 2-g single-dose tinidazole demonstrated clinical cure rates of 83%–100%.20-26 MTZ 2 g one dose (50) TZD 2 g one dose (50) MTZ—50% TDZ—84% MTZ—64% TDZ—94% MTZ 2 g one dose (82) NZ 2 g one dose (100) TZD 2 g one dose (98) MTZ—89% NZ—90% TDZ—83% MTZ −79% NZ—88% TDZ—92% Open-label RCT MTZ 500 mg BID 7 days (50) TDZ 2 g one dose (50) MTZ—92% TDZ—86% MTZ vaginal gel BID 5 days (84) TDZ 2 g one dose (75) MTZ—82% TDZ—84% MTZ 1.6 g single-day split dose (67) TZD 2 g one dose (65) MTZ—98.5% TDZ—100% MTZ 500 mg BID 7 days (287) SEC 2 g 1 dose (290) MTZ—59.5% SEC—60.1% MTZ 2 g one dose (86) TZD 2 g one dose (86) SEC 2 g one dose (86) ORN 1.5 g one dose (86) MTZ—88.4% TDZ—100% SEC—90.7% ORN—100% TDZ and ORN vs. MTZ, p < 0.01 SEC vs. MTZ, NS Unlike FDA guidance for comparative noninferiority trials to evaluate new antibiotics to treat other common infections, guidance for BV antimicrobial approval specifies a placebo-controlled superiority trial.27 Tinidazole was FDA-approved in 2004 based on a placebo-controlled trial that demonstrated efficacy of both 2 g daily for 2 days and for 5 days.28 Earlier placebo-controlled trials and many comparative studies of a single 2-g dose of tinidazole were conducted outside the United States and had a different design than specified in U.S. FDA guidance to evaluate BV treatments, which may explain the divergence of U.S. and international treatment recommendations (i.e., 2 g daily for 2 days vs. single dose).29 Tinidazole has gone off-patent, so no commercial interest now exists for FDA approval of single-dose treatment. However, as shown in Table 2, single-dose tinidazole has compared favorably to both 7-day twice-daily metronidazole and single-dose secnidazole, regimens that have met FDA guidance criteria and have the endorsement agencies outside the United States, supporting its off-label use).5-7 Secnidazole is substantially more expensive than metronidazole and tinidazole, well beyond the means of many women. Based on GoodRx.com (accessed March 1, 2025) for major chain pharmacies at multiple U.S. cities, the current cost of metronidazole 500 mg twice daily for 7 days and of 2-g single-dose tinidazole is about $10; the cost of 2-g single-dose secnidazole is about $300. Tinidazole is widely available in U.S. pharmacies and could be easily stocked in EDs. Author review of Medicaid Preferred Drug Lists (PDL; conducted during December 2024) found that tinidazole is included in 25 states presently (nine additional states require prior authorization); metronidazole is included in 44 states and secnidazole in two states (five states have no publicly accessible online PDL and 11 do not specifically address these treatments). Medicaid would cover costs of ED testing and treatment like many other insurances, through bundled payments, which come against the hospital's bottom line. Regardless of the diagnostic and treatment approach to vaginitis, it should be stressed that a careful history for STI risk and pelvic examination remain important since vaginal discharge and discomfort can also be symptoms of gonococcal and chlamydial cervicitis and pelvic inflammatory disease, and broader STI screening may be indicated. As opposed to NAAT for vaginitis pathogens, gonococcal and chlamydial NAAT is relatively inexpensive and consistently covered by insurance, and laboratories are also required to report these infections to local public health agencies, which helps ensure proper follow-up care. Women with STI risk suspected of TV should be advised of the need for abstinence pending partner evaluation and treatment, which could include expedited partner therapy (EPT) with 2-g single-dose metronidazole or tinidazole in states that allow it. Although not recommenderd in the last U.S. CDC STI guidelines, a recent placebo-controlled clinical trial demonstrated that concurrent treatment of the male partner of a woman with BV significantly reduced the incidence of recurrent vaginitis within 12 weeks.1, 30 Of note, metronidazole is no longer contraindicated in pregnancy, whereas tinidazole is contraindicated in the first 3 months of pregnancy and, therefore, would require pregnancy screening. Secnidazole has not been assigned a pregnany rating. Women who seek care and can follow up at sexual health clinics and primary care offices are different than many from disadvantaged groups for whom there may be only one opportunity to address their symptoms when seen in the ED. Empirical treatment of vaginitis carries risks of overtreatment, although use of a single-dose regimen would minimize stewardship concerns for collateral adverse antibiotic effects. Further, overall treatment effectiveness must be considered in the context of a woman's specific circumstances and needs, such as CDC-endorsed empirical EPT treatment for gonorrhea and chlamydia, and in the case of sexual assault, for which compliance with follow-up visits is acknowledged to be poor.1 For women with the clinical diagnosis of vaginitis, particularly in EDs where point-of-care NAAT testing is not available, we believe empirical treatment with 2-g single-dose tinidazole for BV and TV and 150-mg single-dose fluconazole for Candida should be offered through shared decision making. Reliance on microscopy testing poses a substantial risk of underdiagnosis and undertreatment with subsequent persistent symptoms, additional health care visits, and risk of transmission. Alternatively, if the patient believes she can comply, the CDC-recommended second-day 2-g tinidazole dose or 7-day 500-mg twice-daily metronidazole regimen can also be prescribed empirically to treat BV and TV, and women with a history of recurrent or persistent Candida infection can be prescribed a Day 4 and 7 fluconazole dose.1 Whether empirical or microscopy/point-of-care NAAT-directed treatment is provided, follow-up should be recommended for patients whose symptoms persist beyond 1 week, at which time further diagnostic testing can be considered. The authors thank Shannon Powers and Courtney Schenkelberg (PharmD Student, University of Iowa) for their research of state Medicaid formularies. The authors declare no conflicts of interest. Data sharing not applicable to this article as no datasets were generated or analysed during the current study.

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Periodontitis consists a group of dental disorders that affect about 70 % of the world population. The therapy mainly relies on mechanical removing bacterial biofilm, nevertheless, local or systemic antibacterial agents play a key role in treating the acute conditions. Secnidazole is a newer derivative of commonly used metronidazole with high safety profile and broad spectrum of antimicrobial activity. The aim of the study was to evaluate the applicability of polyelectrolyte complex-based hydrogels composed of anionic tragacanth with addition of xanthan gum and cationic chitosan as carriers for buccal/intra pocket delivery of secnidazole. Prepared hydrogels with 5 % and 10 % (w/w) drug content were evaluated pharmaceutically towards inter alia physicomechanical, rheological and thermal properties, drug release kinetics, swelling behavior or antimicrobial activity. Cytotoxicity against human primary umbilical vein endothelial cells was also assessed with two independent method. Stable compositions with secnidazole were obtained, however, various miscibility of the drug with the polymers was noted. By adding chitosan, antibacterial activity and swelling performance of the gels were improved, nevertheless, drop of the mucoadhesiveness was also recorded. Hydrogels with 5 % secnidazole were selected as effective antimicrobial compositions with the highest cytocompatibility. They might be considered as promising for oromucosal application with special attention given to SEC as an alternative locally administered antimicrobial agent.

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INTRODUCTION: The emergence of multidrug-resistant Klebsiella pneumoniae in hospitals represents a serious threat to public health. Infections caused by Klebsiella pneumoniae are widespread in healthcare institutions, mainly pneumonia, bloodstream infections, and infections affecting neonates in intensive care units; so, it is necessary to combat this pathogen with new strategies. Targeting virulence factors necessary to induce host damage and disease is a new paradigm for antimicrobial therapy with several potential benefits that could lead to decreased resistance. BACKGROUND: The influence of metformin, N-acetylcysteine, and secnidazole on Klebsiella pneumoniae virulence factors production was tested. The production of Klebsiella pneumoniae virulence factors such as biofilm formation, urease, proteases, hemolysins, and tolerance to oxidative stress was evaluated phenotypically using sub-inhibitory concentration (1/8 MIC) of metformin, N-acetylcysteine, and secnidazole. For more confirmation, qRT-PCR was used to assess the relative expression level of rmpA, wcaG, fimH-1, mrkD, ureA, and khe genes regulating virulence factors production. RESULTS: Metformin, N-acetylcysteine, and secnidazole were all found to have a powerful inhibitory effect on the production of virulence factors phenotypically. Our results showed a significant reduction in the expression level of rmpA, wcaG, fimH-1, mrkD, ureA, and khe genes. Furthermore, the tested drugs were investigated in vivo to inform their ability to protect mice against Klebsiella pneumoniae pathogenesis. CONCLUSIONS: Metformin, N-acetylcysteine, and secnidazole inhibited the virulence of Klebsiella pneumoniae. Besides combating resistant Klebsiella pneumoniae, the tested drugs could also serve as an adjuvant to traditional antibiotics.

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A green, rapid, and simple HPLC-External standard method (ESM) and a quantitative analysis of multi- components with a single-marker (QAMS) method were established for the simultaneous determination of five nitroimidazole antimicrobials (Metronidazole sodium chloride injection, Tinidazole injection, Ornidazole sodium chloride injection, Morinidazole sodium chloride injection, Secnidazole tablets) in pharmaceutical preparations. The five specified drugs were chromatographed via HPLC on a ZORBAX SB-C18 (150 mm×4.6 mm, 5 μm particle size) analytical column using a mobile phase consisting of methanol-0.1% v/v triethylamine (26:74 v/v, pH adjusted to 3.0 with phosphoric acid) with isocratic elution and monitored by photodiode array detector at 316 nm. The chromatographic separation was accomplished within a short run time (less than 20 min) for the studied analyte. Using metronidazole as internal reference, the relative correction factors of each constituent were calculated were established, and the contents of each component of 5 nitroimidazole were calculated to achieve QAMS. The measured results were verified by the ESM. The methods were validated in terms of linearity, intra- and inter-batch precision, accuracy, stability, and recovery. The proposed ESM and QAMS methods could simultaneously determination of the studied analyte, and they were successfully applied to the analysis of the above cited drugs in pharmaceutical preparations with excellent accuracy and precision. In addition, the analytical greenness (AGREE) and blue applicability grade index (BAGI) metric tools were used to evaluate the greenness and environmental friendliness of the developed methods. AGREE scores of QAMS and EMS were 0.66 and 0.59, and BAGI scored 82.5 and 77.5, respectively.

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Dientamoeba fragilis (DF), the most common intestinal protozoal pathogen in affluent countries, causes asymptomatic or symptomatic infections with severity ranging from mild to disabling. Currently, many studies of treatment options only have small sample sizes and report results that are partly contradictory. Investigating data retrieved from Helsinki University Hospital and Helsinki City patient records, we searched for the most effective antiprotozoal in treating DF infections. To study microbiological clearance of DF, we collected laboratory results of control samples from patients given one of four commonly used antiprotozoals: doxycycline, metronidazole, paromomycin, or secnidazole. For patients symptomatic prior to antiprotozoal treatment, we also retrieved data on clinical outcomes. Furthermore, we explored factors associated with faecal clearance and clinical cure. A total of 369 patients (median age 38) and 492 treatment episodes were included. Paromomycin (n = 297) proved effective (clearance rate 83%), showing strong association with faecal clearance (aOR 18.08 [7.24–45.16], p < 0.001). For metronidazole the rate was 42% (n = 84), for secnidazole 37% (n = 79), and doxycycline 22% (n = 32). In pairwise comparisons, paromomycin outdid the three other regimens (p < 0.001, χ2 test). Faecal clearance was associated with clinical cure (aOR 5.85 [3.02–11.32], p < 0.001). Faecal clearance, strongly associated with clinical cure, is most effectively achieved with a course of paromomycin, followed by metronidazole, secnidazole and doxycycline. Our findings will be useful in devising treatment guidelines for adults with symptomatic D. fragilis infection.

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