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cefazolin dibenzylamine (Daren)

✓ Approved

Pfizer, Inc. · Small Molecule · Small Molecule

What is cefazolin dibenzylamine?

cefazolin dibenzylamine is a small molecule developed by Pfizer, Inc.. It is approved for therapeutic indications via injectable (others) or intramuscular (im) injection.

Drug Profile

Brand NamesDaren
CompanyPfizer, Inc.
Drug ClassSmall Molecule
RouteInjectable (Others), Intramuscular (IM) Injection
StatusApproved
Sources: ClinicalTrials.gov, Pfizer, Inc.

Therapeutic Indications

cefazolin dibenzylamine is developed for 2 unique indications across 1 therapeutic area.

Therapeutic AreaConditionPhase
Infections and infestationsUrinary tract infection✓ Approved
Infections and infestationsRespiratory tract infection✓ Approved

Related Research Articles

PubMedSurgical endoscopy2026-10-20

Are prophylactic antibiotics routinely necessary in laparoscopic adnexal surgery? A multicenter cohort study.

Miyata Hiromi H, Kobayashi Eiji E, Yasuda Miki M, Chien Hungwu H et al.

The benefit of routine prophylactic antibiotics for clean laparoscopic adnexal surgery remains unclear. We evaluated whether pre-incision cefazolin reduces the incidence of 30-day surgical site infections (SSIs), and we identified perioperative risk factors for SSIs. We conducted a multicenter retrospective cohort study using clinical data from Osaka University and six affiliated hospitals. Among 1,865 patients who underwent laparoscopic adnexal surgery for benign conditions, 1,678 were included after specified exclusions. Patients received either pre-incision cefazolin (n = 1,415) or no prophylaxis (n = 263) according to institutional policy. The primary outcome was the incidence of SSI during the 30-day postoperative interval, classified according to CDC criteria. The association between prophylaxis and SSI was evaluated using inverse probability of treatment weighting (IPTW). Propensity scores were estimated using age, body mass index, diabetes mellitus, endometriosis, and previous abdominal surgery. Risk factors for SSI were assessed using multivariable logistic regression analysis. Exploratory subgroup analyses were performed by repeating the same IPTW procedure within specified subgroups, and procedure-specific supplementary analyses were performed for ovarian cystectomy. SSI occurred in 1.1% of patients in both groups: 16/1,415 in the cefazolin group and 3/263 in the non-antibiotic group. In IPTW-adjusted analyses, the incidence of SSI did not differ between groups (1.1% vs. 1.2%; p = 0.915). In multivariable analysis, operative time ≥120 min was associated with SSI (adjusted odds ratio [aOR] 3.54, 95% confidence interval [CI] 1.41-8.85). In supplementary analyses restricted to an ovarian cystectomy subgroup, uterine manipulator use was associated with SSI (aOR 4.03, 95% CI 1.26-12.90). Routine prophylactic cefazolin was not associated with a significantly lower incidence of 30-day SSI after clean laparoscopic adnexal surgery. Given few SSI events and the potential for residual confounding, our findings support further evaluation of a selective rather than routine approach to prophylactic antibiotic use.

PMID 42897337
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PubMedOpen forum infectious diseases2026-10-20

Cephalexin Model-Informed Dosing Recommendations for Severe Infections: A Pooled Pharmacokinetic Analysis From Infancy to Adulthood.

Haynes Andrew S AS, Gonzalez Daniel D, Messacar Kevin K, Autmizguine Julie J et al.

Cephalexin is increasingly used as initial and oral transition therapy for severe infections, but optimal dosing in this setting remains uncertain. Four cephalexin pharmacokinetic (PK) datasets spanning preterm neonates through young adults were pooled to develop a unified population PK model. Simulations estimated probability of target attainment (PTA) and cumulative fractional response (CFR, target attainment weighted across the pathogen MIC distribution) across fT > MIC targets (free drug time above the minimum inhibitory concentration), MIC distributions for methicillin-susceptible Staphylococcus aureus (MSSA) and Enterobacterales, and multiple dosing regimens. Seventy-one subjects (age 9 days-29 years) contributed 360 plasma samples, best described by a 1-compartment model with first-order absorption and lag time. Apparent volume and clearance scaled with fat-free mass, and clearance increased with postmenstrual age. Absorption was slower in neonates. Cephalexin 25 mg/kg/dose, maximum 1000 mg, every 8 hours, achieved 1-log kill targets for MSSA (PTA ≥ 98% for 35% fT > MIC at MIC = 4 mg/L); every 6-hour dosing was needed at MIC = 8 mg/L. For Enterobacterales, a 60% fT > MIC target was achieved only in infants < 2 months. However, higher-dose regimens (37.5-50 mg/kg, maximum 1500 mg, every 6 hours) achieved CFRs > 90% for 40%-50% fT > MIC targets when cefazolin MICs were ≤2 mg/L. Cephalexin PK varies with age but is well-captured by a unified size- and maturation-scaled model. These data support dosing within the FDA-approved range for systemic MSSA infections. Higher-dose regimens are necessary for adequate target attainment against Enterobacterales. Appropriately dosed cephalexin represents a viable option for selected severe infections, including oral transition therapy.

PMID 42898747
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PubMedFrontiers in veterinary science2026-10-20

Perioperative analgesic effects of opiranserin in canine castration: a pilot study.

Lee Seongwon S, Oh Seonbin S, Lee Inhyung I, Son Won-Gyun WG

Opiranserin, a non-opioid analgesic acting as a glycine transporter 2 inhibitor and 5-HT2A receptor antagonist, was evaluated for reducing intraoperative rescue analgesia and postoperative pain in dogs undergoing castration under isoflurane anesthesia. Eight healthy male Beagle dogs were randomized to receive a continuous rate infusion of opiranserin (5 mg·kg-1·h-1 for 1 h before induction, then 0.33 mg·kg-1·h-1 for 9 h; n = 4) or 0.9% saline (n = 4). Anesthesia was induced with alfaxalone and maintained with isoflurane (1.5% end-tidal); all dogs received meloxicam and cefazolin preoperatively, without locoregional analgesia. Hemodynamic responses (ΔMAP, ΔHR) were recorded across 11 surgical events; rescue remifentanil was given when both increased ≥20% from baseline. Postoperative pain was scored with the Glasgow Composite Measure Pain Scale-Short Form (GCMPS-SF) from 30 min after extubation (T0) through T7, with rescue analgesia at scores ≥5. Primary outcomes were intraoperative rescue analgesia frequency and postoperative GCMPS-SF scores; secondary outcomes were intraoperative hemodynamic responses, postoperative rescue consumption, and adverse effects. Data were analyzed with Mann-Whitney U tests and linear mixed models with Bonferroni-adjusted comparisons. The opiranserin group required fewer intraoperative rescue interventions than the normal saline group (median 2 [2-2] vs. 6.5 [3-9]; p = 0.021). GCMPS-SF scores showed significant effects of group (p = 0.030), time (p = 0.047), and group × time interaction (p = 0.034), with lower scores in the opiranserin group at T1 (adjusted p = 0.012) but not at other time points. Among secondary outcomes, significant overall effects of group were found for ΔMAP (p = 0.011) and ΔHR (p = 0.048), and of surgical event for both (p < 0.001 and p = 0.008), with no group × event interaction; no individual event differed significantly after correction. Cumulative postoperative rescue analgesic consumption and the incidence of adverse effects did not differ between groups. These preliminary findings suggest that opiranserin may reduce intraoperative rescue analgesia requirements and attenuate postoperative pain in dogs, warranting confirmation in larger trials. The absence of significant adverse effects is reassuring but should be interpreted cautiously given the small sample size.

PMID 42898197
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PubMedInternational journal of women's health2026-10-20

OHVIRA Syndrome with Incomplete Vaginal Obstruction, Hematocolpos, and Pyocolpos Despite Regular Menstruation in an Adolescent: A Case Report.

Sembiring Rico Henando RH, Ma'soem Aria Prasetya AP, Siddiq Amillia A

Obstructed hemivagina and ipsilateral renal anomaly (OHVIRA) syndrome is a rare congenital Müllerian anomaly characterized by uterus didelphys, obstructed hemivagina, and ipsilateral renal anomaly. Patients with complete vaginal obstruction typically present shortly after menarche with severe dysmenorrhea and cyclic pelvic pain. Incomplete obstruction may permit partial menstrual drainage, resulting in atypical manifestations and delayed diagnosis. We report incomplete OHVIRA syndrome presenting with preserved menstrual flow despite hematocolpos and pyocolpos. The Zhu classification distinguishes complete obstruction (Class 1) from incomplete obstruction (Class 2), in which some menstrual outflow may occur despite persistent obstruction. In this case, findings supported incomplete obstruction, although a specific small septal opening was not documented. A 13-year-old postmenarchal girl was referred with persistent brown vaginal discharge following menstruation and recent right lower abdominal pain. She reported regular menstrual cycles for one year without dysmenorrhea. Examination revealed normal external genitalia with an intact hymen. Pelvic ultrasonography demonstrated uterus didelphys, hematocolpos, and non-visualization of the left kidney, raising suspicion of OHVIRA syndrome. Pelvic magnetic resonance imaging confirmed uterus didelphys with duplicated cervices and left-sided hematocolpos. According to the Zhu classification, the case was classified as Class 2 OHVIRA syndrome, indicating incomplete vaginal obstruction. According to the ESHRE/ESGE classification, the uterine, cervical, and vaginal anomalies were described as U3b-C2-V2, corresponding to a complete bicorporeal uterus, double cervix, and longitudinal obstructing vaginal septum, respectively. The patient underwent genitoscopy, transverse incision and complete excision of an oblique vaginal septum, drainage of retained collections, vaginal irrigation, and hymenorrhaphy. Approximately 50 mL of purulent material mixed with retained menstrual blood was evacuated, consistent with pyocolpos associated with chronic incomplete obstruction. Microbiological culture was not performed; therefore, the causative organism could not be identified. Cefazolin was administered preoperatively and postoperatively. Postoperative ultrasonography demonstrated complete resolution of the hematocolpos without residual pelvic fluid. During 6 months of telephone follow-up, the patient reported no recurrent symptoms; in-person reassessment was limited by school commitments and distance from the hospital. Incomplete OHVIRA syndrome should be considered in postmenarchal adolescents with persistent postmenstrual brown vaginal discharge, even when menstruation is regular and dysmenorrhea is absent. Preserved menstrual flow does not exclude obstructive Müllerian anomalies. Pelvic ultrasonography, renal evaluation, magnetic resonance imaging, and endoscopic assessment are important for diagnosis and surgical planning. Early recognition and complete vaginal septum excision can relieve obstruction and treat retained collections; long-term reproductive outcomes cannot be determined from the available follow-up.

PMID 42899167
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PubMedPolish journal of veterinary sciences2026-10-19

Antimicrobial susceptibility profiles of Escherichia coli and Enterococcus spp. isolated from companion animals in Indonesia.

Sukmawinata E E, Pisestyani H H, Alfara A A, Tangkonda E E et al.

This study aimed to investigate the antimicrobial susceptibility profile in Escherichia coli and Enterococcus spp. isolated from healthy cats and dogs in Indonesia. A total of 186 rectal swab samples were individually collected from June to October 2025 at 13 animal clinics from three regions. Bacterial isolation was performed using selective agar media, and the species was confirmed by polymerase chain reaction. In this study, we obtained 71 of 164 (43.3%) antimicrobial-resistant (AMR) E. coli and 53 of 94 (56.4%) AMR enterococci by disc diffusion test. The highest resistance of E. coli was observed for ampicillin (36.6%), followed by streptomycin (21.3%), tetracycline (15.9%), cefazolin (13.4%), nalidixic acid (12.8%), cefotaxime (11.0%), gentamicin (11.0%), aztreonam (8.5%), doxycycline (8.5%), chloramphenicol (7.9%), sulfamethoxazole-trimethoprim (6.7%), amoxicillin-clavulanic acid (3.7%), ciprofloxacin (3.0%) and enrofloxacin (2.4%). On the other hand, the highest resistance of enterococci was identified for tetracycline (24.5%), followed by high-level streptomycin (21.3%), erythromycin (21.3%), ciprofloxacin (10.6%), enrofloxacin (9.6%), penicillin (7.4%), linezolid (6.4%), ampicillin (5.3%), fosfomycin (4.3%) and chloramphenicol (3.2%). Multidrug-resistant (MDR) E. coli was detected in 44 of 164 (26.8%) isolates, which were dominated by extraintestinal pathogenic strains (phylogroup B2 and D), while MDR enterococci were detected from 13 of 94 (13.8%) isolates. Our study offers valuable insights into the resistance profiles of Indonesian companion animals. A continuous monitoring strategy for AMR is needed to control the development of AMR bacteria in companion animals.

PMID 42894993
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PubMedInternational urogynecology journal2026-10-15

Postoperative Infection Risk in Sacrocolpopexy: Single vs Dual Antibiotic Prophylaxis.

Mikhail Susana Mustafa SM, Francis Yara Nakhleh YN, Karram Jawad J, Polishook Zvi Y ZY et al.

The optimal antibiotic prophylaxis for mesh-based prolapse surgery remains uncertain. Although cefazolin is widely used, its limited anaerobic coverage may increase the risk of postoperative infections, particularly in women undergoing concomitant hysterectomy. Evidence from hysterectomy cohorts suggests that adding metronidazole reduces surgical-site infections, prompting evaluation of this approach in laparoscopic mesh-augmented apical prolapse repair. The objective was to compare postoperative infection rates in women receiving single-agent versus dual-agent prophylactic antibiotics. This retrospective cohort study included women with pelvic organ prolapse who underwent laparoscopic mesh-augmented apical prolapse repair between 2021 and 2025. Patients received either cefazolin alone or cefazolin plus metronidazole according to the routine practice of the operating urogynecologist. Demographic, operative, and postoperative data were extracted from electronic medical records. The primary outcome was composite postoperative infection within 30 days, including postoperative fever, surgical site or trocar site infection, mesh infection, pelvic abscess, or urinary tract infection. Associations between prophylactic regimen and postoperative infection were evaluated using univariable analyses. The antibiotic prophylaxis regimen was surgeon dependent, with one surgeon routinely administering cefazolin alone and the other cefazolin plus metronidazole. Multivariable logistic regression was performed to adjust for baseline differences between the groups. A total of 523 women met the inclusion criteria; 204 (39.0%) received dual prophylaxis and 319 (61.0%) received cefazolin alone. Overall composite postoperative infection outcome occurred in 18 out of 523 patients (3.4%). Infection rates of the single-agent and dual-prophylaxis groups were similar (3.7% vs 2.9%, p = 0.64). Rates of postoperative fever, surgical-site infection, and urinary tract infection did not differ significantly between groups. No mesh-related infections or pelvic abscesses were observed. After adjustment for baseline differences, the antibiotic regimen was not significantly associated with the composite postoperative infection outcome (aOR 1.30, 95% CI 0.36-4.64; p = 0.689). Composite postoperative infection outcome rates after laparoscopic sacrocolpopexy were low, with no significant difference observed between cefazolin alone and combined cefazolin-metronidazole prophylaxis.

PMID 42878791
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