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The single-dose disposition kinetics of cefonicid were determined in clinically normal lactating goats (n = 6) after intravenous (IV), intramuscular (IM) and subcutaneous (SC) administration of a conventional formulation, and after subcutaneous administration of a long-acting formulation (SC-LA). Cefonicid concentrations were determined by high performance liquid chromatography with ultraviolet detection. The concentration-time data were analysed by noncompartmental pharmacokinetic methods. Steady-state volume of distribution (V ss ) and clearance (Cl) of cefonicid after IV administration were 0.14 ± 0.03 L/kg and 0.51 ± 0.07 L/h·kg, respectively. Following IM, SC and SC-LA administration, cefonicid achieved maximum plasma concentrations of 14.46 ± 0.82, 11.98 ± 1.92 and 17.17 ± 2.45 mg/L at 0.26 ± 0.13, 0.42 ± 0.13 and 0.83 ± 0.20 hr, respectively. The absolute bioavailabilities after IM, SC and SC-LA routes were 75.34 ± 11.28%, 71.03 ± 19.14% and 102.84 ± 15.155%, respectively. After cefonicid analysis from milk samples, no concentrations were found above LOQ at any sampling time. From these data, cefonicid administered at 20 mg/kg each 12 hr after SC-LA could be effective to treat bacterial infections in lactating animals not affected by mastitis problems., (© 2019 John Wiley & Sons Ltd.)

Rationale: Necrotizing fasciitis (NF) is defined as a rare, rapidly progressive, and highly lethal skin infection characterized by necrosis of the fascia and subcutaneous tissue., Patient Concerns: The present study aims to discuss the case of a 35-year-old man who developed NF following a routine sterile right distal radius bone plate removal surgery., Diagnoses: The patient was suspected of NF based on his clinical manifestations, laboratory tests, and imaging results. The diagnosis of NF was confirmed by histological examinations., Interventions: Serial prompt and extensive debridement was performed during the rapid and aggressive extension of the skin infection, together with antibiotics and supportive treatments., Outcomes: The condition of the patient finally improved on the sixth day of disease progression. Skin grafting of his right forearm wound was performed successfully 2 months after the admission., Lessons: NF can occur during the perioperative period for routine clean radius plate removal operation in patients with no risk factor for NF. The objective is to remind the physicians to stay aware of this disease, especially its early clinical signs and symptoms. Urgent subsequent treatment, including surgical debridement, antibiotic therapy, and supporting management, is the key to ensure the survival and better prognosis of patients.

Summary: The approach to treating febrile non-neutropenic hematooncologic patients with central venous catheters varies. We recently introduced once-daily administration of cefonicid and gentamicin for such children who were in good clinical condition and without focal signs of infection. Our 2-year experience of 125 episodes in 54 children is hereby reported. Absolute neutrophil counts were 550 to 16,700/mm. Bacteremia occurred in 6.4% episodes: only in patients with Hickman/Broviac catheters and not in those with port-a-caths [8/37 (21.6%) vs. 0/17 patients, P=0.046; 8/86 (9.3%) vs. 0/39 episodes, P=0.056]. The pathogens were coagulase-negative staphylococci (3), Streptococcus pneumoniae (2), Pseudomonas aeruginosa and Klebsiella pneumoniae (1), methicillin-sensitive Staphylococcus aureus (1), and Streptococcus milleri (1). All patients remained in stable clinical condition and all, except for 2 who became neutropenic and 1 with S. aureus bacteremia who developed cellulitis, defervesced while on the empiric therapy. Three episodes could not be managed as outpatients. No adverse effects were observed. We conclude that our approach is efficacious and safe and, furthermore, that empiric antibiotic therapy may not be indicated for selected patients with port-a-caths. Future study of children with Hickman/Broviac catheters will evaluate the use of cefonicid alone.

Objective: To assess the effect of intra-articular corticosteroids added to systemic antibiotics in experimental septic arthritis., Methods: Rabbits were injected intra-articularly by Staphylococcus epidermidis. Rabbits received no additional treatment and served as control (group 1), were treated with systemic antibiotics (group 2), or treated with systemic antibiotics and intra-articular corticosteroids (group 3). After 15 days animals were killed and joint histopathological-histochemical parameters were assessed., Results: All rabbits survived the experiment. The treated groups (2-3) had lower histological-histochemical scores in comparison with the untreated group (1). Group 3 had significantly lower scores in joint sections in comparison with group 2: (mean (SD) 6.5 (1.4) v 4.0 (1.0), p = 0.001 and 7.4 (2.6) v 4.2 (2.2), p = 0.01), because of lower damage expressed in clustering of chondrocytes, pannus formation, proteoglycan depletion, and synovitis., Conclusion: Addition of local corticosteroids to systemic antibiotics in septic arthritis seems to be harmless, and improves joint histological-histochemical parameters in this experimental setting.

Background: Antibiotic prophylaxis is controversial in patients undergoing axillary lymph node dissection (ALND). We determined whether preoperative antibiotics decreased incidence or treatment cost of infectious complications following ALND., Methods: Two hundred patients entered this prospective, randomized, double-blind trial. Patients received either placebo or cefonicid preoperatively. Loco-regional signs of infection were monitored for 4 weeks postoperatively., Results: There was a trend toward fewer infections in the prophylactic group (placebo 13% versus cefonicid 6%; P = 0.080). Cefonicid significantly decreased severe infections requiring hospitalization (placebo 8% versus cefonicid 1%; P = 0.033). Cefonicid also decreased the treatment cost of infection per patient ($49.80 versus $364.87)., Conclusions: We demonstrated a trend toward fewer overall infections and significantly fewer severe infections in patients given prophylactic antibiotics, which translated into a decrease in the cost of treatment for infectious complications. These findings support antibiotic prophylaxis for patients undergoing ALND.

Several studies have indicated that antibiotics given for 5-7 days post-tonsillectomy are beneficial. A prospective double blind randomized study was undertaken to evaluate the efficacy of a long-acting antibiotic (Cefonicid) given prophylactically at the time of tonsillectomy. Dependent variables were percent weight loss, number of doses of pain medications required postoperatively, the number of days required to resume a normal diet, and return to work. The results of all independent tests indicated that there were no statistically significant differences between the Cefonicid group and the placebo group. The results of this study indicate that single dose prophylactic application of Cefonicid is not effective in adults undergoing tonsillectomy.

The aim of our study was to evaluate the optimal duration of antibiotic prophylaxis in major oncologic surgery of the head and neck using a novel broad spectrum drug combination: clindamycin and cefonicid. A prospective randomized study was carried out on 126 evaluable patients undergoing clean-contaminated (skin to mucosa) surgery for cancer of larynx, pharynx or oral cavity. Cases at high surgical risk (because of need of pedicled or microvascular free flaps reconstruction), were excluded from the study. Within 20 days after surgery, only one case of wound infection was recorded among the 62 patients treated with the one-day schedule, versus three cases registered among the 64 subjects receiving three-day chemoprophylaxis. Episodes of systemic infections and eventual wound complications occurring in the first 20 days after surgery have also been recorded. The role of potential risk factors for postoperative complications has been evaluated. According to our findings, a three-day antibiotic regimen is not more effective than a short-term (one-day) schedule in preventing wound or systemic infection in clean-contaminated head and neck cancer surgery without flap reconstruction.

The serum and saliva levels of cefonicid (Monocid) and ceftriaxon (Rocephin) were studied after iv. administration on mice. It was found that both of the antibiotics were secreted well into saliva and their therapeutic values remained for 4-5 hours.

We report a case of delayed cutaneous reaction to intramuscular treatment with cefonicid, a second generation cephalosporin. An isolated late skin test response was observed to cefonicid only and not to other beta-lactams. A patch test with cefonicid 1% was positive after 48 and 96 hours.

Objective: To examine the disposition of intramuscular (IM) cefonicid in elderly patients with bacterial pneumonia., Design: Pharmacokinetic study., Setting: A 620-bed university-affiliated long-term care institution with its own 39-bed acute care unit., Patients: Nine consecutive elderly patients with bacterial pneumonia treated with IM cefonicid., Measurements: Blood samples were collected on the seventh day of therapy over a 24-hour period and analyzed by high performance liquid chromatography. Pharmacokinetics parameters (volume of distribution, half-life, and clearance) and protein binding were calculated. Clinical outcome of IM cefonicid therapy was also noted., Results: The estimated creatinine clearance (CIcr) ranged from 32 to 145 mL/min. Peak cefonicid serum concentrations occurred at 0.5-1.5 hours, with a mean value of 118 +/- 41 micrograms/mL. Cefonicid concentrations declined monoexponentially to 57 +/- 16 micrograms/mL at 12 hours and 28 +/- 14 micrograms/mL at 24 hours. The mean apparent distribution volume was 0.2 +/- 0.07 L/kg, and the mean apparent total clearance was 15 +/- 12 mL/min. The half-life ranged from 3.1 to 38 hours. A linear correlation was noted between Clcr and cefonicid clearance (r = 0.99)., Conclusions: Cefonicid absorption was variable among these patients, and the serum half-life was longer than previous values noted in younger patients with similar degree of renal dysfunction. Pharmacokinetic and clinical outcome data from our study group indicate the potential role of IM cefonicid in treating elderly patients with bacterial pneumonia.

In a randomized study, we evaluated the efficacy of the "open vaginal vault" method of abdominal hysterectomy, when cefonicid is administrated preoperatively, in reducing postoperative febrile morbidity. The vaginal vault was left open in 72 patients and closed in 65 patients in control groups. No significant difference in postoperative febrile morbidity was noticed in the two groups.

Three types of antibiotic prophylactic regimens were evaluated versus a control without prophylaxis (group A: 3,912 cases) in urologic surgery. The antibiotic regimens were: group B = cefazolin 1 g/12 h/3 days (3,660 cases); group C = cefonicid 1 g/24 h/3 days (2,076 cases), and group D = cefonicid 1 g single dose (3,169 cases). The parameters used were the comparison of the corresponding rates of postsurgical sepsis and operative wound infections. Numeric investigations for the validity of a retrospective study (unpaired data) were performed: homogenicity test, relative risk point estimate and confidence limits (95%), and etiological fraction point estimate and confidence limits (95%). Chi-square for other purposes were performed. Endoscopic handling was considered homogeneous (same infective risk), while open surgery was heterogeneous (p < 0.001). In order to avoid probable bias, a correction factor was used. Although in different degrees, prophylaxis significantly reduced the morbidity of surgical wound infections (p < 0.001; etiological fraction > 90%). The differences (p < 0.01) between groups B and C/D were attributed to pharmacokinetic causes (short T 1/2 of cefazolin). To obtain the maximum protective effect, the use of antibiotics with a T 1/2 of > 4 h is suggested. There was no resistant mutans in previously sensitive strains. However, a significant selection of intrinsically resistant strains was observed. Monodose offers at lest the same advantages as multiple-dose therapy. In addition, the monodose selected in a lesser proportion both the resistant strains (p < 0.001) and the number of microbial associations (p < 0.01).

We evaluated the necessity for antibiotic prophylaxis in uncomplicated transurethral resection of the prostate. A total of 107 patients was entered into a double-blind, prospective, placebo-controlled, randomized trial. Only 7 patients were excluded because they had positive preoperative urine cultures. All patients received a single dose of either 1 gm. cefonicid or saline placebo intramuscularly before surgery. No further antibiotics were administered. Urine cultures were obtained intraoperatively, daily while hospitalized, and at 2 and 4 weeks postoperatively. A growth of 10(4) organisms constituted a positive urine culture. Postoperative infection rates were statistically significant with 12% (6 of 51) in the cefonicid group and 37% (18 of 49) in the placebo group (p = 0.003). During the initial 2 days postoperatively there were no infections in the cefonicid treated patients as opposed to 8 in the placebo group (p = 0.003). Our study demonstrated the need for antibiotic prophylaxis to prevent infection after uncomplicated transurethral resection of the prostate. This can be accomplished by using a single dose, broad-spectrum cephalosporin (cefonicid). This procedure simplifies the implementation and decreases the cost of prophylaxis for transurethral resection of the prostate.

Two hundred patients that underwent ESWL were randomized into 4 groups in order to determine the benefits of antibiotic prophylaxis. All comparisons among groups were not statistically significant. Neither cephalosporin nor quinolone prophylaxis impacted significantly on bacteriuria rate after ESWL. Thus, in patients without infected stones, urinary tract obstruction and ancillary procedures ESWL could be performed without prophylactic antibiotic regimes.

A total of 1489 patients were included in a prospective, randomized study that compared the efficacy of a single dose of cefonicid in 474 patients (Group I) with that of three doses of cefamandole in 510 patients (Group II) and five doses of cefamandole in 505 patients (Group III), for prophylaxis against infection after an operation on bone. The operations involved the insertion of a Moore prosthesis, an Ender and Küntscher nail, a bone-plate, or another device for internal fixation. Patients who had an open fracture or a total joint replacement were not included in the study. The three groups were similar with regard to mean age, sex ratio, duration of preoperative hospitalization, underlying risk factors, and type of operation. The rates of wound infection were not significantly different in the three groups (p = 0.8) or when the rates were stratified according to the type of operation (p greater than 0.3). Staphylococcus aureus and gram-negative bacilli were the most common infecting microorganisms. The rate of mortality related to infection was similar in all three groups (p = 0.2). No adverse side-effects of drugs were encountered. A single preoperative dose of cefonicid, three doses of cefamandole, and five doses of cefamandole were equally effective prophylaxis against infection of the wound in these patients.

In this study the Authors have evaluated the use of cefonicid in "short-term" post-surgical prophylaxis in gynecology. No effects, nor alteration to hematochemical parameters related to the administration of this medicine have been observed and the analysis of data shows that the use of cefonicid contributes to reducing the incidence of post-surgical infections in hospital in a cure group compared to a control group.

Cefonicid is a new cephalosporin that, given in adequate concentrations is able to kill some pathogens such as Gram-positive cocci and many Enterobacteriaceae. In this study we have evaluated 40 patients receiving 1 g of cefonicid i.m. at various times before abdominal or vaginal hysterectomy. The results of the present study indicate that a single dose of 1 g of cefonicid given intramuscularly is useful as prophylaxis and treatment of gynecological infections.

Unlabelled: EFFICACY, renal effects and nephrotoxicity of the cephalosporin cefonicid (CEF) were evaluated in 11 adult patients with urinary tract infection and varying renal function (creatinine cl 19-161 ml/min, mean 75). CEF was administered i.m. for 7 days at a daily dose adjusted to renal function of the patients., Efficacy: At the 4th day and at the end of the treatment urine cultures were negative in all cases; a recurrence of the infection was observed in 4 patients 10 days after completion of therapy. Renal effects and nephrotoxicity: CEF neither modified plasma creatinine, urea, uric acid and their renal clearances nor glomerular filtration rate. Only the urinary enzyme activity of alanine aminopeptidase increased slightly at the end of the therapy. It returned to basal values in the post-treatment period. Urinary enzyme activities of gamma-glutamyltransferase, alkaline phosphatase, N-acetyl-beta-D-glucosaminidase and lysozyme were unmodified during and after treatment with CEF. These results indicate that CEF is an effective antimicrobial agent which does not influence renal function, nor cause nephrotoxic effects.

A single 1-g dose of cefmetazole was compared with a single 1-g dose of cefonicid for prophylaxis in vaginal and abdominal hysterectomy to determine their efficacy and safety. The antibiotics were administered intramuscularly 15-90 minutes before the incision was made. Cefmetazole and cefonicid had similar activity against most of the aerobic organisms recovered, but cefmetazole was significantly more active against anaerobic gram-negative microorganisms. The patterns of regrowth of vaginal flora were similar in the two treatment groups. Patient demographic characteristics and surgical procedures were similar in both groups. The difference in primary prophylactic failure (e.g., cuff cellulitis) with the two study drugs (1 of 53 [1.9%] with cefmetazole and 2 of 28 [7.1%] with cefonicid) did not reach statistical significance, and the results were similar for the two routes of hysterectomy. Cefmetazole, at a dose of 1 g intramuscularly preoperatively, is a safe and effective agent for prophylaxis during hysterectomy.

We compared treatment with one daily intravenous dose of cefonicid and multidose nafcillin in 65 patients with severe infections of the skin or skin structure. Clinical cure or improvement was achieved in 91% of the patients given cefonicid and in 87% of the patients given nafcillin (P = 0.97). The use of cefonicid may allow outpatient therapy of some severe infections.

The usefulness of antibiotic prophylaxis in biliary surgery is well established. When antibiotic prophylaxis is not used, wound infection rates after biliary surgery range from 10% to 25%. With antibiotic prophylaxis, the rates can be reduced to less than 5%. Three questions are still controversial: Do all patients undergoing biliary surgery require antibiotic prophylaxis? What is the ideal antibiotic for use in biliary surgery? What should be the duration of antibiotic prophylaxis? In this study we prospectively evaluated the efficacy of a single dose of antibiotic prophylaxis in biliary surgery, administered to patients at high risk for infection, in a trial comparing cefonicid (a cephalosporin with a long half-life) with mezlocillin (a broad-spectrum ureidopenicillin).

We assessed the efficacy of perioperative antibiotic prophylaxis for surgery in a randomized, double-blind trial of 1218 patients undergoing herniorrhaphy or surgery involving the breast, including excision of a breast mass, mastectomy, reduction mammoplasty, and axillary-node dissection. The prophylactic regimen was a single dose of cefonicid (1 g intravenously) administered approximately half an hour before surgery. The patients were followed up for four to six weeks after surgery. Blinding was maintained until the last patient completed the follow-up and all diagnoses of infection had been made. The patients who received prophylaxis had 48 percent fewer probable or definite infections than those who did not (Mantel-Haenszel risk ratio, 0.52; 95 percent confidence interval, 0.32 to 0.84; P = 0.01). For patients undergoing a procedure involving the breast, infection occurred in 6.6 percent of the cefonicid recipients (20 of 303) and 12.2 percent of the placebo recipients (37 of 303); for those undergoing herniorrhaphy, infection occurred in 2.3 percent of the cefonicid recipients (7 of 301) and 4.2 percent of the placebo recipients (13 of 311). There were comparable reductions in the numbers of definite wound infections (Mantel-Haenszel risk ratio, 0.49), wounds that drained pus (risk ratio, 0.43), Staphylococcus aureus wound isolates (risk ratio, 0.49), and urinary tract infections (risk ratio, 0.40). There were also comparable reductions in the need for postoperative antibiotic therapy, non-routine visits to a physician for problems involving wound healing, incision and drainage procedures, and readmission because of problems with wound healing. We conclude that perioperative antibiotic prophylaxis with cefonicid is useful for herniorrhaphy and certain types of breast surgery.

The kinetic profile in tonsils of cefonicid has been studied in 30 patients who underwent tonsillectomy after administration of a single intramuscular dose of 1 g. Blood and tissue samples were withdrawn 1, 2, 3, 6, 12 and 24 h after administration of the drug. The analytical determination was performed employing a microbiological method. Peak serum levels appeared at the first hour (94.2 +/- 9.83 mg/l), while peak tissue values were determined in samples collected at the third hour (11.9 +/- 3.68 mg/kg). Serum levels at the 24th hour were 3.82 +/- 1.25 mg/l. Levels in the tonsils were 7.54 +/- 2.96 mg/kg at the sixth hour, 3.34 +/- 1.42 mg/kg at the twelfth hour and 0.40 +/- 0.31 mg/kg at the 24th hour.

Previous studies show that chronic pyelonephritis and end stage renal disease may follow acute pyelonephritis in children and adolescents when improperly or inadequately treated. Our study shows that there is a significant decrease in renal function following untreated acute bacterial pyelonephritis due to nephron loss. The acute inflammatory response is responsible for much of the renal damage, although damage from renal ischemia is an additional significant factor. The present study used a combination of an antibiotic and a xanthine oxidase inhibitor (allopurinol) as compared to antibiotic therapy alone begun 72 hours after infection. Both were successful in eradicating the infection rapidly, but did not entirely prevent renal damage. Treatment prior to 72 hours thus is important. It appears that the combined treatment, designed to eradicate the bacteria as well as reduce the post-ischemic reperfusion damage and the phagocytic burst of phagocytosis is ideal, as this combined treatment was effective in preventing almost all renal damage and loss of renal function.

The present study was undertaken in order to investigate the penetration of cefonicid, a long-acting parenteral cephalosporin, with enhanced activity against most gram-positive and gram-negative pathogens, into human lung tissue and lymph nodes in patients undergoing open thoracotomy. Samples of lung tissue, lymph nodes and serum were obtained at various times after a single intramuscular dose of 1 g. The concentration of cefonicid was assayed by an agar diffusion method with Bacillus subtilis used as the test organism. The mean concentrations of cefonicid in serum at 2, 4, 8, 12 and 24 h after the injection were 91.5, 66.1, 35.7, 21.8 and 2.9 micrograms/ml, respectively. The mean levels of cefonicid into the hilar lymph nodes at the same times were 22.3, 18.7, 12.0, 6.9 and 1.5 micrograms/ml, respectively, while its concentrations in lung tissue were lower than those in lung lymph nodes up to the 12th hour (12.1, 14.6, 7.8, 5.4 and 1.9 micrograms/ml, respectively). Our results show that cefonicid was well distributed in interstitial fluid from which pulmonary lymph is formed and that its concentrations in lung tissue and lymph nodes were sufficient to inhibit most pathogens involved in respiratory tract infections. This finding was considered important, because it demonstrated that the high binding by plasma protein of cefonicid did not prevent it from entering lung tissue and fluids in useful quantities.