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PubMedDate not supplied

In vitro experience with cefonicid.

Cefonicid was found to be highly active in vitro against greater than 5,000 bacterial isolates. Its spectrum of activity was similar to that observed with cefamandole, including both gram-positive and gram-negative pathogens. No significant activity was observed against methicillin-resistant staphylococci, enterococci, Pseudomonas, Serratia, Acinetobacter, and Bacteroides species. Studies in which susceptibility disks containing 30 micrograms of cefonicid, cefamandole, or cephalothin were used and zone sizes were plotted against MIC values resulted in similar regression lines. Interpretive breakpoints were less than or equal to 14 mm for defining resistance and greater than or equal to 18 mm for defining susceptibility. The results for isolates tested with cefonicid susceptibility disks were highly predictive of clinical efficacy. On the basis of the observed pharmacokinetics of cefonicid at the usual single daily dose of 1 g, a bacterial strain is considered susceptible if the MIC values are not greater than 16 micrograms/ml. Organisms with MICs greater than 32 micrograms/ml are considered resistant. The profile of the stability of cefonicid to hydrolysis by beta-lactamases is similar to that observed with cefamandole. The affinity of cefonicid to the penicillin-binding proteins of Escherichia coli also resembled that of cefamandole, with its greatest affinity for penicillin-binding proteins 1a, 3, and 1b, in that order.

Anti-Bacterial Agents↗
PubMedDate not supplied

Comparison of cefonicid and cefamandole for the treatment of community-acquired infections of the lower respiratory tract.

Cefonicid is a new "second-generation" parenteral cephalosporin with an antibacterial spectrum similar to that of cefamandole. It has, however, somewhat less activity in vitro against gram-positive cocci. Because of high blood levels and long serum half-life, daily dosing with cefonicid is feasible. Patients with community-acquired infections of the lower respiratory tract were randomized in a ratio of 2:1 to receive cefonicid once daily or cefamandole every 6 hr. All doses were 1,000 mg except for 13 patients given 500 mg of cefonicid. Of 100 patients evaluated, 66 received the study drug. Most infections were due to Streptococcus pneumoniae or Haemophilus influenzae. One-fourth of the patients had no demonstrable pathogen. Ninety-four percent of both groups were cured or improved by therapy. No significant toxicity or adverse effects were seen with cefonicid. One dose per day of cefonicid is adequate therapy for many patients having community-acquired pneumonia who might otherwise be treated with cefamandole.

Adult↗
PubMedDate not supplied

Comparison of cefonicid and cefazolin for treatment of soft-tissue infections.

Cefonicid was compared with cefazolin for the treatment of serious infections of soft tissue. According to a randomized, prospective protocol designed to assign twice as many patients to cefonicid, 38 patients were treated with cefonicid and 19 patients, with cefazolin. Dosages used were 1.0 g once daily intramuscularly or intravenously for cefonicid and 0.5-1.0 g three times a day intramuscularly or intravenously for cefazolin. Clinical diagnoses included cellulitis (39 patients), abscesses (14), infected ulcers (3), and bursitis (1). Bacteriologic diagnoses included Staphylococcus aureus alone (8 patients), group A Streptococcus alone (13), combined S. aureus plus streptococci (8), viridans group streptococci alone (1), and mixed anaerobes (1). Gram-negative rods were isolated from 11 patients, all in mixed cultures with gram-positive species. For two patients, gram-negative organisms were thought to be etiologic. All 57 patients responded satisfactorily to treatment. Treatment with either drug was neither interrupted nor discontinued because of toxicity. Both cefonicid and cefazolin appear to be effective for the treatment of infections of skin and soft tissues. Cefonicid has the advantage of once-daily dosing.

Abscess↗
PubMedDate not supplied

Comparative studies of multiple-dose cefoxitin vs. single-dose cefonicid for surgical prophylaxis in patients undergoing biliary tract operations or hysterectomy.

Three hundred one patients were studied in ongoing, double-blinded, randomized clinical trials of the efficacy and safety of multiple-dose cefoxitin and single-dose cefonicid for the prevention of postoperative surgical infection in patients undergoing elective biliary tract operations or hysterectomy. In the biliary surgery trial, one patient (1.5%) of 66 assessable patients given cefoxitin and three (4.7%) of 64 given cefonicid developed incisional infection of the abdominal wound (P = not significant [NS] ). Two (6%) of 31 patients undergoing vaginal hysterectomy who were given cefoxitin and four (14%) of 29 given cefonicid developed vaginal cuff cellulitis (P = NS); three (6%) of 49 patients undergoing abdominal hysterectomy who were given cefoxitin and none of 37 given cefonicid developed pelvic cellulitis (P = NS). Adverse effects ascribable to one of the study drugs were infrequent and minor in both groups. Levels of cefonicid in serum and the uterus or gallbladder wall 2-3 hr after the preoperative dose--before wound closure--were high (mean, 30-40 micrograms/ml), values five to six times higher than those for cefoxitin. The duration of postoperative hospitalization and the costs of hospital care for the two treatment groups were similar in both trials. These studies suggest that a single preoperative dose of cefonicid provides protection against surgical infection following biliary tract operations and hysterectomy that is comparable to that provided by cefoxitin given both preoperatively and 24 hr postoperatively.

Biliary Tract Diseases↗
PubMed1991

Influence of the unbound concentration of cefonicid on its renal elimination in isolated perfused rat kidneys.

The effect of variations in plasma protein binding on the renal excretion of cefonicid was assessed by using isolated perfused rat kidneys. Cefonicid exhibits preferential binding ex vivo to human serum albumin (HSA), as opposed to bovine serum albumin (BSA), and is eliminated mainly by tubular secretion, a process that was reported to be dependent on the total drug concentration. This contradicts previous studies with antimicrobial compounds and other drugs of low renal extraction in which the unbound drug concentration was shown to be the driving force for carrier-mediated tubular transport. To clarify this discrepancy, we performed perfusion studies by using 6% BSA at initial concentrations of 200 micrograms/ml (n = 6) and 20 micrograms/ml (n = 9) and in a combination of 4% BSA plus 2% HSA at initial concentrations of 200 micrograms/ml (n = 4). The excretion ratio [ER = CLR/(fu x GFR)] of cefonicid decreased with increasing unbound concentrations, whereas no apparent relationship with the total concentration was evident. At similar total concentrations of cefonicid, the renal clearance remained unchanged; the secretion clearance increased significantly in the 4% BSA-2% HSA experiments, reflecting the reduced unbound fraction and unbound drug concentration of cefonicid. The excretion ratio data were compatible with a model in which Michaelis-Menten kinetics were required to describe active transport and secretion was dependent on the unbound cefonicid concentration. As a result, changes in plasma protein binding as a result of drug interactions or disease states could significantly influence the tubular transport capability of compounds with low renal extraction.

Animals↗
PubMed1990

Penetration of cefonicid into human lung tissue and lymph nodes.

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.

Adult↗
PubMed1985

Stability of cefonicid sodium in infusion fluids.

The chemical stability of cefonicid sodium in infusion fluids was analyzed. Cefonicid sodium vials were reconstituted and diluted with sterile water for injection and other commonly used intravenous fluids to concentrations of 325, 220, 40, 20, and 5 mg/mL. Cefonicid concentration was analyzed by high-performance liquid chromatography initially and after storage at room temperature and 5 degrees C. Reconstituted vials were frozen as long as eight weeks, thawed, and kept at room temperature and 5 degrees C and then analyzed. Cefonicid sodium reconstituted in each of the diluents studied exhibited no change in clarity and very little change in potency after 24 hours at room temperature and after 72 hours at 5 degrees C. Some vials with high concentrations became turbid between 72 and 96 hours at 5 degrees C. The thawed vials were chemically stable for 24 hours at room temperature and for 96 hours at 5 degrees C. When reconstituted with sterile water for injection and other commonly used intravenous fluids, cefonicid sodium vials and small-volume infusions are chemically stable for 24 hours at room temperature and for 72 hours at 5 degrees C. Reconstituted cefonicid sodium vials can be frozen and stored for as long as eight weeks, thawed, and then kept at room temperature for 24 hours or at 5 degrees C for 72 hours.

Cefamandole↗
PubMed1990

Cefamandole versus cefonicid prophylaxis in cardiovascular surgery: a prospective study.

We randomized 400 patients who were scheduled for an elective cardiovascular operation involving median sternotomy to receive cefamandole nafate or cefonicid in a prospective double-blind study. Three hundred fifty-seven patients were evaluable for prophylactic efficacy. Chest wound and donor site infections and early prosthetic valve endocarditis occurred more frequently with cefonicid (11 patients, 6.3%) than with cefamandole (4 patients, 2.2%) (p = 0.05). Three patients, all in the cefonicid group, required sternal debridement to control postoperative deep wound infections. Twenty-five miscellaneous postoperative infections (urinary tract infection, pneumonia, intravenous site infection, bacteremia, sepsis, Clostridium difficile diarrhea) occurred in 16 patients (9.19%) in the cefonicid group and four in 4 patients (2.19%) in the cefamandole group (p = 0.003). These data indicate that cefamandole is superior to cefonicid in preventing both surgical wound infections and miscellaneous nonsurgical infections after cardiovascular operations.

Cardiac Surgical Procedures↗
PubMedDate not supplied

Prophylactic antibiotics for elective colorectal surgery or operation for obstruction of the small bowel: a comparison of cefonicid and cefoxitin.

Elective colorectal surgery carries a rate of septic complications of up to 35% in patients not receiving prophylaxis. This can be reduced to 5% in patients receiving appropriate prophylactic agents. The safety and efficacy of cefonicid, a new cephalosporin with a half-life of 4-5 hr, were compared with those of cefoxitin for prophylaxis in patients undergoing elective colorectal procedures or surgery for obstruction of the small bowel. Fifty-seven assessable patients were randomly assigned in a double-blind fashion to therapy with 1 g of cefonicid intravenously (iv) or intramuscularly (im) 1 hr before surgery only or 2 g of cefoxitin iv or im 1 hr before surgery and 2 g every 6 hr for 24 hr. Groups were comparable in terms of underlying diseases. Samples for blood culture were obtained immediately before and after surgery and at 8:00 A.M. on the first and second postoperative days. No blood cultures were positive. Two of 30 patients receiving cefonicid developed wound infections (6%). Two of 27 patients receiving cefoxitin developed wound infections, and one developed an intraabdominal abscess (11%). No significant adverse effects were noted. The results suggest cefonicid may be an effective prophylactic antibiotic for bowel surgery. Most importantly, cefonicid offers the advantages associated with the administration of a single daily dosage, among which are reduction of pharmacy costs and the freeing of nursing hours for patient care.

Adult↗
PubMed1986

Pharmacokinetics of cefonicid in uraemic patients.

Eight subjects with normal renal function and 20 uraemic patients with various degrees of renal insufficiency were given a single iv dose of 1.0 g cefonicid, as a bolus injection. Five groups of subjects were studied: group I, GFR greater than 80 ml/min, group II 30 less than GFR less than 80 ml/min, group III 10 less than GFR less than 30 ml/min, group IV GFR less than or equal to 10 ml/min and group V, haemodialysis patients. Cefonicid concentrations in plasma and urine were measured by microbiological assay (MA) and HPLC method. Results were similar with the two techniques. The mean peak plasma levels were 200-300 mg/l and the apparent volume of distribution was 0.18-0.20 1/kg for all patients. The elimination half-life (T 1(2) beta) increased as renal function decreased: 5.31 +/- 1.30 h in healthy subjects and 58.92 +/- 12.38 h in patients with end-stage renal disease. Urinary elimination of cefonicid was inversely related to the degree of renal impairment: 83% of the dose in 24 h in normal subjects and 13.6% of the dose in patients with severe renal failure. Total body clearance decreased from 23.9 +/- 3.4 ml/min/1.73 m2 (group I) to 1.9 +/- 0.2 ml/min/1.73 m2 (group V). Renal clearance fell from 19.0 +/- 4.9 ml/min/1.73 m2 (group I) to 1.0 +/- 0.4 ml/min/1.73 m2 (group IV). The fractional clearance and the non renal clearance were similar in normal subjects and in uraemic patients. Cefonicid is not haemodializable because of its high protein binding. Dosage of cefonicid should be adjusted according to the degree of renal impairment. Supplemental doses are not necessary after haemodialysis.

Adult↗
PubMed1984

Comparative penetration of cefonicid and cefazolin into the atrial appendage and pericardial fluid of patients undergoing open-heart surgery.

The penetration of cefonicid and cefazolin into cardiac tissue was compared after a single 30-mg/kg dose in 30 patients undergoing aortocoronary artery bypass graft surgery. Samples of the right atrial appendage, pericardial fluid, and serum were obtained at various times and assayed for drug content. The concentrations of cefonicid in serum and the atrial appendage were at least twice those observed for cefazolin at a given time after a dose. The mean (+/- standard deviation) atrial appendage-serum ratio was 0.47 +/- 0.14 for cefonicid and 0.34 +/- 0.06 for cefazolin (P less than 0.005). Pericardial fluid concentrations of cefonicid were slightly lower than those observed in patients receiving cefazolin (P greater than 0.05). A single intravenous dose of cefonicid provides high and sustained concentrations in serum and cardiac tissue and thus may be useful in antibiotic prophylaxis of certain surgical procedures; however, further study of the efficacy of this agent in the prevention and treatment of infections associated with Staphylococcus spp. is needed.

Aged↗
PubMed1986

Multiple-dose pharmacokinetics of cefonicid in patients with impaired renal function.

The pharmacokinetics of multiple-dose administration of cefonicid to patients with normal and impaired renal function were studied by using high-performance liquid chromatography to measure serial serum and urine concentrations. Eighteen patients received an initial dose of 15 mg/kg intravenously over 12 min plus two or three subsequent modified doses at intervals of 24 to 72 h, depending upon the degree of renal impairment. Six patients chronically requiring hemodialysis and 12 nondialysis subjects (creatinine clearance, 10 to 80 ml/min per 1.73 m2) were studied. The concentrations of cefonicid in serum after the initial dose were best described by an open two-compartment model. The elimination half-life of cefonicid ranged between 5.5 and 84.9 h. Mean peak and trough concentrations in serum for all patients were 178.2 +/- 29.3 micrograms/ml (plus or minus standard deviation) and 39.0 +/- 17.5 micrograms/ml, respectively. Trough concentrations were higher in patients requiring hemodialysis than in nondialysis subjects, but the difference was clinically insignificant. The renal clearance/plasma clearance ratio of cefonicid was linearly related to creatinine clearance and decreased with impaired renal function. Therefore, nonrenal mechanisms of elimination become more important as renal function declines. Since cefonicid concentrations were within the therapeutic range for nearly all dosing intervals, we conclude that the guidelines used for dosage reduction and interval prolongation in this study result in therapeutically adequate concentrations in serum and, at the same time, result in no significant drug accumulation.

Adult↗
PubMed1989

Evaluation of cefonicid use in a general hospital.

Recently marketed drugs have limited experience in clinical use. Follow-up evaluation is therefore needed, particularly when these drugs are "restricted use" medicines, such as the second-generation cephalosporins. We present a follow-up of the first use of cefonicid, which was carried out after its substitution for cefuroxime in our hospital. The indication for use, dosing, therapeutic effects, and possible adverse reactions were recorded in 210 of the first 319 medical-surgical inpatients who received cefonicid. Cefonicid was administered to patients who could have been treated with free-use antibiotics on at least 128 occasions; these were cases of community-acquired pneumonia without any risk factor, urinary tract infections, acute exacerbations in patients with chronic lung disease, surgical prophylaxis, and intraabdominal infections. One fatal case of Stevens-Johnson syndrome was seen. Other recorded adverse events were two skin reactions, one tachyarrhythmia with evidence of low cardiac output, six episodes of phlebitis, and nine superinfections during treatment with cefonicid. The use of cefonicid instead of cefuroxime was associated with 20 percent cost savings; however, this study shows that optimal antibiotic prescribing may produce much greater savings.

Adolescent↗
PubMed1989

A trial using early preoperative administration of cefonicid for antimicrobial prophylaxis with hysterectomies.

A single dose of cefonicid given 3.5-5.0 hours or 0.5-1.0 hour preoperatively was compared with cefoxitin given as five doses beginning 0.5-1.0 hour preoperatively for prophylaxis of infection in 202 patients undergoing vaginal or abdominal hysterectomy. The administration of cefonicid 3.5-5.0 hours preoperatively was intended to simulate situations where surgery may be delayed or prolonged. The trial was double-blind, and patients were randomized to one of the three regimens. Operative site infections were noted in 6.2 percent of patients (7/113) who received cefonicid 3.5-5.0 hours preoperatively, in 7.0 percent of patients (3/43) who received cefonicid 0.5-1.0 hour preoperatively, and in 4.3 percent of patients (2/46) who received cefoxitin (p greater than 0.05). Enterococci were isolated most frequently from operative-site infections. When administered 3.5-5.0 hours preoperatively, cefonicid was as effective as more traditional regimens.

Adolescent↗
PubMed1986

Cefonicid. A review of its antibacterial activity, pharmacological properties and therapeutic use.

Cefonicid is a 'second generation' cephalosporin administered intravenously or intramuscularly. It is similar to cefamandole in its superiority to first generation cephalosporins against several enterobacteriaceae as well as its activity against Haemophilus influenzae, including beta-lactamase-producing strains. Its activity against Staphylococcus aureus is similar to that of cefoxitin and inferior to cefamandole and first generation cephalosporins. It has excellent in vitro activity against Neisseria gonorrhoeae, but is inactive against Pseudomonas, Acinetobacter, Serratia, and Bacteroides fragilis. Due to high achievable plasma concentrations and a relatively long half-life, in most clinical trials cefonicid has been administered once daily. It was comparable in efficacy with cefamandole or cefazolin in the treatment of patients with urinary tract, lower respiratory tract, and soft tissue and bone infections. It has also been compared with penicillin in the treatment of uncomplicated gonorrhoea. Results from a small series of patients with endocarditis appear to indicate that cefonicid should not be used in patients with serious staphylococcal infections. Single doses of cefonicid given preoperatively appear to offer a similar degree of protection against post-surgical infection as multiple doses of other antibiotics, but further data from studies involving larger numbers of patients are needed to confirm these impressions. Patients who require prolonged antibiotic therapy, such as those with osteomyelitis being treated as outpatients after a relatively short inpatient course, could benefit from the once daily dose regimen of cefonicid.

Bacterial Infections↗
PubMed1984

Affinity of cefonicid, a long-acting cephalosporin, for the penicillin-binding proteins of Escherichia coli K-12.

The binding of cefonicid (SK&F 75073), a new parenteral cephalosporin, to the penicillin-binding proteins (PBPs) of Escherichia coli K-12 (strain KN-126) was determined by competitive binding studies versus benzyl[14C]penicillin. Cefonicid showed its greatest affinity for PBPs 1a greater than 3 greater than 1b, bound with low affinity to PBPs 4 greater than 2, and did not bind to PBPs 5 and 6. Provisional affinity constants (cefonicid concentration that gave 50% inhibition of [14C]penicillin binding) were determined: PBP 1a, less than 0.25 microgram/ml; PBP 3, 0.7 microgram/ml; PBP 1b, 10 micrograms/ml; PBP 4, 26 micrograms/ml; PBP 2, 90 micrograms/ml; PBPs 5 and 6 greater than 256 micrograms/ml. Direct binding studies with [14C]-cefonicid confirmed this pattern of binding. Subinhibitory concentrations of cefonicid (MIC, broth 0.2 microgram/ml, agar 0.4 microgram/ml) induced filamentation of E. coli KN-126. This implies that PBP 3 is the primary inhibitory site despite the higher affinity of PBP 1a for this cephalosporin.

Bacterial Proteins↗
PubMed1991

Effects of cefonicid on platelet aggregation.

Beta-lactam antibiotics may interfere with platelet aggregation by inhibiting the binding of agonists of platelet aggregation, such as ADP and collagen, to specific receptor sites. The aim of this study was to evaluate in vitro the effects of cefonicid, a semi-synthetic cephalosporin, on platelet aggregation. Spontaneous platelet aggregation and platelet aggregation induced by ADP and collagen were assessed. Platelets from healthy subjects were incubated with cefonicid at final concentrations of 0.1 mg/ml, 1 mg/ml and 10 mg/ml (0.1 mg/ml is the concentration of cefonicid achieved in humans at therapeutic doses). When compared with saline, cefonicid at a concentration of 0.1 mg/ml had no effect on platelet aggregation, but at 1 mg/ml it inhibited ADP-induced aggregation and at 10 mg/ml it also inhibited aggregation induced by collagen. These findings suggest that therapeutic doses of cefonicid do not affect platelet aggregation.

Adenosine Diphosphate↗
PubMed1987

Cefonicid vs. cefoxitin for cesarean section prophylaxis.

A randomized, prospective study compared a long-acting, second-generation cephalosporin, cefonicid (Monocid), with a short-acting, second-generation cephalosporin, cefoxitin (Mefoxin), for cesarean section prophylaxis. One hundred thirty-nine patients were enrolled, with 81 receiving a 1-g intravenous dose of cefonicid after cord clamping and 58 receiving a 2-g dose of intravenous cefoxitin after cord clamping and at 6, 12 and 18 hours postpartum. In those patients receiving cefonicid prophylaxis, endometritis incidence was 17.3% (14 of 81). This finding was not statistically significant (P less than .397) when compared to the 12.1% incidence of endometritis (7 of 58) with cefoxitin. In addition, the febrile morbidity incidence for cefonicid prophylaxis was 23.5% (19 of 81) as compared to 15.5% (9 of 58) for cefoxitin (P less than .25). Because the two drugs appear to be equally efficacious, cefonicid may be the better choice because of its markedly lower cost.

Adult↗