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PubMed1987

Microbiological and pharmacokinetic evaluation of cefonicid, a long-acting cephalosporin.

The in vitro antimicrobial activity of cefonicid has been tested against 27 recent clinical isolates of 7 different species (S. aureus, E. coli, K. pneumoniae, P. mirabilis, S. marcescens, E. cloacae and P. aeruginosa) using the MS-2 Research System, contrast phase microscopy and the colony forming unit assay. With the exception of P. aeruginosa, S. marcescens and E. cloacae, cefonicid showed excellent activity against the different bacterial species tested (i.e. S. aureus, E. coli, K. pneumoniae and P. mirabilis). Tissue penetration of cefonicid after a single i.m. or i.v. dose (1 or 2 g, respectively) was also studied using the suction blister method. In 14 adult subjects with normal renal and liver functions, cefonicid plasma half-life was 5.1 and 5.4 h following i.v. and i.m. administration. Drug concentrations achieved at peak in plasma and suction blister fluid were higher than the minimum inhibitory concentrations for most sensitive pathogens and remained above these values for 24 h. These data support the use of a single daily dose regimen of cefonicid, both i.v. and i.m., for the treatment of most common infections caused by sensitive pathogens in blood and tissues.

Bacteria↗
PubMed1986

Cefonicid, a long acting cephalosporin: in vitro activity compared with three cephalosporins and gentamicin.

Minimum inhibitory concentrations of cefonicid, cefazolin, cefuroxime, ceftazidime and gentamicin were determined against 688 bacterial strains (234 Gram-positive and 454 Gram-negative) from 20 different genera. Cefonicid showed a broader spectrum than cefazolin but was not as active as ceftazidime or gentamicin. Cefonicid most closely resembled cefuroxime in terms of microbiological properties. Disc testing accurately predicted sensitivity to cefonicid except for Staphylococcus aureus (which was sensitive by MIC, but appeared resistant in the disc test) and Proteus vulgaris (which was resistant by MIC but appeared sensitive in the disc test). In combination with gentamicin, synergy or addition was observed in 94% of 35 strains tested by the chequerboard technique. In view of its long half-life and wide range of microbiological activity, cefonicid promises to be a useful addition to the range of cephalosporins already available.

Cefamandole↗
PubMed1984

Cefonicid concentrations in human aqueous humor.

One-gram doses of cefonicid sodium were given intravenously to patients prior to cataract surgery. Although serum levels were high, cefonicid levels in aqueous humor were low: mean peak concentrations of 0.25 and 0.27 mg/L were observed two and four hours after administration, respectively. The unusually high protein binding of cefonicid may explain these observations. The observed concentrations were not above the minimum inhibitory concentrations of cefonicid for those pathogens commonly involved in bacterial endophthalmitis.

Aqueous Humor↗
PubMed1989

Pharmacokinetics of cefonicid in children.

The pharmacokinetics of cefonicid was studied in 17 children requiring antibiotic treatment for respiratory or urinary tract infections. After informed consent had been obtained from the parents, a single dose of cefonicid 50 mg/kg/body weight was given by intramuscular injection. The mean peak serum concentration of 212.63 micrograms/ml was reached at 1.00 h, as absorption occurred at a very fast rate with a mean constant of 3.24 h-1. Mean values for half-life, apparent volume of distribution (Vz), total body clearance (CL), and renal clearance (CLR) were 3.24 h, 0.21 l.kg-1, 16.67 ml.min-1 and 13.60 ml.min-1 respectively. There was an inverse relationship between age and Vz, whereas CL and CLR were positively correlated with age. Cefonicid concentrations in urine were many times higher than the MICs of susceptible strains of bacteria. The study demonstrated that i.m. cefonicid 50 mg.kg-1 gave serum concentrations well within the therapeutic range for susceptible bacteria, and that its pharmacokinetic properties allow single daily doses to be used to treat infections in children.

Absorption↗
PubMed1987

The hematologic effects of cefonicid and cefazedone in the dog: a potential model of cephalosporin hematotoxicity in man.

Cephalosporin antibiotics cause a variety of hematologic disturbances in man, the pathogeneses and hematopathology of which remain poorly characterized. There is a need for a well-defined animal model in which these blood dyscrasias can be studied. In four subacute toxicity studies, the intravenous administration of cefonicid or cefazedone to beagle dogs caused a dose-dependent incidence of anemia, neutropenia, and thrombocytopenia after 1-3 months of treatment. A nonregenerative anemia was the most compromising of the cytopenias and occurred in approximately 50% of dogs receiving 400-500 mg/kg cefonicid or 540-840 mg/kg cefazedone. All three cytopenias were completely reversible following cessation of treatment; the time required for recovery of the erythron (approximately 1 month) was considerably longer than that of the granulocytes and platelets (hours to a few days). Upon rechallenge with either cephalosporin, the hematologic syndrome was reproduced in most dogs tested; cefonicid (but not cefazedone)-treated dogs showed a substantially reduced induction period (15 +/- 5 days) compared to that of the first exposure to the drug (61 +/- 24 days). This observation, along with the rapid rate of decline in red cell mass parameters of affected dogs, suggests that a hemolytic component complicated the red cell production problem and that multiple toxicologic mechanisms contributed to the cytopenia. We conclude that the administration of high doses of cefonicid or cefazedone to dogs can induce hematotoxicity similar to the cephalosporin-induced blood dyscrasias described in man and thus provides a useful model for studying the mechanisms of these disorders.

Anemia↗
PubMed1984

Cefonicid kinetics in subjects with normal and impaired renal function.

Cefonicid is a cephalosporin with a longer t1/2 than currently available cephalosporins. Cefonicid kinetics after an intravenous dose of 7.5 mg/kg were followed in four groups of subjects: group 1, four subjects with normal creatinine clearance (Clcr greater than 80 ml/min); group II, seven subjects with mild renal insufficiency (Clcr 50 to 80 ml/min); group III, five subjects with moderate to severe renal impairment (Clcr 8 to 49 ml/min); and group IV, five subjects with end-stage renal disease who were receiving maintenance hemodialysis (Clcr less than 8 ml/ml). Cefonicid volume of distribution ranged from 6.9% to 17.6% body weight but was not related to Clcr. Elimination t1/2 was 4.6 +/- 0.7 hr in group 1,6.0 +/- 2.7 hr in group II, 25.6 +/- 14.0 hr in group III, and 65.3 +/- 43.6 hr in group IV. There was a strong correlation between plasma cefonicid clearance and Clcr. Nonrenal clearance did not change with decreasing Clcr. Hemodialysis clearance calculated from plasma concentrations and recovery in dialysate was 2.5 +/- 0.9 ml/min. These kinetic parameters were used to formulate dosage regimens for patients with renal impairment.

Cefamandole↗
PubMed1990

In vitro activity of cefonicid compared to other antibiotics against clinical bacterial isolates.

The in vitro activity of cefonicid compared to that of other antibiotics has been evaluated against 401 Enterobacteriaceae, 20 H. influenzae, 17 Branhamella catarrhalis and 71 staphylococci. Cefonicid was always more active than cefazolin, and usually more active than cefamandole and cefuroxime against susceptible gram-negative organisms (E. coli, P. mirabilis, Klebsiella, Shigella, Salmonella, H. influenzae). Cefonicid was ineffective against most strains of Enterobacter, Citrobacter, S. marcescens and M. morganii. Staphylococci were 6 to 8 times less susceptible to cefonicid than to the other cephalosporins.

Cefonicid↗
PubMedDate not supplied

Pharmacokinetic disposition of cefonicid in patients with renal failure and receiving hemodialysis.

Cefonicid is a new cephalosporin with a spectrum of activity similar to that of cefamandole. The pharmacokinetic disposition of the drug was examined in patients with various degrees of renal dysfunction and who were receiving hemodialysis. After patients were given a 7.5 mg/kg dose as an iv infusion, multiple blood and urine samples were obtained at frequent intervals, and the samples were analyzed for cefonicid concentration. Five patients receiving hemodialysis received an additional dose before a dialysis period to assess removal of the drug. The half-life of cefonicid increased markedly with declining renal function (approximately 70 hr in anuric patients). Total clearance and renal clearance decreased linearly with decreases in creatinine clearance. Steady-state volume of distribution remained approximately the same (0.11 liter/kg) in all patients. Cefonicid dosage can be reduced in proportion to decreases in creatinine clearance from normal levels. A simple nomogram is provided.

Adult↗
PubMed1987

Absence of disulfiram-type reactions to single and multiple doses of cefonicid: a placebo-controlled study.

Disulfiram-type reactions after ingestion of alcohol have been reported in patients treated with a number of cephalosporin antibiotics; predominantly with agents containing the methylthiotetrazole side chain, although other similar configurations have also been implicated. Since cefonicid has a sulphonic acid thiotetrazole substitution, we investigated the possibility of a cefonicid-ethanol interaction in 15 healthy volunteers. During the first two crossover phases of the study, single 1 g doses of cefonicid followed by ethanol challenges were compared to placebo followed by ethanol challenges. In the third phase, all volunteers received three consecutive 1 g doses of cefonicid given at 24 h intervals followed by an ethanol challenge. At no time did any of the subjects experience a disulfiram-type reaction, and their blood aldehyde concentrations did not increase throughout the study.

Acetaldehyde↗
PubMed1998

Cefonicid 'restores' the depressed activities of polymorphonuclear cells from chronic haemodialysis patients and renal transplant recipients in vitro.

BACKGROUND: Chronic haemodialysis patients and renal transplant recipients are highly susceptible to infection characterized by high morbidity and mortality and related to an impairment of the phagocytic response. SUBJECTS AND METHODS: In order to elucidate how cefonicid, a cephalosporin with a broad spectrum of activity and once-daily dosage, influences this phagocytic response, the effects of the drug upon the functions of human PMNs from both healthy individuals and immunocompromised patients were investigated. RESULTS: In vitro, PMNs from haemodialysed patients and renal transplant recipients showed a diminished phagocytic efficiency with reduced phagocytosis and bactericidal activity towards intracellular Klebsiella pneumoniae when compared with that seen in PMNs from healthy subjects. Cefonicid significantly affected the activity of PMNs from healthy volunteers, resulting in either an increased percentage of ingested klebsiellae or a reduced intracellular bacterial load when compared with the control, drug-free system. When cefonicid was added to PMNs from uraemic patients a pattern similar to that observed with phagocytes from healthy subjects was detected: the antibiotic was able to 'restore' the depressed primary functions of PMNs, resulting in a significant increase in both phagocytosis and killing activity. CONCLUSIONS: Cefonicid, with its several immunoproperties observed in this study, possesses interesting beneficial properties which make it suitable for the treatment of infections in patients with impaired components of the immune system.

Adult↗
PubMedDate not supplied

Treatment of uncomplicated gonorrhea in women with single-dose cefonicid.

The efficacy of cefonicid (1.0 g given in a single intramuscular dose) was assessed in 50 women with uncomplicated infections due to beta-lactamase-negative strains of Neisseria gonorrhoeae. Forty-three (96%) of 45 cervical infections but only 23 (82%) of 28 anorectal infections were eradicated; overall, 44 (90%) of 49 women were cured of anogenital gonorrhea. Cefonicid failed to eradicate six (55%) of 11 pharyngeal gonococcal infections and 17 (85%) of 20 endocervical infections with Chlamydia trachomatis. Cefonicid had good activity against N. gonorrhoeae in vitro; 41 (98%) of 42 isolates were inhibited by less than or equal to 1.0 micrograms/ml. However, because of its poor efficacy against anorectal and pharyngeal gonococcal infections, single-dose cefonicid is not suitable for the treatment of gonorrhea in women or homosexually active men.

Adolescent↗
PubMed1988

Pharmacokinetics of cefonicid in patients with skin and skin structure infections.

The disposition of cefonicid (2 g intravenously every 24 h) was assessed in 15 patients with skin and skin structure infections. Trough and peak concentrations in serum were measured on two successive days to verify the attainment of steady state; and 1 trough and 12 postdose values of the concentration in serum were collected on the following day. Cefonicid concentrations in serum were determined by high-performance liquid chromatography. The cefonicid serum concentration versus time profile after intravenous infusion was clearly biexponential in all patients. The terminal elimination half-life determined by nonlinear regression analysis was 4.63 +/- 1.49 h (mean +/- standard deviation). The steady-state volume of distribution and total body clearance were 0.12 +/- 0.04 liter/kg and 0.369 +/- 0.110 ml/min per kg, respectively. These results are comparable to parameters derived from previous studies in noninfected normal volunteers. Thus, the disposition of cefonicid is not altered in patients with severe skin and skin structure infections.

Adult↗
PubMed1993

In vitro protein binding of cefonicid and cefuroxime in adult and neonatal sera.

The levels of in vitro protein binding of cefonicid and cefuroxime in human adult and neonatal sera were compared. Binding parameters for each drug were determined within the concentration range of 25 to 3,000 micrograms/ml. Cefonicid exhibited concentration-dependent protein binding in both types of sera, with more extensive binding in adult serum at all concentrations. Two classes of binding sites were found: a high-affinity, saturable site and a low-affinity, nonspecific site. Cefuroxime also showed two-class, concentration-dependent protein binding in adult serum, but binding in neonatal serum was to a single class and was independent of drug concentration. Parameters for class 1 binding sites for cefonicid indicated one binding site per albumin molecule in both adult and neonatal sera, with association constants of 7.0 x 10(4) and 1.3 x 10(4) M-1, respectively. These parameters were also derived for cefuroxime in adult serum and were 0.15 and 7.1 x 10(4) M-1, respectively. In neonatal serum, the combined value (number of binding sites per molecule x equilibrium association constant) was similar to combined values calculated for class 2 binding sites for cefuroxime in adult serum and for cefonicid in neonatal serum (287 versus 195 and 261 M-1, respectively). Cephalosporins have been shown to compete with bilirubin for albumin binding sites. Lower levels of protein binding of cefuroxime in the therapeutic range may mean a lower potential for drug displacement of bilirubin in neonates, on the basis of these results. It may be prudent to select less highly protein-bound agents when treating neonatal infections.

Adult↗
PubMed1988

Disposition of cefonicid in orthopedic surgery patients.

Ten patients undergoing hip reconstructive procedures were given a single prophylactic dose of cefonicid 15 mg/kg to evaluate intraoperative and perioperative drug disposition in the surgical setting. Timed postinfusion serum samples were collected over 24 hours and resulting concentration versus time data were subjected to noncompartmental pharmacokinetic analysis. Bone samples were obtained in eight of ten patients with mean bone concentrations of 13.3 micrograms/g (range 8.2-25.1). Postinfusion serum concentrations at five minutes postinfusion ranged from 200.8 to 316.7 micrograms/ml; the 12-hour mean was 19.1 micrograms/ml (range 4.0-48) and the 24-hour mean was 4.3 micrograms/ml (range 0.0-13.8). Protein binding at three sampling times ranged from 88 to 96.5 percent, increasing over time as total cefonicid concentrations fell. The mean half-life in our patients was 3.5 hours, compared with 4.8 hours in our four controls. These data indicate that altered protein binding and intraoperative events alter the disposition of cefonicid. Although differences in disposition parameters between patients and controls were not statistically significant, suboptimal serum cefonicid concentrations were observed in four orthopedic patients.

Adult↗
PubMed1998

Comparative clinical study of cefonicid, chloramphenicol, and penicillin in community-acquired pneumonia.

Community-acquired pneumonia is one of the most common infectious conditions that require hospitalization. When intravenous treatment is indicated, cefonicid is usually the drug of choice. The aim of this study was to find out if chloramphenicol, which is superior to the standard drugs from a financial point of view, could serve as an equally efficient treatment, especially in the elderly. The outcomes of 3 pneumonia patient groups who were either treated with cefonicid, chloramphenicol or penicillin-G (n = 59, 17, 24, respectively) were retrospectively compared. Data about demographic characteristics of the patients, clinical outcomes, rehospitalization rates, duration of improvement/treatment/ hospitalization and clinical laboratory tests were obtained from each patient's medical records. Only minor differences (even though occasionally significant) were found with respect to rehospitalization and improvement rates, duration of hospitalization, treatment and improvement, death rates and clinical laboratory tests. However, chloramphenicol patients were found to be significantly older than cefonicid patients. Moreover, no bone-marrow suppression was associated with chloramphenicol treatment. All 3 drugs tested seem to have the same efficacy. We conclude that since chloramphenicol is as safe as, and much cheaper than cefonicid, this antibiotic agent is not inferior to the others, its usage in older patients with pneumonia should be considered.

Anti-Bacterial Agents↗
PubMed1992

Cefonicid potentiation of human macrophage activity.

This study was undertaken to evaluate the in vitro effects of cefonicid on phagocyte functions such as phagocytosis and intracellular killing of phagocytosed bacteria. At concentrations of half the MIC cefonicid caused human macrophages to ingest and kill Klebsiella pneumoniae at a greater rate than did drug-free macrophages. Bacteria pretreated with subinhibitory concentrations of cefonicid became more susceptible to the phagocytic and bactericidal activity of macrophages than untreated microorganisms. Sub-MIC cefonicid pretreatment of macrophages did not reduce phagocytosis and killing, confirming the inability of beta-lactam antibiotics to cross biological membranes.

Cefonicid↗
PubMed1989

Pharmacokinetics of cefonicid in serum and its penetration into lung tissue, bronchial mucosa and pleura.

Cefonicid pharmacokinetics in serum and tissue penetration into the lung parenchyma, bronchial mucosa and pleura were studied in 39 patients undergoing lung excision for malignancy. Cefonicid concentrations in serum and tissues samples were assayed at different times after a single 1 g intramuscular administration. The concentrations observed were much higher than the reported minimal inhibitory concentrations for the microorganisms commonly responsible for bronchial and pulmonary infections and therapeutic concentrations were still detectable in the tissues 24 h after dosing. Kinetic findings demonstrated a similar half-life for cefonicid in tissues and in serum. These data provided a further kinetic explanation for the observed clinical efficacy of cefonicid with a single daily dose.

Adult↗
PubMed1986

[In-vitro activity of cefonicid on hospital bacteria. Regression line and proposal for critical values].

Antimicrobial activity of cefonicid, a new second generation cephalosporin, against 315 hospital isolates (4th trimester 1984) was investigated. E. coli and Proteus mirabilis were the most susceptible species. All E. coli strains except one were inhibited at 8 mg/l (modal MIC: 0.5); MICs of all indole + Proteus were 8 mg/l (modal MIC: 0.06). Another group was moderately susceptible: MICs of Klebsiella and Citrobacter ranged from 0.12 to 128 mg/l, but MICs of 50% of these strains were less than or equal to 4 mg/l; MIC was less than or equal to 8 mg/l for 75% of indole + Proteus and Providencia strains; tested Proteus vulgaris were especially resistant (MICs greater than 128 mg/l). Most Enterobacter and Serratia strains showed little susceptibility (modal MIC for both species greater than or equal to 128 mg/l). MICs of all tested Pseudomonas aeruginosa strains were greater than 128 mg/l. 20 of the 24 tested Acinetobacter strains had a MIC of greater than or equal to 128 mg/l. For Staphylococcus aureus, 88% of methicillin-sensitive strains were inhibited by concentrations of 2 to 4 mg/l whereas methicillin-resistant strains were resistant to cefonicid (75%: MIC greater than 64 mg/l). Enterococci were resistant to cefonicid. A correlation curve was established (Enterobacteria and Staphylococci). On the basis of cefonicid's pharmacokinetic characteristics, critical concentrations are proposed.

Bacteria↗