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PubMed1982

[Pharmacokinetics of cefotetan and an aminoglycoside preparation in combined administration. 1. Individual quantification of cefotetan and sisomicin by bioassay and their absorption, distribution, and excretion in rats when given together].

The beta-lactam and aminoglycoside groups of antibiotics are often used in combination. This paper reports a bioassay method for each of cefotetan and sisomicin concentration in body fluids, and pharmacokinetics of both drugs following intravenous administration of cefotetan and intramuscular administration of sisomicin alone and in combination to rats. As to cefotetan determination, a previously reported bioassay method was modified by increasing the NaCl concentration in the sensitivity test agar from 0 to 6%, using Bacillus subtilis ATCC 6633 as the test organism. To assay for sisomicin in the presence of cefotetan, Pseudomonas aeruginosa ATCC 8689, resistant to the beta-lactam antibiotic, was used. Cefotetan (20 mg/kg intravenous) and sisomicin (10 mg/kg intramuscular) were administered concomitantly to rats. The mean plasma concentrations of cefotetan and sisomicin were 16.3 microgram/ml and 16.1 microgram/ml, at 30 minutes after administration respectively. The concentrations were declined to 2.20 microgram/ml for cefotetan and 2.53 microgram/ml for sisomicin at 90 minutes after dosing administration. The calculated plasma half-lives (T 1/2 beta) were 21.3 minutes for cefotetan and 22.2 minutes for sisomicin. The plasma and tissue concentrations of cefotetan administered in combination with sisomicin were nearly the same as those of cefotetan alone. Urinary excretion of cefotetan and sisomicin in the concomitant administration was carried out in rats. Recoveries in urine were 45.9% of the dose for cefotetan and 85.6% of the dose for sisomicin for a period of 24 hours. When each drug was administered alone to rats, cefotetan and sisomicin were recovered 49.8% and 81.6%, respectively, of the dose in the 24-hour urine.

Absorption↗

PubMed1982

[Pharmacokinetics of a cefotetan and an aminoglycoside preparation in combined administration. 2. Absorption and exercise of cefotetan and sisomicin in dogs when the two are given together].

Cefotetan (20 mg/kg i.v.) and sisomicin (10 mg/kg i.m.) were administered alone or in combination to Beagle dogs. The mean plasma concentrations of cefotetan administered in combination with sisomicin at the above dosages were 98.0 microgram/ml at 5 minutes, 45.7 microgram/ml at 30 minutes and 3.46 microgram/ml at 4 hours. These plasma concentrations of cefotetan were similar to those of cefotetan administered alone to the corresponding dogs. The calculated plasma half-lives (T 1/2 beta) of cefotetan were 53.9 minutes in combination with sisomicin and 57.4 minutes alone. The excretion of cefotetan in dog urine were 52.4% and 50.2% of the dose after administration in combination with sisomicin and alone, respectively, during 24 hours. The results indicate that there were no significant differences in the pharmacokinetics of cefotetan alone or in combination with sisomicin in dogs. The maximum concentrations of sisomicin in dogs administered in combination with cefotetan were 20.2 microgram/ml at 30 minutes after dosing. The concentrations of 11.7 microgram/ml at 2 hours and 3.13 microgram/ml at 4 hours of administration were maintained in plasma. The calculated plasma half-lives of sisomicin were 68.8 minutes in combination with cefotetan and 86.4 minutes alone. The urinary rcoveries of sisomicin were 79.3% and 76.1% in combination with cefotetan and alone, respectively, during 24 hours. There were no significant differences in the pharmacokinetics of sisomicin alone and in combination with cefotetan in dogs.

Absorption↗

PubMed1986

A comparative trial between cefotetan and cephazolin for wound sepsis prophylaxis during elective upper gastrointestinal surgery with an investigation of cefotetan penetration into the obstructed biliary tree.

Cefotetan is a cephamycin antibiotic theoretically suited to prophylaxis of wound infection during upper elective gastrointestinal surgery. In a prophylaxis trial 100 patients undergoing this type of surgery were randomly allocated to receive 1g cefotetan or cephazolin iv at induction of anaesthesia. Cefotetan-treated patients had significantly fewer postoperative infections overall (P less than 0.05) and there were no wound infections recorded in this group. In a separate pharmacokinetic study the penetration of cefotetan into common bile duct bile and gallbladder wall was measured in a further six patients, all of whom had been jaundiced preoperatively. At the time of maximum risk concentrations of cefotetan in bile and biliary tissue as well as blood and wound fat were in excess of the minimum inhibitory concentration for the majority of relevant pathogens. Cefotetan appears to be equally or more effective than cephazolin and is a suitable alternative prophylactic agent in elective upper gastrointestinal surgery.

Bile↗

PubMedDate not supplied

Lack of predictability of cefotetan in vitro susceptibility tests against cefotetan-resistant anaerobic bacteria in determining clinical and bacteriologic efficacies.

Interpretive criteria for cefotetan in vitro susceptibility testing appear to be clinically relevant when applied to aerobic bacteria. To determine whether the same was true for anaerobic bacteria, we conducted a retrospective analysis of intraabdominal, gynecologic, and skin and skin structure infections treated with cefotetan. Of the infections, 202 contained at least one anaerobe isolate. Of the 51 patients, 47 (92.9%) from whom one or more cefotetan-resistant anaerobes were isolated were clinically cured or showed improvement. Similarly, cefotetan was efficacious for 95.4% of the patients harboring only cefotetan-susceptible anaerobes. Favorable bacteriologic responses were observed in 94.1% and 97.4% of these patient groups, respectively. The data suggests that the therapeutic utility of cefotetan against anaerobic bacteria cannot be accurately predicted on the basis of in vitro susceptibility test results alone but may be explained by a variety of factors, as discussed in this report.

Bacteria, Anaerobic↗

PubMed1988

Cost-effectiveness study of cefotetan versus cefoxitin and cefotetan versus combination antibiotic regimens.

The clinical efficacy, adverse effects, cost of therapy, and administration time required to treat 141 patients were compared for cefotetan versus cefoxitin (Study A) and cefotetan versus combination antibiotic therapy (Study B). No major differences were observed in clinical efficacy or adverse effects in any of the treatment groups. Cefotetan was more cost-effective than cefoxitin, even though cefoxitin was given for shorter periods. Cefotetan was also more cost-effective than a combination of ampicillin, an aminoglycoside, and clindamycin. Although the ampicillin, aminoglycoside, and metronidazole combination appeared to be the most cost-effective regimen, this combination required the longest administration time (240 percent longer than cefotetan). Cefotetan appears to be comparably efficacious and more cost-effective than other currently used antianaerobic regimens in our institution.

Aminoglycosides↗

PubMed1983

Cefotetan and beta-lactamases. I. An analysis of the affinity of cefotetan for beta-lactamases.

Cefotetan is a new cephamycin whose interaction with a group of eight beta-lactamases isolated from various Gram-negative bacteria has been studied. Using computerized micro-acidimetry, cefotetan was found to be resistant to the hydrolytic action of various enzymes, including those which actively hydrolyse cefotaxime. Despite this resistance to hydrolysis, cefotetan nevertheless shows a certain affinity for these enzymes. These data were submitted to two statistical procedures consisting of correspondence analysis and ascending hierarchical classification. These techniques revealed that cefotetan behaves very much like cefoxitin (another cephamycin) and also like cefotaxime and moxalactam.

Anti-Bacterial Agents↗

PubMed1989

A multicenter study to compare cefotetan alone with cefotetan and metronidazole as prophylaxis against infection in elective colorectal operations.

The role of antibiotic prophylaxis in operations upon the colon and rectum is now well recognized. In this study, the efficacy of cefotetan, a broad spectrum cephamycin antibiotic, given alone (n = 315), is compared with that of the combination of cefotetan and metronidazole (n = 300). The groups were well matched for age, sex, pathologic features and operations performed. There was no statistical difference in the incidence of operation-related infection between the two groups. We conclude that cefotetan given alone is as effective as the combination of cefotetan and metronidazole for prophylaxis against operation-related infection in elective colorectal operations.

Adult↗

PubMed1983

Cefotetan and beta-lactamases. II. An unusual property: the inactivation of some beta-lactamases by cefotetan.

Initially, cefotetan interacts with beta-lactamases to form a classical Michaelis complex characterized by a term Ki (the inhibition constant). In a second phase, this complex develops with time to form a new entity devoid of enzymic activity. This new entity may have the structure of an acyl enzyme with variable stability. In the case of TEM-1 and TEM-2 beta-lactamases, the process is progressively and totally reversible. The same phenomena were observed in varying degrees for Pitton's type 2 (PIT-2) penicillinase, OXA-1 and CARB-1. The Klebsiella oxytoca and Proteus vulgaris beta-lactamases are also inactivated by this same process. However, four other cephalosporinases appear to be unaffected by this mechanism.

Anti-Bacterial Agents↗

PubMed1988

Cefotetan: a review of the microbiologic properties and antimicrobial spectrum.

Cefotetan (formerly ICI 156834 and YM09330) is a 7-methoxy cephalosporin possessing some advantageous antimicrobial spectrum, safety, and pharmacokinetic characteristics compared with other so-called second-generation cephalosporins. The published literature was reviewed and the cefotetan quantitative susceptibility testing data from nearly 31,000 isolates was tabulated. Against 15,769 enteric bacilli, cefotetan was observed to have a potency and spectrum more closely resembling a third-generation cephalosporin and markedly superior to cefoxitin. The mean of all MIC 90s reported for the Enterobacteriaceae ranged from 0.06 to 13 micrograms/ml except for citrobacter species, E. cloacae, Enterobacter species, and C. freundii. The mean MIC 50 for all 22 recorded species was in the susceptible range. Cefotetan was very effective against B. catarrhalis, H. influenzae, and pathogenic Neisseria species. However, cefotetan and cefoxitin were not active against Pseudomonas species, Acinetobacter species, and some rarely isolated species. Cefotetan was moderately active against the staphylococci (mean MIC 50, 7.6 to 26 micrograms/ml) and streptococci (mean MIC 50, 0.9 to 6.6 micrograms/ml). The coagulase-negative staphylococcus species generally had higher cefotetan and cefoxitin minimum inhibitory concentrations compared with the S. aureus isolates. Oxacillin-resistant staphylococci were resistant to cefotetan. The enterococci, JK group diphtheroids, Corynebacterium species, and L. monocytogenes isolates were resistant. A review of 4,751 strict anaerobes showed cefotetan to have a very comparable activity and spectrum to cefoxitin. The 1,291 B. fragilis strains had a mean MIC 50 and MIC 90 of 5.4 and 23 micrograms/ml, respectively. These values were slightly superior to cefoxitin when tested in parallel. More elevated minimum inhibitory concentrations were observed for other B. fragilis group species for cefoxitin and cefotetan. The mean cefotetan MIC 90 for all other anaerobic bacteria except the Eubacterium species and Lactobacillus species predict favorable clinical efficacy. The beta-lactamase stability of cefotetan is very similar to that of other 7-methoxy cephalosporins. Cefotetan also inhibits Type Ia cephalosporinases with high enzyme affinity and is an inducer of these beta-lactamases, although cefotetan is not rapidly hydrolyzed. Synergy between cefotetan and numerous other antibiotics has been reported, but antagonism has also been occasionally observed.

Bacteria, Anaerobic↗

PubMed1986

Cefotetan pharmacokinetics in volunteers with various degrees of renal function.

Twenty-six volunteers with various degrees of renal function were given a single 1-g dose of cefotetan intravenously over 30 min. Concentrations of cefotetan and cefotetan tautomer in plasma and urine were determined by high-performance liquid chromatography. The pharmacokinetic parameters for cefotetan were calculated according to a two-compartment open model. The mean plasma cefotetan concentration at the end of the intravenous infusion did not vary with renal function and ranged between 122 and 126 micrograms/ml. The mean terminal half-life was 4.2 h in normal volunteers and 9.9 h in volunteers with moderate renal impairment. There was a significant linear correlation between the systemic clearance of cefotetan and creatinine clearance. The cumulative amount of cefotetan excreted in the urine over 24 h in normal volunteers was approximately 49% of the dose, but this was reduced in volunteers with moderate renal impairment. The mean urinary cefotetan concentrations generally peaked during the 2- to 4-h interval after dosing. Cefotetan tautomer was sporadically detected in the plasma and urine of approximately 50% of the volunteers. The mean plasma cefotetan tautomer concentrations and mean total cumulative urinary recoveries of cefotetan tautomer were only minimal compared with those for cefotetan. The mean percentage of the dose excreted in the urine as cefotetan tautomer was not significantly affected by the degree of renal impairment. Recommendations for the dosing of cefotetan in renal-impaired patients are given.

Adolescent↗

PubMed2004

Persistence of cefotetan on red blood cells.

BACKGROUND: Cefotetan can cause severe immune hemolytic anemia that may persist long after the drug is discontinued. To study the binding of cefotetan to RBCs, patients who received cefotetan were followed and tested for the presence of antibody to cefotetan. STUDY DESIGN AND METHODS: Patients receiving cefotetan were identified from pharmacy and nursing records. Blood samples obtained for routine hematology tests were analyzed. Cefotetan binding to patients' RBCs was tested using a previously characterized high-titer anticefotetan serum by gel technique. To determine the minimum amount of drug necessary for binding to occur, RBCs were incubated with serial dilutions of cefotetan at pH 7.4. RESULTS: Sixty patients receiving 1 to 25 g i.v. (median, 2 g) of cefotetan were followed for 1 to 123 days (median, 18 days). All were initially positive, for cefotetan on RBCs. Positivity persisted for up to 98 days after the last dose of drug. Fifteen patients became negative during follow-up. The first negative sample occurred at Day 30 to 123. Using the midpoint between the last positive and first negative to estimate of the duration of positivity, we estimate that cefotetan remains RBC-bound for 16.5 to 92 days (median, 67.5 days). During the follow-up period, five patients developed anticefotetan detectable in the serum. Twenty patients receiving other cephalosporin antibiotics showed no specific reactivity of their RBCs with anticefotetan. In vitro studies showed a minimum necessary drug concentration of 1 micromol/L at physiologic pH, which was not significantly altered by RBC pretreatment with ficin, sialydase, or DTT. CONCLUSIONS: Cefotetan is tightly bound to RBCs after intravenous administration and remains detectable for weeks after the last dose. Antibodies to cefotetan may occur in about 8 percent of patients receiving the drug. The minimum necessary concentration for RBC binding is low compared to an estimated plasma concentration of 240 micromol/L from a single i.v. dose of 1 g.

Anemia, Hemolytic, Autoimmune↗

PubMed1988

Multicenter open trial of cefotetan and cefoxitin in elective biliary surgery.

The present study was performed in two phases. In phase I, 112 patients were randomized to either 2 g cefotetan as a single prophylactic dose or 2 g cefoxitin every 6 hours for a maximum of 4 doses; phase II included 148 patients who were randomized to either 1 g cefotetan as a single dose or cefoxitin dosed as in phase I. The randomization was 2:1 cefotetan to cefoxitin in both phases. Nonevaluability rates were 10 percent for the cefotetan patients and 22 percent for the cefoxitin patients, the majority being due to dosing errors. Demographic characteristics demonstrated 88 percent to be female, 81 percent to be less than 65 years of age, and the average weight to be 165 lb. There were no differences in these characteristics among the groups. Common duct exploration was performed in 6 percent of the 2 g cefotetan patients, 9 percent in the 1 g cefotetan patients, and 13 percent in the 2 g cefoxitin patients. There were five clinical failures of prophylaxis: one wound infection in the 2 g cefotetan patients, one wound infection and one drain tract infection in the 1 g cefotetan patients, and one wound infection and one case of cholangitis in the 2 g cefoxitin patients. The clinical success rates were 98 percent in the 2 g cefotetan patients, 98 percent in the 1 g cefotetan patients, and 97 percent in the 2 g cefoxitin patients.

Aged↗

PubMed1989

Pharmacokinetics and pharmacodynamics of total and unbound cefoxitin and cefotetan in healthy volunteers.

Cefotetan is a semisynthetic cephalosporin with a broad spectrum of Gram-negative and anaerobic activity. We compared the pharmacokinetics and serum inhibitory activity of 2 g doses of cefotetan and cefoxitin in six healthy volunteers. The half-life of cefotetan (176 min) was significantly longer than that of cefoxitin (49 min). Despite higher protein binding (85% versus 50%), free cefotetan serum concentrations 12 h post dose (1.6 mg/l) were higher than free cefoxitin serum concentrations 6 h post dose (0.32 mg/l). Total and free serum inhibitory titres for Escherichia coli were greater than 1:8 for 12 h post dose for cefotetan, but only 1 h post dose for cefoxitin. Against Bacteroides fragilis, neither cefoxitin nor cefotetan exhibited free serum inhibitory titres greater than 1:8 at the end of their respective dosing intervals. However, cefotetan titres were equivalent or superior to those of cefoxitin over the entire 6 or 12 h dosing interval. Despite relatively high protein binding, cefotetan demonstrates comparable or superior activity 12 h after dosing to cefoxitin 6 h after dosing. More studies comparing the clinical outcome of cefoxitin and cefotetan are needed but our results support the clinical recommendations that cefoxitin should be given every 6 h, and cefotetan every 12 h.

Adult↗

PubMed1988

Comparative study of cefotetan and cefoxitin in the treatment of intra-abdominal infections.

One hundred eighty-eight patients were enrolled in a multicenter, randomized clinical trial to compare the safety and effectiveness of 1 to 2 gm cefotetan every 12 hours with those of 1 to 2 gm cefoxitin every 6 hours in patients with intra-abdominal infections. Most of the infections were community acquired, were associated with gastrointestinal tract perforation, and were caused by both anaerobic and aerobic bacteria. The median duration of therapy was 6 days for each group. The clinical response rate for the 95 evaluable patients in the cefotetan group was 98%, and that for the 43 evaluable patients in the cefoxitin group was 95%. Bacteriologically, 97% of the 58 evaluable patients in the cefotetan group and 89% of the 27 evaluable patients in the cefoxitin group had a satisfactory or presumed satisfactory response; two patients in the cefotetan group and three in the cefoxitin group were considered bacteriologic failures. Cefotetan was as effective as cefoxitin in eradicating Bacteroides fragilis and other species of Bacteroides, Clostridium sp., and gram-negative bacilli. The incidence of treatment-related adverse reactions for cefotetan (27%) was not statistically different from that for cefoxitin (17%). No clinically significant differences were detected between the treatment groups in changes in the results of clinical laboratory tests performed before and after treatment; a decrease in hematocrit among the cefotetan group was statistically greater (p = 0.04) than that for the cefoxitin group, and a decrease in serum creatinine level for the cefoxitin group was greater than that for the cefotetan group (p = 0.02). Cefotetan may represent an effective, safe, and cost-saving alternative to cefoxitin for the prompt treatment of community-acquired intra-abdominal infections.

Abdomen↗

PubMed2006

Ertapenem versus cefotetan prophylaxis in elective colorectal surgery.

BACKGROUND: Ertapenem, a long-acting carbapenem, may be an alternative to the recommended prophylactic antibiotic cefotetan. METHODS: In this randomized, double-blind trial, we assessed the efficacy and safety of antibiotic prophylaxis with ertapenem, as compared with cefotetan, in patients undergoing elective colorectal surgery. A successful outcome was defined as the absence of surgical-site infection, anastomotic leakage, or antibiotic use 4 weeks postoperatively. All adverse events were collected until 14 days after the administration of antibiotic prophylaxis. RESULTS: Of the 1002 patients randomly assigned to study groups, 901 (451 in the ertapenem group and 450 in the cefotetan group) qualified for the modified intention-to-treat analysis, and 672 (338 in the ertapenem group and 334 in the cefotetan group) were included in the per-protocol analysis. After adjustment for strata, in the modified intention-to-treat analysis, the rate of overall prophylactic failure was 40.2% in the ertapenem group and 50.9% in the cefotetan group (absolute difference, -10.7%; 95% confidence interval [CI], -17.1 to -4.2); in the per-protocol analysis, the failure rate was 28.0% in the ertapenem group and 42.8% in the cefotetan group (absolute difference, -14.8%; 95% CI, -21.9 to -7.5). Both analyses fulfilled statistical criteria for the superiority of ertapenem. In the modified intention-to-treat analysis, the most common reason for failure of prophylaxis in both groups was surgical-site infection: 17.1% in the ertapenem group and 26.2% in the cefotetan group (absolute difference, -9.1; 95% CI, -14.4 to -3.7). In the treated population, the overall incidence of Clostridium difficile infection was 1.7% in the ertapenem group and 0.6% in the cefotetan group (P=0.22). CONCLUSIONS: Ertapenem is more effective than cefotetan in the prevention of surgical-site infection in patients undergoing elective colorectal surgery but may be associated with an increase in C. difficile infection. (ClinicalTrials.gov number, NCT00090272 [ClinicalTrials.gov].).

Adult↗

PubMed1983

Cefotetan: antimicrobial activity in-vitro compared with that of cefotaxime.

The antimicrobial activity of cefotetan and cefotaxime were compared in vitro against 547 strains of aerobes and 24 strains of Bacteroides fragilis. The strains were recent clinical isolates from 20 hospitals. Cefotetan was found to exhibit an activity two- to fourfold lower than that of cefotaxime against most of the enterobacteriaceae. About half the number of Enterobacter aerogenes and Enterobacter cloacae strains resistant to cefotetan were resistant also to cefotaxime. Cefotetan was more active than cefotaxime against most of the strains of Proteus vulgaris. In contrast to cefotaxime which was moderately active, cefotetan was inactive against Pseudomonas aeruginosa. Cefotetan had limited activity against Staphylococcus aureus and Streptococcus faecalis was resistant to both cefotetan and cefotaxime. Bact. fragilis was inhibited more effectively by cefotetan than by cefotaxime. Depending on the species tested, the activity of cefotetan was influenced significantly by the inoculum size in some cases. Different test media did not affect the results.

Anti-Bacterial Agents↗

PubMed2000

Drug-induced hemolysis: cefotetan-dependent hemolytic anemia mimicking an acute intravascular immune transfusion reaction.

Numerous cases of drug-induced hemolytic anemia have been described in patients treated with penicillin or cephalosporin. Second and third generation cephalosporins are more commonly implicated in hemolytic reactions than first generation cephalosporins. We report a case of severe cefotetan-induced hemolytic anemia in a previously healthy 46-year-old woman undergoing an elective hysterectomy. The patient received 2 g of intravenous cefotetan intraoperatively and subsequently at 12 and 24 h post-operatively. She complained of diarrhea and fever on the third post-operative day and was seen in her gynecologist's office on the fifth post-operative day (hemoglobin = 10.5 g/dL). On the seventh post-operative day, she complained of fever and soreness around the suprapubic catheter site and was given a prescription for 500 mg oral cephalexin four times a day. The next day she was seen in the gynecologist's office and reported feeling better. Ten days after the operation her fatigue worsened and her hemoglobin was 4.8 g/dL. She was transfused with 3 units of packed red blood cells (PRBC) and was given 1 g of cefotetan intravenously. During the transfusion of the second unit of PRBC nursing staff observed gross hemoglobinuria and she subsequently developed acute renal failure. Laboratory chemistry parameters were consistent with severe acute hemolysis. The patient's direct antiglobulin test was reactive and her serum reacted with cefotetan-coated red blood cells (RBCs) and serum plus soluble cefotetan reacted with untreated RBCs. The titration endpoint of the serum against cefotetan-coated RBCs was 40,960, while the serum plus soluble cefotetan against uncoated RBCs was 2,560. This case of severe cefotetan-induced hemolysis was complicated by an acute hemolytic event that occurred during the transfusion of PRBC. Clinical and transfusion service staff must consider drug-induced hemolysis in the differential diagnosis of acute anemia.

Anemia, Hemolytic↗

PubMed1988

Multicenter clinical trials comparing cefotetan with moxalactam or cefoxitin as therapy for obstetric and gynecologic infections.

The clinical efficacy and safety of cefotetan was assessed in two multicenter clinical trials involving 335 evaluable patients hospitalized with obstetric and gynecologic infections. In Study I, cefotetan was compared with moxalactam and in Study II, cefotetan was compared with cefoxitin. The clinical response rate in Study I was 67 of 70 patients for cefotetan (96 percent) and 33 of 34 patients (97 percent) for moxalactam. In Study II, the clinical response rate was 138 of 147 patients in the cefotetan group (94 percent) and 76 of 84 patients in the cefoxitin group (91 percent). For the patients with bacteriologic response data, 196 of 205 cefotetan patients (96 percent), 23 of 24 moxalactam patients (96 percent), and 70 of 75 cefoxitin patients (93 percent) had a satisfactory bacteriologic response. Cefotetan was well tolerated and produced no major adverse reactions. The mean amount of cefotetan given was lower than that of moxalactam or cefoxitin.

Adult↗