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PubMed1995

Comparative pharmacokinetics of amoxicillin/clavulanic acid combination after intravenous administration to sheep and goats.

The pharmacokinetic behaviour of an amoxicillin/clavulanic acid combination was studied after intravenous administration of single doses (20 mg/kg per kg body weight) to five sheep and six goats. The objective was to determine whether there are differences between sheep and goats in the disposition of amoxicillin and clavulanic acid. The plasma concentration-time data were analysed by compartmental pharmacokinetic and non-compartmental methods. The disposition curves for both drugs were best described by a biexponential equation (two-compartment open model) in sheep and goats. The elimination half-lives of amoxicillin were 1.43 +/- 0.16 h in sheep and 1.13 +/- 0.19 h in goats, and of clavulanic acid were 1.16 +/- 0.01 h and 0.85 +/- 0.09 h in sheep and goats respectively. The apparent volumes of distribution of amoxicillin and clavulanic acid were similar in the two species. Body clearances of amoxicillin were 0.09 +/- 0.01 L/h kg in sheep and 0.11 +/- 0.01 L/h kg in goats, and of clavulanic acid were 0.07 +/- 0.01 L/h kg and 0.12 +/- 0.01 L/h kg in sheep and goats respectively. The half-lives and body clearances of amoxicillin and clavulanic acid differed significantly between sheep and goats. It was concluded that the disposition of amoxicillin and clavulanic acid administered intravenously as an amoxicillin/clavulanic acid combination to sheep and goats differed between the two ruminant species. Even though the differences in disposition kinetics of both drugs were statistically significant, the same intravenous dosing rate of this antimicrobial combination can generally be used in sheep and goats.

Amoxicillin↗
PubMed1997

Tazobactam-piperacillin compared with sulbactam-ampicillin, clavulanic acid-ticarcillin, sulbactam-cefoperazone, and piperacillin for activity against beta-lactamase-producing bacteria isolated from patients with complicated urinary tract infections.

The antibacterial activity of tazobactam-piperacillin was compared with that of sulbactam-ampicillin, clavulanic acid-ticarcillin, sulbactam-cefoperazone and piperacillin against beta-lactamase-producing bacteria isolated from patients with complicated urinary tract infections. Tazobactam-piperacillin showed a broad antibacterial spectrum against gram-negative and gram-positive bacteria. The minimum inhibitory concentrations (MIC90) of tazobactam-piperacillin were 6.25 micrograms/ml against Escherichia coli, 1.56 micrograms/ml against Proteus mirabilis, 3.13 micrograms/ml against Proteus vulgaris, 6.25 micrograms/ml against methicillin-susceptible Staphylococcus aureus, and 6.25 micrograms/ml coagulase-negative methicillin-susceptible staphylococci. Against all beta-lactamase-producing bacteria tested the antibacterial activity of tazobactam-piperacillin was at least 4- to 64-fold stronger than that of piperacillin, clavulanic acid-ticarcillin, and sulbactam-ampicillin, and similar to or greater than that of sulbactam-cefoperazone except for E. coli.

Ampicillin↗
PubMed1997

Multiple antibiotic resistance (MAR) index and its reversion in Pseudomonas aeruginosa.

The MAR indexes of hospital isolates of Pseudomonas aeruginosa were determined with reference to nine different cephalosporins. The values for all the strains were higher than 0.2 suggesting their origin from a high risk source of contamination where antibiotics are often used. Emergence of MAR pathogenic strains of Ps. aeruginosa indicated possible nosocomial infection in the hospital environment. beta-Lactamases produced by these organisms were tested and their inhibition by clavulanic acid was studied. beta-Lactamase produced by one of these strains (Ps-1) could not be inhibited by clavulanic acid whereas beta-lactamases of three other strains (Ps-2, Ps-3 and Ps-4) could be inhibited by clavulanic acid in the presence of cephalosporins, suggesting a possible use of clavulanic acid in combination with cephalosporins, to combat beta-lactamase induced resistance in Ps. aeruginosa.

Anti-Bacterial Agents↗
PubMed1983

Efficacy of BRL 25000 against Serratia marcescens, Enterobacter cloacae, and Citrobacter freundii in urinary tract infections.

Synergism between amoxicillin and clavulanic acid was not expected against cephalosporinase-producing bacterial strains because clavulanic acid has little inhibitory action on cephalosporinases. However, in a clinical trial of BRL 25000 (amoxicillin-clavulanic acid), excellent results were obtained in complicated urinary tract infections caused by Serratia marcescens, Enterobacter cloacae, and Citrobacter freundii strains which produced cephalosporinase and were highly resistant to amoxicillin alone. The good clinical efficacy of BRL 25000 in such urinary tract infections was probably due to the fact that the urinary concentration of clavulanic acid was higher than its minimal inhibitory concentrations for these strains.

Amoxicillin↗
PubMed1986

Pharmacokinetics and tissue penetration of Timentin: a simultaneous study of serum, urine, lymph, suction blister and subcutaneous thread fluid.

Following iv bolus injection of 3.2 g Timentin (ticarcillin 3.0 g plus clavulanic acid 0.2 g) to 12 volunteers, the antibiotic concentrations were analysed by HPLC methods in serum, urine and fluids from subcutaneous threads, suction blisters and lymph during 8 h. Pharmacokinetic parameters, urine recovery, penetration and ticarcillin/clavulanic acid ratios were calculated. The antibiotic concentration in thread fluid closely followed the serum concentration. For ticarcillin the mean (+/- S.D.) elimination half-lives in serum and thread fluid were 1.0 +/- 0.1 and 1.2 +/- 0.1 h, respectively. For clavulanic acid the half-lives in these fluids were 0.9 +/- 0.1 and 1.0 +/- 0.1 h. The lymph and blister fluid concentration followed a similar pattern, but differed from those in serum, the mean (+/- S.D.) elimination half-lives for both compounds ranging from 1.1 +/- 0.2 to 3.2 +/- 0.3 h. The urine recovery of ticarcillin was 86% and of clavulanic acid 51% of the administered dose. The penetration of clavulanic acid into the different tissue fluids was superior to ticarcillin, ranging from 78 to 88% for clavulanic acid and 52-70% for ticarcillin. The concentration ratios of the two compounds, being 15:1 at the time of injection, varied widely in the different tissue fluids with time. This was also the case with AUC(0-infinity) ratios. A relative decrease of clavulanic acid was observed, most pronounced in serum and thread fluid. However, the antibiotic concentrations achieved in serum, urine and extravascular fluid should be adequate in most infections caused by a wide range of clinically important pathogens.

Adult↗
PubMed1986

Efficacy and pharmacokinetics of Timentin in paediatric infections.

Twenty-four children, ten of whom had an infection due to ticarcillin-resistant, Timentin-sensitive bacteria, were treated with Timentin. A full clinical success was obtained in sixteen cases (13 pyelonephritis, nine of them due to ticarcillin-resistant, Timentin-sensitive Escherichia coli, two neonatal infections and one pneumonia). Four children were improved (1 bronchiectasis, 3 leukaemias), three were unassessable and one failure occurred with a staphylococcal urinary tract infection. A pharmacokinetic study was performed in three newborns (under three months) and ten children (mean age 3 years). Timentin was administered as four daily 30-min iv infusions. The mean dosage used in patients under three months was 225 mg/kg/d ticarcillin and 9 mg/kg/d clavulanic acid. In infants older than three months of age the mean dosage was 250 mg/kg/d ticarcillin and 16 mg/kg/d clavulanic acid. The pharmacokinetic results demonstrated similar serum concentrations of ticarcillin to those in earlier studies, and serum concentrations of clavulanic acid of 3.1 +/- 0.63 mg/l and 2.18 +/- 0.17 mg/l at 1 h and 2 h respectively after infusion in newborns. For children, at the same times, the serum levels were respectively 2.3 +/- 0.9 mg/l and 1.4 +/- 0.9 mg/l. The peak serum concentrations of clavulanic acid were the same in the two groups of dosages (4.7 mg/l), but the half-lives of clavulanic acid were 1.1 h in children older than three months and 1.8 h in infants younger than 3 months. The tolerance was good. Timentin may be useful as a first line antibiotic in infections in hospitalized children in the dosage described, as three or four injections daily, according to the age and the severity of the disease.

Adolescent↗
PubMed1984

The pharmacokinetics of orally absorbed cefuroxime compared with amoxycillin/clavulanic acid.

The pharmacokinetics of a new orally absorbed pro-drug of cefuroxime were compared with those of co-administered amoxycillin and clavulanic acid in six healthy male volunteers. Doses of 600 mg of acetoxyethyl cefuroxime and 500 mg amoxycillin plus 250 mg clavulanic acid were each administered for ten doses 8 hourly. Tissue penetration after the first dose of the antibiotic was estimated by a cantharides blister method. The faecal flora of the volunteers was studied throughout the study. The pharmacokinetics of cefuroxime and amoxycillin were very similar, peak levels of about 6.4 mg/l being found between 2 and 2.5 h after administration. The peak serum level of clavulanic acid was 4.3 mg/l at 1.25 h after administration. The serum half-lives were about 1.1 h for all three agents. No drug accumulation occurred over the four days of the study. The 0-8 h urinary recovery of cefuroxime was 30%. All three agents penetrated the blister fluid rapidly, the main peak levels being 64% of the peak serum level for cefuroxime, 72% for amoxycillin and 55% for clavulanic acid. The incidence of side effects was similar for each regimen. Three volunteers having diarrhoea after cefuroxime showed significant alterations in their bowel flora.

Adult↗
PubMed1998

beta-Lactam synthetase: a new biosynthetic enzyme.

The principal cause of bacterial resistance to penicillin and other beta-lactam antibiotics is the acquisition of plasmid-encoded beta-lactamases, enzymes that catalyze hydrolysis of the beta-lactam bond and render these antibiotics inactive. Clavulanic acid is a potent inhibitor of beta-lactamases and has proven clinically effective in combating resistant infections. Although clavulanic acid and penicillin share marked structural similarities, the biosyntheses of their bicyclic nuclei are wholly dissimilar. In contrast to the efficient iron-mediated oxidative cyclization of a tripeptide to isopenicillin N, the critical beta-lactam ring of clavulanic acid is demonstrated to form by intramolecular closure catalyzed by a new type of ATP/Mg2+-dependent enzyme, a beta-lactam synthetase (beta-LS). Insertional inactivation of its encoding gene in wild-type Streptomyces clavuligerus resulted in complete loss of clavulanic acid production and the accumulation of N2-(carboxyethyl)-L-arginine (CEA). Chemical complementation of this blocked mutant with authentic deoxyguanidinoproclavaminic acid (DGPC), the expected product of the beta-LS, restored clavulanic acid synthesis. Finally, overexpression of this gene gave the beta-LS, which was shown to mediate the conversion of CEA to DGPC in the presence of ATP/Mg2+. Primary amino acid sequence comparisons suggest that this mode of beta-lactam formation could be more widely spread in nature and mechanistically related to asparagine synthesis.

Amidohydrolases↗
PubMed1987

Pharmacokinetic studies on clavulanate potentiated ticarcillin in normal subjects and patients with renal insufficiency.

Pharmacokinetics of the novel combination of ticarcillin with the beta-lactamase inhibitor clavulanic acid (BRL 28500, Timentin, Betabactyl) was investigated in order to calculate the dose reduction factor (DRF) and elaborate dosage recommendations for patients with varying degrees of renal impairment. Serum and urine levels of ticarcillin and clavulanic acid have been determined following the i.v. application of 3.2 g and 5.2 g BRL 28500 consisting of 3.0 g and 5.0 g ticarcillin, respectively, and 0.2 g of clavulanic acid each. 10 healthy volunteers and 9 patients received the 5.2 g formulation, and 6 normal subjects and 9 patients the 3.2 g formulation. The pharmacokinetics of both components of BRL 28500 behave fairly similarly and provides the combination with a logic basis. The dose reduction factor, being 1 by definition in normal renal function, rises in final renal failure to 2-3 for clavulanic acid and to 4-5 for ticarcillin. A dosis reduction to 1/2-1/4 will roughly produce the same AUC in a patient with terminal renal insufficiency as the normal dosage in a healthy subject. The distribution volume of ticarcillin and clavulanic acid was found to be enlarged probably due to overhydration in this group of patients. The recovery of both BRL 28500 components decreased with impaired renal function. The recovery 6 h after administration of 0.2 g clavulanic acid in the 5.2 g (3.2 g) BRL 28500 formulation fell from 58 +/- 12% (52 +/- 6) in healthy subjects to 25 +/- 14% (25 +/- 13) in patients with renal insufficiency.(ABSTRACT TRUNCATED AT 250 WORDS)

Clavulanic Acids↗
PubMed1999

[In vitro activity of beta-lactam agents and beta-lactamase inhibitors in clinical isolates of Acinetobacter baumannii].

Acinetobacter is a Gram-negative coccobacillus frequently associated with nosocomial infections, especially pneumonia in patients using mechanical ventilators in ICUs. Many of the clinical isolates of Acinetobacter baumannii are now resistant to most antibiotics, including the betalactams, making these infections difficult to treat. We compared the in vitro activity of betalactam agents (ampicillin, piperacillin and ticarcillin), betalactamase inhibitors (clavulanic acid, sulbactam and tazobactam) alone and in combination with betalactam agents (amoxicillin-clavulanic acid, ampicillin-sulbactam, piperacillin-tazobactam and ticarcillin-clavulanic) against 156 clinical isolates of A. baumannii using an agar dilution method. In general, we observed a low susceptibility to the betalactam agents tested (ampicillin: 1.9% susceptibility; piperacillin: 10.2%; ticarcillin: 19.8%). We did not observe a significant reduction of the MIC in the combination of betalactam agents and betalactamase inhibitors; only ampicillin/sulbactam showed a high antimicrobial activity (84.6% compared to 14.1%, 37.8% and 33.9% for amoxicillin-clavulanic acid, piperacillin-tazobactam and ticarcillin-clavulanic acid, respectively). Sulbactam was the only betalactamase inhibitor which showed good in vitro activity, with a low MIC(50) and MIC(90) (8 and 32 mg/l, respectively) similar to ampicillin/sulbactam (2 and 16 mg/l, respectively). Sulbactam could be a good therapeutic alternative for the treatment of multiresistant A. baumannii infections.

Acinetobacter↗
PubMed1990

Development of beta-lactamase inhibitors.

The resistance of bacteria to beta-lactam antibiotics was first associated with the production of the enzyme beta-lactamase as long ago as 1940. Since then, increasing numbers of beta-lactamase-producing bacteria capable of inactivating penicillins and cephalosporins have been isolated clinically. One approach to the problem posed by beta-lactamase-producing bacteria has been to seek substances that function as inhibitors of beta-lactamase and that can be used to protect beta-lactam antibiotics from destruction by the bacterial enzymes. The first clinically available inhibitor was clavulanic acid, a metabolite of Streptomyces clavuligerus that was identified in a screening program for naturally occurring beta-lactamase inhibitors. Clavulanic acid is a potent inhibitor of many bacterial beta-lactamases and has been formulated with amoxicillin and ticarcillin to produce broad-spectrum antibiotic combinations active against beta-lactamase-producing bacteria. After the discovery of clavulanic acid, various compounds have been reported to function as inhibitors of bacterial beta-lactamases, but only sulbactam and its prodrug, sultamicillin, have become available commercially. The success of clavulanic acid has confirmed beta-lactamase inhibitors as one solution to the problem of antibiotic-resistant bacteria.

Ampicillin↗
PubMed1992

Effect of beta-lactamase inhibitors on beta-lactamases from anaerobic bacteria.

Three beta-lactamase inhibitors in clinical use--clavulanic acid, sulbactam and tazobactam--were investigated for their activity on beta-lactamases from Bacteroides uniformis, Clostridium butyricum and Fusobacterium nucleatum. Purification of the beta-lactamases was carried out by anion-exchange chromatography, gel filtration and FPLC. The inactivation of beta-lactamase activity was determined spectrophotometrically with nitrocefin as substrate. Various concentrations of the inhibitors were preincubated at 30 degrees C together with the enzyme for different periods of time before determination of the beta-lactamase activity. The three beta-lactamases tested were more susceptible to tazobactam than to clavulanic acid and sulbactam. Clavulanic acid and sulbactam reduced the enzyme activity of the Bacteroides uniformis beta-lactamase more effectively than the Clostridium butyricum and Fusobacterium nucleatum beta-lactamases.

Bacteria, Anaerobic↗
PubMed1998

Pseudobacteremia with amoxycillin-clavulanic acid-resistant Escherichia coli traced to cross-contamination during blood culture processing.

Escherichia coli has seldom been reported to cause pseudobacteremia. The investigation of an outbreak of amoxycillin-clavulanic acid-resistant E. coli pseudobacteremia is described. Seventeen cases occurred over a five-day period. The source of the E. coli was traced to the blood culture specimen of a patient (index patient) with genuine bacteremia as a result of urinary tract infection. The other 16 case-patients had pseudobacteremia which was found to be the result of cross-contamination during subculture of blood specimens. The E. coli strain was carried over from the culture bottle of the index patient, through the contaminated gloved hands of a technician to the culture bottles of the other 16 cases. Although the pseudobacteremia occurred over a five-day period, they all resulted from cross-contamination during blood culture processing within one day. An early outbreak investigation was prompted by the unusual finding of amoxycillin-clavulanic acid resistance in the case E. coli isolates in a short period. The relatedness of the E. coli strains from the 17 cases was confirmed by arbitrary-primed polymerase chain reaction. Clinicians should be alerted to the possibility of a blood E. coli isolate being a contaminant despite its predominant role as a true pathogen.

Amoxicillin-Potassium Clavulanate Combination↗
PubMed2005

Comparative bacteriological efficacy of pharmacokinetically enhanced amoxicillin-clavulanate against Streptococcus pneumoniae with elevated amoxicillin MICs and Haemophilus influenzae.

A new pharmacokinetically enhanced formulation of amoxicillin-clavulanate (2,000 mg of amoxicillin/125 mg of clavulanate twice a day; ratio 16:1) has been designed, with sustained-release technology, to allow coverage of bacterial strains with amoxicillin-clavulanic acid MICs of at least 4/2 mug/ml. The bacteriological efficacy of amoxicillin-clavulanate, 2,000/125 mg twice a day, ratio 16:1, was compared in a rat model of respiratory tract infection versus four other amoxicillin-clavulanate formulations: 8:1 three times a day (1,000/125 mg), 7:1 three times a day (875/125 mg), 7:1 twice a day (875/125 mg), and 4:1 three times a day (500/125 mg); levofloxacin (500 mg once a day); and azithromycin (1,000 mg on day 1 followed thereafter by 500 mg once a day). Bacterial strains included Streptococcus pneumoniae, with amoxicillin-clavulanic acid MICs of 2/1 (one strain), 4/2, or 8/4 microg/ml (three strains each), and Haemophilus influenzae, one beta-lactamase-positive strain and one beta-lactamase-negative, ampicillin-resistant strain. Animals were infected by intrabronchial instillation. Antibacterial treatment commenced 24 h postinfection, with doses delivered by computer-controlled intravenous infusion to approximate the concentrations achieved in human plasma following oral administration. Plasma concentrations in the rat corresponded closely with target human concentrations for all antimicrobials tested. Amoxicillin-clavulanate, 2,000/125 mg twice a day, ratio 16:1, was effective against all S. pneumoniae strains tested, including those with amoxicillin-clavulanic acid MICs of up to 8/4 microg/ml and against beta-lactamase-producing and beta-lactamase-negative ampicillin-resistant H. influenzae. These results demonstrate the bacteriological efficacy of pharmacokinetically enhanced amoxicillin-clavulanate 2,000/125 mg twice a day (ratio 16:1) against S. pneumoniae with amoxicillin-clavulanic acid MICs of at least 4/2 microg/ml and support clavulanate 125 mg twice a day as sufficient to protect against beta-lactamase in this rat model.

Amoxicillin↗
PubMed1995

Effect of ticarcillin and ticarcillin/clavulanic acid on the in-vitro activity of human granulocytes against beta-lactamase-producing Klebsiella pneumoniae.

Clavulanic acid is an effective inhibitor of a broad range of clinically important beta-lactamases and its combination with some beta-lactam antibiotics such as ticarcillin has been shown to extend the inhibition spectrum of the beta-lactams. The activity of ticarcillin, both alone and in combination with clavulanic acid, upon PMN phagocytosis and bactericidal activity towards Klebsiella pneumoniae was investigated. The results indicate that a combination of ticarcillin with clavulanic acid is more active than ticarcillin alone against a beta-lactamase-producing strain of K. pneumoniae, and hence may significantly increase the bacterial vulnerability to phagocyte functions.

Clavulanic Acid↗
PubMed1992

Proposed interpretive criteria and quality control parameters for testing susceptibility of Neisseria gonorrhoeae to beta-lactam-clavulanate combinations.

To support future clinical studies, in vitro susceptibility tests were examined to determine whether Neisseria gonorrhoeae could be tested reliably against two beta-lactam-clavulanate combinations. All isolates that were tested appeared to be susceptible to amoxicillin and ticarcillin in combination with clavulanic acid. In the absence of resistant isolates, only a breakpoint for a susceptible category could be defined for agar dilution tests with amoxicillin-clavulanic acid (MIC of less than or equal to 2.0/1.0 micrograms/ml is tentatively proposed). For disk diffusion tests, a corresponding breakpoint zone diameter of greater than or equal to 28 mm is suggested. The validity of the breakpoints for penicillinase-negative penicillin-resistant strains awaits clinical data. Proposed quality control limits for testing amoxicillin-clavulanic acid by agar dilution and disk diffusion methods are a MIC of 0.25/0.125 to 1.0/0.5 micrograms/ml and zones of 30 to 40 mm in diameter for N. gonorrhoeae ATCC 49226, a MIC of 0.125/0.06 to 0.5/0.25 micrograms/ml for Staphylococcus aureus ATCC 29213, and zones of 30 to 38 mm for S. aureus ATCC 25923. Ticarcillin-clavulanate is currently tested against other species by preparing doubling dilutions of ticarcillin with a constant 2 micrograms of clavulanate per ml. By that method, all gonococci were susceptible to low concentrations. However, the amount of clavulanic acid that is included (2 micrograms/ml) will, by itself, inhibit many strains of N. gonorrhoeae. Consequently, the role of ticarcillin in the combination cannot be determined, and such tests are not recommended.

Amoxicillin↗
PubMed1984

Role of Bacteroides bivius beta-lactamase in beta-lactam susceptibility.

The susceptibility of 46 clinical isolates of Bacteroides bivius to amoxicillin, cefotaxime, cefoxitin, ceftizoxime, cephaloridine, cephalothin, moxalactam, penicillin G, amoxicillin plus clavulanic acid in a ratio of 2:1, carbenicillin, cefamandole, and ceftazidime was determined by an agar dilution technique. For the first eight agents susceptibility testing was also done with the addition of clavulanic acid (0.75 microgram/ml). For all agents, beta-lactamase-positive strains (35, using a nitrocefin slide test) were inhibited at higher concentrations than beta-lactamase-negative strains. Clavulanic acid reduced the susceptibility of the beta-lactamase-positive strains to the level of the beta-lactamase-negative strains to all agents. We prepared crude extracts of beta-lactamase from six strains. Activity against nitrocefin was directly related to their susceptibilities. The beta-lactamase had a mixed-substrate profile, hydrolyzing both penicillins and cephalosporins. Our results suggest a slow inactivation of cefoxitin, ceftizoxime, and moxalactam by the beta-lactamase. Clavulanic acid and cefoxitin inhibited the enzyme, whereas p-hydroxymercuribenzoate and cloxacillin did not. Thus, there was a clear relationship between beta-lactamase activity and susceptibility to beta-lactams, including cefoxitin and third-generation cephalosporins. The substrate and inhibition profiles of the B. bivius beta-lactamase were different from those of enzymes found in the "B. fragilis group."

Anti-Bacterial Agents↗
PubMed1983

The penetration of amoxycillin/clavulanic acid into peritoneal fluid.

Thirty patients undergoing elective abdominal surgery were given 1 g amoxycillin plus 0 . 2 g clavulanic acid as a single intravenous injection at varying times prior to the operation. Sterile assay discs were placed on the peritoneal surface in order to measure peritoneal fluid levels of each agent. Simultaneous serum levels were also measured. A total of 44 simultaneous serum and peritoneal samples were analysed. There was rapid penetration of both agents into peritoneal fluid. The mean peritoneal fluid levels of amoxycillin were 84% (S.D. 34) of the serum level and 66% 42) for clavulanic acid. The peritoneal levels of both agents declined in parallel to the serum levels (the half-lives all being about 1 h) and the ratio of amoxycillin: clavulanic acid in serum and peritoneal fluid was similar to that as administered.

Amoxicillin↗