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PubMed1983

Serum bactericidal activity and kinetics of azlocillin and moxalactam after single and combined administration.

Ten healthy volunteers received 5 g azlocillin and 2 g moxalactam iv in single and combined administration. Serum and urine concentrations were measured with bioassay and HPLC (high pressure liquid chromatography), and serum bactericidal activity (SBA) was determined at 1 h and 6 h against 6 different clinical isolates. The combined applications of both antibiotics resulted in minor differences in serum kinetics and urine recovery in comparison to single administration. SBAs of both antibiotics against Enterobacteriaceae were between 1:4 and 1:8.4 for azlocillin and between 1:3 and 1:8 for moxalactam after 1 h. The combination of both beta-lactam antibiotics did not result in a decrease in SBA against any strain; rather all Enterobacteriaceae showed a slight increase of SBA at 1 h. It can be concluded from these results that combination therapy with azlocillin and moxalactam has no adverse influence on the pharmacokinetics or the bactericidal activity of either substance.

Adult↗
PubMed1983

Pharmacokinetics and clinical aspects of azlocillin in paediatrics.

A pharmacokinetic and clinical study was done in 25 newborn infants suffering predominantly from pseudomonas infections treated with azlocillin. After a single iv dose of 50 mg azlocillin per kg bodyweight in biphasic concentration time course suggested an open two compartment body model. There was a rapid diffusion between the peripheral and the central compartment. The elimination half life calculated from the beta-slope was 2.5-2.6 h, and differences between premature neonates with more than 2000 g body weight and mature neonates were absent. To maintain a median steady state concentration of 50-80 mg/l in the serum 100-200 mg azlocillin/kg body weight per day must be given. Using this dosage non-linear kinetics and an accumulation of the drug would not occur. Bacteriological and clinical results confirm that in neonatal reinfection, and bronchopulmonary and local infection caused by pseudomonas strains, azlocillin has favourable properties.

Azlocillin↗
PubMed1983

The use of azlocillin to treat serious infections.

Azlocillin, a semisynthetic ureidopenicillin that inhibits many Gram-negative and Gram-positive bacteria and many Pseudomonas aeruginosa resistant to carbenicillin, was used to treat 23 episodes of infection in 20 patients. The majority of the patients had severe underlying diseases, including marked reduction in renal function in a number of the patients. Infection sites were lung, urinary tract, skin and primary bacteraemia. Seven patients had bacteraemia. Clinical cure or improvement was achieved in 87% of infections, all patients with bacteraemia due to Pseudomonas spp., Escherichia coli, Listeria spp. and Streptococcus faecalis were cured. Cure was achieved with azlocillin against carbenicillin-resistant Ps. aeruginosa infections. Serum and urine levels were easily maintained in excess of the accepted minimal inhibitory concentrations of the susceptible organism (less than or equal to 64 mg/l). Adverse effects were minor. Azlocillin was a safe, well-tolerated and effective agent to treat suspected or proven infections due to Ps. aeruginosa and other susceptible bacteria.

Adolescent↗
PubMed1983

A comparison of azlocillin and gentamicin in the treatment of serious infections caused by Pseudomonas aeruginosa.

A randomized controlled clinical trial to compare the efficacy and safety of azlocillin and gentamicin was conducted in 42 patients with serious infections, primarily of the skin or skin structure and lower respiratory tract. Pseudomonas aeruginosa was isolated from each of the 25 infection sites in the azlocillin group and 18 in the gentamicin group; most of the sites were also infected by other pathogens. After a mean of 13 days of treatment with azlocillin at 18 g/day, a good clinical response was attained in 96% of the cases, and nearly 90% of the causative organisms were eradicated. In the gentamicin group, administration of 180 mg/day for a mean of 11 days provided a good clinical response in 95% of the cases, and eradication of 92% of the causative pathogens.

Adult↗
PubMed1983

Comparison of azlocillin and ticarcillin in the treatment of urinary tract infection.

This prospective, controlled, randomized double blind study compared the safety and effectiveness of intravenous azlocillin at a dosage of 6 g/day in three divided doses with that of intravenous ticarcillin at 8 g/day in four divided doses for the treatment of urinary tract infections in 35 patients. The clinical and bacteriological responses among the 26 courses evaluable for drug effectiveness (13 in each group) appeared to be somewhat more favourable in the azlocillin treatment group (92.3%) than the ticarcillin group (69.2%). However, statistically, both treatment groups did not differ in a significant manner in regard to effectiveness or adverse reactions. Of the patients who were followed for relapses for three-four weeks after treatment, 66.7% of the azlocillin group and 45.5% of the ticarcillin group remained free of the original infecting organism. Local and systemic tolerance for both drugs was excellent.

Aged↗
PubMed1983

Randomized, double-blind evaluation of azlocillin for the treatment of pulmonary exacerbations of cystic fibrosis.

Patients with cystic fibrosis hospitalized because of deterioration in their pulmonary disease were randomly assigned to receive ten days of intravenous antibiotic therapy with either ticarcillin plus tobramycin (previously the standard regimen at our hospital), azlocillin plus tobramycin or azlocillin plus placebo. Pulmonary function and microbiological responses were similar in the three treatment groups, although patients receiving azlocillin and placebo tended to have a smaller reduction in the concentration of bacteria in the sputum and a greater rate of acquisition of antibiotic-resistant organisms. Overall, in-hospital treatment was associated with a significant improvement in Shwachman score, pulmonary function tests, and PO2. Improvement was noted by day 5 of therapy, continued through day 10, and was partially maintained at follow-up clinic visit one month after discharge. There was also a statistically significant reduction in sputum bacterial concentration, but patients cultured at the conclusion of antibiotic therapy still had a mean of 10(7) cfu/ml in sputum. Pseudomonas aeruginosa, the principal pathogen recovered from sputum cultures in this study, was transiently suppressed to sub-detectable levels in only one patient. There was no correlation between microbiological response and change in any parameter of pulmonary function. By follow-up clinic visit, sputum bacteria had returned to pre-treatment levels, and antibiotic-resistant organisms persisted in all patients from whom they had been recovered during hospitalization.

Adolescent↗
PubMed1983

Comparative efficacy and tolerance study of azlocillin and carbenicillin in patients with cystic fibrosis: a double blind study.

Azlocillin, a new acylureidopenicillin, has been compared to carbenicillin in a controlled, double-blind study for acute exacerbations of pulmonary infections in 29 patients with cystic fibrosis. Twenty-six patients were valid for final analysis of their therapeutic results; 12 treated with azlocillin (group I) at mean dosage of 252 mg/kg/day for a mean duration of 13.2 days of treatment, and 14 treated with carbenicillin (group II) at mean dosage of 505 mg/kg/day for a median duration of 12.6 days. Except for one patient of group I who had Staphylococcus aureus in sputum culture, the remaining patients all had Pseudomonas aeruginosa of mucoid colonial morphology with or without the same organism of rough variety in their sputum culture. Therapeutic efficacy was evaluated according to our scoring system of ten clinical factors, five radiological and five pulmonary function factors with 5 points each and 100 points total if perfect. The percentage of patients who improved by 20% or greater in clinical scores was found in 91.7% of patients in group I and 64.3% of patients in group II, which was statistically significantly different. The percentage of patients who improved by 20% or greater in total scores was found in 80% of group I and 45.5% of group II patients, which was less significant than the evaluation of clinical scores alone. Azlocillin was well tolerated and safe in the dosage employed. Its optimal dosage for patients with cystic fibrosis should be established.

Adolescent↗
PubMed1983

International clinical experience with azlocillin.

Clinical studies with azlocillin were conducted in North America and Europe to assess its efficacy and to monitor its safety. The results of studies from these two areas are compared retrospectively. In North America 631 multiple-dose courses were monitored, while 887 were given in Europe. The most frequently administered daily dose was 18 g in North America and 15 g in Europe. In 71% of the courses a Pseudomonas species was the causative infecting organism in the former area and 51% in the latter. Over 60% of the patients were seriously ill, and about a third were over 60 years of age. A satisfactory bacteriological response, as defined by the eradication or a marked reduction of the organism causing infection was obtained in 74% of patients in North America and in 75% in Europe. 89% of the patients in America responded clinically compared to 92% in Europe. Ps. aeruginosa was eradicated in over 70% of instances. Azlocillin, like other penicillins, possesses a low potential for toxicity. Hypersensitivity reactions and gastrointestinal effects were the most common adverse experiences. No serious problems were encountered with impairment of renal or hepatic function, or blood coagulation. Azlocillin was effective for treating serious infections caused primarily by Ps. aeruginosa.

Adolescent↗
PubMed1983

The tolerance and safety of azlocillin.

The safety of azlocillin was evaluated in 631 patients treated for urinary tract or systemic infections in U.S.A. clinical trials. The mean azlocillin dose was 260 mg/kg/day and the mean duration of treatment was 11.1 days. Twenty patients (3.2%) experienced adverse local reactions and 92 patients (14.6%) experienced adverse systemic reactions. In thirty-one instances (4.9%) they led to premature termination of therapy, but only 14 of 135 reactions were classified as severe. All adverse reactions were reversible if adequate follow-up was done. Hypersensitivity reactions, manifest by rash, fever or eosinophilia occurred in 4.4%, 0.3% and 1.1% respectively. Hypokalaemia was noted in only three instances (0.5%). Hepatotoxicity occurred in 1.7%, diarrhoea in 1.9% and leukopenia in 0.3%. Transient chest discomfort was seen on rapid infusion on three occasions. Overall, azlocillin appeared well tolerated, and had no evident unique toxicity.

Adolescent↗
PubMed1983

Azlocillin kinetics during extracorporeal haemodialysis and peritoneal dialysis.

The kinetic disposition of azlocillin in patients with end stage renal failure was evaluated in six individuals maintained on chronic extracorporeal haemodialysis and in six individuals on peritoneal dialysis. In the absence of renal function the plasma half-life of azlocillin was extended from the normal value of approximately 60 min to 235 +/- 30 min. During peritoneal dialysis the plasma half-life was reduced to 148 +/- 15 min and during extracorporeal haemodialysis it was further reduced to 112 +/- 11 min. Azlocillin was readily dialysed during haemodialysis but its removal rate during peritoneal dialysis was substantially less.

Adult↗
PubMed1986

Ciprofloxacin, azlocillin, ceftizoxime and amikacin alone and in combination against gram-negative bacilli in an infected chamber model.

Ciprofloxacin, azlocillin, ceftizoxime, and amikacin were studied alone and in combination against six Enterobacteriaceae and six strains of Pseudomonas aeruginosa in an infected chamber model in rabbits simulating a closed space infection. In-vivo results were compared with in-vitro tests of inhibition, killing and synergy. Ciprofloxacin was the most effective single agent, with efficacy against five of the six Enterobacteriaceae when used in low doses, and two of the six pseudomonads when used in high doses. The development of in-vitro resistance to ciprofloxacin was observed during therapy in strains which failed to be eradicated. Ciprofloxacin and azlocillin together was the most effective regimen, with efficacy against eleven of the twelve strains. Synergy, as determined by chequerboard testing, did not correlate with in-vivo outcome. Unlike mezlocillin, azlocillin, ceftizoxime or amikacin, MIC testing of ciprofloxacin was predictive of in-vivo success.

Amikacin↗
PubMed1999

Ability of azlocillin and tobramycin in combination to delay or prevent resistance development in Pseudomonas aeruginosa.

The ability of combinations of azlocillin and tobramycin to prevent or delay resistance development in eight Pseudomonas aeruginosa isolates from cystic fibrosis (CF) patients was studied using chequerboard titration and in-vitro serial subculture. No isolate had developed resistance to tobramycin after 12 treatments with the antibiotic combination. Azlocillin resistance had not developed in four isolates after 16 exposures, and was delayed in the other four isolates for at least eight exposures. Beta-lactamase production was responsible for azlocillin resistance in two isolates and occurred to a lesser extent in a third.

Anti-Bacterial Agents↗
PubMed1982

Quality control and interpretive criteria for the azlocillin disk diffusion susceptibility test.

The standardized disk diffusion test was performed with 75-micrograms azlocillin disks to determine individual test, accuracy, and precision control values with Escherichia coli ATCC 25922, Pseudomonas aeruginosa ATCC 27853, and Staphylococcus aureus ATCC 25923. In addition, regression lines for correlating inhibitory zone diameters with the 75-micrograms azlocillin disk and azlocillin minimal inhibitory concentrations were calculated for gram-negative clinical isolates (including Enterobacteriaceae, P. Aeruginosa, other nonfermenters, and Aeromonas hydrophila). Criteria for distinguishing susceptible isolates from resistant isolates, based on an error-rate bound classification scheme, are proposed.

Azlocillin↗
PubMed1982

Effects of azlocillin in combination with clavulanic acid, sulbactam, and N-formimidoyl thienamycin against beta-lactamase-producing, carbenicillin-resistant Pseudomonas aeruginosa.

We investigated the effects of the combination of azlocillin with the beta-lactamase inhibitors clavulanic acid and sulbactam and with N-formimidoyl thienamycin against strains of Pseudomonas aeruginosa with R-factor-mediated carbenicillin resistance. The 10 strains tested (1 R-, 9 R+) were isogenic, except for the presence of individual plasmids determining each of nine plasmid-mediated beta-lactamases found in P. aeruginosa. We utilized a checkerboard technique for testing antibiotic combinations. Low concentrations of clavulanic acid produced synergy with azlocillin against the strains producing the TEM-1, TEM-2, PSE-1, PSE-3, and PSE-4 beta-lactamases; for the strains producing the OXA-1, OXA-2, OXA-3, and PSE-2 beta-lactamases, such synergy was not found. With sulbactam, synergy was demonstrated in all strains except that producing PSE-2 beta-lactamase; for several strains, however, the concentration of sulbactam required to produce synergy was substantially higher than that for clavulanic acid. N-Formimidoyl thienamycin was highly active as a single agent against all of the strains, regardless of beta-lactamase production. The combination of N-formimidoyl thienamycin and azlocillin produced synergy against only two of the strains tested.

Azlocillin↗
PubMed1983

Effect of azlocillin on uric acid levels in serum.

Uric acid levels in serum were observed to fall precipitously in a group of 20 hospitalized asthmatic patients receiving azlocillin, bronchodilators, and steroids. None of the 20 hospitalized controls receiving the antiasthma therapy without azlocillin showed any decline in their uric acid levels. The levels for the azlocillin-treated group fell from a mean of 6.4 mg/dl to mean of 2.3 mg/dl, whereas those for the control group initially were 7.0 mg/dl and fell only to a mean of 6.5 mg/dl.

Adolescent↗
PubMed1983

Excretion of azlocillin and mezlocillin by the normal pancreas and in acute pancreatitis in dogs and rats.

Dogs and rats were studied to evaluate the excretion of two new acyl-ureidopenicillins, azlocillin and mezlocillin, in the pancreatic fluid. After intravenous administration of 55 mg X kg-1 of either drug, an extremely low concentration (less than 3.0 micrograms X ml-1) of both antibiotics was measured in pancreatic juice of conscious dogs. In rats, both azlocillin and mezlocillin were excreted by the pancreas in bactericidal concentrations (greater than 10 micrograms X ml-1) during the first 15 min following their injection. In anesthetized dogs and rats in which acute pancreatitis was induced by injection of sodium taurocholate into the main pancreatic duct, the tissue concentration of mezlocillin (55 mg X kg-1 i.v.) was significantly higher than in the pancreatic tissue of control animals. In both instances, bactericidal concentrations of mezlocillin were measured in the pancreatic tissue. During the first 30 min following its injection, the concentration of mezlocillin was about five times higher in inflammed pancreatic tissue than in the normal pancreas (dogs: 44 +/- 14 vs. 5 +/- 3 micrograms X g-1 tissue; rats: 67 +/- 10 vs. 13 +/- 2 micrograms X g-1). These data indicate that (1) azlocillin and mezlocillin are excreted in bactericidal concentrations by the normal pancreas only in rats but not in dogs, and (2) in both species, bactericidal concentrations of mezlocillin can be observed in the normal pancreatic tissue and in acute pancreatitis; its concentration being significantly higher in acute pancreatitis than in controls.

Acute Disease↗
PubMed1980

Pharmacokinetics of azlocillin in neonates.

The pharmacokinetics of the acylureido-penicillin, azlocillin, were studied after intravenous or intramuscular injections in 53 premature and full-term infants with infections. Effective concentrations wer" achieved in premature babies after doses of 50 mg/kg every 12 h and in full-term infants with 100 mg/kg every 12 h. No untoward effects of azlocillin were observed. On the basis of these studies, a dosage schedule for azlocillin has been established.

Azlocillin↗
PubMed1982

Agar (disk) diffusion test susceptibility of clinical isolates of Pseudomonas aeruginosa to azlocillin, cefotaxime, cefsulodin, lamoxactam, mezlocillin, and piperacillin.

The standardized Bauer-Kirby agar diffusion test served to examine 100 clinical isolates of Pseudomonas aeruginosa against various recently introduced broad-spectrum penicillins and cephalosporins. Neither cefotaxime nor lamoxactam displayed significant activity against this microorganism. Azlocillin, cefsulodin, and piperacillin were significantly more effective (p less than 0.0001) than mezlocillin against the majority of isolates. When compared individually, azlocillin and piperacillin displayed comparable in vitro activity; the same was true for cefsulodin compared with piperacillin. On the other hand, cefsulodin was somewhat more active than azlocillin (p less than 0.05, greater than 0.01) against P. aeruginosa. These data should enable diagnostic laboratories to curtail the number of antimicrobial drugs routinely utilized to examine clinical isolates of P. aeruginosa for antibiotic susceptibility, i.e., piperacillin exclusively.

Azlocillin↗