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PubMed1991

[Pharmacokinetic monitoring of aminoglycoside therapy: an optimal method of administration of individualized doses of gentamicin and sisomicin].

One of the most promising approaches to design the optimal schedule for TDM provides a single determination of a drug content in the blood specimen being collected at the "ideal" sampling time equaled to the inverse value of the elimination rate constant. Three versions of the one-point method when the specimen was collected at the "ideal" time point (3 h after a single i.m. drug administration), as well as at the times of "maximum" (1 h after injection) and "minimum" (6 h after injection) concentrations were compared by the retrospective analysis of the routine TDM data obtained with HPLC-techniques in 47 patients treated with gentamicin or sisomicin. As optimal individualized doses were considered ones calculated on the base of three subsequent determinations of the aminoglycoside concentrations, i.e. 1, 3 and 6 h after injection, and the estimation of individual clearance values (Cli). The optimal doses (DCl) were calculated according to equation DCl = Dp.Cli/Clp, where Dp and Clp are population values of the dose (1 mg/kg) and Cl 72.4 ml/(h.kg), respectively. The approximate values of the individual doses (D) were calculated according to equation D = Dp.Cp/Ci, where Ci is the individual drug serum concentration 1, 3 or 6 h after administration and Cp is the corresponded population value (4.8, 1.9 and 0.8 mg/l, respectively).(ABSTRACT TRUNCATED AT 250 WORDS)

Biological Availability↗
PubMedDate not supplied

[Clinical and bacteriological evaluation of sisomicin in sixteen cases of severe bronchopulmonary infection (author's transl)].

Sisomicin, an aminoglycoside antibiotic, was used as sole bactericidal therapy in sixteen cases of severe bronchopulmonary infection for an average of 11,5 days (range 7 to 14) with a dose of 3,5 mg/kg per day in three intramuscular injections. Fifteen of these hospitalized patients presented with chronic airway obstruction which resulted in lowered O2 saturation (SaO2 congruent to 86,1%, range 74 to 93) and, in twelve patients, hypercapnia (PaCO2 = 55,7 torr, range 33--73). Two of these patients were under continuous assisted ventilation. Two patients had a lower lobe infiltrate and a lung abscess respectively. Proteus (n = 3), Pseudomonas (n = 9), K. pneumoniae (n = 2), E. Coli (n = 1), Enterobacter (n = 1), S. aureus (n = 1) and D. pneumoniae (n = 1) were the dominant organisms in the bronchial secretions isolated by Mulder's method; P. aeruginosa was associated with K. pneumoniae, P. rettgeri and E. coli respectively in three cases. In thirteen cases, either a clinical cure (n = 2) or a definite improvement was observed (sputum volume and purulence, auscultatory signs, temperature). However, among these patients were three cases of superinfection/colonization and two cases of persistent organisms. In addition, in two of the three cases showing no improvement colonization occured. The favorable results of this study appear to be due to vigorous antibiotic therapy combined with intensive adjunct therapy. No adverse local or systemic reactions clearly attributable to the drug were observed.

Adult↗
PubMed1989

Antimicrobial activity of dactimicin in vitro compared with that of dibekacin, netilmicin, sisomicin and micronomicin.

Antimicrobial activity of dactimicin, a pseudo-disaccharide aminoglycoside antibiotic, was compared with those of dibekacin, netilmicin, sisomicin and micronomicin using clinical isolates of four Gram-positive and sixteen Gram-negative bacteria. Dactimicin was more active than the reference amino-glycosides against Serratia marcescens, especially gentamicin-resistant Serratia sp., Proteus vulgaris, P. rettgeri and Klebsiella oxytoca, but less active against Pseudomonas aeruginosa and P. mirabilis. Dactimicin was equally active as the references excepting netilmicin against Gram-positive bacteria and some Gram-negative bacteria including Escherichia coli, K. pneumoniae, Morganella morganii, Haemophilus influenzae, Citrobacter freundii, Enterobacter aerogens, E. cloacae, Acinetobacter calcoaceticus and Campylobacter jejunii. Dactimicin was active against resistant strains possessing various aminoglycoside-modifying enzymes including AAC(3)-1, by which dactimicin was acetylated.

Aminoglycosides↗
PubMed1985

Enzymuria in aminoglycoside-induced kidney damage. Comparative study of gentamicin, amikacin, sisomicin and netilmicin.

Forty-one patients with urinary tract infections were randomly assigned to receive for six days gentamicin, amikacin, sisomicin or netilmicin. The dose for each patient was calculated according to creatinine clearance and lean body mass in order to avoid overdosages. Urinary enzymes (alpha-glucosidase, gamma-glutamyltranspeptidase and muramidase), serum creatinine and creatinine clearance, proteinuria and urinary sediment were evaluated for nephrotoxicity. None of the patients developed nephrotoxicity, but urinary enzymes rose significantly in all. The statistical analysis of enzymuria during the treatment permitted the definition of a rank order of the nephrotoxic potential of the aminoglycosides studied.

Adolescent↗
PubMed1985

[Inhibitor of aminoglycoside phosphotransferases from Micromonospora sp.--a producer of sisomicin].

A substance inhibiting the activity of aminoglycoside-3-'-phosphotransferases of both the actinomycetous and the bacterial origin was detected in the filtrates of the culture fluid and mycelium of Micromonospora sp. producing sisomicin. The activity of the substance against the aminoglycoside inactivating enzymes of different types was studied. It was shown that the quantity of the inhibitor in the culture fluid of Micromonospora sp. correlated with intensity of sisomocin production. Under conditions not providing production of the antibiotic the inhibitory activity was lacking. The inhibitor was purified by ion exchange chromatography on Amberlite CG-50 and KM-cellulose (NH+4 form), gel filtration through Sefadex G-50 and preparative paper chromatography. Stability of the inhibitor at different pH values and different temperatures, its sensitivity to certain enzymes and behaviour in high voltage electrophoresis were studied. The results of ultrafiltration showed that the molecular weight of the inhibitor was relatively low: less than 1000 D.

Chromatography, Gel↗
PubMed1987

[Dependence of the antimicrobial effect on the antibiotic concentration in modelling pharmacokinetic profiles in vitro: a comparison of 2 regimens for the single intravenous administration of sisomicin].

Kinetics of sisomicin antimicrobial effect on E. coli was studied in an in vitro dynamic model. Pharmacokinetic profiles observed in blood of humans treated with different polar dosing schedules i. e. bolus administration and continuous infusion were simulated. The first set of the experiments included simulating the profiles observed at short-term maintenance (0.25-20 min) of relatively high antibiotic levels after bolus administration (Cmax = 0.125-10 micrograms/ml). The second set included simulating the profiles observed at long-term maintenance (1-15 hours) of relatively low antibiotic levels after infusion (Cmax = 0.125-1.75 micrograms/ml). Changes in the viable count in the dynamic model were estimated microcolorimetrically with BioActivity Monitor LKB 2277-202. The use of the recently developed parameters of antimicrobial effect intensity IE and duration TE provided determination of relationship between IE or TE and logarithm of the area under the concentration-time curve (lg AUC). Its own IE (or TE) vs lg AUC curve including 4 phases corresponded to every administration schedule i. e. bolus and infusion. The 1st and 3rd phases reflected weak changes in IE or TE at significant increasing of the AUC and the 2nd and 4th phases reflected a marked increase in IE or TE at insignificant changing of the AUC.(ABSTRACT TRUNCATED AT 250 WORDS)

Bacteriological Techniques↗
PubMed1987

[The antimicrobial activity of sisomicin against fresh clinical isolates].

Antimicrobial activities of sisomicin (SISO) against clinical isolates obtained in the second half of 1986 were investigated together with other 4 aminoglycosides (AGs) (gentamicin (GM), tobramycin (TOB), dibekacin (DKB), amikacin (AMK] and 2 cephems (cefotiam, cefotaxime), and were compared to the results reported in the period of late 1970's through early 1980's in Japan. 1. The incidence of SISO-resistant Staphylococcus aureus in the present study was 18% and is comparable to that of the other studies suggesting that the incidence of SISO resistant strains remains on the stable level. The incidence of SISO-resistant Pseudomonas aeruginosa showed the tendency of slight increase. 2. SISO-resistant strains of Enterobacter spp., Serratia marcescens and Citrobacter freundii did not show increase from the 1970/1980 levels. 3. Isolation rates of SISO-resistant indole(+) Proteus varied depending on strains. Isolation rates of SISO-resistant P. vulgaris and Morganella morganii were both as low as 4%, but that of Providencia rettgeri was as high as 60%. Refering to an American study reporting that the Genus Providencia including P. rettgeri showed high incidence of resistance to SISO as well as to GM or TOB, we pointed out that the antimicrobial activity of AGs against Genus Providencia should be evaluated separately from those of other indole(+) Proteus strains. 4. No SISO-resistant strains of Escherichia coli, Klebsiella pneumoniae or P. mirabilis were found. 5. SISO had good antimicrobial activity against most of the investigated species and SISO may still be regarded as one of the clinically useful AGs.

Bacterial Infections↗
PubMed1985

[In vitro study on the combined effect of mezlocillin and sisomicin on clinically pathogenic P. aeruginosa and E. coli].

Clinically pathogenic Pseudomonas aeruginosa and Escherichia coli were subjected to test in vitro combination effect of mezlocillin (MZPC) and sisomicin (SISO). The chequer board titration method, using brain heart infusion broth (BHIB, Difco), demonstrated the combination effect of MZPC and SISO on the both isolates. The bactericidal combination effects (MBCs) were clearly higher than the bacteriostatic combination effects (MICs). The bactericidal activities of combination with MZPC and SISO were tested on both P. aeruginosa and E. coli. The MZPC plus SISO of low concentrations showed the synergistic effects on both isolates.

Aged↗
PubMed1985

[Studies on the combination action of sisomicin, gentamicin and cefmenoxime, ceftizoxime, cefoperazone, cefotetan against Serratia marcescens and Pseudomonas aeruginosa].

The combined actions of sisomicin (SISO), gentamicin (GM) and cefmenoxime (CMX), ceftizoxime (CZX), cefoperazone (CPZ), cefotetan (CTT) against S. marcescens IFO-3735 and P. aeruginosa IFO-12689 were investigated. The results were summarized as follows. The synergistic effect of the combinations of SISO-CMX, SISO-CZX, SISO-CPZ, SISO-CTT, GM-CMX, GM-CZX, GM-CPZ and GM-CTT using the checker board dilution method on S. marcescens IFO-3735 and P. aeruginosa IFO-12689 were found. Especially the minimum FIC index value of combination of SISO-CTT and GM-CTT were rather low as 0.14 and 0.13, respectively and these synergistic effect was remarkably strong on S. marcescens IFO-3735. With the killing kinetic method, all combinations tested showed the synergistic effect in both bacteria.

Cefmenoxime↗
PubMed1985

[Clinical evaluation of sisomicin following intravenous drip infusion in respiratory tract infections].

The efficacy, safety and utility of sisomicin (SISO) followed intravenous infusion were evaluated in 35 cases with various respiratory infections. For many cases, SISO was given at a daily dosage of 100 mg, and a single dose was infused over about 1 hour. Clinical efficacy was evaluable in 28 cases including pneumonia (14 cases), bronchitis (8 cases), bronchiectasis (4 cases), pulmonary suppuration (1 case) and pulmonary abscess plus pyothorax (1 case). Almost cases had diagnosis of serious infection associated with various diseases. Clinical efficacy was evaluated as "excellent" in 2 cases, "good" in 15 cases, "fair" in 5 cases and "poor" in 6 cases, and efficacy rate in total case was 60.7%. Efficacy rate stratified by disease was calculated as 57.1% in pneumonia, 87.5% in bronchitis, 50.0% in bronchiectasis. Responses against pulmonary suppuration or pulmonary abscess with pyothorax were little or not. Bacteriologically, organisms isolated from sputum cleared in 7 out of 15 evaluable cases, thus the responses rate was 46.7%. Adverse reaction probably due to treatment observed in 2 cases with hepatic dysfunction. Blood levels of SISO at the end of infusion were ranged from 2.1 to 6.4 micrograms/ml, and no tendency of accumulation in blood after repeated infusion was showed.

Adolescent↗
PubMed1985

[Clinical evaluation of sisomicin in the treatment of complicated chronic urinary tract infections administered by intravenous infusion].

The pharmacokinetics of sisomicin (SISO) were determined in 3 patients including a case with mild renal dysfunction after intravenous infusion over 1 hour of a single dose of 50 mg. The peak serum concentration was ranged from 3.3 to 3.9 micrograms/ml with about 2 hours of half-life in patients with normal renal function and 4.5 hours in a patient with renal impaired function. This result suggested that dosage regimen should be adjusted in patients with renal impaired function. Clinical response was evaluated in treatment of 16 cases with chronic complicated UTI. SISO was administered intravenously over 1 or 1.5 hours at a daily dose of 100 or 150 mg. An overall excellent or moderate effect was seen in 68.8% of treatment cases with the evaluation by the UTI committee's criteria. As for clinical laboratory abnormal values, a slight but reversible increase of BUN was observed in 1 case. In conclusion, intravenous administration of SISO appeared to be effective and useful method for treatment of complicated UTI.

Adolescent↗
PubMed1983

[Studies on the combination action of sisomicin, gentamicin and piperacillin, cefmetazole against Pseudomonas aeruginosa and Serratia marcescens].

The combined actions of sisomicin (SISO), gentamicin (GM) and piperacillin (PIPC), cefmetazole (CMZ) against Pseudomonas aeruginosa E-2 and Serratia marcescens T-55 were studied. The following results were obtained. 1. The combinations of SISO-PIPC, SISO-CMZ, GM-PIPC and GM-CMZ using the checker board dilution method on P. aeruginosa E-2 and S. marcescens T-55 were found to have a synergistic effect and the minimum FIC index values were 0.38 in all combinations. 2. With the killing kinetic method, all combinations tested showed a synergistic effect. 3. A synergistic effect of the combinations of SISO-PIPC, SISO-CMZ, GM-PIPC and GM-CMZ was observed in the protective effect on experimental P. aeruginosa E-2 and S. marcescens T-55 infections in mice.

Animals↗
PubMed1983

[Combination action of sisomicin, dibekacin and cefotetan, cefotaxime, latamoxef, and cefsulodin against Escherichia coli, Serratia marcescens, and Pseudomonas aeruginosa].

The combined actions of sisomicin (SISO), dibekacin (DKB) and cefotetan (CTT), cefotaxime (CTX), latamoxef (LMOX), cefsulodin (CFS) against E coli KC-14, S. marcescens T-55 and P. aeruginosa E-2 were studied. The following results were obtained. The combination of SISO-CTT, SISO-CTX, SISO-LMOX, SISO-CFS, DKB-CTT, DKB-CTX, DKB-LMOX and DKB-CFS using the checker board dilution method on E. coli KC-14, S. marcescens T-55, P. aeruginosa E-2 were found to have a synergistic effect and the minimum FIC index values were 0.26--0.50 for SISO and 0.28--0.75 for DKB, respectively. With the killing kinetic method, all combinations tested showed a synergistic effect.

Anti-Bacterial Agents↗
PubMed1984

[Comparison of bacteriological and immunoenzyme methods for the serum determination of sisomicin. Pharmacokinetic application in the human].

A modification of the serum gentamicin immunoenzymatic method (Syva- Biom erieux kit) for sisomicin assay is proposed and compared to the bacteriological reference method. It shows a higher sensitivity (0.1 mg.l-1) with a shortened time of analysis (less than 1 hour) and a good reproducibility (range: 4.7% to 1.6% for concentrations between 0.5 mg.l-1 and 10 mg.l-1) but the concentrations are 15 p. cent lower as compared to the bacteriological method. A pharmacokinetic study, performed in five patients, enables us to demonstrate the praticability of this method for the adaptation of the dosage regimen in renal insufficiency.

Biological Assay↗
PubMed1984

[A pharmacokinetic investigation of sisomicin administered intramuscularly to children].

For the purpose of studying the pharmacokinetic profile of sisomicin (SISO) and the proper conditions for its administration to children, SISO was administered intramuscularly to 10 infants aged less than 1 year, 16 young children and 18 school children at doses of 1.0, 1.5 and 2.0 mg/kg and its serum and urine levels were determined by bioassay. The mean peak levels of SISO in serum appeared at 1/4 hour in the infants, irrespective of the dose; the mean peak levels were 2.27, 3.05 and 4.83 micrograms/ml after the 1.0, 1.5 and 2.0 mg/kg doses, respectively. In the young children, the mean peak levels appeared at 1/4 hour after the 1.0 mg/kg dose and at 1/2 hour after both the 1.5 mg/kg and 2.0 mg/kg doses. The mean peak levels were 2.82, 3.80 and 6.43 micrograms/ml, respectively. In the school children, the mean peak levels appeared at 1/2 hour after all the doses and were 4.34, 5.31 and 6.87 micrograms/ml, respectively. The mean peak levels were in the order of school children greater than young children greater than infants and were dose-dependent. In the infants, the mean urinary recovery was 43.7% for the 1.0 mg/kg dose and 31.2% for the 1.5 mg/kg dose; in the young children, 50.5, 35.9 and 65.6% for the 1.0, 1.5 and 2.0 mg/kg doses, respectively; and in the school children, 54.2, 50.2 and 56.7%. Using the observed serum levels, the pharmacokinetic parameters were calculated according to the one-compartment open model theory. (1) The mean elimination rate constants (K) were calculated at 0.60, 0.67 and 0.56 hr-1 for the infants, young children and school children, respectively. There were found no great differences among the above 3 age groups. The mean absorption rate constants (ka) were 18.5, 7.6 and 5.9 hr-1 and the apparent volumes of distribution per kg body weight, Vd (L/kg), 0.44, 0.26 and 0.22 L/kg, respectively. These 2 parameters were significantly greater in the infants than in the young children and school children. The maximum serum concentration (Cmax) and the time when the concentration reaches a maximum (Tmax) were substantially in agreement with the observed values. The half-lives (T1/2) were 1.16, 1.03 and 1.23 hours for infants, young children and school children, respectively, and did not differ significantly among the 3 groups. A serum level simulation curve constructed by plotting the mean values for K, ka and Vd did not reveal any substantial deviation from the observed values.(ABSTRACT TRUNCATED AT 400 WORDS)

Adolescent↗
PubMed1984

[Clinical experience of sisomicin sulfate by intravenous drip infusion for the treatment of infection complicated by malignant disease].

Sisomicin sulfate (SISO) was used for the treatment of infections complicated by malignant diseases in 10 cases; 4 cases with suspicious sepsis, 2 with pneumonia, 2 with urinary tract infection, 1 with renal abscess and 1 with cholecystitis. SISO was administered by intravenous drip infusion at daily dose from 100 to 150 mg for 6 to 12 days, concomitantly with other antibiotics. Clinical results were as follows; Good in 2, fair in 5, poor in 3 cases. As to the side effects of SISO, cylindruria with aggravation of microscopic hematuria and elevations of GOT, GPT and A1-P were observed each one of them, respectively. The relationship to the SISO, however, was not clear. In view of the above results, the drip infusion of SISO may be useful for the treatment of serious infection complicated by malignant diseases.

Adult↗
PubMed1983

[Comparative study and time changes in the resistance to gentamycin, tobramycin, sisomicin and amikacin of Gram-negative nosocomial bacterial strains isolated from the urinary tract, in relation to the annual use of the aminoglycosides tested].

Changes in susceptibility to four aminoglycosides (gentamycin, amikacin, tobramycin, sisomicin) of bacterial strains, isolated from in-patients with urinary tract infections at the "Santa Maria della Scala" Hospital of Siena, in the period January-April in three consecutive years (1980, 1981, 1982) were studied. The change susceptibility patterns were related to the use of the four antimicrobial drugs in the same periods. Emergence of antibiotic-resistant strains was seen after a wider use, whereas an increasing number of susceptible strains was observed after reducing use of antimicrobial drugs.

Amikacin↗