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PubMedDate not supplied

Twice daily netilmicin therapy in paediatric patients with systemic infections.

This open investigation evaluated twice daily administration of netilmicin in infants and children with systemic infections. Thirty-four patients aged 2-41 months, were enrolled; 28 and 34 were evaluable for efficacy and safety, respectively. Netilmicin was administered intravenously or intramuscularly every 12 h at a dosage of 2.0-4.4 mg/kg (mean 3.5 mg/kg) for 5-15 days (mean 11 days). Throughout the trial, signs and symptoms of infection were evaluated in conjunction with laboratory data to determine patients' clinical response; specimens from appropriate sites were cultured to determine bacteriological response; and laboratory tests were performed to monitor haematopoietic, hepatic and renal functions. Peak and trough serum netilmicin levels were measured during treatment. Clinical responses included complete resolution in 26/28 (93%) patients, improvement in 1/28 (4%) and failure in 1/28 (4%). Bacteriological responses included elimination of 34/36 (94%) pathogens and persistence of 1/36 (3%); response was indeterminate for 1/36 (3%). Peak serum netilmicin levels of 5.1-14.1 micrograms/ml and trough serum netilmicin values of 0.1-1.5 micrograms/ml remained within acceptable ranges during treatment. No clinically significant changes in haematopoietic, hepatic and renal functions were evident during the trial. Untoward reactions were limited to redness and/or induration at the administration site in 4/34 (12%) patients.

Bacteria↗
PubMed1982

Prophylactic netilmicin in surgery.

Seventy-seven elective or emergency surgical patients were treated with a prophylactic course of netilmicin. Netilmicin (150 mg intramuscularly) was given 1 hour prior to operation and continued 12 hourly until the patient was free of risk of post-operative infection. There was no microbiological or clinical evidence of post-operative infection in general surgical or orthopaedic patients. Netilmicin seems to be less nephrotoxic than other aminoglycosides. Netilmicin serum levels were within expected values. Netilmicin was found to be an effective and well-tolerated antibiotic, and prophylactic treatment shortened the mean patient bed-stay and hence costs incurred.

Adult↗
PubMedDate not supplied

Ototoxicity of netilmicin.

Ototoxicity and efficacy of netilmicin was evaluated in 76 consecutive patients with moderate to severe infections with Gram-negative rods and Staphylococcus aureus. Netilmicin alone was efficacious in 47 patients and in another 23 patients cure or improvement was seen with netilmicin combined with another antibiotic, usually penicillin. Therapeutic failure was seen in 4 cases, 2 of which were regarded as netilmicin failures. Vestibular function and hearing acuity was thoroughly examined by electronystagmography and audiometry. In spite of the extensive examination of the audiovestibular function it was possible to detect only one probable case of ototoxicity related to netilmicin, a reversible vestibular dysfunction. The importance of pre-therapeutic audiovestibular examination is stressed.

Adolescent↗
PubMed1991

[Pharmacokinetics and tissue penetration of single-dose netilmicin used for antibiotic prophylaxis during colo-rectal surgery].

Pharmacokinetics and tissue penetration of netilmicin were studied after the use of a single dose (6 mg/kg) given for antibioprophylaxis in colo-rectal surgery. Thirteen patients, scheduled for elective surgery, were given 6 mg/kg IV netilmicin over 30 min, together with 1000 mg IV ornidazole. Netilmicin peak serum concentration (10 min after end of infusion) was 24.4 +/- 3.4 mg/l and trough level (24 h) was 0.9 +/- 0.5 mg/l. Plasma elimination half-life was 409 +/- 70 min, le volume apparent volume of distribution was 38 +/- 101 and total body clearance was 0.07 +/- 0.02 ml/min. Adequate netilmicin levels (5 greater than or equal to CMI 90 of involved pathogens Escherichia coli, Klebsiella pneumoniae, Staphylococcus aureus) were obtained in 100 per cent of patients in abdominal wall and epiploid fat, at time of opening, and in colonic wall at time of anastomosis. Adequate levels were obtained at time of closure in abdominal wall and epiploid fat in 92 to 100 per cent of patients. In situation of allergy to beta-lactam antibiotics, the use of netilmicin in combination with ornidazole may be recommended.

Aged↗
PubMedDate not supplied

Comparison of once-daily and thrice-daily netilmicin regimens in serious systemic infections: a multicenter study in six Asian countries.

Patients with serious systemic infections admitted to eight medical centers in six Asian countries were treated with 300 mg of netilmicin given once daily (group A: 92 patients) or 100 mg of netilmicin given three times daily (group B: 93 patients). Netilmicin was administered by intramuscular injection or slow intravenous infusion until clinical, laboratory, and bacteriologic measures were normalized and for not more than two additional days. A clinical cure was achieved in 88% of the patients from group A and in 68% from group B. The causative micro-organisms were eliminated or infection site healed in 90% of group A and in 88% of group B. The mean treatment duration was 6.9 days in group A and 8.8 days in group B. Two patients in each group developed symptoms of nephrotoxicity; the pretreatment serum creatinine levels in all four patients were in the high borderline range. No other serious side effects were found. It is concluded that netilmicin administered once daily is safe and more effective than netilmicin administered three times daily.

Adolescent↗
PubMed1989

Fluorescence polarization immunoassay of gentamicin or netilmicin in blood spotted on filter paper.

In this improved simple method for determination of aminoglycoside antibiotics in dried-blood spots on filter paper, gentamicin or netilmicin is recovered from the blood spot most effectively by incubation for 60 min in an ultrafiltration tube containing 500 microL of 0.5 mol/L Na2HPO4 buffer. The eluates from the paper are centrifuged, then transferred to an Abbott TDx cartridge for measurement of gentamicin or netilmicin by fluorescence polarization immunoassay. The dried sample on paper is stable for about eight days at ambient temperature. Intra-assay CVs for gentamicin and netilmicin are less than 8.5% and less than 6.1%, respectively. Analytical recovery of gentamicin and netilmicin from the paper exceeded 90%. This method permits simple blood collection and monitoring of the therapeutic concentration of gentamicin or netilmicin in serum, particularly that of newborn infants and small children.

Blood Stains↗
PubMed1987

[Treatment of febrile episodes in neutropenic children by ceftazidime combined with netilmicin. Results of a multicenter study apropos of 88 cases].

Infection is the most important cause of mortality in leucopenic patients. A broad spectrum antibiotic therapy is imperative in febrile and neutropenic patients. In a multicentric study we have used ceftazidime (100 mg/kg/d) and netilmicin (6 mg/kg/d) in 88 children (fever greater than or equal to 38.5 degrees C, neutropenia less than 500/mm3) treated for acute leukemias (59), non Hodgkin lymphomas (13) or solid tumors (16). Median age was 7 years (2 months-16 years). In patients who continued to remain febrile, vancomycin (40 mg/kg/d) was added after 48 hours. The effective treatment was continued until a neutrophil count greater than 1,000/mm3. The first combination (ceftazidime + netilmicin) was effective in 64 children (73%) and the second combination (ceftazidime + netilmicin + vancomycin) in 11 patients. Bacteria were isolated in 39 children: Escherichia coli: 9, Staphylococcus epidermidis: 9, Staphylococcus aureus: 8, Streptococcus: 6, Pseudomonas aeruginosa: 3, Streptococcus pneumoniae: 1, Haemophilus: 1, Klebsiella pneumoniae: 1, Proteus: 1, Serratia: 1, Flavobacterium: 1. In these 39 patients, 30 became apyretic with ceftazidime and netilmicin and 6 after vancomycin. All blood culture were negative after the first combination. The median duration of antibiotic therapy was 14 days (5-9 days: 28, 10-20 days: 43, greater than 20 days: 17). There were no death, no superinfection. Tolerance was good without kidney or liver or biological perturbation. We conclude that the combination ceftazidime and netilmicin is effective in neutropenic children.

Adolescent↗
PubMed1986

Netilmicin pharmacokinetics in uremic patients undergoing hemodialysis.

The pharmacokinetics of netilmicin after i.v. administration were studied in 10 adult hemodialyzed patients during and after a dialysis session. The mean interdialysis half-life was 49.6 h, whereas during dialysis this value was reduced to 5.02 h. The mean volume of distribution of netilmicin was about 20% of the total body weight. The dialyzer clearance of netilmicin, measured at 60 and 150 min after the beginning of the session, was about 50 ml/min; this means that 60-65% of the drug may be lost during the 4.5 h standard dialysis. The total body clearance of netilmicin was similar to the dialyzer clearance values, suggesting that the drug is eliminated almost entirely by hemodialysis and that its renal elimination in our patients is negligible. In conclusion, in uremic hemodialyzed patients netilmicin behaves like other aminoglycosides.

Half-Life↗
PubMed1979

[Netilmicin and tobramycin: comparative evaluation of pharmacokinetics, nephrotoxicity, and therapeutic efficacy in animal studies (author's transl)].

Pharmacokinetics, nephrotoxicity, and therapeutic efficacy of (2S-cis)-4-O-[3-amino-6-(aminomethyl)-3,4-dihydro-2H-pyran-2-yl]-2-deoxy-6-O-[3-deoxy-4-C-methyl-3-(methyl-amino)-beta-L-arabinopyranosyl]-N1-ethyl-D-streptamine sulfate (netilmicin) and tobramycin were investigated in rats. The excretion rates of tubular cells and of the urinary enzyme malic dehydrogenase served as parameter of nephrotoxicity. Both compounds were, similar to other aminoglycosides, tubulotoxic within the range of dosages used for human therapy. Netilmicin, however, produced less renal damage than did tobramycin in all dosages applied. Pharmacokinetic studies revealed lower renal concentrations of netilmicin after repetitive administration. Experimental chemotherapy of the chronic E. coli pyelonephritis in rats with both aminoglycosides resulted in a significant reduction of the renal bacterial counts. In spite of approximately identical serum concentration curves and in vitro activity, especially the low dosage of netilmicin led to more favourable therapeutic results than equal doses of tobramycin. These animal experiments suggest higher renal tolerance and efficacy of netilmicin.

Animals↗
PubMed1982

[Clinical trials of netilmicin against respiratory tract infection].

Netilmicin, a new semisynthetic aminoglycoside antibiotic recently developed by Shering Co., was injected to 5 patients with respiratory tract infection (2 cases of diffuse panbronchiolitis, 2 cases of bronchiectasis and 1 case of bronchial asthma with infection). A daily dose of netilmicin was 200 mg by intramuscular injection and duration of netilmicin therapy was for 7 to 14 days. Clinical response to netilmicin therapy of respiratory tract infection was good in 3 cases, fair in 1 case and poor in 1 case. No subjective and objective findings considered as the side effect was observed and laboratory examinations showed no abnormality. It may be concluded from the above clinical results that netilmicin may be effective for respiratory tract infections and further study may prove its efficacy.

Adult↗
PubMed1995

[In vitro antibacterial activity of piperacillin-tazobactam in combination with netilmicin or amikacin against Enterobacteriaceae resistant to amoxicillin].

The antibacterial in vitro activity of piperacillin and tazobactam (in a concentration ratio of 8/1) was studied in combination with netilmicin or amikacin by a microtiter checkerboard assay against 162 strains of Enterobacteriaceae. These strains were selected for their resistance pattern to beta-lactam antibiotics and their beta-lactamases were characterized by the mean of isoelectric focusing in comparison with reference strains. A comparison of the MICs of piperacillin, alone and in combination, assessed the efficacy of tazobactam as beta-lactamase inhibitor, particularly when a TEM-1 beta-lactamase was produced. When the strains were sensitive to the aminoglycosides (111 netilmicin-sensitive ones and 131 amikacin-sensitive ones), we observed 55% of synergistic effects and 45% of additions with the combinations piperacillin-tazobactam-netilmicin or amikacin. A synergistic effect was usually encountered with P. mirabilis, P. vulgaris, M. morganii and with the strains of E. coli, E. cloacae and S. marcescens which produced a cephalosporinase only. Among the 51 strains that were intermediate or resistant to netilmicin, 8 ones were inhibited by piperacillin-tazobactam-netilmicin at therapeutic levels (3 synergisms, 5 additions). Among the 31 strains that were intermediate or resistant to amikacin, 24 ones (18 synergisms, 6 additions) were inhibited by piperacillin-tazobactam-amikacin at therapeutic concentrations. In most of the cases, the combination of piperacillin-tazobactam with an aminoglycoside enhanced the antibacterial activity of these agents by decreasing the concentrations necessary to inhibit the strains.

Amikacin↗
PubMedDate not supplied

Study on pharmacokinetics and nephrotoxicity of netilmicin in rabbits using a new dosage regimen.

The potential nephrotoxicity and pharmacokinetic parameters of netilmicin were investigated in rabbits after single and multiple dosage regimens (7 mg/kg/12 h) allometrically equivalent to a once-daily regimen of 5 mg/kg/24 h in man. Netilmicin was determined in plasma and renal tissue by a high-performance liquid chromatography (HPLC) technique with fluorescence detection and precolumn derivatization. The renal toxicity was determined by electron microscopy. Statistical comparison between animals that received a single dose and those that received a multiple dosage regimen showed that the only parameter significantly different was the elimination constant K10. The histological study revealed a high interindividual variability in the nephrotoxicity induced by prolonged treatment with netilmicin: 50% of the animals experienced tubular necrosis and the remaining did not. Although plasma concentration time curves did not show significant differences between both groups of animals, the concentrations of netilmicin in renal cortex were higher in the group with tubular necrosis. In conclusion, even though netilmicin was administered in a dosage regimen equivalent to once-daily administration in man, it induced tubular necrosis which was probably related to the duration of treatment. The results also showed that there was no correlation between plasma concentrations of the drug and its potential nephrotoxicity.

Animals↗
PubMed1998

Postantibiotic effects of norfloxacin and netilmicin and their influence on the biological properties of Salmonella strains.

The postantibiotic effect (PAE) and the postantibiotic sub-MIC effect (PA SME) of norfloxacin and netilmicin on two clinical strains--Salmonella typhimurium and Salmonella enteritidis was investigated. After both PAE and PA SME of antibiotics were studied, we determined their effect on the induction of a prophage in the lysogenic S. typhimurium and on Congo red binding by both serovars, as an indicator of invasive ability in vitro. The PAE was induced by 2.MIC and 4.MIC of norfloxacin and netilmicin for 0.5 h. Norfloxacin induced a longer lasting PAE on both Salmonella serovars as compared to netilmicin. Supra-subinhibitory concentrations (PA SMEs) delayed regrowth of tested strains. The PA SMEs of norfloxacin as well as of netilmicin (except 2.MIC + 0.1.MIC concentration) did not allow regrowth of S. enteritidis. The prophage-inductive ability of norfloxacin was more expressive after PA SMEs than PAE. The PA SMEs of netilmicin caused loss of Congo red binding by S. typhimurium cells and decreased this binding by S. enteritidis cells.

Anti-Bacterial Agents↗
PubMed1978

The neuromuscular blocking activity of a new aminoglycoside antibiotic netilmicin sulphate (SCH 20569).

The neuromuscular blocking activity of netilmicin sulphate (Sch 20569), a new aminoglycoside antibiotic, was studied on the rat sciatic nerve-gastrocnemius muscle preparation. The i.v. administration of netilmicin caused a gradual fall, up to complete blockade, of the muscular contraction elicited by nerve stimulation. Conversely, the muscular response to direct stimulation was not affected. The response pattern was similar to that seen with known aminoglycoside antibiotics. The acute toxic effects (LD50 i.p. in mice) of netilmicin were antagonized by pretreatment with neostigmine; this latter partially prevented netilmicin-induced blockade, but was not able to reverse it. Calcium chloride was the only agent effective both to prevent and to reverse the neuromuscular blocking effects of netilmicin.

Animals↗
PubMed1976

Comparative activity of netilmicin, gentamicin, amikacin, and tobramycin against Pseudomonas aeruginosa and Enterobacteriaceae.

Netilmicin (Sch 20569), a semisynthetic aminoglycoside antibiotic, was compared with gentamicin, tobramycin, and amikacin against 242 clinical isolates of Pseudomonas and Enterobacteriaceae. The minimum inhibitory concentration (MIC) was determined in both solid and liquid media. Netilmicin exhibited typical aminoglycoside properties, such as little effect of inoculum size on MIC, relatively small gap between MIC and minimum bactericidal concentration, and potentiation of anti-Pseudomonas activity in the presence of carbenicillin. Netilmicin provided no advantage in antimicrobial activity over gentamicin for either Pseudomonas or Enterobacteriaceae. Nearly complete cross-resistance to netilmicin was encountered with isolates resistant to gentamicin in either solid or liquid media. Netilmicin was less active than gentamicin against isolates of Pseudomonas and Providencia. Major discrepancies between MIC values determined in agar as opposed to those determined in broth were encountered for most isolates of Pseudomonas but also, depending upon antibiotic tested, for between 15 and 40% of isolates of Enterobacteriaceae. This new aminoglycoside agent will be useful clinically only if it is shown to be significantly less toxic than presently available analogues.

Amikacin↗
PubMed1976

In vitro susceptibility of gentamicin-resistant Enterobacteriaceae and Pseudomonas aeruginosa to netilmicin and selected aminoglycoside antibiotics.

Netilmicin (Sch 20569), a semisynthetic aminoglycoside related to gentamicin C(1a), was evaluated in vitro in agar dilution testing against 224 different clinical isolates of gentamicin-resistant Enterobacteriaceae and Pseudomonas aeruginosa in parallel with amikacin, gentamicin, sisomicin, and tobramycin. Netilmicin showed a very high degree of activity against gentamicin-resistant organisms, but amikacin was more active in vitro, particularly against Providencia stuartii and P. aeruginosa. Sisomicin and tobramycin were consistently less active than either netilmicin or amikacin. Netilmicin was bactericidal in broth testing against P. aeruginosa. Netilmicin showed a greater difference between results with agar and broth dilution testing than did amikacin.

Aminoglycosides↗
PubMed1976

In vitro activity of gentamicin, amikacin and netilmicin alone and in combination with carbenicillin against Serratia marcescens.

The inhibitory and bactericidal effects of gentamicin, amikacin, netilmicin (Sch 20569), and carbenicillin were tested against 55 clinical isolates of Serratia marcescens that had been subtyped into 26 strains by biotyping and serotyping. Three major patterns of resistance to gentamicin, netilmicin, and carbenicillin were recognized among these isolates. (i) Most of the 27 isolates that were susceptible to gentamicin (minimal bactericidal concentration [MBC] </=6.25 mug/ml) were susceptible to carbenicillin (MBC </=125 mug/ml) and resistant to netilmicin (MBC >/=12.5 mug/ml). (ii) Most of the 11 isolates with moderate resistance to gentamicin (MBC of 12.5 to 25 mug/ml) were also susceptible to carbenicillin and resistant to netilmicin. (iii) The 17 isolates with high-level resistance to gentamicin (MBC >/= 50 mug/ml) were all highly resistant to carbenicillin (MBC >/=8,000 mug/ml) but susceptible to netilmicin (MBC </=6.25 mug/ml). The susceptibility to amikacin was unpredictable among these groups of isolates but, overall, 80% of the isolates were killed by 25 mug of amikacin/ml, which is within the range of peak serum concentrations used therapeutically. Clinically attainable subinhibitory concentrations of carbenicillin enhanced the activity of the three aminoglycosides against all isolates with MBCs of carbenicillin </=2,000 mug/ml. The 17 isolates with high-level resistance to carbenicillin and gentamicin, as well as the four isolates with high-level resistance to carbenicillin but not to gentamicin, were not susceptible to such enhancement of aminoglycoside activity by carbenicillin.

Amikacin↗
PubMed1977

Comparison of the nephrotoxicity of netilmicin and gentamicin in rats.

The nephrotoxicity of netilmicin relative to that of gentamicin was examined in Sprague-Dawley rats. Balance studies were performed on rats injected with netilmicin or gentamicin (50 mg/kg per day for 14 days, 100 mg/kg per day for 8 days, and 150 mg/kg per day for 8 days). Control rats were injected with saline. Both drugs caused a dose-related decrease in urine osmolality and increases in urine volume, water intake, and serum creatinine; however, the magnitude of these changes was significantly less in netilmicin- than in gentamicin-injected rats. Light microscopy of renal tissue revealed less proximal tubular cell necrosis in netilmicin- than in gentamicin-injected rats. There was no significant difference between the renal cortical concentrations of the two drugs. Both drugs stimulated uptake of p-aminohippurate in rat renal cortical slices to the same degree. The data indicate that netilmicin is less nephrotoxic than gentamicin in rats, that the difference in nephrotoxicity cannot be explained by a difference in drug concentration in the renal cortex, and that the ability of aminoglycosides to stimulate the organic acid transport system of proximal tubular cells does not correlate with their nephrotoxic potential.

Animals↗