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PubMed1983

Netilmicin in human CSF after parenteral administration in patients with slightly and severely impaired blood CSF barrier.

After administration of 150 mg netilmicin samples of CSF and blood were obtained. In one group of nine patients with no or only slight impairment of the blood-CSF-barrier 29 samples of CSF were assayed for netilmicin concentrations. All samples, obtained after the first dose, failed to reveal detectable drug levels. Drug levels up to 0.18 mg/l were detected in samples of CSF of three patients after 3 to 22 doses. Only the lumbar CSF of one patient contained netilmicin concentrations higher than 1.0 mg/l. In comparison 19 samples of CSF, obtained from patients with meningitis after more than one dose of netilmicin, had levels of 0.27-5.0 mg/l. Three CSF samples from patients out of this group, collected after the first dose of netilmicin failed to show any drug activity.

Adult↗
PubMed1983

Netilmicin 150 mg every 12 hours in systemic infections.

Most (76%) of the 284 gentamicin-resistant Enterobacteriaceae isolated from patients hospitalised in Eindhoven or its vicinity proved to be sensitive to netilmicin. The sensitivity rate was 96% for amikacin and 97% for cefotaxime. Thirty-four patients with systemic infections and isolation of netilmicin-sensitive Enterobacteriaceae were treated with 150 mg netilmicin intravenously every 12 h. All except one patient reacted favourably. The patient who did not had a netilmicin-sensitive Escherichia coli septicaemia which recurred during treatment. The treatment was well tolerated. No ototoxicity or permanent nephrotoxicity were noted. Although the variation of serum levels was as great for netilmicin as has been reported for other aminoglycosides, they were in general within acceptable limits. In patients with reduced renal function peak levels above 16 mg/l were found five times more frequently than in patients with normal renal function. However, serum levels should also be monitored in patients with normal renal function.

Adolescent↗
PubMed1984

Netilmicin versus tobramycin in multi-centre studies.

In two prospective, randomized studies conducted in West Germany and involving 80 patients, netilmicin-ticarcillin was compared to tobramycin-ticarcillin in the treatment of serious systemic infections. Both regimens were essentially identical with respect to the clinical and bacteriological results they produced. The netilmicin group developed significantly less nephrotoxicity than the tobramycin group (0% versus 15%, P = 0.03). Ototoxicity also occurred less frequently in the netilmicin-treated patients (3% versus 10%, P = 0.4). In a large collaborative study involving 15 centres, 254 patients were enrolled. Clinical and bacteriological responses were excellent, with netilmicin and tobramycin equally effective, but the incidences of nephrotoxicity and ototoxicity were lower in patients treated with netilmicin than those receiving tobramycin.

Acute Kidney Injury↗
PubMed1984

Clinical experience with netilmicin.

From the results from over 150 clinical trials of netilmicin 3376 completed patient treatment courses have been reviewed to assess its efficacy and safety. Fourteen-hundred and twenty-three patients with 2273 infections caused by 2322 pathogens were evaluable for treatment efficacy. Favourable clinical responses were observed in 90% of the infections treated. Eighty-three per cent of the causative pathogens were eliminated from the infection sites. Netilmicin's safety was evaluated in all patients. Nephrotoxicity considered to be probably netilmicin-related occurred in 1.7% of the patients, and was possibly related in an additional 5.2%. Auditory toxicity was probably netilmicin-related in 1.6% and possibly related in 1.9% of the patients. Vestibular toxicity, probably or possibly drug-related, was observed in 0.62% of the patients. Extensive clinical trials with netilmicin have confirmed its excellent efficacy and safety profile.

Adult↗
PubMed1985

Evaluation of the resistance mechanisms of gentamicin-resistant Gram-negative bacilli and their susceptibility to tobramycin, netilmicin and amikacin.

Two hundred and fifty-three gentamicin-resistant Gram-negative bacilli, isolated from clinical material, were tested for sensitivity to tobramycin, netilmicin and amikacin. Amikacin was effective at 16 mg/l in 90% of cases, whereas there was no difference between netilmicin and tobramycin activity; 13.3% of strains were susceptible to 8 mg/l netilmicin, and 14.8% of strains to 4 mg/l tobramycin. The lack of difference in results between tobramycin and netilmicin is explained by local enzyme patterns. In our population, the AAC(3)II is predominant, and inactivates gentamicin, tobramycin and netilmicin, in contrast to the U.S.A. where ANT (2") seems to be the most common enzyme.

Amikacin↗
PubMed1989

Serum and sputum concentrations of netilmicin in combination with acylureidopenicillin and cephalosporins in clinical treatment of pulmonary exacerbations in cystic fibrosis.

The pharmacokinetics of netilmicin was studied in 14 patients with cystic fibrosis, aged 4-21 years (mean 16 years) during treatment of pulmonary exacerbations of pseudomonas infection. The patients received 24 courses of netilmicin (10 mg/kg/day) in combination with azlocillin (600 mg/kg/day), cefsulodin (200 mg/kg/day) or ceftazidime (150 mg/kg/day) for 9-14 days. Seven patients received two or three courses of different combinations. Serum and sputum concentrations of netilmicin were determined on day 2 and 6. Mean (+/- S.E.M.) trough serum values were 1.4 +/- 0.2 mg/l (same on day 2 and 6), peak values at 10 min 13.6 +/- 1.0 and 13.7 +/- 0.9 mg/l, and serum concentration at 1 h 7.5 +/- 0.6 and 7.5 +/- 0.5 mg/l, on days 2 and 6 respectively. The half-life was about 1 h. The pharmacokinetics did not differ on day 2 and 6. Sputum concentrations increased up to 2-3 h after administration, mean (+/- S.E.M.) peak values being 2.6 +/- 0.6 and 1.5 +/- 0.4 mg/l at day 2 and 6, respectively. The study shows that the pharmacokinetics of netilmicin was not influenced by different combinations with beta-lactams. All patients improved clinically, but pseudomonas growth was only reduced in nine courses. In one case transient resistance to netilmicin developed during the treatment. The clinical efficacy and tolerance were good and similar to those seen with combinations with other aminoglycosides.

Adolescent↗
PubMed1993

Once-daily versus thrice-daily dosing of netilmicin in combination with beta-lactam antibiotics as empirical therapy for febrile neutropenic patients.

In a prospective, randomized trial, netilmicin given once daily (OD) was compared in terms of efficacy and safety with the conventional 8-hourly dosing regimen (TD), both in combination with a broad spectrum beta-lactam, as initial empirical therapy for febrile neutropenic patients; the total daily dosage of netilmicin in each group was 6 mg/kg body weight. Twenty-nine of the 116 (25%) evaluable patients had microbiologically documented septicaemia, most of which were caused by Gram-positive bacteria, 41 (35%) had microbiologically documented infection without bacteraemia and 46 (40%) had possible infection. Highest peak serum concentrations of netilmicin in the OD group were significantly higher and trough serum concentrations significantly lower than in the TD group. A multivariate analysis revealed that neither the dosage regimen nor the peak serum concentration of netilmicin were determinants of a favourable outcome. The response rates of both groups to the initial treatment regimens were comparable and increased similarly following modification of the initial therapy. Response rates were particularly poor in patients with lower respiratory tract infection and in those who remained neutropenic throughout the course of treatment. The incidence of nephrotoxicity was low and did not differ significantly between groups. Once-daily dosing of netilmicin appears to be as effective and as safe as thrice-daily dosing, but is unlikely to further improve the response of febrile neutropenic patients to empirical therapy.

Anemia, Aplastic↗
PubMed1994

Once-daily gentamicin versus once-daily netilmicin in patients with serious infections--a randomized clinical trial.

Consecutive patients with serious infections were randomized between gentamicin 4 mg/kg once daily i.v. or netilmicin 5.5 mg/kg once daily i.v. (with dosage reduction in case of renal dysfunction). Exclusion criteria were neutropenia or severe renal failure. Median first serum trough and peak concentrations were 0.4/9.5 mg/L and 0.4/12.2 mg/L, for gentamicin and netilmicin respectively. A good clinical response was observed in 50/54 (92.6%) evaluable patients treated with gentamicin and in 48/52 (92.3%) netilmicin-treated patients. Nephrotoxicity (a rise of serum creatinine > or = 45 mumol/L) developed in 5/72 (6.9%) gentamicin patients treated > or = 48 hours and in 10/69 (14.5%) netilmicin patients (difference 7.5%, 95% CI -3.9% to +16.2%). High-tone audiometry was performed when possible; no significant differences were found between the regimens with regard to hearing loss or prodromal signs of ototoxicity. We conclude that with once-daily dosing no benefit of netilmicin over gentamicin regarding nephro- or ototoxicity could be demonstrated.

Aged↗
PubMed1985

Single-dose netilmicin therapy of complicated and uncomplicated lower urinary tract infections in children.

Thirty children (age 3 months to 10 years) with complicated and uncomplicated lower urinary tract infections were treated with a single intramuscular injection of netilmicin 4.5 mg/kg. The diagnosis of lower urinary tract infection was based on the absence of fever and the presence of normal values for erythrocyte sedimentation rate, C-reactive protein concentration and urinary excretion of N-acetyl-beta-D-glucosaminidase. Follow-up urine cultures in all children demonstrated a cure rate of 97% and reinfection and relapse rates each of 7% respectively. The subgroup (12 children) with radiological abnormalities of urinary tract showed a cure rate of 92%, and reinfection and relapse rates of 9% respectively. The rates of cure, reinfection and relapse in the complicated and uncomplicated urinary tract infections were not statistically different (p greater than 0.05). A pharmacokinetic study (performed in 5 children) demonstrated that netilmicin urinary concentrations were over the MIC's of the infecting organisms up to 96 hours after the single-dose injection. Netilmicin was well tolerated and no side effects appeared during treatment. Single-dose netilmicin therapy is an effective and safe regimen for complicated and uncomplicated urinary tract infections in children. The response to single-dose netilmicin therapy seems to be related to its prolonged urinary elimination.

Bacterial Infections↗
PubMed1978

Penicillin-netilmicin synergism against Streptococcus faecalis.

The combination of penicillin plus netilmicin was synergistic in vitro against 28 strains of Streptococcus faecalis and compared favorably with penicillin in combination with gentamicin. Similarly, penicillin plus netilmicin was as effective as penicillin plus gentamicin in the therapy of 67 rabbits with enterococcal endocarditis produced with a streptomycin-susceptible (S) or a streptomycin-resistant (R) strain of S. faecalis. After 5 days of infection, control rabbits had bacterial titers of 10(10) colony-forming units (CFU)/g of vegetation. Those treated with penicillin plus netilmicin had mean titers of 10(5.2) and 10(5.1) CFU/g for S and R strains, respectively, and those treated with penicillin plus gentamicin had mean valve titers of 10(5.8) CFU/g for both strains. After 10 days of therapy, mean valve titers with penicillin plus netilmicin were 10(3.8) and 10(4.7) CFU/g, and with penicillin plus gentamicin they were 10(4.5) and 10(5.4) CFU/g for S and R strains, respectively. Thus, if netilmicin proves to be less toxic than other aminoglycoside antibiotics, it may have potential usefulness in the therapy of enterococcal endocarditis.

Animals↗
PubMed1978

Pharmacokinetics of netilmicin in patients with renal impairment and in patients on dialysis.

The pharmacokinetics of netilmicin were examined in 25 adult subjects, 7 normal subjects, and 18 patients with renal impairment. Five were dialysis patients who were studied on and off dialysis. Netilmicin, 2 mg/kg, was infused intravenously over 1 h. The peak serum concentration ranged from 9 to 11 mug/ml. The mean biological half-life of netilmicin for subjects with a creatinine clearance (Ccr) > 70 ml/min was 2.7 h, for those with Ccr > 25 < 70 ml/min it was 10 h, for those with Ccr > 4 < 25 ml/min it was 32 h, and for those who were anephric it was 42 h. Ccr was correlated positively with the elimination constant and the drug's serum clearance. It was negatively correlated with the drug's volume of distribution. The dialyzer clearance of netilmicin was positively correlated with plasma flow rate and was similar to values previously reported for gentamicin. Netilmicin behaves in a fashion similar to other aminoglycosides. Therapeutic guidelines are suggested.

Adult↗
PubMed1978

Comparison of netilmicin and amikacin in treatment of complicated urinary tract infections.

Netilmicin and amikacin, two recently developed aminoglycosides, were compared in a prospective, randomized study of 57 male patients with complicated urinary tract infections. Both drugs were administered intramuscularly every 12 h for 7 to 10 days, netilmicin at 2 mg/kg and amikacin at 7.5 mg/kg. The two groups were comparable as to infecting bacteria and underlying pathology of the urinary tract. No patients had indwelling catheters. All microorganisms isolated were sensitive to both antibiotics. A total of 69% of the patients treated with netilmicin and 57% of the patients treated with amikacin were cured of the infection, as defined by a negative culture at 7 days after discontinuation of treatment. No major side effects were recorded, and no significant changes were noted in parameters of renal function. Of the patients treated with amikacin, 21% experienced temporary local pain at the injection site; no such effect was noted in the netilmicin-treated group. Therefore, netilmicin appeared to be as effective and better tolerated than did amikacin in the treatment of complicated urinary tract infection.

Adult↗
PubMed1979

Influence of single or multiple doses of gentamicin and netilmicin on their cortical, medullary, and papillary distribution.

In this study, the comparative intrarenal distribution and accumulation of both gentamicin and netilmicin were investigated in normal rats. The animals received 1, 3, or 14 injections of 10 mg of gentamicin or netilmicin per kg. A total of 324 animals and 648 kidneys were analyzed. These animals were sacrificed at from 1 h to 25 days after the intraperitoneal injections. At each timed interval, the serum, urine, cortex, medulla, and papilla were analyzed for antimicrobial content. The peak serum values of gentamicin (8 to 12 mug/ml) and netilmicin (9 to 14 mug/ml) were close to those found in humans. There was a progressive increase in the cortical concentrations of both antibiotics from a low of 53 mug/g to a high of 719 mug/g when the animals were given increasing doses of the agents. At most timed intervals, the concentrations of gentamicin within the cortex were slightly lower than those of netilmicin. The accumulation of the drugs was also demonstrated in the medulla, where therapeutic levels could be detected for up to 25 days after the cessation of therapy. Even though gentamicin and netilmicin were transiently present in the papilla after 1 or 3 injections, both drugs could still be detected in the papilla on day 25 after 14 doses. The urinary concentration closely paralleled the papillary concentration. If applicable to humans, the persistence of high levels of both drugs within the medulla and papilla may have therapeutic implications.

Animals↗
PubMed1980

Prospective, randomized trial of netilmicin and amikacin, with emphasis on eighth-nerve toxicity.

The toxicity of netilmicin was compared with that of amikacin in a randomized, prospective trial in 90 adults with a variety of serious gram-negative infections. There was no instance of antibiotic-related nephrotoxicity in the group given amikacin and only one instance in the group given netilmicin. Cochlear toxicity, as measured by a change in audiogram, occurred in 4/14 (28.5%) of the amikacin recipients and 3/19 (15.8%) of the netilmicin recipients. Vestibular toxicity, as determined by a change in ice-water calorics, was noted in 3/16 (19%) of the amikacin-treated patients and 0/15 of the netilmicin-treated individuals. Despite the trend toward lesser ototoxicity with netilmicin, the differences between the drugs were not statistically significant. There was, however, a significant association between male sex and the development of ototoxicity. Although many patients could not be evaluated for efficacy, there did not appear to be any difference in the therapeutic activity of the two drugs.

Aged↗
PubMed1984

Gentamicin, netilmicin, dibekacin, and amikacin nephrotoxicity and its relationship to tubular reabsorption in rabbits.

The role of the tubular reabsorption of aminoglycosides in nephrotoxicity was considered. The tubular reabsorption rate, fractional reabsorption, and net balance, expressed as the excreted to infused aminoglycoside ratio, were concomitantly studied in male rabbits by continuous infusion of gentamicin, netilmicin, dibekacin, and amikacin. Aminoglycoside nephrotoxicity was evaluated by creatinine levels in serum and pathological renal damage after 14 days of a low- or high-dose regimen, comprising either eight, hourly intramuscular injections of gentamicin, netilmicin, or dibekacin (4 mg/kg) or amikacin (16 mg/kg); twelve, hourly intramuscular injections of gentamicin, netilmicin, or dibekacin (15 mg/kg) or amikacin (60 mg/kg); or injections of saline for the control group. Aminoglycosides exhibited three degrees of tubular reabsorption: gentamicin had the highest, netilmicin had the lowest, and dibekacin and amikacin had intermediate degrees of reabsorption. Nephrotoxicity associated with alteration in renal histology was observed with gentamicin and, to a lesser extent, with dibekacin in the high-dose regiment. No nephrotoxicity was noted with netilmicin or amikacin compared with the control group. Concentrations of the aminoglycosides in renal cortex and serum were not predictive of renal toxicity. Except for amikacin, which appeared to exhibit the lowest intrinsic renal toxicity, nephrotoxicity was correlated with the tubular reabsorption of each aminoglycoside. It was concluded that aminoglycoside renal toxicity can be determined by two major factors: importance of transport into tubular cells and intrinsic intracellular toxicity.

Amikacin↗
PubMed1993

Effects of diltiazem on netilmicin-induced nephrotoxicity in rabbits.

Aminoglycoside nephrotoxicity remains a common clinical problem and is the major cause of acute toxic renal failure in hospitalized patients. In recent studies, calcium channel blockers gave controversial results in the prevention of acute ischemic or toxic renal failure. The aims of the study were (i) to describe a rabbit model of mild renal failure (50% reduction in glomerular filtration rate with a mean value of 1.78 +/- 0.46 ml/kg/min) induced by netilmicin given intramuscularly at 20 mg/kg of body weight every 8 h for 5 days, (ii) to investigate the protective effect of diltiazem given at a therapeutic dose (1 mg/kg given intramuscularly every 8 h for 5 days), and (iii) to investigate the mechanisms of this protection through evaluation of function tests, optic histology, and glomerular morphometry. Animals treated with netilmicin and diltiazem exhibited an unchanged glomerular filtration rate compared with controls (3.39 +/- 0.58 versus 3.68 +/- 0.78 ml/kg/min, respectively). This protective effect was not associated with any change in systemic or renal hemodynamics (i.e., no change in renal plasma flow) or changes in the pharmacokinetics of netilmicin, as assessed by fractional excretion and cortical uptake. Netilmicin-induced tubular toxicity was unchanged by diltiazem. Our results suggest that (i) netilmicin exhibits a toxic effect at both the glomerular and the tubular levels, (ii) diltiazem, a calcium channel blocker, when given at low therapeutic doses, is able to prevent the aminoglycoside-induced renal failure through a potential glomerular mechanism. The precise mechanisms of the protection remain to be elucidated. These results deserve clinical evaluation in high-risk patients.

Aldosterone↗
PubMed1996

Once-versus thrice-daily netilmicin combined with amoxicillin, penicillin, or vancomycin against Enterococcus faecalis in a pharmacodynamic in vitro model.

Several in vitro and in vivo studies as well as clinical trials have demonstrated that once-daily aminoglycoside regimens are as effective as or more effective than multiple daily dosings. However, the most favorable aminoglycoside dosing regimen for treating enterococcal endocarditis remains controversial. The same total dose of netilmicin was administered as once-daily (24-micrograms/ml peaks) and thrice-daily (8 micrograms/ml) regimens in a pharmacodynamic in vitro model simulating exposure of Enterococcus faecalis to human serum kinetics. Netilmicin was administered in combination with continuous infusions of amoxicillin, vancomycin, or penicillin against a bacterial biofilm adhering to glass beads. No significant differences in bacterial killing were found after 24 or 48 h between the once- and thrice-daily regimens. Additional experiments considering animal kinetics (half-life of netilmicin, 20 min) instead of human kinetics (half-life, 2.5 h) in the pharmacodynamic model also revealed similar results. The addition of netilmicin synergistically increased the activity of vancomycin (P < 0.05). In contrast, amoxicillin alone was as effective as the combination with netilmicin. Thus, it could not be established in this model that once-daily dosing of aminoglycosides is contraindicated for treating infections caused by E. faecalis.

Amoxicillin↗
PubMedDate not supplied

Collagen shields delivery of netilmicin: a study of ocular pharmacokinetics.

Collagen shields have been used as therapeutic contact lenses to promote corneal epithelial healing and to deliver hydrosoluble drugs. In albino rabbits, we studied the ocular pharmacokinetics of netilmicin, an aminoglycoside antibiotic, released by a 24-hour collagen shield immersed for 10 min in commercially available eye solution of netilmicin, at the standard concentration of 3 mg/ml. The animals were sacrificed after 0.5, 1, 6 and 18 h. The antibiotic concentrations were measured by the microbiological method. The drug levels remained above the MIC for the usual pathogens for 18 h in the cornea and for 6 h in the aqueous humor. In the iris and ciliary body the peak concentration was reached 1 h after shield application, netilmicin concentration decreased thereafter rapidly. The lens and the vitreous did not appear to be permeated by the drug. In the conjunctiva, drug concentrations were low, showing a negligible lateral diffusion of netilmicin released by shields. In conclusion, our findings show, that if the collagen shields are used as delivery systems, a very concentrated drug solution is not required to obtain high and persistent levels of netilmicin in cornea.

Animals↗