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PubMed1998

Determination of netilmicin sulfate by liquid chromatography with pulsed electrochemical detection.

The determination of netilmicin sulfate by liquid chromatography using a column packed with poly (styrene-di-vinylbenzene) and pulsed electrochemical detection on a gold electrode is described. The mobile phase consisted of an aqueous solution containing 35 g 1-1 of sodium sulfate, 0.5 g 1-1 of sodium octanesulfonate, 10 ml 1-1 of tetrahydrofuran and 50 ml 1-1 of 0.2 M phosphate buffer (pH 3.0). The total analysis time was not more than 25 min. The effects of the different chromatographic parameters on this selection were also investigated. When a number of commercial samples of netilmicin sulfate was analyzed using this method, eight different components were separated, three of which were of unknown identities.

Chromatography, Liquid↗
PubMed1985

Clinical pharmacology of netilmicin in preterm and term newborn infants.

Sixty-four neonates, with gestational age ranging from 27 1/2 to 40 weeks, postnatal age from 1 to 15 days, and birth weight from 800 to 3400 gm, were given netilmicin 2.5 mg/kg intramuscularly two or three times per day according to postnatal age, for 5 to 14 days. Serum concentrations were measured before and 1 hour after a dose at least twice during treatment. The serum washout profile of the drug was observed in 22 neonates after discontinuation of therapy. Renal function was studied in 37 infants by measuring serum creatinine concentrations and in 27 by urinary excretion of N-acetyl-glucosaminidase during and up to 15 days after therapy. Behavioral and impedance audiometry, and in infants failing those, auditory brainstem evoked response tests, were performed between 6 and 12 months of age. In 23.5% of the neonates, trough serum levels were greater than 3 micrograms/ml. The serum washout followed a multiexponential decay, accounting for distributional, rapid (initial), and slow (tissue) elimination phases. Linear regression analysis performed between each kinetic parameter and gestational age or birth weight showed that initial elimination half-life, steady-state volume of distribution, and total body clearance were significantly correlated with both variables. Netilmicin did not cause detectable renal or auditory damage.

Acetylglucosaminidase↗
PubMed1984

Determination of sisomicin, netilmicin, astromicin and micronomicin in serum by high-performance liquid chromatography.

A high-performance liquid chromatographic method for monitoring serum levels of the aminoglycoside antibiotics sisomicin, netilmicin, astromicin, and micronomicin, using an amino acid analysis system is described. The procedure involves sample preparation with a CM-Sephadex column, and quantitation using internal standards chosen from each of the other aminoglycosides. The aminoglycosides were separated by reversed-phase ion-pair chromatography on Zorbax C8 and ODS columns, and detected by the post-column derivatization technique. The calibration curves of serum concentration for sisomicin, netilmicin, astromicin, and micronomicin were linear over the ranges 0.32-22.8 micrograms/ml, 0.17-11.6 micrograms/ml, 0.1-6.3 micrograms/ml, and 1.0-30 micrograms/ml, respectively. The coefficients of variation were 2.5, 2.8, 3.1 and 1.9%, at the serum concentrations of 1.3, 1.45, 1.58 and 2.5 micrograms/ml, respectively (n = 6). Determination by the internal standard method using another aminoglycoside gives accurate and reproducible results. This method is applicable also to other aminoglycoside antibiotics.

Aminoglycosides↗
PubMed1978

[Treatment of urinary-tract infections with netilmicin (author's transl)].

Netilmicin, a half-synthetic aminoglycoside, was given to 22 patients with urinary-tract infections at a dose of 2 mg/kg body weight twice daily intramuscularly for 7--9 days. Pharmacokinetics (in ten patients), efficacy and tolerance to the drug were analysed. Mean serum peak concentrations on the first and last days of treatment, was 8.7 microgram/ml at 45 min after injection, 9.5 microgram/ml after 60 min. After 12 hours the level had fallen to 0.8 microgram/ml and 1.2 microgram/ml, respectively. Mean half-life was 3.08 hours for the first and 3.57 hours for the last day. The corresponding mean values for plasma clearance were 53.6 ml/min and 42.4 ml/min, respectively. Within 12 hours an average of 77.6% and 78.0%, respectively, of the netilmicin dose were eliminated in the urine. The causative organism was eliminated in 12 of 16 patients with chronic or reccurent and in all six with acute urinary infections. There were two re-infections and two failures. Superinfection did not occur. Local and general tolerance was good and there were no signs of renal or inner-ear toxicity.

Adult↗
PubMed1987

Serum netilmicin levels in premature AGA infants.

Safe use of aminoglycosides requires close monitoring of serum concentrations. Limited information coupled with marked changes in fluid compartments and renal function during the first week of life in premature neonates makes interpretation of peak and trough levels very difficult. This study was designed to measure serum netilmicin levels following a 2.5 mg/kg IV push infusion. Blood samples were taken on the 5th day of therapy 1 hour before and 1, 6, and 11 hours after a dose. Fifteen premature infants weighing 1000-1500 gm at birth and 20 others whose weight ranged from 1501-2750 gm comprised the study population. All premature infants were appropriate for gestational age (AGA) and of them, only two were severely asphyxiated. At the time of the study, 10 neonates were still on respirators. Serum and urine sodium and creatinine, BUN, and urinalysis were obtained in 28 of these infants. No evidence of renal dysfunction was found. All infants received 100 mg/kg IV ampicillin every 12 hours, but none were being treated with diuretics. Serum netilmicin levels were measured by an enzymatic immunoassay, peak and trough were calculated by extrapolating the first order decay curve. Peak levels ranged from 3.4 to 14 micrograms/ml (means 6.1 +/- 2.5 micrograms/ml SD) and 90% of them were above 4 micrograms/ml. Half of the small premature infants (1000-1500 gm birthweight) presented trough values above 3 micrograms/ml. Pharmacokinetic analysis of our data predicts that a 2.5 mg/kg loading dose followed by 2 mg/kg given every 12 hours will decrease by one-half the number of small prematures exceeding the considered "safe" trough level (greater than 3 micrograms/ml).

Asphyxia Neonatorum↗
PubMed1991

New epidemiological data on resistance to netilmicin and other aminoglycosides.

In previous investigations we considered the increasing resistance of Gram-negative organisms to aminoglycosides over time. We therefore performed further studies to evaluate eventual variations in the incidence of bacterial resistance to aminoglycosides over the last four years. We tested Gram-negative microorganisms recently isolated from pathological materials of various clinical origins with gentamicin, amikacin, tobramycin and netilmicin. Our data show evidence that there was no significant increasing resistance to aminoglycosides, and that netilmicin continues to be active as an anti-Gram-negative antibiotic.

Amikacin↗
PubMed1995

Treatment of streptococcal endocarditis with a single daily dose of ceftriaxone and netilmicin for 14 days: a prospective multicenter study.

A 2-week course of ceftriaxone (2 g) plus netilmicin (4 mg/kg), administered as one short daily iv infusion, was evaluated for the treatment of streptococcal endocarditis in an open multicenter study. Of the 52 patients, 31 were infected with viridans streptococci, 18 with Streptococcus bovis, two with Gemella morbillorum, and one with group C Streptococcus; 48 patients were assessable. Infection was cured in 42 cases, 35 treated medically and seven treated both medically and surgically. Five patients died without evidence of active infection, and one relapsed. The bacteriologic failure was due to a strain of G. morbillorum against which no synergy of ceftriaxone and netilmicin was evident in vitro. The serum creatinine level increased during treatment in four cases, all involving patients > 65 years old who had renal risk factors; in two of these cases, values did not return to baseline during follow-up. Of 40 patients assessed for auditory function, only one developed decreased perception of borderline significance. Other adverse reactions were mild. This regimen was efficacious, safe, and cost-effective for the treatment of streptococcal endocarditis. However, it must be used with caution for patients with preexisting renal impairment or concomitant exposure to other potentially nephrotoxic agents.

Adolescent↗
PubMed1996

Treatment of human brucellosis with netilmicin and doxycycline.

We conducted a prospective, noncomparative, multicenter study to assess the safety and efficacy of doxycycline and netilmicin in the treatment of human brucellosis. The study included 64 patients who had acute brucellosis without endocarditis or neurobrucellosis. The treatment schedule consisted of the administration of 100 mg of doxycycline (or 5 mg/[kg.d] if body weight < or = 40 kg) twice a day orally for 45 days, plus 300 mg of netilmicin (6 mg/[kg.d] if body weight < or = 50 kg) intramuscularly once daily for 7 days. Therapeutic failure was noted in 5 patients (7.7%; 95% confidence interval [CI], 2.5%-17.1%), of whom 2 had spondylitis, 1 had sacroiliitis, and 1 had a splenic abscess that required splenectomy. Relapse was noted in eight patients (12.5%; 95% CI, 5.6%-23.2%). When relapse was considered in combination with initial lack of efficacy, 13 patients (21.9%; 95% CI, 12.3%-33.9%) failed to respond to therapy. Fifteen patients (23%; 95% CI, 13.5%-35.2%) had adverse effects, and one patient (1.5%) had a treatment-limiting adverse effect. Combination therapy with netilmicin/doxycycline may be effective in treating acute brucellosis. However, prospective controlled trials must confirm these results.

Acute Disease↗
PubMed1989

Netilmicin in the treatment of gram-negative bacteremia: single daily versus multiple daily dosage.

Seventy patients with culture-proven bacteremia with gram-negative rods were randomly treated with either a single (S) dose daily or multiple (M) doses daily of netilmicin. All bacterial strains were susceptible to the antibiotic. No differences were found with respect to efficacy. Therapy for bacteremia failed in two M patients, but bacteria persisted in 17 (10 S, 7 M) at the primary infection site. In 12 there was an anatomic or physiologic factor contributing to this persistence. One S patient showed mild nephrotoxicity, but ototoxicity was not found in any of the 35 patients who underwent serial audiography. Mild reversible rises of transaminases were found in 5 of 35 S patients and in 3 of 34 M patients. Once-daily administration of netilmicin seems to be as effective and as safe as conventional multiple daily doses.

Adult↗
PubMed1983

In-vitro activity of cefotetan, other beta-lactams and netilmicin.

In-vitro activity of cefotetan was compared to that of other cephalosporins netilmicin. Cefotetan at very low concentrations inhibited Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and Serratia marcescens. Poor activity was seen for all beta-lactams against Enterobacter and Citrobacter spp. Activity of cefotetan against Staphylococcus aureus was comparable to that of ceftazidime and moxalactam. Netilmicin was the only agent equally active against all Gram-negative bacilli and Staph. aureus tested. Under conditions simulating serum levels cefotetan demonstrated rapid and long-acting bactericidal activity and bacteria exposed to these concentrations required up to 10.2 h to recover from the effect of the antibiotic. Six out of 15 strains did not recover fully.

Anti-Bacterial Agents↗
PubMed1983

Assay of netilmicin in serum by substrate labelled fluoroimmunoassay.

A substrate-labelled fluoroimmunoassay (SLFIA) for gentamicin was used to assay netilmicin by substituting serum calibrators containing netilmicin. The assay proved highly reproducible and the results obtained showed a good correlation with the results of EMIT and microbiological assays.

Biological Assay↗
PubMed1984

Inactivation of netilmicin and amikacin by intact or disrupted leucocytes.

The bio-inactivation of netilmicin and amikacin by binding with intact and disrupted human normal leucocytes was compared. Even after prolonged incubation of the aminoglycosides with intact cells, no binding could be demonstrated. On the other hand, partial binding of netilmicin and amikacin by disrupted leucocytes occurred: a linear relationship between the logarithm of the initial number of cells and the degree of binding of the drug was observed. The decrease in biological activity occurred rapidly in the presence of disrupted cells and remained unchanged during the next 18 h.

Amikacin↗
PubMed1985

Interaction of gentamicin, dibekacin, netilmicin and amikacin with various penicillins, cephalosporins, minocycline and new fluoro-quinolones against Enterobacteriaceae and Pseudomonas aeruginosa.

Thirty strains of Enterobacteriaceae and ten strains of Pseudomonas aeruginosa were selected to study the in-vitro activity of various combinations containing aminoglycosides, by the checkerboard method. The following aminoglycosides: gentamicin, dibekacin, netilmicin and amikacin were used in combination with each of the following: ampicillin, ticarcillin, piperacillin, cefazolin, cefuroxime, ceftazidime, norfloxacin, enoxacin and minocycline. Synergy was not a constant feature of beta-lactam+aminoglycoside combinations. Discrepancies occurred with the same strain submitted to combinations containing different aminoglycosides. The combinations containing new quinolones+aminoglycosides were usually additive, although occasionally synergy occurred. The combination minocycline+aminoglycoside was usually additive but partial antagonism (FIC or FBC index: 1 X 5- less than 2) occurred in 10 to 40% of the strains depending on the aminoglycoside. The combinations of beta-lactams with dibekacin or netilmicin most frequently produced partial or full synergy against strains of Ps. aeruginosa susceptible to all four aminoglycosides tested.

Amikacin↗
PubMed1993

Effectiveness of netilmicin and tobramycin against Pseudomonas aeruginosa in vitro and in an experimental tissue infection in mice.

The activity of netilmicin and tobramycin against Pseudomonas aeruginosa was assessed in vitro in the presence of constant and exponentially declining concentrations, and in mice in an experimental thigh infection. The activity in vitro at constant concentrations was expressed as the maximal killing rate (ER) during 3 h of exposure. On the basis of the quantitative relation between E(R) and the drug concentration, the numbers of cfu expected at consecutive times, at constant as well as at declining concentrations, were predicted. The relationship between observed numbers and predicted values of ERt were similar under both conditions for both drugs. On the same basis the numbers of cfu expected in the experimental thigh infection were predicted. There was indeed a significant linear relationship between observed numbers of cfu in homogenized muscle and the values predicted on the basis of the pharmacokinetics of the aminoglycosides, but the slope of this relationship was only 0.22. There was no difference in this respect between the two antibiotics. It is concluded that the efficacy of netilmicin and tobramycin against P. aeruginosa is considerably less in vivo than in vitro, but the relation is about the same for the two drugs; therefore the slightly higher activity of tobramycin in vitro is relevant in the in-vivo situation.

Animals↗
PubMed1994

Monitoring serum concentrations for once-daily netilmicin dosing regimens.

A once-daily dosing regimen for aminoglycosides is less expensive, at least as effective and possibly less toxic than multiple-daily dosing regimens. Once-daily dosing might also allow the frequency of measuring the serum concentrations of these antibiotics to be reduced since two of the major objectives of monitoring, high peak and low trough concentrations, are more likely to be achieved with this regimen. A novel strategy for monitoring serum concentrations which relies on a single sample obtained 8 h after a dose, as opposed to both trough and peak samples, is evaluated here. Serum kinetics of netilmicin were studied prospectively in 51 adult patients with initial serum creatinine concentrations of < 130 mumol/L who were treated with a median daily dosage of 400 mg. Concentrations measured 8 h after administration were within the target range of 1.5-6 mg/L in 113 of 134 dosing intervals studied. Concentrations above and below this range correlated significantly with higher and lower 24-h trough concentrations and areas under the curve respectively. There was also a significant correlation between 8-h netilmicin concentrations and nephrotoxicity (P < 0.05); a relative increase of > or = 25% in the serum creatinine concentration or an absolute increase of > 25 mumol/L was detected in 0 of 7 patients with an 8-h concentration of < 1.5 mg/L, in 3 of 33 patients (9.1%) with an 8-h concentration of 1.5-6 mg/L and in 4 of 11 patients (36%) with an 8-h concentration of > 6 mg/L.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗
PubMed1996

Pharmacokinetics of once-a-day netilmicin (6 mg/kg) in neonates.

The pharmacokinetics of once a day netilmicin (6 mg/kg) was studied in 21 neonates. The babies were divided into three groups according to gestational age: group I aged > 36 weeks; group II between 34-36 weeks and group III < 34 weeks. Serum concentrations were variable between patients and the concentration 24 h after the first dose ranged from 0.8 to 3.8 mg/L with only two babies having concentrations of < 1 mg/L while seven had concentrations of > 2 mg/L. There were also large patient-to-patient variations in serum half-life, volume of distribution, area under the curve and relative plasma clearance such that these parameters could not be correlated to gestational age or weight. Absolute plasma clearance was correlated with both gestational age and weight. There was evidence of accumulation between the first and second dose for all three patient groups and for patients of gestational age < 34 weeks (group III) these observations were statistically significant. A netilmicin dosage of 4.5 mg/kg once a day may be more suitable for all neonates supported by assay of serum concentrations.

Female↗
PubMed1999

An open, randomized, multicentre study comparing the use of low-dose ceftazidime or cefotaxime, both in combination with netilmicin, in febrile neutropenic patients. German Multicentre Study Group.

To reduce drug acquisition costs, the clinical and bacteriological efficacy of low-dose ceftazidime i.v. (1 g tid) was compared with cefotaxime i.v. (2 g tid). Both regimens were combined with netilmicin i.v. (2 mg/kg bodyweight tid), in an open, randomized, multicentre trial in febrile neutropenic patients. The addition of antibiotics for gram-positive coverage was part of the protocol; alteration in the antibiotics for gram-negative cover or premature discontinuation of the study antibiotics were judged as failure. One hundred and eighty six patients were randomized by nine German centres, the patients matched for age, underlying diseases and duration of neutropenia (median duration 14 days) in both treatment arms. Infections were documented microbiologically in 29% of the patients, clinically in 16% and suspected (fever of unknown origin) in 102/186 patients (55%). The 82 pathogens isolated were predominantly gram-positive bacteria. In an intent-to-treat analysis, the overall response rate without modification at the final evaluation was 58% in the ceftazidime group and 34% in the cefotaxime group (P < 0.01). The success rates with modification were 84% and 64%, respectively. The failure rate in a highly immunosuppressed subgroup of the patients (bone marrow transplant recipients) was higher for cefotaxime (53%) than for the ceftazidime arm (14%) (P < 0.001). Response rates were significantly higher in the ceftazidime group for patients with microbiologically documented and possible infections. No major bacterial superinfections occurred in the low-dose treatment arm. The tolerability was good for both regimens. Low-dose ceftazidime combined with netilmicin proved to be superior to recommended doses of cefotaxime/netilmicin in febrile neutropenic patients.

Adolescent↗
PubMed1997

Comparison of a fluorescence polarization immunoassay of netilmicin in plasma, peritoneal dialysate, and urine with a high-performance liquid chromatographic method.

The quantitative analysis of netilmicin in plasma, peritoneal dialysate, and urine using the fluorescence polarization immunoassay (FPIA) of the Abbott TDx system is compared with the modified high-performance liquid chromatography (HPLC) method of Peng et al., which was chosen as a reference. Using the least square method, we found that the results of the FPIA (y) correlated well with those obtained with HPLC (x). The three regression equations for the plasma, peritoneal dialysate, and urine samples, respectively, were y = 0.71x + 0.44 with r = 0.88 and n = 45; y = 0.94x + 1.22 with r = 0.93 and n = 95; and y = 0.92x + 0.70 with r = 0.93 and n = 61. The corresponding mean errors (FPIA-HPLC) with their 95% confidence intervals were -0.19 (-0.38 to -0.02), 0.69 (-0.42 to 1.81), and -0.13 (-1.13 to 0.87) microgram/ml. According to results of the Wilcoxon matched-pairs signed-ranks test, these errors did not represent a significant bias. The FPIA is thus suitable for analyzing netilmicin in the three biological fluids studied except when dialysate is contaminated with Amuchina. In this case, HPLC should be used.

Chromatography, High Pressure Liquid↗