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PubMed1982

[Reproduction study on netilmicin. (2) Fertility study in rats (author's transl)].

Fertility study on netilmicin (NTL), a new aminoglycoside antibiotic, was carried out in Sprague-Dawley rats (Slc : SD). NTL was administered intramuscularly to male rats at the daily dose of 12.5, 25, 50 and 100 mg/kg from 6 to 15 weeks of age for 9 weeks before mating and during the mating period, and to 10 weeks old female rats at the daily dose levels from day 14 before mating through day 7 after gestation. The increase of kidney weight at the dose of 12.5 mg/kg and more, the decreases of food intake and body weight were observed in treated male rats. The decreases of food intake and body weight were observed in female rats treated with the dose of 50 and 100 mg/kg. No dose-related changes were observed in mating and fertility ratios of parent animals, numbers of corpora lutea and implantations, fetal mortality, external, visceral and skeletal anomalies, body weight, body length and tail length of fetuses. Therefore, it can be concluded that maximum non-toxic dose level of NTL on rat fertility is 100 mg/kg.

Abnormalities, Drug-Induced↗
PubMed1982

[Reproduction study on netilmicin. (3) Perinatal and postnatal study in rats (author's transl)].

Perinatal and postnatal study on netilmicin (NTL), a new aminoglycoside antibiotic, was carried out in Sprague-Dawley rats (Slc : SD). NTL was administered intramuscularly from day 17 of gestation throughout day 20 after delivery at the daily dose of 12.5, 25, 50 and 100 mg/kg. Water intake of pregnant and nursing dams was increased in the animals treated with 50 mg/kg or more of NTL. The increase of cecum weight was observed in F1 animals in all treated groups at 3 weeks of age. However, birth rate, suckling rate, weanling rate, body weight, postnatal development, behavior and reproductive function remained within normal ranges in all treated groups.

Abnormalities, Drug-Induced↗
PubMed1982

[Reproduction study on netilmicin. (4) Teratological study in rabbits (author's transl)].

Teratological study on netilmicin (NTL), a new aminoglycoside antibiotic, was carried out in New Zealand White rabbits. NTL was administered intramuscularly from day 60 to day 18 of gestation at the dose levels of 12.5, 35 and 100 mg/kg. The decrease of food intake, water intake and depression of body weight were observed in the pregnant animals treated with 100 mg/kg of NTL. Body weight and tail length of fetuses were significantly decreased in the animals treated with 35 and 100 mg/kg compared with those in saline control or vehicle control groups. However, no dose-related changes or anomalies were detected in mortality, external, visceral and skeletal examinations of fetuses. Thus, it can be concluded that NTL has no adverse effect on rabbit fetuses.

Abnormalities, Drug-Induced↗
PubMed1982

[Immunogenicity study of netilmicin (author's transl)].

Immunogenicity of netilmicin (NTL) was studied and following results were obtained. The antisera obtained from rabbits immunized with both NTL alone and NTL . HSA mixture did not show positive response in the heterologous 3-hour PCA reaction and the passive hemagglutination test against the challenge of either NTL alone of NTL . OVA mixture. Guinea pigs immunized with NTL alone did not exhibit systemic anaphylaxis when elicited with NTL alone. The antisera obtained from BALB/c mice immunized with NTL-OVA conjugate adsorbed to A1(OH)3 gel gave positive response in the 24-hour PCA reaction by the method described by MOTA, whereas did not respond to intact NTL in the same system. Similar responses were also obtained in the animals immunized with either gentamicin or gentamicin.protein mixture used as control.

Animals↗
PubMed1982

[Absorption, distribution, metabolism and excretion of netilmicin in rats (IV). Distribution in kidney and transmigration to fetus or suckling (author's transl)].

Distribution in kidney and transmigration to fetus or suckling in rats were studied in male, pregnant or lactating rats after intramuscular administration of 14C-netilmicin (20 mg/kg). 1. After administration to male rats, the radioactivity in the kidney declined slowly with a half-life of approximately 6 days. 2. The radioactivity in the kidney was distributed in the renal cortex. The distribution pattern was further investigated by means of microautoradiography. The radioactivity was specifically observed in lysosomal granules of the proximal tubules at 6 hours after administration and reached maximum at 24 hours after administration, then declined gradually. On the other hand, the radioactivity in the distal tubules was lower than that of the proximal tubules. The highest radioactivity in the distal tubules was detected later than 24 hours after administration. 3. In pregnant rats (20th day of gestation), the distribution of radioactivity in the tissues were almost the same as those in the male rat. The small amount of radioactivity was detected in the fetal kidney and bone. 4. In mother rats (14 days after parturition), the radioactivity in the milk was 3 approximately 4 mcg equivalent of netilmicin/ml during 24 hours after administration. The small amount of radioactivity (0.13% of dose) was observed in the gastrointestinal contents of a suckling with 6 hours after administration.

Animals↗
PubMed1982

[Absorption, excretion and metabolism of netilmicin in beagle dogs (author's transl)].

Pharmacokinetics of netilmicin (NTL), a new aminoglycoside antibiotic, injected intramuscularly to Beagle dogs were compared with those of gentamicin (GM), and the relationship between NTL dosage administered and plasma level and urinary excretion was examined. 1. When administered to 6 male Beagle dogs at a dose of 10 mg/kg, the plasma level showed a broad peak (ca. 23 mcg/ml) at 10 to 45 minutes after administration and declined thereafter with half-life of 65 minutes. On the other hand, the plasma level of GM administered at a dose of 10 mg/kg showed a peak (ca. 24mcg/ml) at 15 to 45 minutes after administration and the elimination half-life was 75 minutes. Both of the urinary concentrations of NTL and GM administered at a dose of 10 mg/kg were highest in the 4- to 6-hour urine, whereas NTL and GM recovered in the 24-hour urine were 51.7% and 57.7% of the dose administered, respectively. The pharmacokinetic profile of NTL administered intramuscularly to Beagle dogs appeared to be almost identical to that of GM. 2. The peak plasma level of ca. 50 mcg/ml was obtained at 10 to 60 minutes after administration of NTL at 20 mg/kg, and the half-life was 74 minutes. NTL recovered in the 24-hour urine was 69.7% of the dose administered. 3. TLC-bioautograms showed no biologically active metabolites of NTL in the urine collected from Beagle dogs given the antibiotic intramuscularly.

Animals↗
PubMed1982

[Ototoxicity study of netilmicin in pregnant guinea pigs and the embryo].

The ototoxicity of netilmicin (NTL) in pregnant guinea pigs (Hartley strain) and the newborn was examined and compared to that of gentamicin (GM). NTL was administered intramuscularly at dose of 90 mg/kg to pregnant guinea pigs from day 0 to day 35 of pregnancy (the early period of pregnancy) or from day 42 of pregnancy to 1 day prior to delivery (the late period of pregnancy). GM at dose of 45 mg/kg or physiological saline were administered intramuscularly to pregnant guinea pigs during the late period of pregnancy. Four of 5 dams given NTL during the early period of pregnancy, 4 of 7 dams given TNL during the late period of pregnancy, and 2 of 4 dams given GM during the late period of pregnancy died. No pinna reflex loss in frequency range from 2 to 20 KHz were detected in mother guinea pigs treated with NTL either during the early period of pregnancy or during the late period of pregnancy. GM caused a loss of pinna reflex at 20 KHz in mother guinea pigs treated during the late period of pregnancy. Histopathologically, no damages were detected in the cochlea of mother guinea pigs treated with NTL during the early or late period of pregnancy, whereas slight scattered loss of hair cells was seen in the vestibulum. However, GM at dose of 45 mg/kg, caused an incomplete scattered loss of outer hair cells in the spiral organ, moderate atrophy of the spiral ganglion cells and a partial loss of hair cells in the vestibular organs in mother guinea pigs treated during the late period of pregnancy. In newborn guinea pig from the pregnant one treated with NTL during the early period of pregnancy, there was no loss of pinna reflex. The same results were obtained in newborn guinea pigs from the pregnant ones treated with either NTL or GM during the late period of pregnancy. No histopathological damages were detected. The present study suggests that NTL has a minimal effect on the auditory and vestibular organs in pregnant guinea pigs and the newborn and is considered to be 1 of the aminoglycosides with low ototoxic potential.

Animals↗
PubMed1994

[Clinical studies on the time-difference combination therapy with netilmicin and minocycline in methicillin-resistant Staphylococcus aureus infections].

Twenty-eight patients with methicillin-resistant Staphylococcus aureus (MRSA) infections were clinically studied for the effectiveness of the time-difference combination use of netilmicin (NTL) and minocycline (MINO). The patients were treated with NTL 100 mg and two hours later, with MINO 100 mg intravenously, twice daily, in the morning and evening for 14 days. Of 26 patients, MRSA was eradicated in 16 (61.5%), decreased in one, and unchanged in nine. Superinfections occurred with Serratia marcescens and Pseudomonas aeruginosa in two patients. The clinical efficacies were assessed in two patients with septicemia, 16 with pneumonia, and eight with chronic bronchitis. The obtained results were excellent in four patients, good in 15, fair in six, and poor in one patient. The rate of effectiveness was 73.1% (19/26). The overall clinical effectiveness judged by the committee was good in 19, fair in five, and poor in two patients. The efficacy rate was also 73.1% (19/26). Coagulase type II of MRSA was found in 23 patients, and coagulase type III in three patients, with overall clinical efficacy rates of 73.9% (17/23) and 66.7% (2/3), respectively. A side effect of eruption was observed in one patient, and its incidence was 3.6% (1/28). Abnormal laboratory test results were observed in 16 patients (57.1%), including abnormal liver function in 14 patients, abnormal kidney function in three, and increased eosinophils in three. Laboratory abnormalities occurred twelve of 16 bedridden patients, and this rate was higher than that in non bedridden patients. However, these abnormalities were all mild, transient, and immediately recovered after the treatment. In conclusion, the time-difference combination therapy using NTL and MINO was effective in the treatment of MRSA infections.

Adolescent↗
PubMed1993

[Antibiotic therapy of perforated appendicitis in children: comparison between the amoxicillin-clavulanic acid and the benzylpenicillin-netilmicin-metronidazole combinations].

In a multicentre trial we compared the clinical efficacy of amoxicillin/clavulanate used as a single-agent therapy with that of the three-agent combination usually prescribed in the post-operative period for appendicular peritonitis in children. Only bacteriologically documented peritoneal infections were included. Sixty-four patients were randomly distributed between two groups: Group A (29 cases) treated with amoxicillin/clavulanate, first administered iv (100 mg/kg/d), followed by conversion to the oral route (50 mg/kg/d) once the patient had been afebrile for 48 hours; Group B (35 cases) first treated by the iv route with benzylpenicillin (100,000 IU/kg/d) plus netilmicin (5 mg/kg/d) plus metronidazole (30 mg/kg/d), followed by conversion to the oral route for metronidazole (30 mg/kg/d). In both groups, the total duration of parenteral and oral treatment was not less than 5 days. One hundred and seventy nine bacterial strains were recovered from peritoneal fluid samples obtained during surgery; 86% of these were sensitive to amoxicillin/clavulanate. Clinical efficacy, assessed on the basis of time until return to normal temperature and gut transit and duration of hospitalization, was identical in both groups, with follow-up monitoring on day 30 showing recovery in all cases. Cure was obtained without any problems of infection in 25/29 patients in group A and in 34/35 patients in group B (non significant difference). Tolerance was excellent and identical in the two groups with the exception of three cases of thrombophlebitis which occurred in group B. The results of this study suggest that amoxicillin/clavulanate may be useful as single-agent therapy as a first-line curative treatment for appendicular peritonitis in children.

Adolescent↗
PubMed1993

[Microbiological determination of netilmicin using a thin-layer chromatography scanner].

We presented a new colorimetric bioassay of aminoglycoside antibiotics, which were represented by netilmicin (NTL) in this study, based on the discoloration of thymolphthalein (TP) in paper (indicator-disc) by carbon dioxide produced by Bacillus subtilis. To evaluate the amount of the carbon dioxide, the following experiment was carried out. One milliliter of B. subtilis suspension containing 4.5 x 10(7) colony forming units/ml, 1 ml of nutrient broth, 0.9 ml of 0.1 M phosphate buffer (pH 8.0) and 0.1 ml NTL sample solution were added to an incubation container, which was then placed in a water-bath (37 degrees C) for 3 hours. The oxygen concentration in the head space of flask was determined using gas-chromatograph. The dose-response curves showed good correlation between amounts of NTL and carbon dioxide produced by B. subtilis. The indicator-disc containing TP and sodium hydroxide was placed into the Reacti-flask and then incubated in the same manner as described above. After incubation, concentration of blue colored TP was determined using a TLC scanner. The discoloration of blue color to white showed the proportionality between NTL concentrations and the degrees of discoloration of TP. The method can accurately measure NTL levels down to 2.5 micrograms/ml in water using 0.1 ml samples, and should be adequate for rapid bioassay.

Bacillus subtilis↗
PubMed1978

Comparative toxicity of netilmicin and gentamicin in squirrel monkeys (Saimiri sciureus).

Netilmicin was found to be less toxic than gentamicin when administered at comparable dosage levels to squirrel monkeys (Saimiri sciureus). This finding is based upon data obtained from the following determinations: length of survival period; change in body weight; observation of general change in behavior after daily injection; ataxia, as measured by the squirrel monkey platform-runway test; acoustic reflex threshold; levels of blood urea nitrogen and serum creatinine (and pathology of the kidney); and microbiological antibiotic assay.

Acute Disease↗
PubMed1977

In vitro activity of netilmicin.

The activity of netilmicin against a variety of bacteria was similar to that of gentamicin, sisomicin, and tobramycin, but it was less active than these three drugs against Pseudomonas aeruginosa. Synergy with penicillin G against enterococci was demonstrated.

Amikacin↗
PubMed1977

Enhancement of antistaphylococcal activity of nafcillin and oxacillin by sisomicin and netilmicin.

The in vitro activity of sisomicin, netilmicin, nafcillin, and oxacillin against 35 strains of Staphylococcus aureus isolated from blood cultures of patients with endocarditis or septicemia was studied. The effects of combinations of either of the two newer aminoglycosides and either of the two penicillinase-resistant penicillins on the killing of S. aureus were investigated. All S. aureus strains were susceptible to the four antibiotics. Enhancement of antistaphylococcal activity was demonstrated by the antibiotic combinations.

Blood↗
PubMed1978

Netilmicin: clinical efficacy, tolerance, and toxicity.

Netilmicin, a new aminoglycoside antibiotic, has increased in vitro bactericidal activity against many strains of Enterobacteriaceae as compared to other aminoglycosides. It is a poor substrate for some of the common gentamicin-inactivating enzymes, and it has minimal toxicity in experimental animals. In 27 hospitalized patients, clinical cure was achieved in all, and the initial infecting organism persisted in only one. Therapeutic serum and urine levels were easily obtained in most patients. No ototoxicity was observed in two patients whose treatment required inordinately high serum levels and in whom other risk factors were present. Ototoxicity in 1 of 21 patients studied was unilateral, partially reversible, and not associated with high serum levels. Although nephrotoxicity occurred in 4 of 25 patients (16%), other host factors could have accounted for the toxicity in two patients. A new observation, not noted with other aminoglycoside antibiotics, was the elevation of serum alkaline phosphatase in 43% of the patients studied.

Adolescent↗
PubMed1990

Comparative ototoxicity of ribostamycin, dactimicin, dibekacin, kanamycin, amikacin, tobramycin, gentamicin, sisomicin and netilmicin in the inner ear of guinea pigs.

Nine aminoglycoside antibiotics, ribostamycin (RSM), dactimicin (DAC), dibekacin (DKB), kanamycin (KM), amikacin (AMK), netilmicin (NTL), tobramycin (TOB), gentamicin (GM) and sisomicin (SISO) were administered intramuscularly to guinea pigs for 4 weeks, and ototoxicity and drug concentration in the inner ear fluid were determined. RSM and DAC showed the weakest ototoxicity against the cochlea and vestibular organs. AMK and KM were more toxic to cochlea than vestibular organs. DKB, TOM, GM and SISO were equally toxic to vestibular organs and cochlea. NTL was more toxic to vestibular organs than cochlea. As judged from the pinna reflex response and hair cell damage in the cochlea, the order of auditory toxicity was the following: SISO greater than GM greater than TOB greater than AMK greater than DKB greater than KM greater than NTL, DAC RSM, whereas the vestibular toxicity was in the following order: SISO greater than GM greater than DKB greater than TOB greater than NTL greater than AMK greater than KM greater than DAC, RSM. RSM, causing the weakest ototoxicity, showed a low drug concentration in the inner ear fluid, while GM, causing severe ototoxicity, showed the highest drug level under the same conditions.

Aminoglycosides↗
PubMed1992

Imipenem versus netilmicin and vancomycin in the treatment of CAPD peritonitis.

Imipenem/cilastatin is a new thienamycin antibiotic with a broad bactericidal spectrum. We undertook a prospective randomised study to compare the safety and efficacy of intraperitoneal (IP) imipenem/cilastatin (2 gm daily) [group A; 21 patients, mean age 49.2 years] with a combination of IP netilmicin and vancomycin (500 and 60-100 mg daily resp.) [group B; 20 patients, mean age 55.2 years] in CAPD peritonitis. Each patient underwent 4 daily CAPD exchanges with antibiotics in alternate exchanges. The causative organisms were similar in both the groups as was the duration of therapy (gr.A: 6.8 +/- 0.27 days; gr.B: 7.2 +/- 0.51 days; p = NS). Complete cure was marginally better with imipenem/cilastatin (gr.A; 94.1%, gr.B: 83.3%) with less relapses (gr.A: 1 episode; gr.B: 3 episodes). One episode in gr.A (S. aureus) and 2 in gr.B (Yeast & Proteus) failed to resolve and required catheter removal. Two gr. A patients developed generalised convulsions which settled after discontinuation of the drug. Whilst the results show no significant difference in the outcome in the two groups, the use of IP imipenem would offer a possible advantage as a single antibiotic. Larger experience is needed before imipenem can be recommended as a 'blind' first line agent for CAPD peritonitis.

Female↗
PubMed1978

Radioimmunoassay and radioenzymatic assay of a new aminoglycoside antibiotic, netilmicin.

A radioimmunoassay and a radioenzymatic assay for netilmicin, a new aminoglycoside, were developed in our laboratories to assist in the study of the pharmacology of the drug and to establish values for use in its monitoring. The assays are sensitive, precise, and rapid, giving results that correlate (r = 0.90) with each other and with those of a microbiological assay in which Klebsiella pneumoniae is used as the test organism. Preliminary pharmacological studies show the drug to have a biological half-life of 135 min. which is comparable to that for other aminoglycosides.

Biological Assay↗