Summary
Synopsis
Netilmicin is a semisynthetic aminoglycoside derived from sisomicin. It is active against most Gram-negative and some Gram-positive bacteria, including many gentamicin-resistant strains. Netilmicin has proved to be effective in Gram-negative infections of the urinary tract, skin and skin structure, and lower respiratory tract, as well as in intra-abdominal infections, septicaemia and other miscellaneous infections. In some trials, the more easily implemented once daily administration of netilmicin has been as effective as multiple dosing regimens. However, further investigation is required to confirm that efficacy and safety are not compromised with once daily administration. Comparative studies have generally revealed similar clinical and bacteriological efficacies between netilmicin and gentamicin, amikacin or tobramycin.
As with other aminoglycosides, the principal adverse effects of netilmicin are nephrotoxicity and ototoxicity. Although animal studies strongly suggest that these are less common with netilmicin than with related drugs, there appears to be no difference in their incidence in clinical use; in clinical trials the incidence of nephrotoxicity and ototoxicity has been low, with the symptoms in many cases being minor and reversible.
Netilmicin is, therefore, an effective antibacterial drug for the parenteral treatment of severe infections, offering theoretical advantages in safety which may indicate its use for patients believed to be at risk of adverse effects.
Antibacterial Activity
Many species of Enterobacteriaceae, including gentamicin-resistant strains, are susceptible or moderately susceptible to netilmicin in vitro, although for a proportion of such strains the minimum inhibitory concentration (MIC) exceeds 4 to 8 mg/L (more for Providencia species and P. stuartii) and resistance to netilmicin may occur. Resistance among species of Enterobacteriaceae is more widespread against gentamicin, slightly more so against tobramycin and sisomicin, and unusual against amikacin. In common with other aminoglycosides, the in vitro activity of netilmicin against P. aeruginosa varies widely between studies (MIC90S 2 to 128 mg/L), possibly a reflection of the percentage of gentamicin-resistant strains among the isolates tested, as gentamicin-resistant strains of P. aeruginosa are at best moderately susceptible to netilmicin. Acinetobacter species and A. calcoaceticus are resistant to netilmicin in vitro in Canadian studies, although A. calcoaceticus was susceptible in northern European studies and A. calcoaceticus subspecies lwoffii and anitratus have been reported to be susceptible. Neisseria gonorrhoeae and Haemophilus influenzae, including β-lactamase-producing strains, are susceptible to netilmicin and the other aminoglycosides, with amikacin being the least potent inhibitor in vitro. Staphylococci, including S. aureus, S. epidermidis and coagulase-negative staphylococci, are susceptible to netilmicin in vitro. Methicillin-resistant strains of S. aureus are also susceptible to netilmicin, but gentamicin-resistant strains are only moderately so. Streptococci, including S. pneumoniae, S. pyogenes, Group D streptococci and enterococci, are moderately susceptible/resistant to netilmicin, and Enterococcus faecalis is resistant. Several species of mycobacteria are also moderately susceptible/resistant to netilmicin. In common with gentamicin, netilmicin is inactive against anaerobes such as Bacteroides fragilis and Clostridium species.
As with other aminoglycosides, the in vitro activity of netilmicin is influenced by the composition of the medium and by gross changes in the size of inoculum. This is particularly true of in vitro tests with P. aeruginosa, in which the concentration of divalent cations such as magnesium and calcium is critical. For many organisms, the minimum bactericidal concentration of netilmicin is within 2 dilutions of the MIC and the killing rate is equal to that of gentamicin and amikacin. Netilmicin is inactivated in vitro by high concentrations of many β-lactam antibiotics. It is unlikely that the interaction between aminoglycosides and β-lactam antimicrobials is of clinical significance but, in general, aminoglycosides and β-lactam antimicrobials should not be mixed in intravenous infusions. Synergy with several penicillins and cephalosporins has also been demonstrated in vitro against a wide range of organisms, although this appears to be less marked than with amikacin and tobramycin.
Netilmicin and the other aminoglycosides are bactericidal by binding to intracellular ribosomes and interfering with bacterial protein synthesis. Resistance to netilmicin is believed to be caused predominantly by plasmid-mediated enzymes; it is less susceptible than gentamicin to adenylating enzymes and equally resistant to phosphorylation. In comparison with amikacin, netilmicin is more susceptible to acetylation. The prevalence of resistance to aminoglycosides due to inactivating enzymes differs around the world, with the reported incidence of acetylating enzymes being less common among gentamicin-resistant organisms isolated in the USA.
Pharmacokinetics
As with other aminoglycoside antibiotics, netilmicin is not significantly absorbed from the gastrointestinal tract. Mean peak plasma concentrations after single intravenous doses of 1 to 2 mg/kg have ranged from 3.9 to 16.6 mg/L. After intramuscular injection, the bioavailability of netilmicin is almost complete. Mean peak plasma netilmicin concentrations of 5.5 to 9.3 mg/L were reached after a 2 mg/kg dose. Multiple dose regimens of netilmicin (usually 1.7 to 2.5 mg/kg every 8 hours for 7 to 12 days) give mean Cmax values of about 6 to 9 mg/L, whereas once daily administration of 4.5 to 6.5 mg/kg for similar periods results in mean values of 11 to 20 mg/L.
The apparent volume of distribution of netilmicin is about 0.15 to 0.3 L/kg, consistent with the low lipid solubility of the aminoglycosides. The drug distributes throughout the body, although concentrations in most tissues studied have been below the MIC, for most organisms. Cerebrospinal fluid (CSF) concentrations, for example, are only 25% of the simultaneous plasma concentration. Netilmicin does not significantly bind to plasma proteins.
Netilmicin is excreted renally in a biphasic pattern. Renal clearance of the drug varies considerably, but is calculated to be about 60 to 75% of total body netilmicin clearance. Limited tubular resorption occurs as illustrated by greater creatinine clearance than netilmicin renal clearance. The initial elimination half-life is about 2 to 3 hours, similar to that of gentamicin. However, the terminal phase elimination half-life calculated in 3-compartment models ranged from 36.9 to 198 hours, and was significantly longer than corresponding values for gentamicin and tobramycin.
The clearance of netilmicin is significantly reduced in patients with renal impairment. The ‘loading dose’ does not need to be reduced, but subsequent administration should be adjusted according to creatinine clearance initially, and to drug clearance as soon as monitoring allows. Netilmicin is removed from plasma during haemodialysis, but cessation of the procedure is associated with a rebound rise in netilmicin plasma concentrations. Thus, blood should not be drawn for at least 2 hours postdialysis when calculating the additional dosage required.
Liver failure does not alter the dose of netilmicin required to achieve therapeutic plasma concentrations. In cystic fibrosis, the pharmacokinetics of netilmicin are not altered, but the dose should be calculated according to bodyweight.
Absorption of netilmicin is considerably faster, and elimination slower, in neonates than in adults. This is probably due to renal immaturity, and the pharmacokinetics will change markedly during the first few days/weeks of life. Calculation of the dosage using body surface area rather than weight may be helpful. In the elderly, the dosage of netilmicin needs to be reduced in line with the decline in renal function which often occurs with age.
Plasma concentration monitoring at regular intervals is essential when administering netilmicin, particularly in neonates, the elderly and in patients with renal impairment.
Therapeutic Trials
Netilmicin has been evaluated in the treatment of serious and life-threatening infections in comparative and uncontrolled trials, most of which were not blinded. Cumulated results of clinical trials with netilmicin reveal favourable clinical responses and bacterial eradication, respectively, in 96 and 87% of complicated urinary tract infections; 88 and 90% of septicaemia; 89 and 77% of skin and skin structure infections; 91 and 87% of intra-abdominal infections; 86 and 70% of lower respiratory tract infections; and 85 and 73% of evaluable miscellaneous infections. Similarly, results cumulated in a Japanese postmarketing surveillance study reveal clinical efficacy in 74 to 86% of infections at various body sites. Bacteriological eradication rates in several series of cumulated data ranged from 76 to 83% overall; bacterial persistence or reinfection occurred most frequently with P. aeruginosa and Serratia species. Some preliminary trials in various infections indicate similar efficacy for once daily as for 3 times daily regimens of netilmicin.
Several comparative studies which examined infections at many different infection sites generally revealed similar clinical and/or bacteriological efficacy between netilmicin and gentamicin, amikacin or tobramycin. In studies which examined urinary tract infections (UTIs) in particular, netilmicin was similar to or not statistically different in clinical efficacy from gentamicin or amikacin in complicated infections and from gentamicin in pyelonephritis. However, while a statistical analysis was not provided, bacterial eradication at the end of treatment was achieved in only 62% of chronic P. aeruginosa UTIs treated with netilmicin versus 100% of those treated with ceftazidime. In women with uncomplicated UTI, a single 150mg intramuscular dose of netilmicin was similar in efficacy to a 5-day oral course of co-trimoxazole (trimethoprim + sulphamethoxazole) and the aminoglycoside caused no reported adverse effects.
In intra-abdominal infections, the combinations of netilmicin plus either clindamycin or tinidazole were equally effective. Moreover, in comparative studies which mainly assessed patients with intra-abdominal infections, bacteriological and clinical efficacy rates were similar whether cefoxitin was combined with netilmicin or gentamicin, and whether clindamycin was combined with netilmicin or tobramycin. In the treatment of peritonitis in chronic ambulatory peritoneal dialysis patients, the combination of netilmicin intra-peritoneally plus vancomycin intravenously was significantly (p < 0.0005) superior to that of gentamicin plus clindamycin, and was less likely to lead to the emergence of resistant Staphylococcus epidermidis; in a second study intraperitoneal netilmicin was similar in efficacy to intraperitoneal cefamandole. Women with acute pelvic inflammatory disease responded equally well to the combinations of benzylpenicillin (penicillin G) plus either gentamicin or netilmicin. Moreover, either gentamicin or netilmicin administered alone appeared similar in clinical efficacy in obstetric and gynaecological patients with systemic infections (mostly surgical wound infections). In addition, netilmicin was significantly (p < 0.05) superior to cefotaxime in both clinical and bacteriological efficacy in the treatment of septicaemia, and a single intramuscular injection of netilmicin 300mg cured 100% of 690 women and 510 men with uncomplicated nonpharyngeal gonorrhoea.
Small non-comparative studies in paediatric patients reveal netilmicin clinical efficacy rates of 87 to 100% and pathogen eradication rates of 70 to 96%. There were no statistically significant differences in clinical and/or bacteriological efficacy between netilmicin plus benzylpenicillin and cefotaxime in neonatal sepsis, between netilmicin and tobramycin in serious paediatric Gram-negative infections, and between a single intramuscular dose of netilmicin and a single oral dose of fosfomycin trometamol in paediatric lower respiratory tract infections. In acute exacerbations of cystic fibrosis due to P. aeruginosa, the combination of ticarcillin plus netilmicin was not statistically different from ticarcillin plus tobramycin in decreasing sputum organism counts, in clinical improvement and in short term pathogen eradication rates. Netilmicin plus either azlocillin or ticarcillin was also equally effective in achieving symptomatic improvement in acute exacerbation of cystic fibrosis.
Clinical response rates of 73 to 95% have been achieved in non-comparative studies in febrile granulocytopenic adults and children administered combination therapy consisting of netilmicin plus (in most instances) a penicillin or a cephalosporin. In comparative analyses, there were no statistically significant differences in rates of efficacy whether piperacillin was administered in combination with netilmicin or with tobramycin, and whether ticarcillin was combined with netilmicin, gentamicin or amikacin. Also in immunologically compromised patients, the combination of various β-lactam antibacterial drugs with netilmicin resulted in efficacy rates ranging from a low of 57% with cefoperazone to a high of 81% with piperacillin, and the combined use of netilmicin, ampicillin and methicillin did not differ significantly in efficacy from that of cefotaxime alone.
A 24-hour perioperative course of surgical prophylaxis with netilmicin plus methicillin resulted in a significantly (p = 0.04) reduced wound infection rate versus placebo in reconstructive vascular surgery. In elective colorectal surgery, 24-hour perioperative prophylaxis with netilmicin plus metronidazole was similar in efficacy to a 24-hour course of ticarcillin plus clavulanic acid, and to a 5-day course of doxycycline. There was no statistically significant difference in wound infection rates between head and neck tumour surgery patients administered netilmicin plus clindamycin prophylaxis, and those administered clindamycin alone.
Adverse Effects
Although studies in animals have clearly shown that netilmicin is less nephrotoxic and less ototoxic than other aminoglycosides administered at high doses, no obvious differences among these drugs have been found during clinical use in humans. In clinical trials, most of which have monitored serum concentrations of netilmicin and adjusted the dosage accordingly, the incidence of nephrotoxicity has been approximately 2 to 3%. In most cases this was defined as a rise in serum creatinine concentrations, normally reversible on withdrawal of the drug. Because of the small numbers of affected patients in individual studies, there is no consensus over which risk factors significantly predispose to nephrotoxicity, but impaired renal function, high dosages, long duration of treatment, and high serum concentrations have variously been associated with this effect.
Similarly, ototoxicity has been rare in published studies and no clear differences among the aminoglycosides have been reported in humans. Most cases have involved loss of hearing at high frequencies which has not been symptomatic and very few cases of vestibular damage have been reported. Again, no risk factors have been shown consistently to render patients susceptible to ototoxicity. There is some evidence that once daily administration may be less ototoxic than multiple dosing regimens. Other adverse effects include asymptomatic elevations of serum enzyme concentrations and minor reactions not clearly associated with treatment.
Dosage and Administration
Netilmicin is administered by intravenous or intramuscular injection, the recommended adult dosage being 1.5 to 2.0 mg/kg every 12 hours for complicated urinary tract infection, and 4.0 to 6.5 mg/kg/day administered as 1.3 to 2.2 mg/kg every 8 hours or 2.0 to 3.25 mg/kg every 12 hours in serious systemic infections. For adult patients with normal renal function, the dosage for urinary tract infections or non-life-threatening infections is 4.0 to 6.0 mg/kg/day given in 3 equal doses every 8 hours, 2 equal doses every 12 hours, or once daily. Measurement of serum netilmicin concentrations, with maintenance within the ranges 6 to 10 (peak) and 0.5 to 2 (trough) mg/L, are desirable. Should therapy be extended in duration beyond the usual 7 to 14 days, monitoring for changes in renal, auditory and vestibular function is important.
In infants and children aged between 6 weeks and 12 years the recommended dosage is 5.5 to 8.0 mg/kg/day, administered either as 1.8 to 2.7 mg/kg every 8 hours or as 2.7 to 4.0 mg/kg every 12 hours. In neonates aged less than 6 weeks, 4.0 to 6.5 mg/kg/day is administered as 2.0 to 3.25 mg/kg every 12 hours.
Patients with impaired (but stable) renal function receive an initial or loading dose identical to that of patients with normal renal function. Several methods are available for calculating the ensuing reduced dosage, but pharmacokinetic determination based on measurements of serum drug concentrations is the most accurate.
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Various sections of the manuscript reviewed by: A. Digranes, Department of Microbiology and Immunology, the Gade Institute, Haukeland Hospital, Bergen, Norway; R. Fujii, Research Institute of Chemotherapy for Mother and Child, Tokyo, Japan; H. Giamarellou, First Department of Propedeutic Medicine, Athens University School of Medicine, Laïko General Hospital, Athens, Greece; D. Greenwood, Department of Microbiology University Hospital, Queen’s Medical Centre, Nottingham, England; R. Herbrecht, Hospices Civils de Strasbourg, Hopital De Hautepierre, Strasbourg, France; R. Janknegt, Klinische Farmacie, Sittard, The Netherlands; Y. Kawada, Department of Urology, Gifu University School of Medicine, Gifu-Shi, Japan; H. Neu, Division of Infectious Diseases, Collge of Physicians and Surgeons of Columbia University, New York, New York, USA; R. Norrby, University of Lund, Department of Infectious Diseases, University Hospital of Lund, Lund, Sweden; D. Pastel, Cedars-Sinai Medical Center, Department of Pharmacy, Los Angeles, California, USA; C Watanakunakorn, Department of Internal Medicine, St Elizabeth Hospital Medical Center, Youngstown, Ohio, USA; L. Weinstein, Brigham and Women’s Hospital, Boston, Massachusetts, USA; R. Wise, Department of Medical Microbiology, Dudley Road Hospital, Birmingham, England.
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Campoli-Richards, D.M., Chaplin, S., Sayce, R.H. et al. Netilmicin. Drugs 38, 703–756 (1989). https://doi.org/10.2165/00003495-198938050-00003
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DOI: https://doi.org/10.2165/00003495-198938050-00003