Post Marketing Assessment of the Efficacy and Safety of Netromax (Netilmicin) in the Indian Pediatric Population.

Objective: A post-marketing study of Netilmicin (Netromax™) in Indian pediatric patients to assess the safety and efficacy of the drug in various susceptible infections. Method: The study was carried out by 129 pediatricians from across India in 10 states (Maharashtra, Delhi, Uttar Pradesh, Andhra Pradesh, Odisha, Chhattisgarh, Karnataka, Madhya Pradesh, West Bengal, and Bihar) from November 2011 to February 2012. A total number of 542 case report forms were collected and considered eligible for further analysis based upon the completeness of data. The disease profile of patients included bacteremia, septicemia (including neonatal sepsis), severe respiratory tract infections (RTI), intra-abdominal infections (including peritonitis), kidney and genitourinary tract infections, skin and soft tissue infections, burns, bone and joint infections, wounds and perioperative infections. Result: Demographic analysis showed the median age of patients to be 13 months and median duration of therapy was 5 days. Intravenous route (IV) (n= 340) was preferred over intramuscular route (IM) (n=202) by the physicians. Netilmicin was administered in the therapeutic dose range depending upon the age and severity of the condition. The results revealed a favorable clinical efficacy and safety profile of Netilmicin. Clinical Improvement was observed in 98% (n=532) of patients among whom, clinical resolution (Defined as the absence of the infection) was achieved in 63% (n=343) patients. Whereas, partial improvement (defined as partial disappearance of original symptoms and no further requirement of antibiotics) was observed in 35% (n=189) of patients. Adverse events were reported in 11% of the entire study population and were mild in nature. There was no serious adverse event reported during the study period. Conclusion: The present post-marketing study confirmed that at the given doses and duration of therapy, NetromaxTM exhibited remarkable antibacterial efficacy with no serious incidences of toxicity. Thereby giving evidence that NetromaxTM treatment is safe and effective among the Indian pediatric population.

Antimicrobial-induced endotoxaemia in patients with sepsis in the field of acute pyelonephritis.

BACKGROUND: In vitro results have shown that antimicrobial agents may induce the Gram-negative bacteria to release endotoxins (LPS), which in turn, could trigger the secretion of cytokines from monocytes. AIMS: To compare the effect of cefuroxime, netilmicin or ciprofloxacin on serum levels of LPS and tumour necrosis factor-alpha (TNFalpha). METHODS: Seventy-four patients with acute pyelonephritis caused by Gram-negative bacteria and signs of sepsis were randomly assigned to receive one of three intravenous regimens of cefuroxime, netilmicin or ciprofloxacin. Blood samples were collected before therapy and at specified time intervals for 96 hours after the initiation of treatment for the determination of serum levels of LPS and of TNFalpha. RESULTS: Patients treated with cefuroxime presented an early peak of LPS and of TNFalpha in serum two hours after the initiation of treatment compared to the other study groups. After that time interval, concentrations of LPS and TNFalpha were similar in all the study groups. Fever accompanied by endotoxaemia was still detected for 48 hours after the start of therapy in 36, 37.5 and 36% of patients treated with cefuroxime, netilmicin and ciprofloxacin respectively. The corresponding figures for these agents at 72 hours were 28, 12.5 and 24%, respective and 12, 4.2 and 4% at 96 hours (P value not significant). CONCLUSIONS: With the exception of an early peak in the serum levels of LPS and TNFalpha in patients treated with cefuroxime, no significant difference could be detected amongst the study groups as far as their effect on serum levels of LPS and TNFalpha were concerned. This suggests that these three antimicrobial agents may be administered safely at the early stages of sepsis.

Eficacia de la netilmicina en infecciones de vías urinarias / Effectivenes of netilmycin in infections of urinary tract

Se estudiaron 20 pacientes de ambos sexos, de edades primedio de 39 años, con infección no complicada de las vías urinarias, sintomáticos y con bacteriuria, causada por gérmenes susceptibles "in vitro" a < 1.25 mcg/ml de netilmicina. El aminoglucósido se administró en una dosis única diaria intramuscular de 3 mg/kg de peso corporal durante 14 días. Antes de aplicar el esquema terapéutico, durante la ejecución del mismo ya continuación se reañozarpm estidops de ñabpratprop ára evaluar las funciones renal, hepática y hematopoyética, asi como audiometrías y pruebas calóricas para valorar las funciones coclear y vestibular del VII nervio craneal. Se determinó la biodisponibilidad del antimicrobiano en el plasma de los pacientes los días 2, 5, 9 y 14 de tratamiento.

Evaluation of distal tubular function in aminoglycoside induced nephropathy

Acute metabolic acidosis potentiates the nephrotixicity of aminoglycosides by impairing the adequate excretion of ammonium and titratable acidity. The present study assesses distal tubular function after aminoglycoside administration in the rat. Two aminoglycosides, gentamicin and netilmicin were given to rats either in low doses equivalent to those used clinically (BG4 and BN5 groups) or in doses ten times higher (BG40 and BN50). The rats were subjected to acute metabolic alkalosis and the pCO2 of urine was continuously evaluated. the regression lines obtained by plotting the differences between urine and blood pCO2 as a function of urinary HCO3 in low dose models were simsilar to those obtained for the control group. However, the slopes obtained for BG40 and BN50 were significantly different from the control, suggesting an impairment of H+ secretion