Despite considerable advances in the comprehension of neonatal pharmacology, improved resources for newborn clinical studies, and clear inclusion of neonates as a relevant age group for studies carried, the limited testing of medications in this susceptible age group is both a continuing challenge and concern.
Acquainted with the awareness of how infants vary from adults in their response to medications and how newborns, in particular, differ not only from adults but also from older infants and children, Associate Professor of Pharmacology, via Saint Andrea, Pisa, Italy — Gian Maria Pacifici conducted a Systematic literature review and appropriate empirical therapy regarding the treatment of (suspected) sepsis (taking into account susceptibility patterns, cost & risk of adverse events) in neonates and children.
Testing the safety and efficacy of a bactericidal antibiotic called ‘Cefotaxime’ for management of meningitis and sepsis in neonates, Gian Pacifici carried out cohort study in a pediatric research centre in Pisa Italy.
In this study, Total 33 infants and children, between 1-5 years of age suffering from respiratory tract infections were administered with cefotaxime. About 97% of patients resulted in cure and improvement, with elimination of 94% of isolated pathogens. The toxicity showed to be minimal. While there is no difference reported in disposition of cefotaxime in this age group and adults, with an eradication of half-life of about 1.5 hours, a total serum clearance of 10 ml/min.kg, and a renal clearance of 6 ml/min.kg and a distribution volume of 1 l/kg.
In a similar study conducted by Gian Maria Pacifici, single dose pharmacokinetics of cefotaxime and desacetylcefotaxime after a daily intravenous infusion of 50.0mg/kg in very low birth weight neonates were evaluated. Both cefotaxime (CTX) and desacetylcefotaxime (dCTX) were measured from serum using a high-performance liquid chromatography. On comparison of cefotaxime and desacetylcefotaxime pharmacokinetics parameters, CTX dose of 50.0mg/kg twice daily may provide effectual serum concentrations for susceptible infections outside the central nervous system.
For gonococcal infections a daily single dose of 25 mg/kg per dose, while a single dose of 100 mg/kg was given intravenously or intramuscularly to newborns with gonococcal ophthalmia prophylaxis, whose mothers have gonorrhoea at the time of delivery. Though Cefotaxime is revealed to be discordant to vancomycin, azithromycin, fluconazole, sodium bicarbonate, and protamine sulphate, but the study communicated Rare Side effects but included diarrhoea, rash, phlebitis, eosinophilia and granulocytopenia.
In an attempt to identify the association of extensive use of third-generation cephalosporins in hospitalized infants with the emergence of resistance in faecal gram-negative bacilli, two infants, aged 8.5 to 11 months, were admitted having meningitis induced by Streptococcus pneumonia. Failure of cefotaxime led to the determination of high penicillin G-resistant strains. MICs for penicillin were found to be > 2 μg/ml, and cefotaxime MICs were 2 μg/ml. Both infants reported to have had instantly reacted to a combination of intravenous imipenem and rifampicin. It is thus obligatory to test in-vitro susceptibilities of Streptococcus pneumoniae to β-lactam agents when meningitis is detected in infants; says Gian Maria Pacifici.
During Gian Pacifici’s study period, a total of 246 Children with a mean age of 10 months were diagnosed with multiresistant Salmonella typhimurium systemic infections (Salmonellosis). Of these, 220 were detected with multi-resistant Salmonellosis without metastatic focal infections and 26 had Salmonellosis with metastatic focal infections, including 12 children with meningitis. In 81% (199) children, the multi resistant Salmonellosis was considered to be hospital-acquired. Severe malnutrition, Diarrhoeal disease, and measles were observed to be the most prominent causes of admission. Approximately 99% of children had fever, 72% had diarrhea and 72% found to be with respiratory symptoms. 159 Of 246 children were treated with cefotaxime. In this group, 16 children died. However, 64 of the 87 children who were not given cefotaxime died, while 4% cases of relapse occurred in children with bacteraemia treated with cefotaxime.
These current findings by Gian Maria Pacifici, Associate Professor of Pharmacology confirm the high efficacy of cefotaxime in treating severe systemic infections with multi resistant Salmonella typhimurium infection (bacterial disease affecting the intestinal tract).
From Gian Maria’s findings, it was observed that prescription of cefotaxime in treating severe systemic infections is good, implicating rational approach in giving the treatment, but prescription by generic name and Overuse of antimicrobials is not there which requires the improvement. In acute respiratory tract infections, use of antibiotic, specifically in newborns, is always an area of concern. The overuse as well as misuse of antibiotics, especially in children can not only lead to bacterial resistance but become a cause to various undesirable side effects associated with its use – Gian Maria Pacifici like a responsible researcher added.
One of the crucial tasks undertaken by Gian Pacifici during this course of research has been to examine the drug (cefotaxime) utilization pattern of different diseases, the use of neonatal evaluation tools, reviewing extensive off-label use of medications for treatment of neonates. These together have become very important tool in assessment of neonatal health care system. It literally helped throw a light on an array of aspects of prescribing pattern in the particular area in specific period, and will help to peruse it. Such studies will also assist in execution of potentially different ways to improve prescribing trends for neonatal medical management.
Based on the available evidence, Gian asserts Cefotaxime should be the most effective in managing variety of infectious processes caused by susceptible organisms. The author reveals that it is also highly useful in opposing serious gram‐negative infections, because of its superlative activity against most of these organisms and its low toxicity profile.
She further added: As there cannot always be immediate access of sensitivity and culture report for outpatient setting, there is always conundrum for prescribing an antibiotic. There is still a need of appropriate educational programmes in order to introduce prudent use of antibiotics that necessitates development of standard principles for antibiotic prescription. Moreover, she puts in the plea to create awareness in parents on the subject of the risk-benefit of antibiotics or other drugs for the self-limiting condition.
The present probing by the professor are regularly required to study the drug prescribing practices so that appropriate awareness and analysis will be generated.
The findings from this study highlight the vital aspects to optimize the rational use of cefotaxime and other anti-microbial drugs against acute respiratory tract infections in neonatal and can help to establish the prescribing guidelines.
Full Research Link: http://www.oasispub.org/clinical-pharmacology-of-cefotaxime-in-infants-and-children/
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