NORMIX ® is a rifaximin-based drug
THERAPEUTIC GROUP: Antibiotic - Intestinal antimicrobial
and Gram - with related diarrheal symptoms, in the treatment of diarrheal manifestations associated with altered intestinal flora and in the prevention of infectious complications associated with surgical operations.NORMIX ® is also indicated as an adjuvant in the therapy of hyperammonemia.
, active ingredient of NORMIX ® is an antibiotic belonging to the rifamycin family, particularly indicated in the treatment of intestinal microbial infections, given its low systemic absorption, estimated at a maximum of around 1%.
This important pharmacokinetic property allows the aforementioned antibiotic to reach the intestinal tract at high concentrations, to exert the therapeutic action directly in situ, minimizing the work of the excretory and excretory organs in metabolizing it.
The "broad spectrum of action", which makes rifaximin indicated both in the treatment of infections by Gram + and Gram - bacteria, is justified by the mechanism with which it acts, characterized by the ability to block the transcription process of bacterial DNA, through the "inhibition of" the enzyme RNA polymerase.
. In particular, the emphasis is placed on the increased intestinal bacterial growth, which, diagnosed with a lactulose breath test, and treated with rifaximin, proved to be an important cause of the aforementioned pathology. It is therefore important to consider, at least in the Italian population, the possible bacterial growth as a cause of irritable bowel syndrome, and the administration of rifaximin as a possible therapeutic approach.
2. RIFAXIMINA AND TREATMENT OF ACUTE DIARRHEA
Gut Liver. 2010 Sep; 4: 357-62. Epub 2010 Sep 24.
Efficacy of rifaximin compared with ciprofloxacin for the treatment of acute infectious diarrhea: a randomized controlled multicenter study.
Hong KS, Kim YS, Han DS, Choi CH, Jang BI, Park YS, Lee KM, Lee ST, Kim HS, Kim JS.
Acute diarrhea is often associated with various types of bacterial infections. For years, treatment with ciprofloxacin has been one of the most used therapeutic choices, so much so that it has created a large number of particularly resistant bacterial strains. In this randomized study, it was noted that rifaximin can be more effective than ciprofloxacin in guaranteeing remission of the disease, improving symptoms in 78% of cases treated and restoring correct intestinal health in 57% of patients, values significantly higher than those registered with ciprofloxacin.
3. RIFAXIMINA AND ABDOMINAL PAIN IN PEDIATRIC AGE
J Pediatr Gastroenterol Nutr. 2011 Jan 12.
Double-blind, Placebo-controlled Antibiotic Treatment Study of Small Intestinal Bacterial Overgrowth in Children With Chronic Abdominal Pain.
Collins BS, Lin HC.
Abdominal pain in pediatric age is often related to intestinal bacterial hyperproliferation, which represents a potential risk factor for the onset of irritable bowel syndrome. Although various studies support the efficacy of rifaximin therapy in resolving bacterial overgrowth. bowel syndrome in irritable bowel syndrome, this study instead demonstrates the poor resolutive capacity of the same therapy in children with intense abdominal pain and a positive lactulose test (diagnostic index of bacterial overgrowth).
to therapy with NORMIX ® for which it would be necessary to change the choice of the antibiotic towards a more effective and active one.Among the excipients contained in the oral suspension of NORMIX ® it is possible to detect the presence of sucrose, which could be associated with the appearance of side effects in patients with fructose intolerance and glucose-galactose malabsorption.
The presence of dizziness and headache, associated with the intake of rifaximin, could make it dangerous to drive and use machines.
PREGNANCY AND BREASTFEEDING
At the moment there are no studies able to characterize the safety profile of rifaximin on the health of the fetus when taken during pregnancy, nor the pharmacokinetic characteristics (secretion in breast milk).
Therefore, the intake of NORMIX ® should be limited during pregnancy and breastfeeding to cases of real need and under strict medical supervision.
More rare were disorders affecting the vascular, hepatobiliary, skeletal muscle, renal and skin systems, in any case not clinically relevant and completely transient.
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