Treatment (in adults and children> 12 years) of gastrointestinal diseases that have been caused or caused by bacteria sensitive to rifaximin, such as: intestinal infections; traveler's diarrhea; hepatic encephalopathy; symptomatic, uncomplicated diverticulatory disease of the large intestine in adult patients using the high resident diet.
Composition:
1 tabl powl. contains 200 mg of rifaximin. 5 ml of the reconstituted suspension contains 100 mg rifaximin.
Action:
Semi-synthetic derivative of rifamycin with a broad spectrum of antibacterial activity. Bactericidal - irreversibly binds to the β subunit of the bacterial DNA-dependent RNA polymerase and, as a result, inhibits the synthesis of bacterial RNA and proteins. It affects most strains of bacteria, both Gram-negative and Gram-positive, aerobic and anaerobic, responsible for causing gastrointestinal infections and travelers' diarrhea. Species sensitive - Gram-negative aerobes:Salmonella spp., Shigella spp., Escherichia coli (including enteropathogenic strains),Proteus spp., Campylobacter spp., Pseudomonas spp., Yersinia spp., Enterobacter spp., Klebsiella spp., Helicobacter pylori; Gram-negative anaerobic: Bacteroides spp. (inclusive from Bacteroides fragilis),Fusobacterium nucleatum;Gram-positive oxygen: Streptococcus spp., Enterococcus spp. (includingEnterococcus fecalis), Staphylococcus spp.; Gram-positive anaerobic:Clostridium spp. (includingClostridium difficile andClostridium perfringens); Peptostreptococcus spp. The broad antimicrobial spectrum of rifaximin allows reducing the presence of excess bacteria in the large intestine and, consequently, the production of ammonia and other toxic substances, which in the case of advanced liver disease with disruption of detoxification processes are involved in the pathogenesis and symptomatology of hepatic encephalopathy. Rifaximin is virtually absorbed from the gastrointestinal tract (<1%). The antibiotic acts locally in the intestine, where it gets very high concentrations; they are much higher than the MIC value for the studied enteropathogens.
Contraindications:
Hypersensitivity to rifaximin, other rifamycins or to any of the excipients. Intestinal obstruction (even partial), severe ulcerative intestinal damage.
Precautions:
Do not use in patients with diarrhea complicated by fever or with the presence of blood in the stool - these symptoms are usually an expression of significant intestinal mucous membrane involvement by invasive intestinal pathogens and rifaximin, with insignificant absorption in the gastrointestinal tract, is not effective in these cases. In case of prolongation of infectious diarrhea symptoms over 24-48 h or worsening of the course of disease, rifaximine should be discontinued and other treatment should be implemented. In patients with diarrhea after treatment, pseudomembranous colitis should be considered. In case of long-term treatment with large doses or in the case of damage to the intestinal mucosa, a small amount of the drug (<1%) may be absorbed, which may lead to a reddish urine (the active substance has a red-orange color). The efficacy and safety of rifaximin in children <12 years has not been established. The granules contain sucrose (5.8 g in 20 ml) - granules should not be used in patients with fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase deficiency; the sucrose content should be taken into account when using granules in diabetic patients.
Pregnancy and lactation:
Due to the lack of data, the drug should not be used during pregnancy. It is not known whether rifaximin is excreted in human milk, but probably its concentration is insignificant due to low systemic absorption - in breast-feeding women it should be decided to stop feeding or administering rifaximin.
Side effects:
Common: flatulence, abdominal pain, constipation, sudden need to empty, diarrhea, flatulence, nausea, painful pressure on the stool, vomiting, fever, headache.Uncommon: upper abdominal pain, ascites, indigestion, dry mouth, gastrointestinal motility disorder, presence of fresh blood in the stool, stool with mucus admixture, lymphocytosis, monocytosis, neutropenia, palpitations, dizziness, diplopia, asthenia, unspecified unpleasant chest pain, chest pain, chills, lack of efficacy, fatigue, flu-like illness, peripheral edema, pain, candidosis, yeast vaginal infection, sunburn, increase in AST, increase in blood pressure, presence blood cells in the urine, anorexia, back pain, muscle contraction, weakness of muscle strength, muscle pain, lack of taste, hypoaesthesia, sleep disorders, insomnia, glycosuria, pollakiuria, polyuria, excessive menstruation, dry throat, shortness of breath, nasal obstruction, sore throat and larynx, cold sweats, rash, beach rash mista, redness of the face. In addition, the following side effects were seen after marketing (very rarely): anaphylactoid reaction, angioedema, facial edema, dermatitis, exanthema, pruritus, urticaria.
Dosage:
Orally.Intestinal infections and traveler's diarrhea (adults and children> 12 years): 200 mg every 8 hours to 400 mg every 8-12 hours.Hepatic encephalopathy (adults and children> 12 years): 400 mg every 8 hours. Treatment duration should not exceed 7 days.Symptomatic, uncomplicated diverticulatory disease of the large intestine in patients using the high-resocyte diet (adults): 400 mg every 12 hours for 7 days; if necessary, the treatment can be repeated every month in the Next 11 months (in total a maximum of 12 cycles of 7 days each); after complete resolution of symptoms, treatment should be discontinued. A single treatment period with rifaximin should not exceed 7 days. Each re-inclusion should be preceded by a period of 30 days without rifaximin.Special groups of patients. In patients with impaired liver function, there is no need to modify the dosage. The pharmacokinetics of rifaximin has not been studied in patients with impaired renal function and in patients ≥65 years of age.
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