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Manufacturers: Laboratoires Synthelabo Groupe, Sanofi-Winthrop Industrie (France)
Active ingredients
- Nifuroxazide
Disease class
- Bacterial intestinal infection, unspecified
Clinical and pharmacological group
- Antibacterial drugs
Pharmacological action
- Antibacterial
Pharmacological group
- Other synthetic antibacterial agents
Pharmacological properties
Antimicrobial agent, nitrofuran derivative. Blocks the activity of dehydrogenases and inhibits the respiratory chain, the tricarboxylic acid cycle and a number of other biochemical processes in the microbial cell. Destroys the microbial cell membrane, reduces the production of toxins by microorganisms. Highly active against Campilobacter jejuni, Escherichia coli, Salmonella spp., Shigella spp., Clostridium perfringens, Vibrio cholerae pathogenic Vibrions and Vibrio parahaemolyticus, Staphylococcus spp.
Weakly sensitive to nifuroxazide: Citrobacter spp., Enterobacter cloacae and Proteus indologenes. Resistant to nifuroxazide: Klebsiella spp., Proteus mirabilis, Providencia spp., Pseudomonas spp.
Does not disturb the balance of intestinal microflora. In acute bacterial diarrhea, it restores intestinal eubiosis. When infected with enterotropic viruses, it prevents the development of bacterial superinfection.
Pharmacokinetics
After oral administration, nifuroxazide is practically not absorbed from the digestive tract and exerts its antibacterial effect exclusively in the intestinal lumen. Nifuroxazide is excreted by the intestines: 20% unchanged, and the remaining amount of nifuroxazide is chemically modified.
Ersefuril
The drug ersefuril, produced by the world-famous transnational pharmaceutical company Sanofi Aventis, belongs to the group of antibacterial agents and is used to treat acute diarrhea. Diarrhea is defined as an increase in bowel movements up to 3 or more times a day due to a thinning of the stool consistency. If this condition lasts more than 2 weeks, then it is considered to be a chronic form of diarrhea; if less, then it is acute. Diarrhea can be non-infectious and infectious. In developed countries, infectious diarrhea is most often caused by viruses transmitted by the fecal-oral route through food, water, or household contact. A separate form of this disease is traveler's diarrhea, which can sometimes develop when a person changes his geographic location. Treatment of diarrhea is carried out in several areas: rehydration therapy, taking zinc supplements, vitamins, macro- and microelements, using special diets, symptomatic treatment and antibacterial therapy. The need to include antibacterial agents in the treatment regimen depends on the clinical picture of the disease. If diarrhea is non-inflammatory in nature, the degree of dehydration is low and the disease does not risk taking a chronic form, then you can do without antibacterial agents. If diarrhea occurs in an inflammatory manner against the background of severe dehydration and tends to become chronic, then antibacterial therapy is mandatory. Moreover, in the vast majority of cases, drug selection is carried out empirically, because the cost of stool culture is too high to use this diagnostic method on an ongoing basis. Ersefuril is the drug of choice for acute infectious diarrhea, which occurs without significant deterioration in the patient’s general condition, fever, or symptoms of poisoning (exo- or endogenous). Along with other nitrofurans, ersefuril prevents the occurrence of certain oxido-reductase reactions in bacterial cells.
When used in recommended doses, it has a bacteriostatic effect, i.e. does not destroy bacteria, but prevents their growth and reproduction. In high doses, the drug exhibits bactericidal activity, i.e. cause the death of microorganisms. Ersefuril is effective against infectious diarrhea caused by Escherichia coli, Campylobacter jejuni, Salmonella spp, Shigella spp, Vibrio cholerae, Vibrio parahaemolytique, Staphylococcus spp., Clostridium perfringens. Enterobacter cloacae, Citrobacter spp., Proteus indologenes are slightly sensitive to ersefuril. Completely resistant to the drug Proteus mirabilis, Providencia spp., Klebsiella spp., Pseudomonas spp. Ersefuril has virtually no effect on the normal saprophytic intestinal microflora (does not cause dysbiosis). Resistance to the drug does not develop in microorganisms sensitive to it.
Ersefuril is available in capsule form. The drug is used in adults and children over 6 years of age. Adults take 4 capsules per day (total 800 mg) in 2-4 doses, children - 3-4 capsules per day in the same 2-4 doses. The duration of the medication course is no more than 1 week. The active substance of ersefuril - nifuroxazide - is practically not absorbed from the gastrointestinal tract: 99% of the taken amount remains in the intestines and fully fulfills its antibacterial purpose there. Elimination of ersefuril from the body is carried out by the intestines. If diarrhea is prolonged, accompanied by severe vomiting or complete loss of appetite, parenteral administration of water and electrolytes for rehydration should be considered. If there is no improvement due to more than two days of taking ersefuril, adjustments to the treatment should be made and, possibly, antimicrobials with good systemic diffusion should be prescribed.
Directions for use and doses
Inside. For dosing, a double-sided measuring spoon is used, with a volume of 2.5 ml on one side and 5 ml on the other side. The suspension must be shaken well before use.
Children aged 1-6 months: 2.5 ml 2 or 3 times a day (with an interval of 8-12 hours).
Children aged 6 months to 3 years: 2.5 ml 3 times a day (interval between doses 8 hours).
Children aged 3 to 6 years: 5 ml 3 times a day (interval between doses is 8 hours). Children from 6 to 18 years old: 5 ml 3-4 times a day (interval between doses 6-8 hours).
Adults: 5 ml 4 times a day (interval between doses 6 hours).
The duration of treatment is 5-7 days, but not more than 7 days. If there is no improvement within the first three days, you should consult a doctor. The drug should be used according to the method of application and in the doses indicated in the instructions. If necessary, you should consult your doctor before using the drug.
Ersefuril 200 mg No. 14 caps.
Trade name ErsefurilÒ International nonproprietary name Nifuroxazide Dosage form Capsules 200 mg Composition One capsule contains the active substance - nifuroxazide 200.00 mg, excipients: corn starch, sucrose, magnesium stearate, gelatin capsule composition: titanium dioxide (E 171), iron (III ) yellow oxide (E 172), gelatin. Description Yellow capsules of oblong shape, size No. 1. The contents of the capsules are yellow powder. Pharmacotherapeutic group Antidiarrheal drugs. Other intestinal antimicrobials. Nifuroxazide. ATC code A07AX03 Pharmacological properties Pharmacokinetics With intact intestinal mucosa, absorption of the drug is extremely low. Pharmacodynamics Ersefuril belongs to nitrofuran derivatives containing a nitro group (NO2) which has an antiseptic effect. The NO2 radical can be reduced to nitroso derivatives, which alter the bases of bacterial DNA. All these derivatives have bacteriostatic and bactericidal effects. Ersefuril has an inhibitory effect on the activity of dehydrogenases and protein synthesis in bacterial cells, mostly in the intestinal lumen. Ersefuril does not cause resistance in bacterial strains and does not inhibit the saprophytic intestinal flora, which is the first protective barrier of the gastrointestinal tract against pathogenic microorganisms. Clinical studies have found that nifuroxazide does not increase the population of resistant bacteria in the intestines and yeast fungi compared to an antibiotic (for example, taking neomycin for 7 days). Other clinical studies have shown that nifuroxazide has no effect on fecal flora in healthy subjects, either after high doses (1200 mg) or at usual therapeutic doses (800 mg/day for 6 days). Activity of nifuroxazide against some strains: very sensitive group minimum inhibitory concentration (MIC <8 mg/l): Campylobacter, Vibrio cholerae, Shigella Clostridium perfrigers; moderately sensitive group (MIC < 8 to 32 mg/l): Escherichia coli, Salmonella, Haffnia, Yersinia, Staphylococcus, Enterococcus; resistant group (MIC > 32 mg/l): Klebsiella, Enterobacter, Serratia, Proteus mirabillis, Providentia, Pseudomonas, Acinetobacter. Indications for use - acute bacterial diarrhea, if there is no suspicion of the spread of infection to other organs and systems (i.e. deterioration of the general condition, fever, signs of intoxication). This therapy does not replace diet and rehydration if necessary. Method of administration and dosage: For adults, a daily dose of 800 mg is recommended, divided into 2-4 doses, regardless of food intake, for example, 1 capsule (200 mg) 4 times a day or 2 capsules (400 mg) 2 times a day for Adolescents over 15 years of age up to 18 years of age, a daily dose of 600–800 mg is recommended, divided into 2-4 doses, regardless of food intake, for example, 1 capsule (200 mg) 3-4 times a day or 2 capsules (400 mg) 2 times in a day. The maximum daily dose for adults and adolescents is 800 mg. The duration of treatment is 3 days. If diarrhea does not stop within 2 days of treatment, the therapeutic approach should be reconsidered. Side effects - allergic reactions: skin rashes, urticaria, Quincke's edema, anaphylactic shock Contraindications - hypersensitivity to nitrofuran derivatives, or to any of the components of the drug - children and adolescents under 15 years of age (due to the risk of inhalation) - fructose intolerance, glucose-galactose malabsorption syndrome, sucrase-isomaltase deficiency - pregnancy and lactation Drug interactions Ersefuril is not recommended for use in combination with drugs leading to disulfiram-like reactions or with central nervous system depressants. Special instructions If diarrhea persists for more than 3 days during treatment, treatment should be reconsidered. The need and volume of oral or infusion rehydration therapy is determined in accordance with the severity of diarrhea, age and condition of the patient (including concomitant diseases). Peculiarities of the drug's influence on the ability to drive a vehicle or operate potentially dangerous mechanisms. No effect. Overdose There are no data on overdose of nifuroxazide. In case of overdose, it is necessary to monitor the patient's condition and provide symptomatic therapy. Release form and packaging 14 capsules each in a blister pack made of polyvinyl chloride film and aluminum foil. 1 or 2 strip packaging along with instructions for medical use in the state and Russian languages are placed in a cardboard pack. Storage conditions At a temperature not exceeding 30C. Keep out of the reach of children! Shelf life: 5 years Do not use after the expiration date indicated on the package. Conditions for dispensing from pharmacies Without a prescription Manufacturer Sanofi Winthrop Industry, France for Sanofi-Aventis France, France
special instructions
When treating diarrhea, rehydration therapy must be carried out simultaneously with nifuroxazide therapy. Treatment of diarrhea in children under 3 years of age should be carried out under medical supervision. In case of bacterial diarrhea with signs of systemic damage (deterioration of general condition, increased body temperature, symptoms of intoxication or infection), you should consult a doctor to decide on the use of systemic antibacterial drugs.
If symptoms of a hypersensitivity reaction appear (skin rash and itching, difficulty breathing, shortness of breath), you should stop taking the drug.
Due to the content of methyl parahydroxybenzoate, the drug may cause allergic reactions (possibly delayed).
Drinking alcohol during therapy with nifuroxazide is prohibited.
Impact on the ability to drive vehicles and perform work that requires increased concentration and speed of psychomotor reactions
The drug does not have a negative effect on the ability to drive vehicles and/or other mechanisms.
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