Nifuroxazide FT suspension for internal use 220mg/5ml in 90ml bottles in package No. 1

Name:
Nifuroxazide ft. Release formSuspension. INN Nifuroxazide. FTH Antimicrobial agent; nitrofuran.
Description:
Suspension of light yellow color with a banana smell. Stratification of the suspension is allowed, which is eliminated by shaking. Composition 5 ml of suspension contains: Active substance: 220.0 mg of nifuroxazide Excipients: granulated sugar, simethicone emulsion 30%, carbomer, methyl parahydroxybenzoate, Banana flavor, sodium hydroxide, citric acid monohydrate, purified water. Pharmacotherapeutic group Other intestinal antimicrobial agents. ATC code: A 07 AX 03. Pharmacological properties Pharmacodynamics Nifuroxazide is an intestinal antiseptic, a derivative of 5-nitrofuran, has a local antibacterial effect against gram-positive (Staphylococcus family) and gram-negative (Enterobacteriaceae family: Escherichia, Citobacter, Enterobacter, Klebsiella, Salmonella, Shigella, Proteus , Yersinia) bacteria. He is active against bacteria of the Pseudomonas species and strains of subgroup A of the species Proteus inconstans, Providentia alcalifaciens. He destroys the saprophytic bacterial flora of the digestive tract (does not cause dysbacteriosis). Does not cause the emergence of resistant strains resistant to the drug. The effectiveness of the drug is not determined by the pH environment in the intestinal lumen and does not depend on the sensitivity of bacteria to antibiotics. Nifuroxazide inhibits the activity of dehydrogenases and disrupts protein synthesis in microbial cells. Reduces the production of toxins by microorganisms. Pharmacokinetics After oral administration, it is practically not absorbed in the gastrointestinal tract, creates a high concentration of the active substance in the intestine and has an exclusively local antiseptic effect. The drug does not have a systemic effect on the body, does not cause general toxic effects. It is excreted from the body unchanged in the feces. The absorption of nifuroxazide is extremely low if the intestinal mucosa is not disturbed. Indications for use Treatment of acute diarrhea of bacterial origin in the absence of signs of invasion (for example, deterioration in general condition, fever, signs of toxic infection). Concomitant rehydration therapy is determined by the severity of diarrhea, age, gender, body weight of the patient, and the presence of comorbidities. Dosage and administration Inside. Shake the vial of NIFUROXAZIDE several times before use. For dosing, use the dosing cup enclosed in the package. It is recommended to take the drug at regular intervals, regardless of the meal. If necessary, the suspension can be washed down with water. Age Dose Frequency of administration from 2 to 6 months 2.5 ml 2 times a day (every 12 hours) from 7 months to 6 years 5 ml 3 times a day (every 8 hours) over 6 years 5 ml 4 times a day (every 6 hours) adults 5 ml 4 times a day (every 6 hours) The duration of treatment is not more than 7 days. In the treatment of acute diarrhea, depending on the general condition of the patient, it is necessary to replenish (oral or intravenous) the volume of fluid in the body. Side effect The frequency of occurrence of adverse reactions is indicated as: very often (≥ 1/10); often (from ≥ 1/100 to < 1/10); infrequently (from ≥ 1/1000 to < 1/100); rarely (from ≥ 1/10000 to < 1/1000); very rarely (< 1/10000). From the gastrointestinal tract: with individual hypersensitivity, abdominal pain, nausea, increased diarrhea may occur. With severe symptoms, it is necessary to stop taking nifuroxazide and in the future you should not take nifuroxazide and other nitrofuran derivatives. On the part of the blood and lymphatic system: in isolated cases - granulocytopenia. From the skin and subcutaneous tissue: rarely - reactions in the form of skin rash, itching; persistent papular urticaria is possible (if there is a contact allergy to nifuroxazide). Nifuroxazide is generally well tolerated with little to no side effects. Please report any side effects not listed in this leaflet to your doctor or pharmacist. Contraindications - hypersensitivity to nifuroxazide or to any of the auxiliary components; - Hypersensitivity to nitrofuran derivatives; - fructose intolerance, glucose-galactose malabsorption syndrome, sucrase-isomaltase deficiency; - children's age up to 2 months. Overdose Symptoms of an overdose of nifuroxazide are unknown. In case of overdose, gastric lavage and symptomatic treatment are recommended. Interaction with other drugs There is no evidence that nifuroxazide interacts with other drugs. During treatment with NIFUROXAZIDE, simultaneous oral administration of other drugs should be avoided due to the strong adsorption properties of the drug. Precautions NIFUROXAZIDE is not prescribed as monotherapy for the treatment of intestinal infections complicated by septicemia. NIFUROXAZIDE is not recommended for more than 7 days. If diarrhea persists after 2 days of treatment, therapy should be reassessed and the need for oral rehydration or replacement with fluid rehydration should be reassessed. Rehydration is an essential part of treating diarrhea in children under 2 years of age. In case of progression of the disease (deterioration of the general condition, fever, symptoms of intoxication), an antibiotic should be prescribed, because. nifuroxazide is not absorbed from the gastrointestinal tract. While taking the drug, you must adhere to a diet with the exception of raw vegetables and fruits, juices, spicy, fatty and indigestible foods. During treatment with NIFUROXAZIDE, the use of alcoholic beverages is strictly prohibited due to the risk of developing a disulfiram-like reaction (exacerbation of diarrhea, vomiting, abdominal pain, skin flushing, feeling of heat in the face and upper body, noise in the head, shortness of breath, tachycardia, feeling of fear) . If a hypersensitivity reaction occurs (skin rash, itching, shortness of breath), the drug should be discontinued. If during the period of drug therapy symptoms of dehydration appear, rehydration therapy is required (for an adult - about 2 liters of fluid per day) in accordance with the clinical condition of the patient. NIFUROXAZIDE contains sugar, which should be taken into account when prescribing the drug to patients with diabetes mellitus. It is not recommended to take the drug with hereditary disorders of tolerance to fructose, sucrose. 5 ml of suspension contains 0.11 bread units. Use in children The drug should not be administered to children under 2 months of age. Pregnancy and lactation Preclinical animal studies have not revealed teratogenic and fetotoxic effects of nifuroxazide. Clinical data on the effect of the drug during pregnancy and lactation are not available. In this regard, care must be taken when prescribing nifuroxazide to pregnant and lactating women. Influence on the ability to drive vehicles and other complex mechanisms Does not affect. Release form and packaging Suspension for internal use 220 mg / 5 ml in 90 ml bottles in package No. 1. The bottle, together with a dosing cup and a leaflet, is placed in a cardboard box. Storage conditionsKeep in a place protected from light at a temperature not exceeding 25°C. Keep out of the reach of children! Shelf life 2 years. The expiration date is indicated on the packaging. After opening the bottle, store no more than 28 days. Do not use after the expiry date stated on the packaging. 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