Properties
- Form
- suspenzia
- Dosage mg
- 40მგ/
- Pack
- 1
What is it?
DIALIN-M International Nonproprietary Name Nifuroxazide Dosage Form Oral suspension. Description: Yellow suspension with orange flavor. Composition 5 ml of suspension contains: Active substance: Nifuroxazide 200 mg. Excipients: Carbomer, sucrose, citric acid monohydrate, methylparahydroxybenzoate, ethanol 96%, orange flavoring, sodium hydroxide, purified water. ATC code A07AX03 Pharmacotherapeutic group Other antimicrobials used for intestinal infections. Pharmacological properties Pharmacodynamics Nifuroxazide is a nitrofuran derivative, an effective intestinal antiseptic. At recommended doses, it does not cause systemic or toxic effects. The exact mechanism of action is unknown. It is believed that nifuroxazide blocks the activity of dehydrogenases, inhibits cellular respiration and the tricarboxylic acid cycle, and also disrupts protein synthesis in microbial cells. It reduces the production of toxins by microorganisms. It has high activity against Gram-negative bacteria: Campylobacter jejuni, Escherichia coli, Salmonella spp., Shigella spp., Clostridium perfringens, pathogenic vibrios: Vibrio cholerae and Vibrio parahaemolyticus; Gram-positive bacteria: Staphylococcus spp. Weakly sensitive to nifuroxazide: Citrobacter spp., Enterobacter cloacae, and Proteus indologenes. Resistant to nifuroxazide: Klebsiella spp., Proteus mirabilis, Providencia spp., Pseudomonas spp. Nifuroxazide does not affect the saprophytic intestinal flora. Pharmacokinetics After oral administration, nifuroxazide is practically not absorbed from the gastrointestinal tract, which creates a high concentration of the active substance in the intestine (99% of the administered drug remains in the intestine). Nifuroxazide is metabolized in the intestines, and more than 20% is excreted unchanged. Nifuroxazide and its metabolites are excreted in the feces. Indications for use Acute bacterial diarrhea without worsening of general condition, fever, or intoxication (along with rehydration, which is carried out by oral fluid and electrolyte intake, or, if necessary, by intravenous administration). The volume of fluid administered should correspond to the severity of diarrhea, the patient's age, and clinical condition. Method of administration and dosage The drug is taken orally, regardless of food intake. Shake the bottle before use until a homogeneous suspension is obtained. If necessary, the suspension can be taken with water. Use the measuring cup provided in the package for dosing. Children from 1 month to 6 months: 100 mg (2.5 ml of suspension) 2 times a day (200 mg per day). Children from 6 months to 2 years: 100 mg (2.5 ml of suspension) 3 times a day (300 mg per day). Children from 2 to 6 years: 200 mg (5 ml of suspension) 3 times a day (600 mg per day). Children from 6 years of age and adults: 200 mg (5 ml of suspension) 3-4 times a day (600-800 mg per day). Course of treatment - no more than 7 days. Elderly patients There are no clinical studies indicating differences in treatment response between elderly and young patients. Liver and kidney dysfunction There are no clinical studies indicating differences in treatment response between patients with liver and kidney dysfunction and patients with normal liver and kidney function. Children The drug is not used in children under 1 month of age. Contraindications Hypersensitivity to nifuroxazide, nitrofuran derivatives, and/or other components of the drug; pregnancy; prematurity and neonatal period up to 1 month. Adverse reactions Frequency categories for adverse reactions are defined as follows: very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1000, < 1/100); rare (≥ 1/10000, < 1/1000); very rare (< 1/10000); frequency unknown (cannot be estimated from available data). Skin and subcutaneous tissue disorders: frequency unknown - maculopapular erythematous rash, eczema, acute generalized exanthematous pustulosis, photosensitivity reactions. Immune system disorders: frequency unknown - allergic reactions, including rash, urticaria, angioneurotic edema, anaphylactic shock. Blood and lymphatic system disorders: frequency unknown - thrombocytopenia, hemolytic anemia, agranulocytosis. Effects on laboratory and instrumental research results: increased transaminase activity. Kidney and urinary tract disorders: change in urine color. Reporting of suspected adverse reactions Reporting of suspected adverse reactions after drug registration is important. If a patient experiences a serious adverse reaction to the drug or notes a new adverse reaction not described in this section, please report it according to the national pharmacovigilance system. Special instructions Warnings When treating diarrhea with nifuroxazide, rehydration therapy should be carried out. Prevention or treatment of dehydration is carried out using oral or intravenous solutions. In children, it is necessary to ensure frequent fluid intake (every 15 minutes). The established volume of oral rehydration solutions should correspond to the loss of body weight of the child, e.g., with a decrease in body weight of 5-10%, the recommended volume of oral rehydration solution is 50-100 ml/kg of body weight per day. If the frequency of bowel movements is more than 6 per day, diarrhea lasts more than 24 hours, or leads to weight loss, as well as in the presence of vomiting and fever, it is necessary to consult a doctor. In such situations, treatment should be carried out under medical supervision. In the treatment of children with acute or prolonged severe diarrhea, or refusal to eat, rehydration is a very important factor. In case of infectious diarrhea with clinical signs of invasive infection, antibacterial drugs with good systemic diffusion should be used. Precautions If rehydration is indicated for the patient, it is recommended to use solutions intended for this purpose, in accordance with the instructions for dilution and use. If rehydration is not necessary, compensation for lost fluid should be ensured by consuming large amounts of salt and sugar-containing beverages (taking into account the average daily water requirement of 2 liters). During diarrhea, attention should be paid to dietary recommendations: raw vegetables, fruits, green vegetables in any form, spicy food, frozen products, and cold drinks should be excluded from the diet. Preference should be given to rice and meat. Exclusion of milk and dairy products should be considered on a case-by-case basis. Excipients The drug contains ethanol (less than 100 mg per dose), so its use is not recommended in patients with liver disease, epilepsy, alcoholism, as well as during pregnancy and lactation. The drug contains 1 g of sucrose per dose. Patients with rare hereditary diseases - fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase deficiency - should not take this drug. The drug contains less than 1 mmol of sodium (23 mg) per dose, i.e., it is practically "sodium-free". Due to the presence of methylparahydroxybenzoate, DIALIN-M may cause allergic reactions (possibly delayed). Effect on ability to drive vehicles and operate machinery Does not affect. Fertility, pregnancy and lactation Pregnancy There is insufficient data regarding possible teratogenic and fetotoxic effects when nifuroxazide is taken during pregnancy. Animal studies have shown reproductive toxicity. Therefore, as a precautionary measure, its administration during this period is not recommended. Lactation The drug can be used by breastfeeding women with short-term treatment. Fertility Animal studies have shown reproductive toxicity. The potential risk to humans has not been established. Interaction with other drugs Simultaneous use with drugs that suppress central nervous system function or drugs that cause disulfiram-like reactions is not recommended. Overdose In case of overdose, gastric lavage and intestinal cleansing, symptomatic and supportive therapy are recommended. Dosage form 60 ml of oral suspension in a yellow glass bottle with a plastic screw cap. 1 bottle, along with a measuring cup and instructions for medical use, is placed in a cardboard box. Storage conditions Store at a temperature not exceeding 25°C. Keep out of reach of children! Shelf life 3 years from the date of manufacture. Do not use after the expiry date. Dispensing conditions Prescription only.
