The need to update instructions on the use of appropriate drugs has been identified.
Section "Pharmacological properties" subsection "Pharmacodynamics" is presented in the following edition: "Nifuroxazide is an antimicrobial agent derived from nitrofuran. It blocks the activity of dehydrogenases and depresses respiratory chains, the cycle of tricarboxylic acids and a number of other biochemical processes in the microbial cell. It breaks the membrane of the microbial cell, toxins by microorganisms. Campylobacter jejuni, Escherichia coli, Salmonella spp, Shigella spp; Clostridium perfringens, Vibrio cholerae, pathogenic Vibrions and Vibrio parahaemolytique, Staphylococcus spp. Weakly sensitive to nifuroxazide: Citrobacter spp, Enterobacter cloacae and Proteus indologenes. Resistant to nifuroxazide: Klebsiella spp, Proteus mirabilis, Providencia spp., Pseudomonas spp. He disturbs the balance of the intestinal microflora. With acute bacterial diarrhea, eubiosis of the intestine is restored. When infected with enterotrophic viruses prevents the development of bacterial superinfection. "
Subsection "Pharmacokinetics" should be presented in the following edition: "After oral administration nifuroxazide practically not absorbed from the digestive tract, and its antibacterial action exerts exclusively in the lumen of the intestine. Nifuroxazide is excreted by the intestine: 20% unchanged, and the rest of the nifuroxazide is chemically altered. " The section "Indications for use" should be presented in the following edition: "Acute bacterial diarrhea, proceeding without deterioration of the general condition, fever, intoxication".
The section "Contraindications" should be presented in the following edition: "Hypersensitivity to nifuroxazide, to derivatives of nitrofuran and other components of the drug, pregnancy." Indicate in this section the age limits: for drugs in dosage form suspension - the period of the newborn to 1 month, prematurity; for preparations in the medicinal form of a capsule, tablets covered with a film membrane - children's age till 3 years. Also supplement the section with contraindications caused by the composition of excipients (for example, lactose, fructose, sucrose).
Section "Pregnancy and lactation" report as follows: "there was no evidence of teratogenic effects in animal studies, however, as a precautionary measure to take. nifuroxazide during pregnancy is not recommended.During the lactation period, it is possible to continue breastfeeding in the case of a short course of treatment with the drug. It is necessary to consult a doctor. "
In the section "Method of administration and dose" the dosage regimen for the suspension should be stated as follows: "Children from 1 to 6 months: 100 mg (indicate the amount of drug in ml, depending on the concentration and the possibility of dosing with the proposed dispensing devices) 2-3 (intervals between doses 8-12 hours) Children from 6 months to 3 years: 100 mg (indicate the amount of drug in ml, depending on the concentration and the possibility of dosing with the proposed dosing devices) 3 times a day (the interval between admission Children from 3 to 6 years: 200 mg (indicate the amount of drug in ml, depending on the concentration and the possibility of dosing with the proposed dosing devices) 3 times a day (interval between meals 8 hours.) Children from 6 to 18 years: 200 mg (indicate the amount of drug in ml, depending on the concentration and the possibility of dosing with the proposed dosing devices) 3-4 times a day (the interval between doses is 6-8 h).Adults: 200 mg (indicate the amount of drug in ml, depending on the concentration and the possibility of dosing with the proposed dosing devices) 4 times a day (interval between doses 6 hours). "
The dosage regimen for capsules, tablets coated with a film coat should be read as follows: "Children from 3 to 6 years: 200 mg (specify the amount of the drug, depending on the dosage form and dosage) 3 times a day (interval between doses 8 hours). Children from 6 to 18 years: 200 mg (specify the amount of the drug depending on the dosage form and dosage) 3-4 times a day (the interval between doses is 6-8 hours) .Adults: 200 mg (indicate the amount of the drug, depending on dosage form and dosage) 4 times in day (interval between doses 6 hours) ".
For all medicinal forms at the end of the section, indicate: "The duration of the course of treatment is 5-7 days, but not more than 7 days.If there is no improvement during the first 3 days of admission, you should consult a doctor. Use the drug only according to the method of administration and in those doses specified in instructions. If necessary, please consult a doctor before using the medication. "
The section "Side effect" is presented in the following edition: "Allergic reactions (skin rash, urticaria, Quincke's edema, anaphylactic shock.) If any of the side effects indicated in the instruction are aggravated, or you notice any other side effects not indicated in the instruction, about this doctor. "
The section "Overdose" should be presented in the following edition: "Symptoms of overdose are not known. Treatment is symptomatic".
The section "Interaction with other medicinal products" should be presented in the following edition: "It is not recommended to use simultaneously with drugs causing the development of disulfiram-like reactions, drugs that depress the central nervous system. If you are taking other medications (including over-the-counter drugs) before use * the trade name preparation * consult a doctor. "
The section "Special instructions" should be read as follows: "In the treatment of diarrhea, simultaneous therapy with nifuroxazide requires rehydration therapy, and treatment of diarrhea in children under 3 years of age should be performed under the supervision of a physician (specify only for a dosage form - suspension).In the case of bacterial diarrhea with signs of systemic damage (worsening of the general condition, fever, symptoms of intoxication, or infection), you should consult your doctor to decide on the use of antibacterial agents of systemic action. If symptoms of hypersensitivity (dyspnea, rash, itching) appear, stop taking the drug. The use of alcohol during therapy with nifuroxazide is prohibited. "If methylparahydroxybenzoate is present in the excipients, indicate:" In connection with the content of methyl parahydroxybenzoate, the drug may cause allergic reactions (possibly delayed). "If sucrose is present in the excipients, indicate its content in a single / dose in X. If ethanol is present in the formulation, it is necessary to indicate in this section the ethanol content of the preparation (in percent) and the amount of ethane and in a single and daily doses of the drug in grams (in terms of absolute alcohol), provided that the ethanol content in the maximum daily dose of the drug in the range of 0.05-3 g in the section "With caution" indicate: "liver disease, alcoholism, cerebral trauma,cerebral diseases, lactation period, children's age ", and if the ethanol content is more than 3 g in a daily dose, indicate the listed conditions in the section" Contraindications ", make the necessary warnings in the section" Influence on the ability to drive vehicles and mechanisms. "
The section "Influence on the ability to drive vehicles and mechanisms" is presented in the following edition: "The drug does not affect the ability to drive vehicles and mechanisms ".