Active substanceNifuroxazideNifuroxazide
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  • Dosage form: & nbspfromIngestion for oral administration
    Composition:

    To 5 ml of suspension:

    Active substance:

    Nifuroxazide

    200.00 mg

    Excipients:

    Sucrose

    1000.00 mg

    Methylparahydroxybenzoate

    5.00 mg

    Ethanol 96%

    0.05 ml

    Carbomer

    10.50 mg

    Lemon acid

    0.75 mg

    Banana flavor

    10.00 mg

    Sodium hydroxide solution 32%

    to pH 5.2-5.8

    Purified water

    up to 5 ml

    Description:Suspension yellow, with a banana odor.
    Pharmacotherapeutic group:Antimicrobial agent - nitrofuran
    ATX: & nbsp

    A.07.A.X.03   Nifuroxazide

    Pharmacodynamics:

    Nifuroxazide is an antimicrobial agent derived from nitrofuran. It blocks the activity of dehydrogenases and depresses the respiratory chains, the cycle of tricarboxylic acids and a number of other biochemical processes in the microbial cell. Destroys the membrane of a microbial cell, reduces the production of toxins by microorganisms.

    Highly active in relation to 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.

    Pharmacokinetics:

    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.

    Indications:

    Acute bacterial diarrhea, proceeding without deterioration of the general condition, fever, intoxication.

    Contraindications:

    - Hypersensitivity to nifuroxazide, to derivatives of nitrofuran and other components of the drug;

    - intolerance to fructose, glucose-galactose malabsorption syndrome or insufficiency of sucrose and isomaltase;

    - pregnancy;

    - period of newborns (up to 1 month), prematurity.

    Carefully:

    - Diseases of the liver,

    - alcoholism,

    - craniocerebral trauma,

    - diseases of the brain,

    - lactation period,

    - children's age (over 1 month).

    Pregnancy and lactation:

    In studies on animals, there was no teratogenic effect. However, as a precautionary measure, nifuroxazide during pregnancy, 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.

    Dosing and Administration:

    Inside.

    A 10 ml measuring cup is used for dosing.Before use, the suspension should be shaken well.

    Children from 1 to 6 months: 100 mg (2.5 ml) 2-3 times a day (the interval between doses is 8-12 hours).

    Children from 6 months to 3 years: 100 mg (2.5 ml) 3 times a day (the interval between doses is 8 hours).

    Children from 3 to 6 years: 200 mg (5 ml) 3 times a day (interval between doses 8 hours).

    Children from 6 years to 18 years: 200 mg (5 ml) 3-4 times a day (the interval between doses is 6-8 h).

    Adults: 200 mg (5 ml) 4 times a day (the interval between doses is 6 hours).

    The duration of the course of treatment is 5-7 days, but not more than 7 days. If there is no improvement within the first 3 days, you should consult a doctor.

    The drug should be used according to the method of administration and at the doses specified in the instructions.

    If necessary, before using the drug, you should consult your doctor.

    Side effects:

    Allergic reactions (skin rash, hives, Quincke's edema, anaphylactic shock).

    If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, tell your doctor.

    Overdose:

    Symptoms overdoses are unknown.

    Treatment: symptomatic.

    Interaction:

    It is not recommended simultaneous use with drugs that cause the development of disulfiram-like reactions, or oppressive central nervous system.

    If you are taking other medications (including over-the-counter drugs), consult your doctor before applying Mirofuril.

    Special instructions:

    When treating diarrhea concomitantly with nifuroxazide therapy, rehydration therapy should be performed.

    Treatment of diarrhea in children under 3 years should be carried out under the supervision of a doctor.

    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 a hypersensitivity reaction develop (skin rash and itching, shortness of breath, shortness of breath), stop taking the drug.

    In connection with the content of methyl parahydroxybenzoate, the drug may cause allergic reactions (possibly delayed).

    The use of alcohol during therapy with nifuroxazide is prohibited.

    It should be noted that the Mirofuril suspension contains 1% ethanol and sucrose.

    The content of ethanol and grain units in single and maximum daily doses of the drug:

    Age-specific and maximum daily doses

    The amount of ethanol (in terms of absolute alcohol) in grams

    Number of bread units

    1 month - 3 years

    Single dose 2.5 ml

    0.019 g

    0,05

    The maximum daily dose of 7.5 ml

    0.057 g

    0,15

    3 years - 6 years

    Single dose 5 ml

    0.038 g

    0,1

    The maximum daily dose of 15 ml

    0.114 g

    0,3

    Adults and children over 6 years of age

    Single dose 5 ml

    0.038 g

    0,1

    The maximum daily dose of 20 ml

    0.152 g

    0,4

    Effect on the ability to drive transp. cf. and fur:

    It has not been studied, but it must be taken into account that the formulation ethanol.

    Form release / dosage:

    Suspension for oral administration, 200 mg / 5 ml.

    Packaging:

    For 90 ml in bottles of dark glass, sealed with a screw cap made of polypropylene with the control of the first opening.

    One bottle with a polypropylene measuring cup and instructions for use are placed in a pack of cardboard.

    Storage conditions:

    In the dark place at a temperature of 15 ° C to 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    2 years.

    Do not use after the expiration date indicated on the package.

    Terms of leave from pharmacies:Without recipe
    Registration number:LP-003932
    Date of registration:02.11.2016 / 05.06.2017
    Expiration Date:02.11.2021
    The owner of the registration certificate:OBNINSKAYA CHEMICAL - PHARMACEUTICAL COMPANY, CJSC OBNINSKAYA CHEMICAL - PHARMACEUTICAL COMPANY, CJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp09.06.2018
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