Active substanceNifuroxazideNifuroxazide
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  • Dosage form: & nbsporal suspension
    Composition:

    5 ml of the suspension contain:

    active substance: nifuroxazide - 220.0 mg;

    Excipients: carbomer 11.00 mg, sucrose 1100.00 mg, sodium hydroxide 2.20 mg, citric acid monohydrate 0.83 mg, 30% emulsion simethicone (antifoam emulsion) 11.00 mg methyl parahydroxybenzoate 5.50 mg, banana flavor - 4,57 mg, water up to 5,00 ml.

    Description:Suspension of light yellow color, with a banana smell; during storage, the formation of a precipitate is possible, after shaking it returns to the state of a homogeneous suspension.
    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.

    Nifuroxazide does not disturb 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, nitrofuran derivatives or any excipients 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.

    Pregnancy and lactation:

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

    Dosing and Administration:

    It is applied inside.

    Before taking the drug, shake the bottle several times to make the suspension homogeneous. The drug can be washed down with water.

    Children aged from 1 to 6 months:

    110 mg (1 small measuring spoon of suspension) 2-3 times a day (the interval between doses is 8-12 h).

    Children aged 6 months to 3 years:

    110 mg (1 small measuring spoon of suspension) 3 times a day (interval between doses 8 hours). Children aged 3 to 6 years:

    220 mg (1 large measuring spoon of the suspension) 3 times a day (interval between doses 8 hours).

    Children aged 6 to 18 years:

    220 mg (1 large measuring spoon of the suspension) 3-4 times a day (the interval between doses is 6-8 h).

    Adults:

    220 mg (1 large measuring spoon of the suspension) 4 times a day (the interval between doses is 6 hours).

    The drug Stopdiar should be used for 5-7 days, but not more than 7 days. If there is no improvement within the first 3 days, you should consult a doctor.

    Use the drug only according to the method of administration and the doses specified in the instructions. If necessary, please consult with your doctor before using the medication.

    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 of overdose are not known.

    Treatment is symptomatic.

    Interaction:

    It is not recommended simultaneous use with drugs that cause 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 using Stoppediar, consult your doctor.

    Special instructions:

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

    Treatment of diarrhea in children under 3 years is recommended 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.

    When symptoms of hypersensitivity (dyspnea, rash, itching) occur, stop taking the drug.

    During therapy, alcohol is not allowed.

    The drug Stopdiar contains sucrose. Patients with rare hereditary impairments of fructose tolerance, glucose-galactose malabsorption or insufficiency of sucrose and isomaltase should not take this drug.

    In connection with the content of methylparahydroxybenzoate, Stopdiar can cause allergic reactions (possibly delayed).

    In one small measuring spoon the suspension contains 0.09 XE (bread units), in one large measuring spoon the suspension contains 0.18 XE.

    The daily dose of the suspension for children aged 1 month to 3 years contains 0.27 XE. The daily dose of the suspension for children aged 3 to 6 years contains 0.54 XE. The maximum daily dose of the suspension for children aged 6 to 18 years old contains 0.72 XE.

    The daily dose of the suspension for adults contains 0.72 XE.

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

    The drug does not affect the ability to drive vehicles and mechanisms.

    Form release / dosage:

    Suspension for oral administration, 220 mg / 5 ml.

    Packaging:

    To 90 ml of the suspension in an orange glass bottle 125 ml, equipped with a liner made of polyethylene, facilitating the pouring out of the suspension, clogged with a screw cap made of polyethylene.

    1 bottle together with a double metering spoon made of polystyrene with a capacity of 2.5 ml and 5 ml and instructions for use in a cardboard pack.

    Storage conditions:

    At a temperature of no higher than 25 ° C.

    Keep out of the reach of children!

    Shelf life:

    3 years.

    Do not use after the expiry date printed on the package.

    The opened vial should be stored no more than 14 days.

    Terms of leave from pharmacies:Without recipe
    Registration number:П N012440 / 01
    Date of registration:10.10.2008 / 02.02.2017
    Expiration Date:Unlimited
    The owner of the registration certificate:GEDEON RICHTER, OJSC GEDEON RICHTER, OJSC Hungary
    Manufacturer: & nbsp
    Representation: & nbspGEDEON RICHTER OJSC GEDEON RICHTER OJSC Hungary
    Information update date: & nbsp21.02.2017
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