Active substanceNifuroxazideNifuroxazide
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  • Dosage form: & nbsptoapsules
    Composition:

    1 capsule contains:

    active substance: nifuroxazide 100/200 mg;

    Excipients: sugar (sucrose), category "extra", corn starch, microcrystalline cellulose, magnesium stearate; capsule hard gelatinous: body and cap capsule - titanium dioxide, iron oxide yellow, gelatin.

    Description:

    Hard gelatin capsules No. 2 (for a dosage of 100 mg) or No. 0 (for a dosage of 200 mg) with a body and a lid of yellow color. The contents of the capsules are a mixture of powder and granules of yellow color.

    Pharmacotherapeutic group:Antimicrobial agent - nitrofuran
    ATX: & nbsp

    A.07.A.X.03   Nifuroxazide

    Pharmacodynamics:

    Nifuroxazide - an intestinal antiseptic, a derivative of 5-nitrofuran, is highly active against Campylobacter jejuni, Escherichia coli, Salmonella spp., Shigella spp; Clostridium perfingens, 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 presumably inhibits the activity of dehydrogenases and the synthesis of proteins in bacterial cells. Does not cause the emergence of drug-resistant strains, nor has cross-resistance been observed with other antibacterial drugs.

    The effectiveness of the action of nifuroxazide does not depend on the pH that exists in the lumen of the intestine, nor on the sensitivity of microorganisms to antibacterial drugs.Does not affect the composition of the normal bacterial flora of the digestive tract. 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, sugar / isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption, pregnancy, children under 3 years.
    Pregnancy and lactation:

    Pregnancy

    In studies on animals, there was no teratogenic effect. However, as a precautionary measure, nifuroxazide during pregnancy is not recommended.

    Breastfeeding period

    During the period of breastfeeding, 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. The capsule should be swallowed whole, washed down with a small amount of water.

    Children from 3 to 6 years: 2 capsules of 100 mg or 1 capsule of 200 mg 3 times a day (the interval between meals is 8 hours).

    Children from 6 to 18 years: 2 capsules of 100 mg or 1 capsule of 200 mg 3-4 times a day (the interval between doses is 6-8 hours).

    Adults: 2 capsules of 100 mg or 1 capsule of 200 mg 4 times a day (the interval between meals 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.

    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,inform the doctor about it.

    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 use, consult a doctor.

    Special instructions:

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

    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 a doctor to decide on the appointment of antimicrobial agents for systemic action.

    During the treatment with a drug, alcohol is prohibited.

    When symptoms of an allergic reaction appear (including shortness of breath, rash, itching), stop taking the medication.

    It should be noted that 1 capsule with a dosage of 100 mg contains 0.036 g of sugar (sucrose),that is 0.0036 XE; 1 capsule with a dosage of 200 mg contains 0.071 g of sugar, which is 0.0071 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:

    Capsules, 100 mg and 200 mg.

    Packaging:

    By 7, 8, 10 or 14 capsules in a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered.

    For 1, 2, 4 contour squares, together with instructions for use, are placed in a pack of cardboard.

    Storage conditions:

    Store in a place protected from light, out of reach of children, at a temperature of no higher than 25 ° C.

    Shelf life:

    3 years.

    Do not use after the expiration date.

    Terms of leave from pharmacies:Without recipe
    Registration number:LP-003940
    Date of registration:07.11.2016 / 02.03.2017
    Expiration Date:07.11.2021
    The owner of the registration certificate:OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC Russia
    Manufacturer: & nbsp
    Representation: & nbspOBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSCOBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSCRussia
    Information update date: & nbsp23.06.2018
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