Active substanceNifuroxazideNifuroxazide
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  • Dosage form: & nbspcapsules
    Composition:

    Composition per one capsule:

    Active substance:

    Nifuroxazide 100,000 mg 200,000 mg

    Excipient:

    Sucrose 35.500 mg 71,000 mg

    Corn starch 34,000 mg 68,000 mg

    Microcrystalline cellulose 4,500 mg 9,000 mg

    Magnesium stearate 1,000 mg 2,000 mg

    Capsule shell:

    Gelatin 60.085 mg 94.080 mg

    Titanium dioxide (E171) 0.610 mg 1.920 mg

    Iron oxide yellow * 0.305 mg

    * For capsules with a dosage of 100 mg

    Description:

    Capsules 100 mg:

    Hard gelatin capsules number 2, body and lid yellow. The contents of the capsules are yellow powder or yellow powder with inclusions in the form of small pieces of compressed mass, or a compressed yellow powder that crumbles when pressed lightly.

    Capsules 200 mg:

    Hard gelatin capsules No. 0, body and cap of white color. The contents of the capsules are yellow powder or yellow powder with inclusions in the form of small pieces of compressed mass, or a compressed yellow powder that crumbles when pressed lightly.

    Pharmacotherapeutic group:Antimicrobial agent, nitrofuran
    ATX: & nbsp

    A.07.A.X.03   Nifuroxazide

    Pharmacodynamics:

    A broad-spectrum antimicrobial agent, a derivative of 5-nitrofuran. It is assumed that the antimicrobial activity of nifuroxazide is caused by the presence in its composition NO2-group, which causes inhibition of dehydrogenase activity and disrupts the synthesis of proteins in pathogenic bacteria. 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.

    When used in therapeutic doses, it has bacteriostatic action, in high - bactericidal.

    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 has no effect on saprophyte flora, does not disturb the balance of normal intestinal flora. 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, which occurs without deterioration of the general condition, fever, intoxication.

    Contraindications:

    - hypersensitivity to nitrofuran derivatives or other components of the drug;

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

    - pregnancy;

    - children's age up to 3 years (for this dosage form).

    Pregnancy and lactation:

    Use during pregnancy is contraindicated.

    Nifuroxazide is not absorbed from the gastrointestinal tract and does not enter the systemic circulation, however, the use of the drug during lactation is possible only on strict indications, and the issue of stopping breastfeeding should be resolved.
    Dosing and Administration:

    Inside. Nifuroxazide therapy should not last more than 7 days.

    Capsules 100 mg:

    Adults and children over 6 years of age, the drug is prescribed 2 capsules (200 mg) 4 times a day, a daily dose of 800 mg.

    For children 3-6 years, the drug is prescribed 2 capsules (200 mg) 3 times a day, daily dose - 600 mg.

    Capsules 200 mg:

    Adults and children over 6 years of age, the drug is prescribed 1 capsule (200 mg) 4 times a day, daily dose - 800 mg.

    For children 3 to 6 years, the drug is prescribed 1 capsule (200 mg) 3 times a day, daily dose - 600 mg.

    If there is no improvement within the first three days of admission, you should see a doctor.

    Side effects:

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

    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, report this doctor.

    Overdose:

    The drug is not absorbed from the digestive tract and does not enter the systemic circulation. Symptoms of overdose are not known. In case of exceeding the dose, gastric lavage and symptomatic treatment are recommended.

    Interaction:

    There is no evidence that nifuroxazide interacts with other drugs.

    With the simultaneous administration of ethanol, a disulfiram-like reaction may develop (abdominal pain, nausea, vomiting, headache, tachycardia, blurred vision, weakness, convulsions).

    It is not recommended simultaneous use with drugs that depress the central nervous system.

    Special instructions:

    When treating diarrhea concomitantly with nifuroxazide therapy, rehydration therapy (oral or intravenous) should be performed in accordance with the patient's condition and the intensity of diarrhea.

    It is forbidden to use alcohol during therapy, as it increases the sensitivity of the body to nifuroxazide.

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

    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.

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

    The drug does not affect psychomotor activity and the ability to drive vehicles and work with mechanisms.

    Form release / dosage:Capsules 100 mg, 200 mg.
    Packaging:

    Capsules 100 mg:

    10 capsules in a planar cell package. By 1, 2, 3, 4 or 5 contour mesh packages together with instructions for use in a pack of cardboard.

    Capsules 200 mg:

    For 7, 8 or 10 capsules in a planar cell package. By 1,2, 3, 4 or 5 contour mesh packages together with instructions for use in a pack of cardboard.
    Storage conditions:

    In the dark place at a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:3 years. Do not use the drug after the expiry date printed on the package.
    Terms of leave from pharmacies:Without recipe
    Registration number:LP-003340
    Date of registration:27.11.2015
    Expiration Date:27.11.2020
    The owner of the registration certificate:OBNINSKAYA CHEMICAL - PHARMACEUTICAL COMPANY, CJSC OBNINSKAYA CHEMICAL - PHARMACEUTICAL COMPANY, CJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp24.08.2016
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