Active substanceNifuroxazideNifuroxazide
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  • Dosage form: & nbspcapsules
    Composition:

    1 capsule contains:

    Dosage of 100 mg

    active substance: nifuroxazide - 100.0 mg;

    Excipients: corn starch - 44.0 mg; sucrose 36.0 mg; magnesium stearate - 0.9 mg;

    capsules, hard gelatinous: titanium dioxide 2.0%; iron oxide yellow (iron oxide) - 0.6286%; gelatin - up to 100%.

    Dosage 200 mg

    active substance: nifuroxazide - 200.0 mg;

    Excipients: corn starch - 88.0 mg; sucrose - 72.0 mg; magnesium stearate - 1.8 mg;

    capsules, hard gelatinous: titanium dioxide 2.0%; iron oxide yellow (iron oxide) - 0.6286%; gelatin - up to 100%.

    Description:

    Hard gelatin capsules No. 2 (for a dosage of 100 mg) and No. 0 (for a dosage of 200 mg) are yellow. The contents of the capsules are a mixture of granules and yellow powder. Presence of the compressed mass of yellow color, disintegrating at pressing is admissible.

    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. In acute bacterial diarrhea restores intestinal eubiosis. When infected with enterotrophic viruses prevents the development of bacterial superinfection.

    Pharmacokinetics:

    After oral administration nifuroxazide practically not absorbed from the digestive tract and exerts its antibacterial action 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, derivatives of nitrofuran or other components of the drug;

    - Pregnancy;

    - Children under 3 years of age (for this dosage form);

    - deficiency of sugar / isomaltase, intolerance to fructose, glucose-galactose malabsorption.

    Pregnancy and lactation:

    Pregnancy

    In studies on animals, there was no teratogenic effect. However, as a precaution, take the drug Nifuroxazide during pregnancy is contraindicated.

    Breastfeeding period

    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.

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

    Nifuroxazide therapy should not last more than 7 days.

    Capsules 100 mg

    Children from 3 to 6 years

    2 capsules (200 mg) 3 times a day (the interval between meals is 8 hours).

    Children from 6 to 18 years

    2 capsules (200 mg) 3-4 times a day (the interval between doses is 6-8 hours).

    Adults

    2 capsules (200 mg) 4 times a day (the interval between meals is 6 hours).

    Capsules 200 mg

    Children from 3 to 6 years

    1 capsule (200 mg) 3 times a day (the interval between meals is 8 hours).

    Children from 6 to 18 years

    1 capsule (200 mg) 3-4 times a day (the interval between doses is 6-8 hours).

    Adults

    1 capsule (200 mg) 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 three days of admission, you should see 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 drug Nifuroxazide.

    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

    Symptoms of overdose are not known.

    Treatment

    Symptomatic.

    Interaction:

    It is not recommended simultaneous use with drugs that cause the development of disulfiram-like reactions (abdominal pain, nausea, vomiting, headache, tachycardia, blurred vision, weakness, convulsions), drugs that depress the central nervous system.

    If you are taking other medicines (including OTC drugs) before applying the drug Nifuroxazide consult a doctor.

    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.

    In the case of bacterial diarrhea with signs of systemic damage (worsening of the general condition, fever, symptoms of intoxication in case of infection), you should consult a 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 is prohibited.

    Indication for patients with diabetes mellitus

    One single dose (2 capsules 100 mg or 1 capsule 200 mg) of the drug Nifuroxazide contains 72.0 mg of sucrose, which corresponds to 0.006 of the Grain Unit (XE). The maximum daily dose (8 capsules 100 mg or 4 capsules 200 mg) contains 288 mg of sucrose, which corresponds to 0.024 XE (1 XE = 12 grams of carbohydrates).

    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:

    5, 7, 8, 10, 14 or 15 capsules in a planar cell pack of film polyvinylchloride and aluminum foil.

    14, 15, 28, 30, 56 or 60 capsules in a can of high-density polyethylene.

    3 contour packs of 5 capsules, 2 or 4 contour packs of 7 capsules, 7 contour packs of 8 capsules, 3 or 6 loop packs of 10 capsules, 1, 2 or 4 contour packs of 14 capsules, 1, 2 or 4 contourcell packs of 15 capsules or one pot together with instructions for use in a pack of cardboard.

    Storage conditions:

    Store in a dark place at a temperature of no higher than 25 ° C. Keep out of the reach of children.

    Shelf life:

    2 years.

    Do not use after expiry date.

    Terms of leave from pharmacies:Without recipe
    Registration number:LP-004463
    Date of registration:19.09.2017
    Expiration Date:19.09.2022
    The owner of the registration certificate:VERTEKS, AO VERTEKS, AO Russia
    Manufacturer: & nbsp
    Information update date: & nbsp05.10.2017
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