Active substanceNifuroxazideNifuroxazide
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  • Dosage form: & nbspcapsules
    Composition:

    Composition per one capsule for a dosage of 100 mg:

    active substance:

    nifuroxazide 100.0 mg

    Excipients:

    lactulose-300.0 mg, microcrystalline cellulose-23.0 mg, potato starch- 9.0 mg, magnesium stearate-4.0 mg, sucrose, to obtain a mass of the contents of the capsule 460.0 mg.

    capsules, hard gelatinous No. 0 [gelatin (up to 100%, water (14-15%), dye quinoline yellow (0.5834%), dye sunset (0.0026%), titanium dioxide (0.9740%)];

    for a dosage of 200 mg:
    active substance:
    nifuroxazide 200.0 mg

    Excipients:

    lactulose-300.0 mg, microcrystalline cellulose-58.0 mg, potato starch-18.0 mg, magnesium stearate-6.0 mg, sucrose, to obtain a mass of the contents of the capsule, 630.0 mg.

    capsules, hard gelatinous00 [gelatin (up to 100%), water (14-15%), lid: dye crimson [Ponso 4R] (0.079801%), blue dye patented (0.00165%), dye sunset (0.093301%), titanium dioxide (0.813158%),

    body: dye quinoline yellow (0.583356%), dye sun, sunset (0.002565%), titanium dioxide (0.974035%)].

    Description:Hard gelatin capsules No. 0 yellow (for a dosage of 100 mg) and capsule No. 00 with a yellow casing and an orange lid (for a dosage of 200 mg).The contents of the capsules are a granular powder of yellow color with white impregnations.
    Pharmacotherapeutic group:antimicrobial agent-nitrofuran
    ATX: & nbsp

    A.07.A.X.03   Nifuroxazide

    Pharmacodynamics:

    A broad spectrum antimicrobial agenti is a 5-nitrofuran derivative. Used to treat infections of the gastrointestinal tract. Nifuroxazide blocks the activity of dehydrogenases and depresses the respiratory chain, the cycle of tricarboxylic acids and other biochemical reactions in the bacterial cell. It destroys the membranes of sensitive bacteria, reduces the production of toxins by microorganisms. Activates immunity, increases the activity of phagocytes and the complement titer.

    Effective against gram-positive microorganisms:

    Staphylococcus spp .;

    Streptococcus spp.
    and Gram-negative microorganisms:
    Salmonella spp .;
    Klebsiella spp .;
    Enterobacter spp .;
    Escherichia coli;
    Shigella spp .;
    Proteus spp .;
    Haemophilus influenzae;
    Campilobacter spp .;

    Edwarsiella spp .;

    Citrobacter spp .;

    Vibrio cholerae;

    Yersinia enterocolitica.

    Nifuroxazide does not affect the state of normal microflora of the human intestine. 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 in the gastrointestinal tract and does not have a systemic effect. Antibacterial activity against sensitive species of bacteria manifests only in the lumen of the intestine. In unchanged form is excreted by the intestine. The rate of elimination depends on the dose of the drug and the motility of the gastrointestinal tract.
    Indications:

    Acute and chronic diarrhea of ​​infectious genesis (without signs of helminthic invasion).

    Chronic colitis and enterocolitis.

    Contraindications:

    Hypersensitivity to nifuroxazide, other components of the drug, other derivatives of 5-nitrofuran.

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

    Children up to 3 years (for this form).

    Pregnancy and lactation:

    There are no data on adverse effects on the fetus during pregnancy. If necessary, with caution, the drug can be given to pregnant women and women breastfeeding.

    Dosing and Administration:

    Adults and children over 7 years: 2 capsules of 100 mg or 1 capsule of 200 mg 4 times a day, (800 mg / day).

    Children 3-7 years: 2 capsules of 100 mg or 1 capsule of 200 mg 3 times a day, (600 mg / day).

    The duration of therapy with nifuroxazide is no more than 7 days.
    Side effects:Allergic reactions.
    Overdose:

    Specific symptoms of overdose are not described. Standard emergency measures are recommended.

    Interaction:No data on the interaction of nifuroxazide with other drugs have been published.
    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 duration of diarrhea.

    During therapy with nifuroxazide, alcohol intake is not allowed.

    Effect on the ability to drive transp. cf. and fur:The drug does not adversely affect the ability to drive, vehicles, and / or other mechanisms
    Form release / dosage:

    Capsules 100 mg and 200 mg.

    Packaging:

    10 capsules (100 mg dosage) or 5, 7, 8 capsules (200 mg dosage) are placed in a contoured cell pack of a polyvinylchloride film and aluminum foil printed lacquer.

    For 30 capsules (100 mg dosage) or 16, 28 or 30 capsules (200 mg dosage) in a plastic bottle with a screw cap or a polymer can with a screw cap.

    3 contour packagings (for 100 mg dosage) or 2 contour packs of 8 capsules, 4 contour packs of 7 capsules or 6 out-of-box packs of 5 capsules (for 200 mg dosage) or 1 bottle or 1 can with Instructions for use are placed in a pack of cardboard.

    Storage conditions:

    In a place protected from moisture and light, at a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    5 years. Do not use after expiry date.

    Terms of leave from pharmacies:Without recipe
    Registration number:LP-001566
    Date of registration:06.03.2012
    The owner of the registration certificate:AVVA RUS, OJSC AVVA RUS, OJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp30.07.2015
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