Active substanceNystatinNystatin
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  • Dosage form: & nbsprectal suppositories
    Composition:

    For one suppository.

    Active substance:

    Nystatin

    - 55.5 mg (250,000 IU)

    - 111.0 mg (500,000 IU)

    Excipients:

    propyl parahydroxybenzoate (nipazole)

    2.0 mg

    2.0 mg

    citric acid monohydrate

    - 0.075 mg

    - 0.075 mg

    paraffin liquid (petroleum jelly)

    - 10.0 mg

    - 10.0 mg

    The basis for suppositories:

    hard fat

    - a sufficient amount until a suppository of 2.0 g

    Note. The amount of nystatin is indicated for a drug with an activity of 4500 U / mg in terms of dry matter. In the case of the use of higher activity nystatin, the amount thereof is correspondingly reduced, increasing the amount of the base.

    Description:

    Suppositories yellow, torpedo-shaped, with a maximum diameter of 1.2 cm.

    Pharmacotherapeutic group:Antifungal agent
    ATX: & nbsp

    G.01.A.A   Antibiotics

    G.01.A.A.01   Nystatin

    Pharmacodynamics:

    Antifungal agent, an antibiotic from the group of polyenes. By binding to sterols in the cell membrane of fungi, it breaks its permeability, which leads to the release of the main components of the cell. Active with respect to Candida albicans.

    Pharmacokinetics:Has a weak resorptive effect. When topical application through the mucous membranes is not absorbed. It is excreted through the intestine. Do not cumulate.
    Indications:

    Treatment of candidiasis of the rectum.

    Prevention of fungal infections of the rectum in pre- and postoperative periods during surgical interventions.
    Contraindications:

    Hypersensitivity to the components of the drug, children under 18 years of age (there is no data on the efficacy and safety of nystatin in rectal dosage form in children).

    Pregnancy and lactation:The application is possible if the potential benefit to the mother is greater than the potential risk to the fetus and the baby.The drug is almost not absorbed through the rectal mucosa, so it does not penetrate breast milk. In case of side effects, consult a doctor.
    Dosing and Administration:

    The suppository, previously released from the contoured cell package with scissors (cutting the package along the contour of the suppository), is injected deep into the rectum.

    Adults 1 suppository 2 times a day (morning and evening).

    The course of treatment is 10-14 days. Duration of treatment and the need for repeated courses is determined by the doctor.

    When preventing fungal lesions of the rectum in pre- and postoperative periods with surgical interventions, the course of treatment is 7 days.

    Side effects:

    Diarrhea, abdominal pain, fever, chills, allergic reactions.

    The risk of spreading resistant forms of fungi is possible, which requires the discontinuation of the drug.

    Interaction:

    With the simultaneous use of nystatin with clotrimazole, the activity of the latter decreases.

    Effect on the ability to drive transp. cf. and fur:During the treatment with the drug, it is possible to manage motor vehicles and engage in other potentially hazardous activities,requiring increased concentration of attention and speed of psychomotor reactions.
    Form release / dosage:

    Suppositories rectal 250 000 units and 500 000 units.

    Packaging:

    There are 5 suppositories in a contiguous cell package.

    2 contour squares, together with instructions for use, are placed in a cardboard box.

    Storage conditions:

    In a dry, dark place at a temperature of no higher than 20 ° C.

    Keep out of the reach of children.

    Shelf life:2 years. Do not use after the expiry date printed on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:P N000840 / 01-2001
    Date of registration:24.04.2008 / 14.09.2012
    Expiration Date:Unlimited
    The owner of the registration certificate:BIOSINTEZ, PAO BIOSINTEZ, PAO Russia
    Manufacturer: & nbsp
    Information update date: & nbsp21.06.2018
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