Indoprolone® (Indoprolon®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceIndolcarbinolIndolcarbinol
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    MiraxBioPharma, ZAO     Russia
  • Indoprolone®
    capsules inwards 
    MiraxBioPharma, ZAO     Russia
    • Dosage form: & nbspcapsules
    Composition:

    1 capsule contains:

    active substance: indolcarbinol (intrinol) 0.200 g;

    Excipients: lactose monohydrate (sugar milk) 0.140 g, corn modified starch 0.095 g, microcrystalline cellulose 0.064 g, magnesium stearate 0.001 g;

    cellulose capsule:

    capsule body: hydroxypropylmethylcellulose (hypromellose) up to 100%, purified water 4-6%, titanium dioxide E 171 2%;

    capsule cover: hydroxypropylmethylcellulose (hypromellose) up to 100%, water purified 4-6%, titanium dioxide E 171 2.2025%, dye sunset yellow E 110 0.1358%).

    Description:

    TOcellulose aps №0 with a white body and an orange cover. The contents of the capsule are powder from white to light yellow or light brown, with a weak specific odor.

    Pharmacotherapeutic group:Mastodinia remedy - estrogen receptor modulator
    ATX: & nbsp

    G.03.X.C   Selective modulators of estrogen receptors

    Pharmacodynamics:

    The drug Indoprolone® is a universal corrector of pathological hyperplastic processes in the tissues of the breast. The therapeutic effect of the active ingredient Indoprolone ® - indolcarbinol (intrinol) is its antiestrogenic and antiproliferative effect.The main property of indolcarbinol is its ability to cause selective death of breast cells with abnormally high proliferative activity. Indolcarbinol modulates the cytochrome system in such a way that the resulting isoform of cytochrome P450 - CYP1A1 hydroxylates estrogens in the 2-nd position, with the formation of 2-hydroxyestrone (2-OHE1). The resulting metabolite is an antagonist of the estrogen receptor and blocks its activation by estrogen itself, as well as by their dangerous metabolites, in particular 16α-hydroxyestrone (16α- OHE1), the proportion of which among metabolites is reduced. So the induction of estrogen-dependent genes is suppressed, and the cell ceases to receive excessive estrogen-dependent stimulation. Indolcarbinol also facilitates the removal of epigenetic modification of tumor suppressor genes and blocks other signaling mechanisms (cytokines) that stimulate pathological cell growth in the breast tissue by suppressing the signal cascades from the corresponding receptors.

    Course use of the drug helps to reduce the intensity and disappearance of pain in the mammary gland atcyclic mastalgia (mastodynia).

    The use of Indoprolone® does not lead to an increase in body weight. Indoprolone® refers to practically non-toxic preparations (LD50> 5 g / kg).

    Indications:

    Cyclic mastalgia, including against the background of benign breast hyperplasia.

    Contraindications:

    The drug should not be used in the presence of any of the following states:

    - hypersensitivity to the components of the drug;

    - hereditary intolerance to galactose, deficiency of lactase or glucose-galactose malabsorption;

    - the period of pregnancy and breastfeeding;

    - Children under 18 years.

    Pregnancy and lactation:

    Contraindicated use of the drug Indoprolon ® during pregnancy and breastfeeding.

    Dosing and Administration:

    Inside, 2 times a day for 200 mg. The daily dose of the drug is 400 mg. Capsules are taken before meals. Duration of treatment 6 months.

    Side effects:

    Violations of the genitals and mammary gland: violations menstrual cycle in the form of lengthening or shortening.

    Disorders from the gastrointestinal tract: pain in the epigastric region.

    Laboratory and instrumental data: increased concentrations of thyroid-stimulating and follicle-stimulating hormones, prolactin and estradiol; decreased creatinine concentration; eosinophilia.

    Disorders from the metabolism and nutrition: weight loss.

    Overdose:

    Possible symptoms of an overdose include nausea, vomiting, diarrhea.

    The specific antidote is unknown. If suspected of an overdose of Indoprolone®, symptomatic therapy is recommended.

    Interaction:

    Indolucarbinol affects the activity of cytochrome P450 isoenzymes, so caution should be exercised when combined with medicaments with cytochrome P450 isoenzymes involved in the metabolism (indirect anticoagulants, glucocorticosteroids, oral hypoglycemic agents, antiarrhythmic, antiepileptic, digitalis preparations, sex hormone preparations), since may need to adjust their dose.

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

    Based on the characteristics of pharmacodynamics and the profile of undesirable effects, it is unlikely,that the drug Indoprolone® has an impact on the ability to drive vehicles and work with machinery.

    Form release / dosage:

    Capsules, 200 mg.

    Packaging:

    For 20 capsules in a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered.

    For 60, 90 or 120 capsules in cans of polymeric, sealed with a stretched plastic lid with a control of the first opening or in cans of polymeric for packing medicines.

    3 or 6 contour packs of 20 capsules, or each jar, together with the instructions for use, are placed in a pack of cardboard.

    Storage conditions:

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

    Keep out of the reach of children.

    Shelf life:

    2 years.

    He apply at the expiration date indicated on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-003085
    Date of registration:13.07.2015
    Expiration Date:13.07.2020
    Date of cancellation:2020-07-13
    The owner of the registration certificate:MiraxBioPharma, ZAO MiraxBioPharma, ZAO Russia
    Manufacturer: & nbsp
    Information update date: & nbsp31.10.2017
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