Composition, form of production and packaging
Capsules are hard, gelatinous, size No. 0, with a white body and an orange lid. Contents of the capsule: powder from white to light yellow or light brown in color.
indolcarbinol 0.2 g
Excipients: lactose monohydrate (sugar milk) - 0.14 g, corn modified corn starch - 0.095 g, microcrystalline cellulose - 0.064 g, magnesium stearate - 0.001 g.
20 pcs. - Cellular outline packaging (aluminum / PVC) (3) - cardboard packs.
20 pcs. - Cellular outline packaging (aluminum / PVC) (6) - cardboard packs.
60 pcs. - polymer cans (1) - packs of cardboard.
90 pcs. - polymer cans (1) - packs of cardboard.
120 pcs. - polymer cans (1) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2014.
Selective modulator of estrogen receptors.
Indinol В® Forto is a universal corrector of pathological hyperplastic processes in the tissues of the breast. The therapeutic effect of the preparation Indinol В® Forto is based on its antiestrogenic and antiproliferative action. The main property of the drug Indinol В® Forto is its ability to cause selective death of breast cells with abnormally high proliferative activity.
Indolcarbinol, which is part of the preparation Indinol В® Forto, modulates the cytochrome system in such a way that the cytochrome P450 - CYP1A1 isoform forms hydroxylates estrogens in the 2-position to form 2-hydroxyestrone (2-ONE1). The resulting metabolite is an antagonist of the estrogen receptor and blocks its activation by estrogen itself, as well as their dangerous metabolites, in particular 16 -? - hydroxyestrone (16? -OHE1), whose proportion among metabolites decreases. So the induction of estrogen-dependent genes is suppressed, and the cell ceases to receive excessive estrogen-dependent stimulation. The drug also blocks other signaling mechanisms (cytokines) that stimulate pathological cell growth in the mammary gland tissues, 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 during cyclic mastalgia (mastodynia).
The use of the drug Indinol В® Forto does not lead to an increase in body weight. Indinol В® Forto refers to practically non-toxic preparations (LD 50 > 5 g / kg).
- Treatment of cyclic mastalgia (mastodynia), incl. against a background of benign breast hyperplasia.
Inside, 2 times / day for 200 mg.
The daily dose of the drug is 400 mg. Capsules are taken before meals.
Duration of treatment 6 months.
On the part of the reproductive system: violations of the menstrual cycle in the form of lengthening or shortening.
On the part of the digestive organs: pain in epigastrium.
Laboratory indicators: increased concentrations of thyroid-stimulating and follicle-stimulating hormones, prolactin and estradiol, decreased creatinine concentration, eosinophilia.
Other: weight loss.
According to clinical studies, the number of patients with adverse events did not differ significantly between groups of patients receiving Indinol В® Forto (26.9%) and placebo (20.0%). All revealed undesirable reactions were little expressed and were stopped independently or by the appointment of symptomatic therapy.
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.
- hypersensitivity to the components of the drug;
- hereditary intolerance to galactose;
- deficiency of lactase;
- glucose-galactose malabsorption;
- Children and adolescence under 18 years.
PREGNANCY AND LACTATION
IndinolВ® Forto is contraindicated in pregnancy and lactation.
APPLICATION FOR CHILDREN
Contraindication: children and adolescence under 18 years.
Impact on the ability to drive vehicles and manage mechanisms
Based on the characteristics of pharmacodynamics and the profile of undesirable effects, it is unlikely that Indinol В® Forto influences the ability to manage transport connections and work with machinery.
Symptoms: nausea, vomiting, diarrhea are possible.
Treatment: a specific antidote is unknown. If you suspect an overdose of Indinola Forto, symptomatic therapy is recommended.
Taking into account the influence of indolcarbinol on the activity of cytochrome P450 isoenzymes, 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) to. may need to adjust their dose.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored in a dry place, protected from light and out of reach of children, at a temperature of no higher than 25 В° C. Shelf life - 2 years. Do not use after the expiration date printed on the package.