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Indinol-forto

Препарат Индинол-форто. ЗАО "МираксБиоФарма" Россия


Producer: CJSC Miraksbiofarm Russia

Code of automatic telephone exchange: G03XC

Release form: Firm dosage forms. Capsules.

Indications to use: Mastalgiya.


General characteristics. Structure:

Active ingredient: 200 mg of indolcarbinol.

Excipients: lactoses monohydrate (sugar milk), the starch corn modified cellulose microcrystallic, magnesium stearate.

The universal proofreader of pathological hyperplastic processes in tissues of a mammary gland.




Pharmacological properties:

Pharmacodynamics. The selection modulator of estrogenic receptors.

Therapeutic effect of the drug Indinol® of Forto is the cornerstone of it anti-oestrogenic and anti-proliferative action. The main property of the drug Indinol® of Forto is his ability to cause selective death of cells of a mammary gland with abnormally high proliferative activity.

The indolcarbinol which is a part of the drug Indinol® of Forto modulates tsitokhromny system in such a way that the formed P450 cytochrome isoform - CYP1A1 hydroxylates estrogen in the 2nd situation, with education 2 hydroxyestrones (2-OHE1). The received metabolite is an antagonist of a receptor of estrogen and blocks its activation by estrogen, and also their dangerous metabolites, in particular, 16-α-гидроксиэстроном (16α-ОНЕ1) which share among metabolites decreases. So induction estrogen - dependent genes is suppressed, and the cell ceases to receive excessive is oestrogenic - dependent stimulation. Drug also blocks other alarm mechanisms (tsitokinovy) stimulating pathological cellular growth in tissues of a mammary gland by means of suppression of alarm cascades from the corresponding receptors.

Course use of drug promotes reduction of intensity and disappearance of a pain syndrome in a mammary gland at a cyclic mastalgiya (mastodynia).

Use of the drug Indinol® of Forto does not lead to increase in body weight. Индинол® the Fort treats almost non-toxic drugs (LD50> of 5 g/kg).


Indications to use:

— treatment of a cyclic mastalgiya (mastodynia), including against the background of a benign hyperplasia of a mammary gland.


Route of administration and doses:

Inside, 2 times/days on 200 mg. The daily dose of drug makes 400 mg. Capsules accept before food. Duration of a course of treatment is 6 months.


Features of use:

Drug Indinol® use of Forto at pregnancy and in the period of a lactation is contraindicated.

Influence on ability to driving of motor transport and to control of mechanisms

Proceeding from features of a pharmacodynamics and profile of undesirable effects, it is improbable that Forto's Indinol® exerts impact on ability to manage transporty soyedstvo and to work with the equipment.


Side effects:

From reproductive system: disturbances of a menstrual cycle in the form of lengthening or shortening.

From digestive organs: pain in epigastriums.

Laboratory indicators: increase in concentration of thyritropic and follicle-stimulating hormones, prolactin and oestradiol, decrease in concentration of creatinine, eosinophilia.

Other: decrease in body weight.

According to clinical trials the number of patients with the undesirable phenomena had no significant differences between groups of the patients receiving Forto's Indinol® (26.9%) and placebo (20.0%). All revealed undesirable reactions were a little expressed and were stopped independently or purpose of symptomatic therapy.

If any of the side effects specified in the instruction are aggravated, or you noticed any other side effects which are not specified in the instruction, report about it to the doctor.


Interaction with other medicines:

Considering influence of indolcarbinol on activity of isoenzymes of P450 cytochrome, it is necessary to be careful at combined use with medicines in which metabolism P450 cytochrome isoenzymes participate (indirect anticoagulants, glucocorticosteroids, peroral hypoglycemic means, antiarrhytmic, antiepileptic, foxglove drugs, drugs of sex hormones) since correction of their dose can be required.


Contraindications:

— hypersensitivity to drug components;

— hereditary intolerance of a galactose;

— deficit of lactase;

— glyukozo-galaktozny malabsorption;

— pregnancy;

— breastfeeding;

— children's and teenage age up to 18 years.


Overdose:

Symptoms: nausea, vomiting, diarrhea are possible.

Treatment: the specific antidote is unknown. At suspicion on Indinol Forto's overdose symptomatic therapy is recommended.


Storage conditions:

Drug should be stored in dry, protected from light and unavailable to children mesty at a temperature not above 25 °C. A period of validity - 2 years. Not to use after the period of validity specified on packaging.


Issue conditions:

According to the recipe


Packaging:

20 pieces - strip packagings planimetric (aluminia/PVC) (3) - packs cardboard.
20 pieces - strip packagings planimetric (aluminia/PVC) (6) - packs cardboard.
60 pieces - banks polymeric (1) - packs cardboard.
90 pieces - banks polymeric (1) - packs cardboard.
120 pieces - banks polymeric (1) - packs cardboard.



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