INDINOL FORTO®

A non-hormonal drug for the treatment of cyclic pain and reduction of discomfort in the breast, including its benign diseases.

 

Description

Capsules No. 0 with white body and orange cap. Inside the capsule there is white to light yellow or light brown powder with characteristic odor.

 

Indications

Indinol Forto is indicated for use in adults aged 18 years and older. Cyclical mastalgia, including in the presence of benign breast hyperplasia.

 

Dosage Regimen

Adults
200 mg twice daily.
The recommended daily dose is 400 mg.
The recommended treatment duration is 6 months.

Special populations
No data are available.

Children
The safety and efficacy of Indinol® Forto in children aged 0 to 18 years have not yet been established. No data are available.

 

Method of Administration

For oral use.

 

Counterindications

— Hypersensitivity to indole-3-carbinol (intrinol) or to any of the excipients
— Hereditary lactose intolerance, lactase deficiency or glucose-galactose malabsorption
— Pregnancy and breastfeeding
— Children under the age of 18

 

Adverse Reactions

 

Summary of the Safety Profile
Information on adverse reactions was obtained from clinical trials, post-marketing safety studies, and spontaneous reports for which a causal relationship between the medicinal product and the adverse event was considered reasonably possible and confirmed. The most commonly reported adverse reactions were nervous system disorders (headache) and gastrointestinal disorders (abdominal pain).

 

Pharmacological Properties

 

Pharmacodynamic Properties
Pharmacotherapeutic group: selective estrogen receptor modulators
ATC code: G03XC.

 

Mechanism of Action
Indolecarbinol is a broad-spectrum modulator of pathological hyperplastic processes in breast tissue and has a beneficial effect on the pathogenesis of benign breast diseases. The therapeutic effect of indolecarbinol is primarily based on its pathogenetically substantiated anti-estrogenic activity, mediated through suppression of estrogen receptor signaling cascades and intracellular signaling pathways that stimulate cell growth. This contributes to a reduction in cellular proliferative potential.
One of the mechanisms of action of indolecarbinol is its ability to induce programmed selective cell death (apoptosis) in breast tissues with abnormally high proliferative activity.

 

Pharmacodynamic Effects

Indolecarbinol modulates the cytochrome system in such a way that the resulting cytochrome P450 isoform, CYP1A1, hydroxylates estrogens at the 2-position, resulting in the formation of 2-hydroxyestrone (2-OHE1). The resulting metabolite acts as an estrogen receptor antagonist and blocks receptor activation by estrogens themselves, as well as by their potentially harmful metabolites, particularly 16α-hydroxyestrone (16α-OHE1), the proportion of which among estrogen metabolites is reduced. As a result of increased production of 2-OHE1 and a reduced proportion of the aggressive metabolite 16α-OHE1, the overall estrogen balance is improved and an anti-estrogenic effect is achieved. This suppresses the induction of estrogen-dependent genes, thereby reducing excessive estrogen-dependent stimulation of the cell.
Indolecarbinol also blocks other signaling mechanisms (cytokine-mediated pathways) that stimulate pathological cell growth in breast tissue by suppressing signaling cascades from the corresponding receptors, thereby exerting an antiproliferative effect. Binding of indolecarbinol to aryl hydrocarbon receptors and modulation of proteins involved in the regulation of apoptosis activate molecular mechanisms of selective cell death in cells with abnormally high proliferative activity.

Through its anti-estrogenic activity and ability to induce selective cell death (apoptosis), indolecarbinol exerts an antiproliferative effect, thereby providing an oncoprotective effect on breast tissue.

 

Clinical Efficacy and Safety
A course of treatment with the medicinal product helps reduce the intensity of breast pain and may lead to its resolution in patients with cyclic mastalgia (mastodynia).
The use of indolecarbinol does not result in weight gain.
Indolecarbinol is classified as a practically non-toxic substance (LD50 > 5 g/kg).

 

Children
Not indicated for use in children under 18 years of age.