Composition
1 tablet contains:
Active ingredient:
bicalutamide 50 mg;
Auxiliary substances:
Magnesium alumometasilicate,
Sodium Carboxymethyl Starch,
Magnesium stearate,
Ludipress (lactose monohydrate, lovidone, crospovidone).
Pharmacological action
Bicalutamide is an antitumor agent, it is a racemic mixture with nonsteroidal antiandrogenic activity mainly of the (R) – enantiomer, and has no other endocrine activity.
Bicalutamide binds to androgen receptors on the surface of target organ cells, suppresses the stimulating effect of androgens, without activating gene expression. As a result, there is a regression of malignant neoplasms of the prostate gland.
In some patients, discontinuation of bicalutamide may lead to the development of a clinical syndrome of” withdrawal ” of antiandrogens.
Indications
Prostate cancer:
– the treatment of prostate cancer in combination with a gonadotrophin-releasing hormone (GnRH analogue) or surgical castration;
– monotherapy or adjuvant therapy in combination with radical prostatectomy or radiotherapy for locally advanced prostate cancer (T3-T 4, any N, M0; T1-T 2, N+, M0);
– treatment of locally advanced, nemetallicheskih of prostate cancer in cases where surgical castration or other medical intervention is inappropriate or not applicable.
Contraindications
Hypersensitivity to bicalutamide or any other component of the drug Bicana.
Concomitant use of terfenadine, astemizole and cisapride.
Bicalutamide is contraindicated in children and women.
With caution:
Lactose intolerance, lactase deficiency and glucose-galactose malabsorption (because the drug contains lactose); impaired liver function; simultaneous use with cyclosporine or slow calcium channel blockers; simultaneous use with drugs that inhibit microsomal oxidation of drugs (cimetidine or ketoconazole).
How to take, course of use and dosage
Inside, regardless of the meal, with a sufficient amount of liquid.
The drug Bikana is prescribed for adult men (including the elderly). In advanced prostate cancer-inside 50 mg once a day, in combination with the simultaneous start of treatment with an analog of GnRH or surgical castration.
For locally advanced non-metastatic prostate cancer-150 mg once a day.
Bicalutamide should be taken continuously for at least 2 years.
If there are signs of disease progression, the drug should be discontinued.
Impaired renal function: no dose adjustment is required.
Hepatic impairment: No dose adjustment is required in patients with mild hepatic impairment.
In patients with moderate or severe hepatic impairment, increased accumulation of bicalutamide is possible, and therefore Bicana should be used with caution.
Active ingredient
Bicalutamide
Conditions of release from pharmacies
By prescription
Dosage form
Tablets
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