Clinical and pharmacological group: & nbsp

Androgens, antiandrogens

Included in the formulation
  • Androblock®
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  • Balutar®
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    TAD Pharma GmbH     Germany
  • Bicalutamide
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    BIOCAD, CJSC     Russia
  • Bicalutamide
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    ATOLL, LLC     Russia
  • Bicalutamide
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    BIOCAD, CJSC     Russia
  • Bicalutamide
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  • Bicalutamide
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  • Bicalutamide
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  • Bicalutamide Grindeks
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    GRINDEX, JSC     Latvia
  • Bicalutamide Cabi
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  • Bicalutamide Canon
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  • Bicalutamide Sandoz®
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    Sandoz d.     Slovenia
  • Bicalutamide-Siguardis
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    SIGARDIS ENG, LLC     Russia
  • Bicalutamide-Teva
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  • Bicutulter
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  • Bicutulter
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  • Bicane®
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    NATIVA, LLC     Russia
  • Bikaprost®
    pills inwards 
  • Bilumide®
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    VEROPHARM SA     Russia
  • Bilumide®
    pills inwards 
    VEROPHARM SA     Russia
  • Calumid®
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    GEDEON RICHTER, OJSC     Hungary
  • Calumid®
    pills inwards 
    GEDEON RICHTER, OJSC     Hungary
  • Casodex®
    pills inwards 
    AstraZeneca UK Ltd     United Kingdom
  • Casodex®
    pills inwards 
    AstraZeneca UK Ltd     United Kingdom
  • Included in the list (Order of the Government of the Russian Federation No. 2782-r of 30.12.2014):

    VED

    ONLS

    АТХ:

    L.02.B.B.03   Bicalutamide

    Pharmacodynamics:

    Antiandrogenic nonsteroid drug. It is a racemic mixture, with anti-androgenic activity predominantly possessing the (R) -enantiomer. The drug does not have other kinds of endocrine activity. The drug binds to androgen receptors and, without activating the expression of genes, suppresses the stimulating effect of androgens. As a result, regression of prostate tumors occurs.

    In some patients, discontinuation may lead to the development of a clinical syndrome of anti-androgen withdrawal.

    Pharmacokinetics:

    Suction

    After oral administration, it is quickly and completely absorbed from the digestive tract. Simultaneous food intake does not affect absorption.

    Distribution

    With a daily intake of bicalutamide in a dose of 50 mg Css (R) -enantiomer in plasma is about 9 μg / ml. At an equilibrium state, about 99% of all enantiomers circulating in the blood form the active (R) -enantiomer.

    With a daily intake of the drug, the concentration of the (R) enantiomer in the plasma increases approximately 10-fold due to the long half-life, which allows you to take the drug 1 time per day.

    The association with plasma proteins is high (for a racemic mixture of 96%, for the (R) -enantiomer 99.6%).

    Metabolism

    Intensively metabolized in the liver by oxidation and the formation of conjugates with glucuronic acid.

    Excretion

    Metabolites are excreted in urine and bile approximately in equal proportions.

    (S) -enantiomer is eliminated from the body much faster (R) -enantiomer, the half-life of the latter is about 7 days.

    Pharmacokinetics in special clinical cases

    The pharmacokinetics of the (R) -enantiomer are not affected by age, renal dysfunction, mild or moderate hepatic impairment.

    There is evidence that in patients with severe impairment of liver function, the elimination of the (R) enantiomer from the plasma is slowed.

    In patients with moderate and severe violations of liver function, cumulation of bicalutamide in the body can be observed.

    Indications:

    Common prostate cancer (in combination with an analogue GnRG or with surgical castration).

    II.C60-C63.C61   Malignant neoplasm of prostate

    Contraindications:

    Simultaneous reception with terfenadine, astemizole, cisapride; hypersensitivity to bicalutamide and other components of the drug.

    The drug is not intended for use in women and children.

    Carefully:

    Caution should be used when prescribing the drug simultaneously with cyclosporine or slow calcium channel blockers. It may be necessary to reduce the dose of these drugs, especially when potentiating or developing unwanted reactions. After the start of use or discontinuation of the drug, it is recommended to carefully monitor the concentration of cyclosporine in the blood plasma and the clinical state of the patient.

    Use caution at the same time bicalutamide and drugs that inhibit microsomal liver enzymes (for example, cimetidine, ketoconazole). The use of these combinations may lead to an increase in the plasma bicalutamide concentration and, possibly, an increase in the incidence of undesired reactions.

    Pregnancy and lactation:

    Contraindicated in women and should not be given to pregnant women or during lactation.

    Dosing and Administration:

    A drug appoint adult men (including the elderly) with advanced prostate cancer in combination with an analogue of GnRH or with surgical castration in a dose of 50 mg once a day. Treatment should be started at the same time as the beginning of the GnRH analogue or surgical castration.

    Patients with impaired renal function and with mild violations of liver function correction of the dose is not required.

    In patients with moderate and severe impairment of liver function can be observed increased cumulation of the drug.

    Side effects:

    The drug is well tolerated by most patients, and only in rare cases it has to be canceled because of the side effects it causes.

    Hot flashes, anemia, dizziness, abdominal pain, constipation, nausea, peripheral edema, hematuria, hepatotoxicity, transient increase in hepatic transaminase activity, cholestasis, decreased appetite, decreased libido, depression, drowsiness, dyspepsia, flatulence, alopecia, hirsutism or growth restoration hair, dry skin, itchy skin,erectile dysfunction, chest pain, weight gain.

    Overdose:

    Cases of overdose in humans are not described. There is no specific antidote, so if necessary, symptomatic therapy is performed. Dialysis is ineffective, because bicalutamide strongly binds to proteins and is not excreted in the urine unchanged. It shows general supportive therapy and monitoring of vital body functions.

    Interaction:

    There is no data on the pharmacodynamic or pharmacokinetic interaction between the drug and GnRH analogues.

    Contraindicated concomitant use with such drugs as terfenadine, astemizole and cisapride.

    A drug enhances the effect of indirect anticoagulants coumarinovogo number (including warfarin), since it can displace these drugs from the sites of their binding to proteins. It is recommended that prothrombin time be regularly monitored when administered to patients receiving indirect coumarin anticoagulants.

    Special instructions:

    The drug is metabolized in the liver. Given the possibility of slowing the excretion of bicalutamide and cumulation of bicalutamide in patients with severe liver function disorders, it is advisable to periodically evaluate liver function.Most changes in liver function occur during the first 6 months of treatment.

    In case of development of pronounced changes in liver function, the drug should be stopped.

    In patients taking GnRH agonists, a decrease in glucose tolerance was observed. This effect can lead to the development of diabetes mellitus or a decrease in glucose tolerance in patients with diabetes mellitus. Therefore, in patients taking and GnRH agonists, it is necessary to monitor the concentration of glucose in the blood.

    Impact on the ability to drive vehicles and manage mechanisms

    When using the drug, drowsiness and dizziness may occur, so care should be taken when driving vehicles or other moving mechanisms.

    Instructions
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