Bicalutamide canon tab p / 50 mg of the film 30 pc

$16.53

Bicalutamide canon tab p / 50 mg of the film 30 pc

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Description

Composition
Active substance:
1 tablet of 50 mg film-coated contains 50 mg bicalutamide; 1 tablet 150 mg film-coated contains 150mg bicalutamide ;.
Excipients:
Corn starch, sodium croscarmellose (primelloza), lactose monohydrate (milk sugar), povidone, sodium stearyl fumarate; composition of the film coating: Opadry II White, including: polyvinyl alcohol, macrogol (polyethylene glycol), talc, titanium dioxide.
Description:
Tablets, coated membrane coated white or almost white, round, biconvex.
Product form:
Tablets, film-coated 50mg, 150mg.
For tablet dosage 50 mg: 7, 10 or 30 tablets in blisters of PVC film and aluminum foil printed patent.
At 2, 4 blisters of 7 tablets or 1, 3, 6 contour cell packs of 10 tablets, or 1, 2 blisters of 30 tablets together with instructions for use placed in a pile of cardboard.
For tablet dosage 150 mg: 7, 10 or 15 tablets in blisters of PVC film and aluminum foil printed patent.
At 2, 4 blisters of 7 tablets or 1, 3, 6 contour cell packs of 10 tablets, or 2, 4 blisters with 15 tablets with instructions for use placed in a pile of cardboard.
Contraindications
-Increasing sensitivity to bicalutamide or other components of the formulation; -Defitsit lactase, lactose intolerance, glucose-galactose malabsorption; – Women; -Childhood; – Simultaneous treatment with terfenadine, astemizole, and cisapride.
Carefully:
If abnormal liver function.
Dosage
50 mg
Indications
-Monoterapiya or adjuvant therapy in combination with an analog of gonadotropin releasing hormone (GnRH) or surgical castration, advanced prostate cancer; -Treatment locally advanced prostate cancer (T3-T4, any N, M0, T1-T2, N +, M0) as a single agent or adjuvant therapy in combination with radical prostatectomy or radiotherapy; -Treatment of locally advanced non-metastatic prostate cancer in cases where surgical castration or other drugs are ineffective or inappropriate.
Interaction with other drugs
There is no evidence of pharmacokinetic or pharmacodynamic interactions between bicalutamide and GnRH analogues.
In in vitro studies have shown that (R) -enantiomer bicalutamide inhibited CYP 3A4, to a lesser extent affecting the activity of isozymes CYP 2C9, 2C19, 2D6. In clinical studies using phenazone as a marker for the activity of cytochrome P450 (CYP) is detected potential drug’s ability to interact with other medications, but the application of bicalutamide for 28 days in patients receiving midazolam, area under “concentration – time” curve (AUC) midazolam was increased by 80%.
Concomitant use bicalutamide with drugs such as terfenadine, astemizole and cisapride. Caution must be exercised when applying bicalutamide simultaneously with cyclosporin blockers “slow” calcium channel; drugs that inhibit microsomal liver enzymes, such as ketoconazole or cimetidine (may require dose reduction of these drugs). Simultaneous administration may lead to an increase in plasma concentrations of bicalutamide, and possibly an increase in the incidence of adverse effects.
It enhances the effect of anticoagulants of the coumarin series, including warfarin (competition for protein binding). It is recommended to regularly monitor the prothrombin time in the appointment of bicalutamide in patients receiving oral anticoagulants coumarin.
Overdose
Cases of overdose have not been described in humans. No specific antidote. Overdose Treatment – symptomatic, requires monitoring of vital body functions. Hemodialysis is ineffective, since bicalutamide is firmly bound to plasma proteins and is excreted in the urine in unchanged form.
pharmachologic effect
Pharmacological group:
Antineoplastic drug – an anti-androgen.
Pharmacodynamics:
Antitumor agents, non-steroidal anti-androgenic drug – competitive antagonist of endogenous androgens. By binding to receptors on the surface of cells Organs, making them inaccessible to androgens, while increasing the concentration of hormones in the plasma. This results in a regression of prostate tumors.
Application bicalutamide 150 mg / day patients with localized (T1-T2, N0 or NX, MO) or locally (TK-T4, any N, M0; any T, N +, M0) prostate cancer reduces the risk of disease progression and the relative the risk of metastasis in the bone.
However, the effectiveness of bicalutamide against survival rates lower than that in the performance of surgical castration.
In some patients, discontinuation may lead to the development of the syndrome of “cancellation” antiandrogens (after the abolition of 10-15% of patients there comes a temporary stabilization of the disease).
Pharmacokinetics:
Once inside quickly and completely absorbed from the gastrointestinal tract (GIT) (food intake does not affect absorption). Relationship to plasma proteins – 96-99%. It is extensively metabolized in the liver (by oxidation and formation of conjugates with glucuronic acid) to inactive (S) – and the active (R) -enantiomers. The time to reach maximum plasma concentration (TStah) (R) -enantiomer -. H 31.3 (S) -enantiomer is excreted much faster (R) -enantiomer, the half-life (T1 / 2) of the last – about 7 days. With daily administration of bicalutamide in a dosage of 150 mg / day equilibrium plasma concentration (Css) (R) -enantiomer of -22 micrograms / ml. When Css about 99% of all circulating blood enantiomers is active (R) -enantiomer. With daily administration concentration (R) -enantiomer in the plasma is increased by approximately 10 times due to the long T1 / 2. Displayed in the kidneys and in bile metabolites in equal proportions. Pharmacokinetics (R) -enantiomer does not depend upon the age, renal function against moderate impaired liver function; in patients with severe hepatic impairment slows elimination of (R) -enantiomer from the plasma.
Pregnancy and breast-feeding
Canon Bicalutamide is contraindicated in women and must not be given to pregnant or lactating.
Conditions of supply of pharmacies
Prescription.
side effects
Classification of the WHO frequency of side effects: very often -> 1/10 assignments (> 10%) frequently – by> 1/100 to 1%, and
special instructions
Bicalutamide is extensively metabolized in the liver. Given the possibility of slowing down excretion of bicalutamide and accumulation of bicalutamide in patients with severe hepatic impairment, it is advisable to periodically assess liver function.
Most of the changes of liver function occur in the first six months of treatment.
Bicalutamide should be used with caution in patients with moderate and severe hepatic impairment.
Serious liver when using the drug are rare, reported cases fatal. In the case of pronounced changes in liver function and / or increasing functional tests by more than 2 times the drug must be stopped.
When co-administered with cyclosporin, after the start of use or withdrawal bicalutamide recommended careful monitoring of cyclosporin plasma concentrations and condition of the patient.
In patients with disease progression on higher concentrations of prostate-specific antigen (ASA) should consider stopping treatment with bicalutamide.
Given the possibility of drug inhibiting activity of cytochrome P450 (isozyme CYP 3A4), caution should be exercised while the use of bicalutamide with drugs metabolized mainly involving isoenzyme CYP 3A4. It is recommended to regularly monitor the prothrombin time in the appointment of bicalutamide in patients receiving oral anticoagulants coumarin.
Patients receiving GnRH agonists, there was a decrease in glucose tolerance. This effect may lead to the development of diabetes or impaired glucose tolerance in patients with diabetes. In this connection, in patients receiving bicalutamide in combination with GnRH agonists necessary to control the blood glucose concentration.
Effects on ability to drive and use other mechanisms:
In the application of bicalutamide may experience drowsiness or dizziness, and therefore caution should be exercised when driving vehicles or other moving machinery.
Storage conditions
In a dry, dark place at a temperature not higher than 25 ° C. Keep out of the reach of children.
Dosing and Administration
Adult males including the elderly: the prevalence of prostate cancer in combination with a GnRH analogue or surgical castration: the interior of 50 mg once a day.
In locally advanced prostate cancer: the interior of 150 mg once a day.
Bicalutamide should be taken continuously, for at least 2 years.
If signs of progression of the disease taking the drug should be discontinued.
Renal dysfunction: a dose adjustment is required.
Impaired function of the liver: in mild hepatic impairment dose adjustment is required. Patients with impaired liver function moderate and severe there may be drug accumulation – require dose adjustment.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist

Additional information

Weight0.100 kg
Manufacturer

KANONFARMA

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