Bicalutamide Canon, 150 mg 30 pcs

Pharmacodynamics

Anti-androgenic nonsteroidal agent. By binding to receptors that have an affinity for androgens, it suppresses androgen activity, as a result of which regression of the prostate tumor is observed. It has no other endocrine activity.

Pharmacokinetics

After oral administration is well absorbed from the gastrointestinal tract. Food intake does not affect bioavailability.

The binding to plasma proteins is 96%. It is extensively metabolized in the liver by oxidation and formation of glucuronide conjugates.

Extracted as metabolites with urine and bile in approximately equal proportions.

Cumulation of bicalutamide in the body is possible.

Indications

Cancer

Prostate cancer – as part of combination therapy with a GnRH analogue or with surgical castration.

Active ingredient

Bicalutamide

Composition

Active ingredient:

bicalutamide 150 mg.

Associates:

Corn starch 107 mg, croscarmellose sodium 19.5 mg, lactose monohydrate 132.9 mg, povidone 7.6 mg, sodium stearyl fumarate 3 mg.
Film coating composition: Opadray II white 12 mg.

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How to take, the dosage

Individual, depending on the indication and treatment regimen.

Interaction

When bicalutamide was used for 28 days against midazolam, the AUC of midazolam was increased by 80%.

Concomitant use of bicalutamide with cyclosporine or calcium channel blockers may result in potentiation or adverse reactions.

Theoretically it is possible to increase plasma concentrations of bicalutamide when used concomitantly with liver microsomal enzyme inhibitors, which may be accompanied by an increased incidence of adverse reactions.

In vitro studies have shown that bicalutamide can displace the coumarin-type anticoagulant warfarin from plasma protein binding sites.

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Special Instructions

Use with caution in patients with moderate to severe hepatic dysfunction because bicalutamide may cumulate in the body.

Hepatic function should be monitored regularly during treatment. In case of development of severe changes it is necessary to discontinue bicalutamide.

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Contraindications

• Simultaneous use with terfenadine, astemizole, cisapride
• childhood
• high sensitivity to bicalutamide
• do not prescribe for female patients.

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Side effects

Endocrine system disorders: hot flashes, breast pain and gynecomastia, decreased libido.

Digestive system disorders: abdominal pain, diarrhea, nausea, vomiting, increased transaminases, jaundice, cholestasis.

CNS disorders: asthenia and depression are possible.

Dermatological reactions: alopecia, hair growth restoration, itching, dry skin.

Others: hematuria.

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Overdose

There have been no cases of overdose in humans. There is no specific antidote.

The treatment is symptomatic. Dialysis is not effective because bicalutamide is firmly bound to proteins and is not excreted unchanged by the kidneys.

General supportive therapy and monitoring of vital body functions are indicated.

Pregnancy use

It is not prescribed for female patients.

Similarities

Casodex, Bicalutamide