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
Weight | 0.030 kg |
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Shelf life | 2 years |
Conditions of storage | In a dry, light-protected place at a temperature not exceeding 25 °C |
Manufacturer | Kanonfarma Production ZAO, Russia |
Medication form | pills |
Brand | Kanonfarma Production ZAO |
Other forms…
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