Bicalutamide Canon pills 50mg, 30pcs

Composition

Active ingredient:

bicalutamide 50 mg.

Auxiliary substances:

corn starch 35 mg,

croscarmellose sodium 6.5 mg,

lactose monohydrate 44.3 mg,

povidone 3.2 mg,

sodium stearyl fumarate 1 mg.

Composition of the film shell:

Opadray II white 4 mg

Pharmacological action

Pharmacodynamics

Antiandrogenic nonsteroidal drug. Binding to androgen-related receptors, it suppresses androgen activity, resulting in regression of the prostate tumor. It does not have other types of endocrine activity.

Pharmacokinetics

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

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

It is excreted as metabolites in the urine and bile in approximately equal proportions.

Accumulation of bicalutamide in the body is possible.

Indications

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

Use during pregnancy and lactation

Do not prescribe to female patients.

Contraindications

• Concomitant use with terfenadine, astemizole, cisapride;
• children;
• hypersensitivity to bicalutamide;
• do not prescribe to female patients.

Side effects

From the endocrine system: hot flashes, breast tenderness and gynecomastia, decreased libido.

From the digestive system: abdominal pain, diarrhea, nausea, vomiting, increased transaminase levels, jaundice, cholestasis.

From the central nervous system: possible asthenia, depression.

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

Other: hematuria.

Interaction

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

When bicalutamide is co-administered with cyclosporine or calcium channel blockers, potentiation or the development of adverse reactions may occur.

Theoretically, it is possible to increase the concentration of bicalutamide in blood plasma when it is used simultaneously with inhibitors of microsomal liver enzymes, which may be accompanied by an increase in the frequency of adverse reactions.

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

How to take, course of use and dosage

Individual, depending on the indications and treatment regimen.

Overdose

Cases of overdose in humans are not described. There is no specific antidote.

Treatment is symptomatic. Dialysis is not effective because bicalutamide binds strongly to proteins and is not excreted unchanged by the kidneys.

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

Special instructions

Use with caution in patients with moderate to severe hepatic impairment, as accumulation of bicalutamide in the body is possible.

Regular monitoring of liver function is required during treatment. In case of severe changes, it is necessary to stop taking bicalutamide.

Form of production

Film-coated tablets

Storage conditions

Store in a dry place, protected from light, at a temperature not exceeding 25 °C

Shelf life

2 years

Active ingredient

Bicalutamide

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Description

For adults as directed by your doctor

Indications

Cancer