Bicalutamide pills 50mg №30

pharmachologic effect

Pharmacodynamics

Antiandrogenic nonsteroidal agent. By binding to receptors that have affinity for androgens, it inhibits the activity of androgens, as a result of which a regression of the prostate tumor is observed. Does not possess other types of endocrine activity.

Pharmacokinetics

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

Plasma protein binding is 96%. It is extensively metabolized in the liver by oxidation and the formation of glucuronide conjugates.

Excreted in the form of metabolites with urine and bile in approximately equal proportions.

Cumulation of bicalutamide in the body is possible.

Indications

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

Contraindications

• Simultaneous administration with terfenadine, astemizole, cisapride;
• childhood;
• hypersensitivity to bicalutamide;
• Do not prescribe to female patients.

Use during pregnancy and lactation

Do not prescribe to female patients.

special instructions

Use with caution in patients with moderately severe and severe liver dysfunction, because cumulation of bicalutamide in the body is possible.

During the period of treatment requires regular monitoring of liver function.In the case of the development of severe changes, it is necessary to stop taking bicalutamide.

Composition

Active substance: bicalutamide 50 mg.

Excipients: Corn starch 35 mg, croscarmellose sodium 6.5 mg, lactose monohydrate 44.3 mg, povidone 3.2 mg, sodium stearyl fumarate 1 mg.

The composition of the film shell: Opadry II white 4 mg.

Dosage and administration

Individual, depending on the indications and treatment regimen.

Side effects

On the part of the endocrine system: hot flashes, breast tenderness and gynecomastia, decreased libido.

Gastrointestinal: abdominal pain, diarrhea, nausea, vomiting, increased transaminase levels, jaundice, cholestasis.

From the side of the central nervous system: possible asthenia, depression.

Dermatologic: alopecia, hair regrowth, itching, dry skin.

Other: hematuria.

Drug interaction

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

With the simultaneous use of bicalutamide with cyclosporine or Calcium channel blockers, potentiation or development of undesirable reactions is possible.

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

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

Overdosage

Cases of overdose in humans are not described. There is no specific antidote.Symptomatic treatment. Dialysis is not effective because bicalutamide binds strongly to proteins and is not excreted by the kidneys unchanged. General supportive therapy and monitoring of vital body functions is shown.

Storage conditions

Store in a dry, dark place at a temperature not exceeding 25 ° C.

Keep out of the reach of children.