Bicalutamide Canon tablets coated. 50 mg 30 pcs. (Bykalutamyd)

Release form

Film-coated tablets

Packing

30 pcs.

Indications

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

Contraindications

Concomitant use with terfenadine, astemizole, cisapride

children

hypersensitivity to bicalutamide

is not prescribed to female patients.

Use during pregnancy and lactation

Do not use in female patients.

Special instructions

Use with caution in patients with moderate to severe impaired liver function, because cumulation of bicalutamide in the body is possible.

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

Composition

Active ingredient:

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.

Composition of the film coat:

Opadry II white 4 mg.

Dosage and administration

Individual, depending on the indications and treatment regimen.

Drug Interactions

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 adverse reactions is possible.

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

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

Overdose

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

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

General supportive therapy and monitoring of vital functions of an organism are shown.

Storage conditions

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

Keep out of the reach and sight of children.

Shelf life

2 years.

Pharmacy conditions

prescription

dosage form

tablets

Kanonfarma, Russia



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