Description
Latin name
Bicalutamide Canon
Release form
Film-coated tablets.
Packing
30 pcs
Indications
Prostate cancer – as part of combination therapy with an analog 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.
Composition
1 tablet contains:
Active substances:
bicalutamide 150 mg.
Excipients:
corn starch 107 mg,
croscarmellose sodium 19.5 mg,
lactose monohydrate 132.9 mg,
povidone 7.6 mg,
sodium stearyl fumarate 3 mg.
Composition of the film coat:
Opadry II white 12 mg.
Dosage and administration
Individual, depending on the indications and treatment regimen.
Side effects of
From the endocrine system: hot flashes, tenderness of the mammary glands and gynecomastia, decreased libido.
From the digestive system: abdominal pain, diarrhea, nausea, vomiting, increased levels of transaminases, jaundice, cholestasis.
From the side of the central nervous system: asthenia, depression are possible.
Dermatological reactions: alopecia, hair growth restoration, itching, dry skin.
Other: hematuria.
Drug Interaction
When using bicalutamide for 28 days on midazolam administration, midazolam AUC increased by 80%.
When bicalutamide is co-administered with cyclosporine or calcium channel blockers, potentiation or development of adverse reactions is possible.
It is theoretically possible to increase the concentration of bicalutamide in blood plasma when co-administered with inhibitors of microsomal liver enzymes, which may be accompanied by an increase in the incidence of adverse reactions.
In vitro studies have shown that bicalutamide can displace the anticoagulant coumarin series 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 of children.
Expiration
2 years.
Deystvuyuschee substances
Bykalutamyd
dosage form well
Dosage Formsand
tablets
