Casodex film-coated tablets 150 mg No. 28

Casodex tablets are indicated for monotherapy or as adjuvant therapy in combination with radical prostatectomy or radiotherapy in patients with locally advanced prostate cancer at high risk of disease progression.

Composition

Active ingredient: bicalutamide;

1 film-coated tablet contains 150 mg of bicalutamide;

Excipients: lactose monohydrate, magnesium stearate, hypromellose; macrogol 300; povidone, sodium starch (type A); titanium dioxide (E 171).

Contraindication

Contraindicated for women and children.

It should not be prescribed to patients who have experienced hypersensitivity reactions to the active substance or any excipients included in the preparation.

Concomitant use of bicalutamide with terfenadine, astemizole, or cisapride is contraindicated.

Method of application

Adult men, including the elderly, one 150 mg tablet orally once a day.

The significant 150 mg dose must be taken for a long time, at least up to 2 years or until signs of disease progression appear.

Application features

Pregnant women

Contraindicated.

Children

Contraindicated.

Drivers

With caution.

Overdose

There are no data on overdose in humans. There is no specific antidote; treatment is symptomatic. Dialysis may be ineffective because bicalutamide is extensively protein bound and is not recovered unchanged in the urine. In case of overdose, general supportive care is indicated, including monitoring of vital signs.

Side effects

Interaction

Caution should be exercised when prescribing bicalutamide with drugs that may inhibit the oxidation of the product (such as cimetidine, ketoconazole). Theoretically, this may lead to an increase in bicalutamide plasma concentrations and may lead to an increase in the side effects of the drug.

Due to the fact that antiandrogen therapy may lead to prolongation of the QT interval, caution should be exercised when prescribing bicalutamide concomitantly with drugs that can prolong the QT interval or cause the development of torsade de pointes, such as class IA (quinidine, disopyramide) or class III (amiodarone, sotalol, dofetilide, ibutilide) antiarrhythmic drugs, methadone, moxifloxacin, neuroleptics, etc.

Storage conditions

Store in the original packaging at a temperature not exceeding 30 °C.

Keep out of reach of children.

Shelf life - 4 years.