Procadex Tablets (Bicalutamide)

Adult dose

1. Adult men and elderly patients receiving this drug in combination with a luteinizing hormone-releasing hormone (LHRH) analogue or in combination with surgical castration : Administer 50 mg of bicalutamide orally once daily. Start taking this drug at least 3 days before administration of the LHRH analogue or on the day of surgical castration. 2. Patients with locally advanced, nonmetastatic prostate cancer at high risk of disease progression, receiving this drug as monotherapy or as adjuvant therapy to radical prostatectomy or radiotherapy : Adult men and elderly patients: Administer 150 mg of bicalutamide orally once daily. This 150 mg regimen should be continued for at least 2 years or until disease progression.

This medication should not be used by women and children under 18 years of age. Additionally, it should not be administered to patients who have had an allergic reaction to this drug or any of its ingredients. It should also not be used in conjunction with specific medications such as terfenadine, astemizole, and cisapride. Patients with a history of liver damage or severe liver impairment should not be treated with this medication, and those with liver dysfunction should use it cautiously. Since this medication contains lactose, patients with hereditary issues such as lactose intolerance, lactase deficiency, or glucose-galactose malabsorption should not take it. It is important to conduct regular liver function tests while using this medication, and if liver damage or failure occurs, treatment should be stopped immediately. As this drug is primarily metabolized by the liver, there is a risk of accumulation in patients with decreased liver function. The drug may affect the nervous system, potentially causing dizziness or drowsiness; caution is recommended when driving or operating machinery. Regular blood tests are necessary as anemia may be indicated, and if abnormalities are found, treatment should be discontinued and appropriate measures taken. Rarely, cardiovascular adverse reactions such as myocardial infarction, heart failure, and arrhythmias have been reported, so caution is advised for patients with heart disease. The medication may cause skin-related side effects such as rash, itching, and hair loss. Patients with lactose hypersensitivity should check the lactose content in this medication and exercise caution. This drug may interact with other medications, particularly those metabolized via the CYP3A4 pathway, so consultation with healthcare providers is necessary when taking them together. Caution is particularly warranted when used with anticoagulants such as warfarin, as the risk of bleeding may increase, necessitating frequent blood coagulation tests. This medication presents a risk of QT interval prolongation, so care should be taken if used with drugs that may affect heart rhythm. This drug should not be used during pregnancy or while breastfeeding. In case of overdose, as there are no specific antidotes, appropriate treatment should be given based on symptoms, and blood dialysis may not be effective. This medication should be kept out of reach of children and stored in its original container to prevent degradation in quality.

• Anemia
• dizziness
• facial flushing
• abdominal pain
• constipation
• nausea
• diarrhea
• rash
• hematuria
• gynecomastia

This drug should be stored in a tightly sealed container to protect it from air and moisture. It is recommended to maintain storage temperatures between 1 and 30 degrees Celsius.

Appearance

White round film-coated tablets

Package unit

28 tablets (14 tablets/PTP X 2)