Calutamide 50 Milligrams (Bicalutamide)

Adult dose

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

This medication should not be administered to women and children under 18 years of age. Additionally, patients who have had an allergic reaction to this medication or any of its components should not use it. It is also prohibited to take it in conjunction with certain medications such as terfenadine, astemizole, or cisapride. This medication should not be administered to patients with a history of liver damage or severe liver impairment. It contains lactose, thus patients with lactose intolerance or related genetic disorders should not take it. Caution is required when using this drug in patients with liver function issues. Since the drug is primarily metabolized by the liver, if liver function is impaired, there is a heightened risk of side effects due to accumulation in the body. Taking this medication may lead to side effects such as anemia, dizziness, facial flushing, dyspepsia, skin rash, hematuria, gynecomastia, and fatigue. Serious side effects such as myocardial infarction, heart failure, liver toxicity, and interstitial lung disease have also been reported in some patients. If serious side effects or abnormal symptoms occur, immediate consultation with medical personnel is necessary. While taking this medication, regular liver function tests are important. Treatment may be halted if liver damage is suspected. Additionally, since this drug inhibits certain liver metabolic enzymes, caution is necessary due to potential interactions with other drugs. Caution is also needed when driving or operating machinery as confusion or drowsiness may occur. This medication is contraindicated for women, and women who are pregnant or breastfeeding should not use it. Children under 18 years of age should also not use it. In the case of elderly patients, close monitoring of their condition is required due to possible heart and circulatory function decline during administration. In cases of overdose, since there are no specific antidotes, appropriate treatment should be provided based on symptoms, and blood dialysis may have limited effectiveness. This medication should be stored out of reach of children and in its original container to prevent quality degradation or misuse.

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

This medication should be stored at room temperature below 30 degrees Celsius, in a tightly sealed container to prevent exposure to air or moisture. This will help maintain the effectiveness of the drug for an extended period.

Appearance

White or nearly white round film-coated tablet

Package unit

28 tablets/box [(14 tablets/PTP)x2]