Medication info
Casodex Tablets (Bicalutamide)

Casodex Tablets (Bicalutamide)

Prescription medicationTabletOral
Ingredient · strength
Bicalutamide›50mg / 1 tablet
Manufacturer / importer
Shinpoong Pharmaceutical Co., Ltd.
Appearance
White round film-coated tablet
Packaging
28 tablets (14 tablets/PTP x 2)
Approval status
Active

MFDS item code 200702739 · Notified 2007.02.28 · Insurance code 648503130

Summary

Main use
Treatment of advanced prostate cancer and high-risk, locally advanced, nonmetastatic prostate cancer
Who takes it
Adults
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.

Ingredients

Manufacturer
Shinpoong Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of advanced prostate cancer and high-risk, locally advanced, nonmetastatic prostate cancer

View approved original text

This medication is used to treat advanced prostate cancer in combination with luteinizing hormone-releasing hormone (LHRH) analogs or in conjunction with castration surgery. It is also administered alone to patients with locally advanced non-metastatic prostate cancer at high risk of progression, or as an adjunct therapy along with radical prostatectomy or radiation therapy. This enhances the effectiveness of prostate cancer treatment and improves the patient's treatment outcomes.

How to take

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.

Precautions

This medication should not be administered to women or children under the age of 18. Patients with allergies to this drug or its components should not use it. It can be dangerous to administer this drug to patients taking specific medications like terfenadine, astemizole, or cisapride. Patients with a history of liver damage or severe liver impairment should not take this medication. This drug contains lactose; therefore, patients with lactose intolerance or related genetic disorders should avoid it. Patients with poor liver function should use caution, as this medication is primarily metabolized in the liver, leading to a risk of drug accumulation and increased side effects. While taking this medication, side effects such as anemia, dizziness, facial flushing, dyspepsia, rash, gynecomastia, weakness, and erectile dysfunction may occur. Rarely, serious side effects such as liver failure, cardiac issues, or pulmonary diseases can occur, thus any abnormal symptoms should prompt immediate consultation with a physician. Regular liver function tests are essential as this drug may affect liver function. Additionally, as this drug can interact with other medications metabolized in the liver, it is important to inform the doctor or pharmacist of any concurrent medicines. Caution is advised when driving or operating machinery as somnolence may occur. Individuals with lactose sensitivity should verify before administration due to the lactose content. Patients with diabetes or those at risk for diabetes should carefully monitor blood sugar changes. Patients with heart conditions or those at risk for QT prolongation should have thorough discussions with healthcare providers prior to administration. Pregnant or nursing women should not use this medication. Elderly patients may have an increased risk of cardiac and circulatory side effects, thus conditions should be carefully monitored during use. In case of overdose, suitable treatment according to symptoms will be necessary as there are no specific antidotes, and blood dialysis may not be effective. Finally, store this medication out of the reach of children and keep it in its original container to prevent misuse or degradation of quality.

Side effects

  • Anemia
  • dizziness
  • facial flushing
  • abdominal pain
  • constipation
  • nausea
  • diarrhea
  • rash
  • hematuria
  • gynecomastia
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  • breast fullness
  • weakness
  • edema
  • loss of appetite
  • decreased libido
  • depression
  • drowsiness
  • myocardial infarction
  • heart failure
  • indigestion
  • abdominal distension
  • vomiting
  • hepatotoxicity
  • jaundice
  • elevated aminotransferase levels
  • alopecia
  • hirsutism
  • dry skin
  • itching
  • erectile dysfunction
  • chest pain
  • weight gain
  • hypersensitivity reaction
  • angioedema
  • urticaria
  • interstitial lung disease
  • liver failure
  • photosensitivity reaction
  • angina pectoris
  • symptoms of heart failure
  • prolonged PR and QT intervals on ECG
  • arrhythmia
  • nonspecific ECG changes
  • leukopenia
  • thrombocytopenia
  • dry mouth
  • insomnia
  • stupor
  • dyspnea
  • nocturia
  • sweating
  • hyperglycemia
  • weight loss
  • diabetes
  • headache
  • pelvic pain
  • chills
  • ejaculation disorders
  • epididymitis
  • groin discomfort
  • pneumonia

Not everyone experiences these, and they can vary from person to person.

Storage

Store this medication in a tightly sealed container to prevent exposure to air or moisture, ideally at room temperature below 30 degrees Celsius, to maintain its effectiveness for a longer duration.

Appearance and packaging

Appearance

White round film-coated tablet

Package unit

28 tablets (14 tablets/PTP x 2)

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.