Medication info
Bicalud Tablets (Bicalutamide)

Bicalud Tablets (Bicalutamide)

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

MFDS item code 200703389 · Notified 2007.03.23 · Insurance code 641801720

Summary

Main use
Treatment of advanced and high-risk, locally advanced, nonmetastatic prostate cancer
Who takes it
Adults
Adult dose
1. Adults and elderly men receiving this medicine in combination with a luteinizing hormone-releasing hormone (LHRH) analog or 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. Monotherapy in patients with locally advanced, nonmetastatic prostate cancer at high risk of disease progression, or adjuvant therapy to radical prostatectomy or radiation therapy : Adult and elderly men: Administer 150 mg of bicalutamide orally once daily. Continue this 150 mg regimen for at least 2 years or until the disease progresses.

Ingredients

Manufacturer
Kwangdong Pharmaceutical Co., Ltd.

Efficacy & effects

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

View approved original text

This medication is used for the treatment of advanced prostate cancer. It inhibits the progression of prostate cancer in combination with luteinizing hormone-releasing hormone (LHRH) analogs or with castration surgery. It can also be administered alone to patients with locally advanced and non-metastatic prostate cancer, or as an adjuvant therapy following radical prostatectomy or radiotherapy. This medicine helps increase the treatment efficacy for prostate cancer patients and slows the progression of the disease.

How to take

Adult dose

1. Adults and elderly men receiving this medicine in combination with a luteinizing hormone-releasing hormone (LHRH) analog or 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. Monotherapy in patients with locally advanced, nonmetastatic prostate cancer at high risk of disease progression, or adjuvant therapy to radical prostatectomy or radiation therapy : Adult and elderly men: Administer 150 mg of bicalutamide orally once daily. Continue this 150 mg regimen for at least 2 years or until the disease progresses.

Precautions

This medication should not be used by women or children under 18 years of age. Patients who are allergic to this drug or any of its components should not be administered this medication. It is also contraindicated in patients taking specific drugs such as terfenadine, astemizole, or cisapride. Patients with a history of liver damage or severe liver dysfunction should not take this drug. Additionally, this medication contains lactose, so patients with lactose intolerance or related genetic disorders should avoid it. Patients with impaired liver function may have a slower metabolism of this drug, increasing the risk of drug accumulation, so it should be used cautiously. Various side effects may occur while taking this medication, with common ones including anemia, dizziness, facial flushing, indigestion, rash, hematuria, gynecomastia, and weakness. Rarely, serious side effects such as liver dysfunction, liver failure, heart problems, and lung diseases may occur, so it is essential to consult a healthcare professional immediately if any abnormal symptoms appear. Regular monitoring of liver function is important, and if severe liver damage is suspected, the medication should be discontinued immediately. This drug is mainly metabolized in the liver and may inhibit enzymes involved in liver metabolism, so caution is required regarding interactions with other medications, especially specific heart medications, immunosuppressants, and antibiotics. Always inform your healthcare provider about any concomitant medications. This drug does not affect driving or machine operation abilities; however, caution is needed as drowsiness or confusion may occur. This medication is prohibited for use by women, and pregnant or nursing women should not take it. It should not be administered to children under 18 years. In elderly patients, cardiac and circulatory function may be impaired, so careful administration should be considered due to the potential for side effects. In case of overdose, there is no specific antidote, so appropriate treatment should be administered based on symptoms, and dialysis may not be effective. This medication should be kept out of reach of children and stored in its original container for safety.

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
  • dyspepsia
  • abdominal bloating
  • 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
  • confusion
  • dyspnea
  • nocturia
  • sweating
  • hyperglycemia
  • weight loss
  • diabetes mellitus
  • headache
  • pelvic pain
  • chills
  • ejaculation disorder
  • epididymitis
  • groin discomfort
  • pneumonia
  • elevated AST
  • elevated ALT
  • decreased libido
  • pneumonia

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

Storage

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is important to maintain the storage temperature between 1 and 30 degrees Celsius to help preserve the drug's efficacy and safety.

Appearance and packaging

Appearance

White round film-coated tablet

Package unit

28 tablets (14 tablets/PTP*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.