Medication info
PMS Bicalutamide Tablet 50mg (Bicalutamide (Non-differentiated))

PMS Bicalutamide Tablet 50mg (Bicalutamide (Non-differentiated))

Prescription medicationTabletOral
Ingredient · strength
Bicalutamide micronized›50mg / 1 tablet
Manufacturer / importer
Pharmascience Korea
Appearance
White circular film-coated tablet
Packaging
30 tablets/blister [15 tablets/PTP X 2]
Approval status
Active

MFDS item code 202008129 · Approved 2020.11.23 · Insurance code 627600250

Summary

Main use
Treatment of advanced prostate cancer and high-risk locally advanced nonmetastatic prostate cancer
Who takes it
Adults
Adult dose
1. Adult males and elderly patients receiving concomitant treatment with a luteinizing hormone-releasing hormone (LHRH) analogue 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 LHRH analogue or at the time of surgical castration. 2. Monotherapy or adjuvant therapy to radical prostatectomy or radiotherapy in patients with high-risk, locally advanced, nonmetastatic prostate cancer : Adult males 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

Importer
Pharmascience Korea

Efficacy & effects

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

  • Advanced prostate cancer
  • locally advanced prostate cancer
  • non-metastatic prostate cancer
View approved original text

This medication helps in the treatment of advanced prostate cancer when used in conjunction with luteinizing hormone-releasing hormone (LHRH) analogues or castration surgery. It is also administered alone to patients with locally advanced or non-metastatic prostate cancer or used as an adjunctive therapy following radical prostatectomy or radiotherapy. This contributes to improving the treatment efficacy for prostate cancer and suppressing disease progression.

How to take

Adult dose

1. Adult males and elderly patients receiving concomitant treatment with a luteinizing hormone-releasing hormone (LHRH) analogue 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 LHRH analogue or at the time of surgical castration. 2. Monotherapy or adjuvant therapy to radical prostatectomy or radiotherapy in patients with high-risk, locally advanced, nonmetastatic prostate cancer : Adult males 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 used in women and children under 18 years of age. Those with an allergy to this drug or its ingredients should not take it. It may pose risks when used with certain heart-related medications, so those taking such medications should avoid this drug. Patients with a history of liver damage or severe liver dysfunction should not be given this drug. This medication contains lactose, so those with lactose intolerance or hereditary lactase deficiency should avoid it. In patients with compromised liver function, this drug may be eliminated slowly from the body, leading to the risk of accumulation, and thus should be used with caution. While taking this medication, various side effects such as dizziness, abdominal pain, skin rash, hematuria, gynecomastia, weakness, etc., may occur, and if any abnormal symptoms appear, immediate communication with healthcare professionals is necessary. Serious liver issues, such as liver dysfunction or jaundice, can occur rarely, thus regular liver function tests are needed. Since this drug is metabolized in the liver, caution is required when taking it with other medications that may affect liver function. Caution may be needed while driving or operating machinery, as confusion or drowsiness may occur. Patients taking anticoagulants should frequently monitor their condition through blood tests as this medication can affect blood coagulation. Pregnant or breastfeeding women should not use this medication. This medication should not be used in children under 18 years of age. Elderly patients may be at a higher risk of heart and circulatory system side effects, so administration should be closely monitored. In case of overdose, there is no specific antidote, so 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. This drug may affect reproductive capacity, so adequate contraception should be employed during treatment and for some time after. Since there may be interactions with other medications taken with this drug, all medications being taken should be disclosed to healthcare professionals.

Side effects

  • Anemia
  • dizziness
  • facial flushing
  • abdominal pain
  • constipation
  • nausea
  • diarrhea
  • rash
  • hematuria
  • gynecomastia
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  • breast swelling
  • weakness
  • edema
  • loss of appetite
  • decreased libido
  • depression
  • drowsiness
  • myocardial infarction
  • heart failure
  • dyspepsia
  • abdominal bloating
  • vomiting
  • hepatotoxicity
  • jaundice
  • elevated amino transferase levels
  • alopecia
  • hirsutism
  • dry skin
  • itching
  • erectile dysfunction
  • chest pain
  • weight gain
  • hypersensitivity reactions
  • angioedema
  • urticaria
  • interstitial lung disease
  • liver failure
  • photosensitivity
  • increased PT/INR
  • angina
  • symptoms of heart failure
  • prolonged PR and QT interval on ECG
  • arrhythmia
  • nonspecific ECG changes
  • leukopenia
  • thrombocytopenia
  • dry mouth
  • insomnia
  • confusion
  • 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

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. Additionally, it is recommended to store the medication at room temperature, ideally between 1°C to 30°C. This will help maintain the drug's efficacy for an extended period.

Appearance and packaging

Appearance

White circular film-coated tablet

Package unit

30 tablets/blister [15 tablets/PTP X 2]

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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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.