Medication info
Calutamide 150 mg (Bicalutamide)

Calutamide 150 mg (Bicalutamide)

Prescription medicationTabletOral
Ingredient · strength
Bicalutamide›150mg / 1 tablet
Manufacturer / importer
Jongkundang Co., Ltd.
Appearance
White or nearly white round film-coated tablet
Packaging
28 tablets/box [(14 tablets/PTP)x2]
Approval status
Active

MFDS item code 200903782 · Approved 2009.05.28 · Insurance code 643305110

Summary

Main use
Treatment of locally advanced, nonmetastatic prostate cancer
Who takes it
Adults
Adult dose
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.

Ingredients

Manufacturer
Jongkundang Co., Ltd.

Efficacy & effects

Treatment of locally advanced, nonmetastatic prostate cancer

View approved original text

This medication is used for the treatment of localized advanced or non-metastatic prostate cancer in patients with a high risk of progression. It can be administered alone or as an adjunct to radical prostatectomy or radiotherapy to enhance treatment effect. It also provides effective management for patients for whom surgical or medical castration is not suitable. This helps delay the progression of prostate cancer and improve the treatment outcomes for patients.

How to take

Adult dose

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.

Precautions

This medication should not be used in women and children under 18 years of age. Patients who have had an allergic reaction to this drug or its components should not take it. It should not be used in conjunction with certain medications such as terfenadine, astemizole, and cisapride, and it should also be avoided by patients with a history of liver damage or severe liver dysfunction. Additionally, patients sensitive to lactose, i.e., those with genetically determined galactose intolerance, lactase deficiency, or glucose-galactose malabsorption should avoid this medication. As this medication is primarily metabolized in the liver, it must be administered with caution to patients with poor liver function as drug accumulation may cause side effects. When taking this medication, common side effects may include dizziness, flushing, abdominal pain, constipation, nausea, diarrhea, rash, hematuria, gynecomastia, fatigue, reduced appetite, decreased libido, depression, drowsiness, myocardial infarction, heart failure, dyspepsia, abdominal distension, vomiting, alopecia, hirsutism, dry skin, itching, hematuria, erectile dysfunction, chest pain, weight gain, headache, epididymitis, inguinal discomfort, vomiting, weight loss, elevated AST, elevated ALT, decreased libido, pneumonia. Rarely, cardiac issues, hepatic toxicity, skin hypersensitivity reactions, lung disease, etc., have been reported; any unusual symptoms should prompt immediate consultation with a doctor. Regular liver function tests should be conducted, and if severe liver damage is suspected, the medication should be discontinued. As this medication is metabolized in the liver, caution is required when used in conjunction with other medications that affect liver metabolism, as there may be interactions with some drugs that require dose adjustments. It has little effect on driving or operating machinery, but caution should be taken if symptoms of confusion are present. This medication must not be used by women, pregnant women, or nursing mothers, and it should not be administered to children under 18 years of age. When administering to elderly patients, there may be a higher incidence of cardiac and circulatory adverse effects, so their condition should be closely monitored. In case of overdose, there is no specific antidote, so appropriate treatment should be received based on symptoms; blood dialysis may not be effective. This medication should be kept out of the reach of children, stored in its original container to prevent misuse or quality deterioration. Moreover, long-term use of this medication may affect male fertility, so it is advisable to use appropriate contraception for a period after treatment.

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 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
  • symptoms of heart failure
  • ECG PR and QT interval prolongation
  • 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

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

Storage

This medication should be stored in a tightly closed container to prevent exposure to air or moisture, and it is recommended to keep it at room temperature below 30 degrees Celsius. Proper storage can maintain the effectiveness of the medication for a longer time.

Appearance and packaging

Appearance

White or nearly white round film-coated tablet

Package unit

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

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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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.