Medication info
Cadex Tablet (Bicalutamide)

Cadex Tablet (Bicalutamide)

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

MFDS item code 201603104 · Approved 2016.05.31 · Insurance code 671806090

Summary

Main use
Treatment of high-risk locally advanced nonmetastatic prostate cancer and advanced prostate cancer
Who takes it
Adults
Adult dose
1. In combination with a luteinizing hormone-releasing hormone (LHRH) analog or surgical castration, adult men and elderly patients: 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. As monotherapy or as adjuvant therapy to radical prostatectomy or radiotherapy in patients with high-risk, locally advanced, nonmetastatic prostate cancer: 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
Daewon Pharmaceutical Co., Ltd.

Efficacy & effects

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

View approved original text

This medication treats advanced prostate cancer in combination with LHRH analogs or in conjunction with castration surgery. It can also be administered alone to patients with locally advanced and non-metastatic prostate cancer who are at high risk or used as an adjuvant therapy for radical prostatectomy or radiation therapy. This drug helps inhibit the progression of prostate cancer and enhances therapeutic effects.

How to take

Adult dose

1. In combination with a luteinizing hormone-releasing hormone (LHRH) analog or surgical castration, adult men and elderly patients: 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. As monotherapy or as adjuvant therapy to radical prostatectomy or radiotherapy in patients with high-risk, locally advanced, nonmetastatic prostate cancer: 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 used by women or children under 18 years of age. It should also not be administered if there is an allergy to this drug or its ingredients. In particular, it should not be taken in combination with certain drugs such as terfenadine, astemizole, or cisapride. Patients with a history of liver damage or severe liver impairment should also avoid this medication. Moreover, it should not be given to patients with lactose intolerance or genetic lactose metabolism disorders. Patients with liver function issues should use this drug cautiously as its metabolism may be slowed, increasing the risk of drug accumulation in the body. Common side effects may include dizziness, blood pressure changes, skin rash, dyspepsia, gynecomastia, and asthenia. Abnormal liver function, cardiac issues, blood abnormalities, and rarely severe pulmonary diseases or liver failure have also been reported, so any abnormal symptoms should be promptly discussed with healthcare professionals. It is important to regularly undergo liver function tests to monitor liver health. Due to breakdown in the liver, this drug can burden the liver, and its use should be discontinued if severe liver damage occurs. This drug inhibits certain liver enzymes (CYP3A4), so interactions may change the effectiveness or increase side effects when used with other drugs metabolized by the liver. While it does not significantly affect driving or machine operation, there may be risks of confusion or drowsiness, requiring caution. This drug can affect blood coagulation, so patients on anticoagulants should be monitored for bleeding risks through blood tests. This medication is not advised for use in pregnant or breastfeeding women. Elderly patients may experience adverse reactions related to the heart and circulatory system more frequently, thus monitoring their condition closely is required. In cases of overdose, as there is no specific antidote, proper treatment should be administered according to symptoms, and dialysis may not be effective. This medication should be kept out of the reach of children and stored safely in its original container. Lastly, this drug may affect male reproductive ability, so using appropriate contraception for a period after administration is recommended.

Side effects

  • Anemia
  • dizziness
  • facial flushing
  • abdominal pain
  • constipation
  • nausea
  • diarrhea
  • rash
  • hematuria
  • gynecomastia
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  • breast tenderness
  • weakness
  • edema
  • loss of appetite
  • decreased libido
  • depression
  • drowsiness
  • myocardial infarction
  • heart failure
  • dyspepsia
  • abdominal distension
  • vomiting
  • hepatotoxicity
  • jaundice
  • increased aminotransferase levels
  • alopecia
  • hirsutism
  • dry skin
  • itching
  • erectile dysfunction
  • chest pain
  • weight gain
  • hypersensitivity reactions
  • angioedema
  • urticaria
  • interstitial lung disease
  • liver failure
  • photosensitivity reactions
  • increased PT/INR
  • angina
  • heart failure symptoms
  • prolonged PR and QT intervals on ECG
  • arrhythmia
  • nonspecific ECG changes
  • leukopenia
  • thrombocytopenia
  • dry mouth
  • insomnia
  • confusion
  • dyspnea
  • nocturia
  • sweating
  • hyperglycemia
  • weight loss
  • diabetes
  • headache
  • pelvic pain
  • chills
  • ejaculatory dysfunction
  • 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 avoid exposure to air or moisture. It is also recommended to store it in a cool place at room temperature below 30 degrees Celsius, away from direct sunlight.

Appearance and packaging

Appearance

White round film-coated tablets

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.

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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.