Medication info
Prokalin Tablets 50 mg (Bicalutamide)

Prokalin Tablets 50 mg (Bicalutamide)

Prescription medicationTabletOral
Ingredient · strength
Bicalutamide›50mg / 1 tablet
Manufacturer / importer
HK inno.N Corporation
Appearance
White round film-coated tablets
Packaging
28 tablets (14 tablets/PTP x 2)
Approval status
Active

MFDS item code 200703394 · Notified 2007.03.20 · Insurance code 640003750

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
HK inno.N Corporation

Efficacy & effects

Treatment of advanced 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 is used for the treatment of advanced prostate cancer, inhibiting cancer progression when used with luteinizing hormone-releasing hormone (LHRH) analogs or castration surgery. Additionally, it can be given alone to patients with locally advanced or non-metastatic prostate cancer or used as adjuvant therapy alongside radical prostatectomy or radiation therapy. This helps increase the effectiveness of prostate cancer treatment and prevent cancer recurrence.

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 drug should not be used in women and children under 18 years of age. Do not take this medication if you have an allergic reaction to this drug or its components. This drug should not be administered to patients taking specific medications such as terfenadine, astemizole, and cisapride. Patients with a history of liver damage or severe liver impairment may be at risk when using this medication, hence caution is necessary. This drug contains lactose, therefore patients with lactose intolerance or related genetic disorders should avoid taking it. Patients with liver function issues should be cautious as this drug is primarily metabolized in the liver, posing a risk of accumulation in the body. While taking this drug, side effects such as dizziness, facial flushing, dyspepsia, skin rash, hematuria, and gynecomastia may occur, so consult medical personnel immediately if unusual symptoms arise. Rarely, serious side effects such as heart issues, liver function deterioration, and hypersensitivity reactions may occur, requiring regular check-ups and monitoring. This medication may cause changes in liver function; therefore, it is important to have regular liver function tests. This medication can inhibit specific enzymes in the liver, posing a risk of interaction with other medications, so be sure to inform your doctor about any other drugs you are taking. Caution is required when driving or operating machinery as confusion or drowsiness may occur. Since this drug contains lactose, patients with lactose hypersensitivity should consult a physician before use. Patients with diabetes or issues with blood glucose control should regularly check their blood sugar levels while on this medication. Patients with arrhythmias or prolonged QT intervals should be evaluated for heart condition before taking this drug. This drug is contraindicated for women; pregnant or nursing women should never take it. In case of overdose, there is no specific antidote, so appropriate treatment should be given according to symptoms, and blood dialysis may not be effective. Keep this medication out of reach of children and store it securely in its original container. This medication may affect male reproductive function, so it is recommended to use appropriate contraception methods for a certain period after taking it. Elderly patients may experience adverse reactions related to the heart and circulatory system more frequently, so their condition should be monitored closely during treatment.

Side effects

  • Anemia
  • dizziness
  • facial flushing
  • abdominal pain
  • constipation
  • nausea
  • diarrhea
  • rash
  • hematuria
  • gynecomastia
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  • breast distension
  • weakness
  • edema
  • loss of appetite
  • decreased libido
  • depression
  • drowsiness
  • myocardial infarction
  • heart failure
  • dyspepsia
  • abdominal bloating
  • vomiting
  • hepatotoxicity
  • jaundice
  • increased 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
  • headache
  • pelvic pain
  • chills
  • ejaculation disorder
  • epididymitis
  • inguinal 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 protect it from air and moisture. It is important to maintain a storage temperature between 1 degree and 30 degrees Celsius at room temperature. This will help preserve the effectiveness of the drug and ensure its safe use.

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.

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.