Abiraterone Tablet 500mg (Abiraterone Acetate (Unfractionated))

Adult dose

The recommended dosage is 1,000mg (2 tablets of 500mg) once daily, and it must be taken on an empty stomach. It should be taken at least 2 hours after a meal, and no food should be consumed for at least 1 hour after taking the drug. The tablet should be swallowed whole with water. Patients with recovered liver function may reduce their dosage to 500mg (1 tablet) once daily, but the reduced dosage should not be taken with food.

This drug should not be administered to women who are pregnant or may become pregnant. Individuals who are allergic to this drug or its components should avoid taking it. It is not suitable for patients with lactose intolerance or certain genetic metabolic disorders. Co-administration with radium-223 chloride may pose risks, so it should not be used together. Caution is required for patients with symptoms of mineralocorticoid excess, such as hypertension, hypokalemia, and fluid retention; blood pressure and potassium levels should be monitored regularly. Patients with poor liver function are at risk of hepatotoxicity and should have liver function tests frequently; treatment should be discontinued if liver enzyme levels rise significantly. Patients with a history of cardiovascular disease should also exercise caution with this drug, especially as safety has not been established in heart failure patients. This drug may cause side effects such as hypertension, hypokalemia, fluid retention, and peripheral edema, as well as urinary tract infections. Muscle-related adverse reactions such as myopathy or rhabdomyolysis have also been reported. Taking this drug with food can increase absorption and alter safety and efficacy, thus it must be taken on an empty stomach. It may interact with other medicines, so especially when taking drugs metabolized in the liver, consultation with a doctor or pharmacist is essential. Women who are pregnant or breastfeeding should not use this drug, and male patients should ensure proper contraception, such as using condoms, during sexual intercourse with women who may become pregnant. It is not to be administered to children. In case of overdose, treatment should be stopped immediately, and heart rhythm and liver function should be monitored with appropriate care required. Keep the drug out of reach of children and store it in the original container.

Serious side effects

Hives, severe swelling (edema), chest tightness, shortness of breath, cold sweat, pallor, severe allergic reaction, high fever with severe rash, blisters, skin peeling, oral/ocular mucosal pain, severe skin adverse reactions, difficulty breathing or shortness of breath, asthma attack, respiratory abnormalities accompanied by cough + fever, yellowing of the skin or eyes (jaundice), extreme lethargy, liver abnormalities (jaundice), sudden and severe

Mild side effects

• Hypokalemia
• increased alanine aminotransferase
• increased aspartate aminotransferase
• hypertension
• urinary tract infection
• fatigue
• joint swelling/discomfort
• constipation
• diarrhea
• dyspepsia

This drug should be stored in a tightly sealed container to prevent exposure to air and moisture. It is important to maintain a storage temperature between 1 degree and 30 degrees Celsius.

Appearance

Purple oval film-coated tablets

Package unit

56 tablets (PTP) - 56 tablets/box [(14 tablets/PTP x 4)]