TabletsMRP Under Process
Official PMBI MRP is being updated for catalog code 2785.
Locate Jan Aushadhi KendraClinical Overview
Abiraterone Acetate Tablets (250mg, 500mg) is an oral prodrug inhibitor of androgen biosynthesis on the WHO Model List of Essential Medicines. It is converted to abiraterone, which selectively and irreversibly inhibits the 17-alpha-hydroxylase and C17,20-lyase activities of the CYP17A1 enzyme in testicular, adrenal, and intratumoral prostate cancer tissues. This shuts down androgen synthesis across all three sources, depriving androgen-dependent prostate cancer cells of testosterone and DHT. Because CYP17 inhibition blocks cortisol production, secondary ACTH elevation triggers mineralocorticoid excess (hypertension, hypokalemia, edema); therefore, abiraterone MUST ALWAYS be co-administered with oral prednisone. Indicated in combination with prednisone for metastatic castration-resistant prostate cancer (mCRPC) and metastatic high-risk castration-sensitive prostate cancer (mCSPC).
Active Pharmaceutical Ingredients
Verified Clinical References
Usage Guidelines
Take orally 1000 mg (four 250 mg tablets or two 500 mg tablets) once daily on an EMPTY STOMACH: at least 1 hour before or 2 hours after food with water. Swallow whole. Taking with food increases absorption up to 10-fold, creating unpredictable exposure. MANDATORY: Co-administer Prednisone 5 mg orally twice daily (or 5 mg once daily). Patients must also maintain continuous medical castration (GnRH analogue) if not surgically castrated.
General Administration Advice: Adhere strictly to the prescribed dosage, frequency, and treatment course. For oral medications, swallow with sufficient water. Never stop antibiotics, psychiatric medications, or antihypertensives abruptly without clinical direction.
Possible Side Effects
Common: Hypertension, hypokalemia, peripheral edema, fatigue, hot flushes, diarrhea, transaminase elevations. Rare/Severe: Severe mineralocorticoid excess, cardiac arrhythmias (due to hypokalemia), hepatotoxicity, and adrenocortical insufficiency upon abrupt cessation of prednisone.
*Note: Individual physiological responses vary. While many patients experience few or no side effects, notify your treating physician if adverse reactions persist or if hypersensitivity (angioedema, skin rash, dyspnea) occurs.
Precautions & Warnings
Must be taken on an empty stomach. Mandatory co-administration of oral prednisone to prevent mineralocorticoid excess. Monitor serum potassium, blood pressure, and liver transaminases every 2 weeks for the first 3 months and monthly thereafter. Women who are pregnant must not touch broken tablets.
Schedule H (Prescription Required)
This medication is scheduled under statutory drug regulatory frameworks (CDSCO / Drugs & Cosmetics Rules). Dispensing requires a valid medical prescription from a registered medical practitioner. Self-medication or unsupervised dosage adjustment carries significant clinical risks.
Medical Disclaimer: Statutory Clinical Disclaimer: The information provided is for educational and price-transparency purposes only and does not constitute medical advice, oncological diagnosis, or chemotherapy protocol guidance. Cancer therapies require specialized administration under the direct supervision of a registered medical oncologist in an accredited healthcare facility.