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Bdron (250mg / 500mg) - Abiraterone Acetate Tablets

Bdron is a potent androgen biosynthesis inhibitor used in the treatment of metastatic castration-resistant prostate cancer (mCRPC) and metastatic high-risk castration-sensitive prostate cancer (mCSPC). It works by reducing androgen production, which fuels the growth of prostate cancer cells.

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General Information:
Generic Name: Abiraterone Acetate
Brand Name: Bdron
Packing: Typically available in bottles of 60 and 120 tablets
Strength: 250mg, 500mg per tablet
Manufacturer: BDR Pharmaceuticals Internationals Pvt
Form: Tablet
Category: Anti-cancer drug (Androgen Biosynthesis Inhibitor)
Product Introduction:
Bdron contains Abiraterone Acetate, a prodrug of abiraterone, which is converted in the body to its active form. It inhibits the enzyme CYP17A1, thereby reducing androgen production in the testes, adrenal glands, and prostate tumor tissue. It is used in combination with prednisone or prednisolone to manage prostate cancer.

Uses:
Bdron is indicated for:
  1. Metastatic castration-resistant prostate cancer (mCRPC)
  2. Metastatic castration-sensitive prostate cancer (mCSPC)
  3. High-risk locally advanced prostate cancer (off-label in some cases)
  4. In combination with androgen deprivation therapy (ADT)
  5. To delay disease progression and improve survival
  6. As part of hormonal therapy for late-stage prostate cancer

Storage Instructions:
  1. Store below 30°C, in a dry place
  2. Protect from moisture and heat
  3. Keep in original container
  4. Keep out of reach of children

How It Works (Mechanism of Action):
Abiraterone acetate inhibits CYP17A1, a critical enzyme in androgen biosynthesis. This inhibition prevents the formation of testosterone and other androgens, which are essential for the growth of prostate cancer cells. The result is reduced tumor progression and prolonged survival in patients with advanced prostate cancer.

Side Effects:
Common side effects:
  1. Fatigue
  2. Joint swelling or pain
  3. Hot flashes
  4. Increased blood pressure
  5. Hypokalemia (low potassium)
  6. Edema (fluid retention)
Serious side effects:
  1. Hepatotoxicity (liver function abnormalities)
  2. Adrenal insufficiency
  3. Cardiac disorders (arrhythmias, heart failure)
  4. Hypertension crisis
  5. Severe hypokalemia

Dosage (Typical Recommended Dose): 
  1. 250mg tablets: 1000mg (4 tablets) once daily
  2. 500mg tablets: 1000mg (2 tablets) once daily
  3. Administer with 5mg prednisone or prednisolone twice daily
  4. Dosage may be modified based on liver function and side effects

Method of Administration:
  1. Take orally, on an empty stomach (at least 1 hour before or 2 hours after eating)
  2. Swallow tablets whole with water; do not crush or chew
  3. Take at the same time each day, with prednisone

Precautions:
  1. Monitor liver function tests (LFTs) regularly
  2. Use caution in patients with cardiovascular disease, hypertension, or adrenal insufficiency
  3. Not recommended during pregnancy or breastfeeding
  4. Potassium levels should be regularly monitored
  5. Consider calcium and vitamin D supplements for bone health

Drug Interactions:
  1. Avoid use with CYP3A4 inducers/inhibitors (e.g., rifampin, ketoconazole)
  2. May alter the effect of warfarin, digoxin, and other narrow-therapeutic drugs
  3. Caution with diuretics and corticosteroids due to risk of hypokalemia
  4. Abiraterone may interact with antihypertensives and cardiac medications

Allergies:
  1. Contraindicated in patients with known hypersensitivity to abiraterone or its excipients
  2. Allergic reactions may include rash, swelling, or difficulty breathing

Overdose Information:
  1. In case of overdose, monitor for signs of mineralocorticoid excess (hypertension, hypokalemia, fluid retention)
  2. Provide supportive care
  3. Contact a medical professional immediately

Missed Dose Instructions:
  1. If a dose is missed, take it the next day at the usual time
  2. Do not double the dose to make up for a missed one
  3. Continue with the regular dosing schedule

Additional Notes:
  1. Periodic monitoring of liver enzymes, electrolytes, blood pressure, and cardiac function is essential
  2. Male patients should use effective contraception if their partner is of childbearing potential
  3. This medicine should not be handled by pregnant women
  4. Educate patients on potential side effects and the importance of adherence to corticosteroid co-administration

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