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Abiratas 500mg - Abiraterone Acetate Tablets

Abiratas 500mg is a hormonal therapy used to treat metastatic prostate cancer. It works by blocking the production of androgens (male hormones), which fuel the growth of prostate cancer cells.

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General Information:
Generic Name: Abiraterone Acetate
Brand Name: Abiratas 500mg
Packing: Bottle of 60 tablets
Strength: 500 mg
Manufacturer: Intas Pharmaceuticals Ltd.
Form: Oral Tablets
Category: Hormonal Therapy / Anti-androgen / CYP17 Inhibitor
Product Introduction:
Abiratas 500mg contains Abiraterone Acetate, an oral androgen biosynthesis inhibitor. It is prescribed for metastatic castration-resistant prostate cancer (mCRPC) and metastatic high-risk castration-sensitive prostate cancer (mCSPC). It is always used in combination with prednisone to reduce the risk of mineralocorticoid-related side effects.

Uses:
Abiratas 500mg is used for:
  1. Metastatic castration-resistant prostate cancer (mCRPC)
  2. Metastatic high-risk castration-sensitive prostate cancer (mCSPC)
  3. Combination therapy with prednisone to improve outcomes
  4. Delayed disease progression in advanced prostate cancer
  5. Reduction of tumor burden and cancer-related symptoms
  6. Prolonging overall survival in late-stage prostate cancer patients

Storage Instructions:
  1. Store at room temperature (15°C – 30°C)
  2. Keep in original container, tightly closed
  3. Protect from moisture and heat
  4. Keep out of reach of children

How It Works (Mechanism of Action):
Abiraterone inhibits CYP17A1, a critical enzyme in androgen biosynthesis found in the testes, adrenal glands, and prostate tumor tissue. This results in decreased levels of testosterone and other androgens, leading to slowed growth or shrinkage of androgen-dependent prostate cancer cells.

Side Effects:
Common side effects:
  1. High blood pressure
  2. Hypokalemia (low potassium)
  3. Fluid retention and swelling
  4. Fatigue
  5. Joint or muscle pain
  6. Hot flashes
Serious side effects:
  1. Liver function abnormalities
  2. Adrenal insufficiency
  3. Cardiac disorders (arrhythmia, chest pain)
  4. Severe electrolyte imbalances
  5. Increased risk of fractures

Dosage (Typical Recommended Dose):
  1. 1,000 mg (two 500 mg tablets) once daily
  2. Must be taken on an empty stomach – at least 1 hour before or 2 hours after a meal
  3. Always given with prednisone 5 mg twice daily, unless otherwise directed

Method of Administration:
  1. Taken orally with water, whole – do not crush or chew
  2. Must be taken consistently at the same time each day
  3. Prednisone is co-administered to counteract mineralocorticoid excess

Precautions:
  1. Monitor liver function tests (LFTs) before and during treatment
  2. Check blood pressure, potassium, and fluid retention regularly
  3. Not recommended during pregnancy or breastfeeding
  4. Men with partners of childbearing potential should use effective contraception
  5. Use cautiously in patients with heart or liver disease

Drug Interactions:
  1. Strong inducers or inhibitors of CYP3A4 may affect abiraterone levels
  2. Interacts with rifampin, ketoconazole, phenytoin, and some HIV drugs
  3. Can affect metabolism of warfarin, theophylline, and other CYP2D6 substrates
  4. Avoid grapefruit or grapefruit juice

Allergies:
  1. Do not use in patients with known hypersensitivity to Abiraterone or excipients
  2. Signs of allergy: rash, itching, swelling, breathing difficulty – seek emergency care

Overdose Information: 
  1. Symptoms may include electrolyte disturbances, hypertension, liver toxicity
  2. No specific antidote; treatment is supportive
  3. Contact poison control or a healthcare professional immediately if overdose is suspected

Missed Dose Instructions:
  1. If a dose is missed, skip it and take the next dose at the regular time
  2. Do not double the dose to make up for a missed one
  3. Continue taking prednisone as prescribed

Additional Notes:
  1. Periodic monitoring is essential for liver enzymes, blood pressure, potassium, and fluid balance
  2. Educate patients on the importance of adherence to prednisone to avoid adrenal complications
  3. Abiraterone does not replace surgical or chemical castration – patients should be on GnRH therapy or have undergone orchiectomy

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