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Mytera 500mg - Abiraterone Acetate Tablets

Mytera 500mg contains Abiraterone Acetate 500mg, used in the treatment of metastatic prostate cancer. It works by lowering androgen levels in the body, helping to slow cancer growth and improve survival outcomes.

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General Information:
Generic Name: Abiraterone Acetate
Brand Name: Mytera
Packing: Typically available in bottles of 60 tablets
Strength: 500 mg per tablet
Manufacturer: BDR Pharmaceuticals Int'L Pvt. Ltd.
Company: Mylan Pharmaceuticals Pvt. Ltd.
Form: Tablet
Category: Anti-cancer drug (Androgen Biosynthesis Inhibitor)
Product Introduction:
Mytera 500mg is a prescription medication used in the treatment of advanced prostate cancer, specifically metastatic castration-resistant prostate cancer (mCRPC) and metastatic hormone-sensitive prostate cancer (mHSPC). It works by inhibiting androgen (testosterone) production, which is necessary for the growth of prostate cancer cells. It is typically taken in combination with prednisone or prednisolone to reduce side effects and enhance effectiveness.

Uses of Mytera 500mg:
Mytera 500mg is used for:
  1. Metastatic Castration-Resistant Prostate Cancer (mCRPC): Prostate cancer that continues to grow despite low testosterone levels.
  2. Metastatic Hormone-Sensitive Prostate Cancer (mHSPC): Cancer that has spread but still responds to hormone therapy.
  3. Reducing Prostate-Specific Antigen (PSA) Levels: Helps in slowing cancer progression.
  4. Delaying Tumor Progression: Slows tumor growth and improves overall survival.
  5. Managing Symptoms of Advanced Prostate Cancer: Helps relieve pain, urinary difficulties, and discomfort.
  6. Combination with Prednisone: Helps reduce side effects like high blood pressure and fluid retention.

How It Works (Mechanism of Action):
Mytera 500mg contains Abiraterone Acetate, a CYP17 enzyme inhibitor that works by:
  1. Blocking CYP17 enzyme activity, which is required for the production of androgens (testosterone and other male hormones).
  2. Reducing androgen levels in the testes, adrenal glands, and tumor cells.
  3. Slowing down prostate cancer growth by starving the cancer cells of testosterone.
  4. Enhancing survival rates in advanced prostate cancer patients.

Dosage & Administration:
  1. Recommended dose: 1,000 mg per day (2 tablets of 500 mg each).
  2. Taken once daily on an empty stomach (at least 1 hour before or 2 hours after meals).
  3. Must be taken with prednisone (5 mg twice daily) to reduce side effects.
Method of Administration:
  1. Swallow the tablet whole with water.
  2. Do not crush, chew, or break the tablet.
  3. Take on an empty stomach (food increases drug absorption, leading to severe side effects).
  4. Avoid grapefruit juice, as it can interfere with drug metabolism.
  5. Take at the same time every day for consistent drug levels.

Side Effects of Mytera 500mg:
Common Side Effects:
  1. High blood pressure (Hypertension)
  2. Low potassium levels (Hypokalemia) – May cause muscle weakness or cramps.
  3. Swelling in legs & feet (Edema, Fluid retention)
  4. Liver enzyme elevation (Hepatotoxicity)
  5. Increased cholesterol & triglycerides
  6. Joint or muscle pain
  7. Fatigue, dizziness, headache
Severe Side Effects:
  1. Heart problems (Irregular heartbeat, chest pain, heart failure)
  2. Liver damage (Hepatitis, liver failure) – Symptoms include yellowing of the skin/eyes and dark urine.
  3. Severe low potassium levels – Can lead to irregular heartbeat and muscle paralysis.
  4. Adrenal insufficiency – The body may stop producing enough cortisol.
  5. Severe allergic reactions – Rash, swelling of the face/tongue, difficulty breathing.

Precautions & Warnings:
  1. Not for use in women or children.
  2. Avoid alcohol, as it may increase liver damage.
  3. Monitor blood pressure and potassium levels regularly.
  4. Patients with diabetes should be cautious, as this drug can increase blood sugar levels.
  5. People with liver disease or heart problems should be monitored closely.
  6. Elderly patients may be more prone to side effects.

Drug Interactions:
Avoid taking Mytera 500mg with:
  1. Rifampin, Phenytoin, Carbamazepine – May reduce effectiveness.
  2. Ketoconazole, Itraconazole, Clarithromycin – Can increase drug toxicity.
  3. Warfarin & Blood Thinners – Increases bleeding risk.
  4. Diuretics (Furosemide, Spironolactone) – May worsen potassium imbalances.
  5. HIV medications (Ritonavir, Efavirenz) – May alter drug levels in the body.
  6. Heart medications (Digoxin, Diltiazem, Verapamil) – Requires close monitoring.

Allergy Warnings:
  1. Do not take Mytera 500mg if you are allergic to Abiraterone Acetate or any of its ingredients.
  2. Signs of an allergic reaction include rash, swelling, severe dizziness, or difficulty breathing.

Storage Instructions:
  1. Store at room temperature (20-25°C / 68-77°F).
  2. Keep away from moisture and direct sunlight.
  3. Store in original container with lid tightly closed.
  4. Keep out of reach of children.

Overdose Information:
Symptoms of Overdose:
  1. Severe high blood pressure
  2. Extreme weakness or confusion
  3. Signs of liver damage (yellow skin, dark urine)
  4. Dangerously low potassium levels (irregular heartbeat, muscle weakness)
What to Do in Case of Overdose?
  1. Seek immediate medical attention.
  2. Contact a poison control center or go to the nearest hospital.
  3. Bring the medication bottle for reference.

Missed Dose Instructions:
  1. If you miss a dose, take it as soon as you remember, unless it is close to the next dose.
  2. Do not take two doses at the same time to make up for a missed dose.
  3. Continue with your regular dosing schedule.

Additional Notes:
  1. Men taking Mytera should use contraception if their partner is pregnant or may become pregnant.
  2. Do not donate blood while on this medication, as it may harm recipients.
  3. Regular liver function tests (LFTs) are necessary to check for toxicity.
  4. This medicine does not cure prostate cancer, but it helps control the disease and improve survival rates.

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