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

Samtica contains Abiraterone Acetate, a hormonal therapy used to treat prostate cancer. It works by inhibiting androgen production, which fuels the growth of cancer cells in the prostate.

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General Information:
Generic Name: Abiraterone Acetate
Brand Name: Samtica
Packing: Bottle 60 and 120 Tablets
Strengths: 250mg, 500mg
Manufacturer: Samarth Life Sciences Pvt Ltd
Form: Oral Tablets
Category: Anti-androgen, Antineoplastic agent
Prescription Status: Rx-only
Product Introduction:
Samtica is a prescription medicine used for the treatment of metastatic castration-resistant prostate cancer (mCRPC) and metastatic high-risk castration-sensitive prostate cancer (mCSPC). It is administered in combination with prednisone to reduce side effects associated with hormone suppression.

Uses:
Samtica (Abiraterone Acetate) is used for:
  1. Metastatic Castration-Resistant Prostate Cancer (mCRPC)
  2. Metastatic Castration-Sensitive Prostate Cancer (mCSPC)
  3. Prostate cancer in patients who failed initial hormone therapy
  4. Combination therapy with prednisone
  5. Delayed progression in high-risk prostate cancer patients
  6. Pre- or post-chemotherapy use based on clinical need

Storage Instructions:
  1. Store at room temperature, below 30°C
  2. Keep away from moisture and direct sunlight
  3. Store in original container, tightly closed
  4. Keep out of reach of children and pets

How It Works (Mechanism of Action):
Abiraterone Acetate is a CYP17 inhibitor that blocks an enzyme required for androgen (male hormone) production in the testes, adrenal glands, and prostate tumor tissue. By lowering androgen levels, it slows or stops the growth of prostate cancer cells.

Side Effects:
Common side effects:
  1. High blood pressure (hypertension)
  2. Low potassium (hypokalemia)
  3. Fluid retention and swelling (edema)
  4. Joint pain
  5. Increased liver enzymes
  6. Fatigue
Severe side effects:
  1. Adrenal insufficiency
  2. Liver toxicity
  3. Cardiac disorders (arrhythmia, heart failure)
  4. Severe electrolyte imbalance
  5. Bone fractures (with long-term use)

Dosage (Typical Recommended Dose):
  1. 250mg tablets: 1000 mg (4 tablets) once daily
  2. 500mg tablets: 1000 mg (2 tablets) once daily
  3. Must be taken with prednisone 5 mg orally twice daily
  4. Dosage may be adjusted based on liver function and treatment response

Method of Administration:
  1. Take orally, once daily
  2. Must be taken on an empty stomach (no food 2 hours before or 1 hour after)
  3. Swallow tablets whole with water; do not crush or chew
  4. Administer at the same time each day for best results

Precautions:
  1. Not for use in women or children
  2. Use with caution in patients with liver or heart conditions
  3. Regular monitoring of blood pressure, liver enzymes, and potassium levels is essential
  4. Effective contraception must be used during and for at least 3 weeks after treatment
  5. Not to be used in pregnancy – may cause fetal harm

Drug Interactions:
  1. Avoid CYP3A4 inducers or inhibitors – may affect drug metabolism
  2. May interact with warfarin, diuretics, and drugs that affect QT interval
  3. Monitor blood levels of prednisone if co-administered
  4. Avoid using with drugs causing hypokalemia or hepatotoxicity

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

Overdose Information:
  1. In case of overdose, symptoms may include severe hypertension, hypokalemia, or liver toxicity
  2. Immediate medical attention and supportive care are required
  3. No specific antidote available; management is symptomatic

Missed Dose Instructions:
  1. If a dose is missed, skip the missed dose
  2. Take the next dose at the scheduled time
  3. Do not double up on doses to make up for a missed one

Additional Notes:
  1. Periodic ECG, liver function tests, and electrolyte monitoring is necessary
  2. Patients should avoid foods that are high in salt or potassium unless advised
  3. Handle with care – hazardous drug precautions should be followed when handling or disposing
  4. Abiraterone may cause infertility in males with long-term use

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