Abiraterone Acetate Tablets USP 250mg Technical Specification:

Product Name:Abiraterone Acetate Tablets USP 250mg
Brand Name:Generics
Strength:250mg, 500mg
Dosage Form:Tablets
Packing:60s, 120s
Route of Administration:For Oral Use only.
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Anti-Cancer
Indication: Abiraterone is used in combination with other medicine to treat a certain type of prostate cancer that has spread to other parts of the body.
Storage:Store at 20°C to 25°C (68° F to 77° F); excursions permitted from 15°C to 30°C (59° F to 86° F) [see USP Controlled Room Temperature].

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Abiraterone Acetate Tablets USP 250mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Abiraterone Acetate Tablets USP 250mg
    Each tablet contains:
    Abiraterone Acetate USP……………250mg
    Excipients…………………………………. q.s.

THERAPEUTIC INDICATIONS:

Abiraterone is used in combination with other medicine to treat a certain type of prostate cancer that has spread to other parts of the body.

CAUTION & WARNING:

Caution: It is dangerous to take this preparation except under medical supervision.

Warning: Cytotoxic Agent: Women who are or may be pregnant should not handle abiraterone acetate tablets without gloves (see patient information leaflet)

Warning: To be sold by retail on the prescription of an Oncologist only.

Keep out of reach and sight of children.

Dispense in tight container as defined in USP.

Swallow whole tablet. Do not crush or chew.

STORAGE & DOSAGE:

Storage: Store at 20°C to 25°C (68° F to 77° F); excursions permitted from 15°C to 30°C (59° F to 86° F) [see USP Controlled Room Temperature].

Dosage: As directed by Oncologist.

For Oral use. Read the package insert before use.

Why Taj Pharmaceuticals?

Choosing Taj Pharma for your Abiraterone Acetate Tablets offers several compelling reasons:

  • Proven Track Record: Taj Pharma has a long-established reputation for pharmaceutical excellence. With years of experience, we have consistently delivered high-quality medications to meet the healthcare needs of patients.
  • Quality Assurance: We adhere to rigorous quality control standards, ensuring that every Abiraterone Acetate Tablet meets the highest quality and safety standards. Your health and well-being are our top priorities.
  • Innovation: Taj Pharma is committed to innovation in healthcare. We continually invest in research and development to provide cutting-edge pharmaceutical solutions, enhancing treatment options and patient outcomes.
  • Reliability: We understand the importance of reliable and consistent access to medications. Taj Pharma ensures a stable supply of Abiraterone Acetate Tablets to meet patient demand.
  • Compliance: We strictly adhere to regulatory and ethical standards, ensuring that our products are manufactured and distributed in compliance with global pharmaceutical regulations.
  • Patient-Centric Approach: Taj Pharma places patients at the center of everything we do. We strive to improve the lives of individuals by providing effective and affordable medications.
  • Global Reach: Taj Pharma’s presence extends globally, allowing us to serve a wide range of healthcare needs worldwide. We are committed to making quality healthcare accessible to all.
  • Commitment to Health: Our dedication to healthcare excellence is reflected in our unwavering commitment to improving health outcomes and the overall quality of life for patients.

Taj Pharma is the ideal choice for Abiraterone Acetate Tablets due to our established reputation, commitment to quality, innovation, and patient-centric approach. Trust us to provide you with top-quality pharmaceutical solutions that enhance your health and well-being.

What is Abiraterone Acetate Tablets and its use?

Abiraterone Acetate Tablets are a medication used in the treatment of advanced prostate cancer. Here is an overview of Abiraterone Acetate Tablets and their use:

  • Medication Type: Abiraterone Acetate is a type of medication classified as a “steroidogenesis inhibitor.” It works by interfering with the production of androgens (male hormones) in the body, particularly in the testes, adrenal glands, and tumor tissues. This is crucial because androgens, such as testosterone, can stimulate the growth and progression of prostate cancer cells.
  • Use in Prostate Cancer: Abiraterone Acetate Tablets are primarily prescribed for the treatment of metastatic castration-resistant prostate cancer (mCRPC). This is a type of prostate cancer that continues to progress despite other forms of treatment and has spread to other parts of the body.
  • Mechanism of Action: Abiraterone Acetate inhibits an enzyme called CYP17A1 (17-alpha-hydroxylase/17,20-lyase), which is involved in the production of androgens. By blocking this enzyme, the medication reduces the levels of androgens, including testosterone, that fuel the growth of prostate cancer cells.
  • Combination Therapy: Abiraterone Acetate is often used in combination with another medication called prednisone or prednisolone. This combination helps reduce certain side effects of Abiraterone and enhances its effectiveness in treating prostate cancer.
  • Treatment Goals: The use of Abiraterone Acetate Tablets aims to slow down the progression of prostate cancer, alleviate symptoms, and improve the quality of life for patients with advanced prostate cancer. It may not be curative, but it can provide valuable additional time and relief from symptoms.
  • Monitoring: Patients taking Abiraterone Acetate Tablets typically require regular medical monitoring, including blood tests to assess hormone levels and to monitor for potential side effects. Adjustments to the treatment regimen may be made based on the patient’s response and any observed side effects.
  • Prescription and Medical Guidance: Abiraterone Acetate Tablets should only be prescribed by a qualified healthcare provider experienced in the treatment of prostate cancer. The dosage and duration of treatment will be tailored to the individual patient’s condition and needs.

How does Abiraterone Acetate Tablets Work?

Abiraterone Acetate Tablets work by inhibiting a key enzyme involved in the production of androgens, which are male hormones, particularly testosterone. The medication is primarily used in the treatment of advanced prostate cancer, where androgens can stimulate the growth and progression of cancer cells. Here’s how Abiraterone Acetate Tablets work:

  • Androgen-Dependent Prostate Cancer: In many cases of prostate cancer, the growth and survival of cancer cells are dependent on androgens, such as testosterone. These hormones bind to and activate androgen receptors on prostate cancer cells, leading to cell proliferation and tumor growth.
  • CYP17A1 Inhibition: Abiraterone Acetate is a potent inhibitor of the enzyme CYP17A1 (17-alpha-hydroxylase/17,20-lyase). This enzyme plays a critical role in the production of androgens in the body, specifically in the adrenal glands, testes, and even in prostate tumor tissues.
  • Reduction in Androgen Production: By blocking CYP17A1, Abiraterone Acetate interferes with the synthesis of androgens, particularly testosterone and its precursors. This leads to a significant reduction in the levels of circulating androgens in the body.
  • Suppression of Androgen Receptor Activation: With decreased androgen levels, the activation of androgen receptors on prostate cancer cells is diminished. As a result, the signaling pathways that promote cancer cell growth and survival are disrupted.
  • Slowing Tumor Growth: By reducing androgen production and the stimulation of androgen receptors, Abiraterone Acetate effectively slows down the growth and progression of prostate cancer cells. This is especially valuable in cases of metastatic castration-resistant prostate cancer (mCRPC), where cancer cells continue to thrive despite low testosterone levels.
  • Combination Therapy: Abiraterone Acetate is often used in combination with corticosteroids like prednisone or prednisolone. These corticosteroids help mitigate side effects associated with Abiraterone and may also have some anti-cancer effects.
  • Improved Quality of Life: While Abiraterone Acetate may not be curative, it can provide relief from symptoms, delay disease progression, and improve the overall quality of life for individuals with advanced prostate cancer.

Abiraterone Acetate Tablets are a targeted therapy specifically designed for the treatment of advanced prostate cancer. They do not affect all hormone production in the body and are not used as a hormone replacement therapy. Treatment with Abiraterone Acetate should be guided by a qualified healthcare provider experienced in the management of prostate cancer. Regular monitoring of hormone levels and side effects is typically part of the treatment regimen.

Benefits of Abiraterone Acetate Tablets:

  • Effective Treatment: Abiraterone Acetate Tablets are highly effective in slowing down the progression of advanced prostate cancer, particularly in cases of metastatic castration-resistant prostate cancer (mCRPC).
  • Symptom Relief: By reducing the growth and spread of cancer cells, these tablets can provide relief from symptoms associated with prostate cancer, such as pain, urinary difficulties, and bone problems.
  • Extended Survival: Abiraterone Acetate treatment can extend the overall survival of patients with mCRPC, offering valuable additional time to patients.
  • Combination Therapy: They are often used in combination with corticosteroids like prednisone or prednisolone to enhance their effectiveness and manage potential side effects.
  • Quality of Life: Improved disease control and symptom relief can significantly enhance the overall quality of life for individuals with advanced prostate cancer.

Side Effects of Abiraterone Acetate Tablets:

  • Fatigue: Many patients report fatigue or weakness as a common side effect.
  • Hypertension (High Blood Pressure): Abiraterone Acetate can lead to an increase in blood pressure. Regular monitoring and blood pressure management are essential.
  • Fluid Retention and Edema: Some individuals may experience fluid retention, leading to swelling, especially in the legs and ankles.
  • Hot Flashes: Hormone-related side effects like hot flashes, similar to those experienced during menopause, may occur.
  • Joint and Muscle Pain: Musculoskeletal symptoms such as joint and muscle pain are possible.
  • Gastrointestinal Issues: Abdominal discomfort, diarrhea, and nausea may occur.
  • Liver Function: There may be changes in liver function tests, which should be monitored by healthcare providers.
  • Cardiovascular Events: In some cases, an increased risk of cardiovascular events such as heart attacks has been observed, particularly in patients with pre-existing cardiovascular risk factors.
  • Adrenal Insufficiency: Abiraterone Acetate can affect adrenal function, potentially leading to adrenal insufficiency. Corticosteroid supplementation (e.g., prednisone) is often used in conjunction with Abiraterone to mitigate this risk.
  • Bone Health: There may be a risk of bone-related issues, so monitoring bone health is important.
  • Changes in Liver Enzymes: Abiraterone Acetate may lead to changes in liver enzyme levels, which should be closely monitored.

It’s crucial for individuals receiving Abiraterone Acetate Tablets to maintain regular communication with their healthcare provider, report any side effects promptly, and follow their provider’s recommendations for managing these side effects. The benefits of treatment often outweigh the potential side effects, but individual responses can vary, and personalized care is essential for optimizing outcomes.

Frequently asked questions (FAQs) about Abiraterone Acetate Tablets:

  1. What is Abiraterone Acetate, and what is its primary use?

Abiraterone Acetate is a medication used in the treatment of advanced prostate cancer, particularly in cases of metastatic castrationresistant prostate cancer (mCRPC).

  1. How does Abiraterone Acetate work in the treatment of prostate cancer?

Abiraterone Acetate inhibits the production of androgens, including testosterone, which are hormones that promote the growth of prostate cancer cells.

  1. Is Abiraterone Acetate a curative treatment for prostate cancer?

Abiraterone Acetate can slow down the progression of prostate cancer, provide symptom relief, and extend survival, but it is not typically considered curative.

  1. Are there specific patient groups that benefit most from Abiraterone Acetate treatment?

Abiraterone Acetate is often prescribed for patients with advanced prostate cancer, especially when other treatments have failed or are no longer effective.

  1. Are there any potential side effects associated with Abiraterone Acetate Tablets?

Yes, there can be side effects, which may include fatigue, hypertension (high blood pressure), fluid retention, hot flashes, joint and muscle pain, gastrointestinal issues, and changes in liver function, among others.

  1. How should Abiraterone Acetate Tablets be taken?

Abiraterone Acetate is usually taken orally as a tablet, often once a day, with or without food. It is often prescribed in combination with corticosteroids like prednisone or prednisolone.

  1. Can Abiraterone Acetate Tablets be used in combination with other prostate cancer treatments?

Yes, they are sometimes used in combination with other treatments, such as radiation therapy or immunotherapy, depending on the individual patient’s condition and treatment plan.

  1. Is Abiraterone Acetate suitable for all prostate cancer patients?

Not all prostate cancer patients are candidates for Abiraterone Acetate treatment. Eligibility is determined by a healthcare provider based on the patient’s specific diagnosis and medical history.

  1. How often should patients on Abiraterone Acetate Tablets be monitored by their healthcare provider?

Patients should be regularly monitored by their healthcare provider to assess treatment effectiveness and manage any potential side effects. The frequency of monitoring can vary.

  1. Can Abiraterone Acetate Tablets interact with other medications or medical conditions?

Abiraterone Acetate can interact with certain medications and may not be suitable for patients with certain medical conditions. It’s important to inform healthcare providers about all medications and medical history.

As Abiraterone Acetate Tablets Exporters; We can cater to export business queries from the following geographies. We are exporting our Abiraterone Acetate Tablets product in the Following Countries-

Russia and CIS Countries: Azerbaijan, Armenia, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan, Uzbekistan and Ukraine

GCC/ Middle East Countries: Saudi Arabia, Yemen, Oman, Bahrain, UAE, Lebanon, Jordan, and Iraq.

African Countries: Nigeria, Tanzania, Sudan, Zambia, Benin, Angola, Liberia

Southeast Asia: Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand, Vietnam, Brunei Darussalam

Other Asian Countries: Nepal, Myanmar, Malaysia, Cambodia, Bhutan, Sri Lanka, Mauritius

Abiraterone Acetate Tablets Regulatory Documents:

  • Certificate of Analysis (COA)
  • Method of Analysis (MOA)
  • Stability Data (Accelerated stability / Long-term stability / Zone 4b)
  • CTD Dossier / ACTD Dossiers / eCTD Dossiers
  • Certificate of Pharmaceuticals Product (COPP)
  • Free Sale Certificate (FSC)
Contact the most reliable manufacturer of Abiraterone Acetate Tablets, Taj Pharmaceuticals Limited, to get bulk quantities at a reasonable price.

To Place Orders:

Direct line: +91 8448 444 095 / WhatsApp +91 74 0000 9975 / 74 0000 9976
E-Mail: info@tajpharma.com 
Toll free: 1-800-222-434 / Toll free: 1-800-222-825
General EPA BX: +91 22 2637 4592 / +91 22 2637 4593

GENERIC NAME OF THE MEDICINAL PRODUCT:

a) Abiraterone Acetate Tablets USP 250mg
b) Abiraterone Acetate Tablets USP 500mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Abiraterone Acetate Tablets USP 250mg
Each tablet contains:
Abiraterone Acetate USP……………250mg
Excipients…………………………………. q.s.


b) Abiraterone Acetate Tablets USP 500mg
Each tablet contains:
Abiraterone Acetate USP……………500mg
Excipients…………………………………. q.s.

THERAPEUTIC INDICATIONS:

Abiraterone is used in combination with other medicine to treat a certain type of prostate cancer that has spread to other parts of the body.

CAUTION & WARNING:

Caution: It is dangerous to take this preparation except under medical supervision.
Warning: To be sold by retail on the prescription of an Oncologist only.
Warning: Cytotoxic Agent: Women who are or may be pregnant should not handle abiraterone acetate tablets without gloves (see patient information leaflet)
Keep out of reach and sight of children.
Dispense in tight container as defined in USP.
Swallow whole tablet. Do not crush or chew.

STORAGE & DOSAGE:

Storage: Store at 20°C to 25°C (68° F to 77° F); excursions permitted from 15°C to 30°C (59° F to 86° F) [see USP Controlled Room Temperature].
Do not refrigerate.
Dosage: As directed by Oncologist.
For Oral use. Read the package insert before use.