Bicalutamide Tablets USP 50mg Technical Specification:

Product Name:Bicalutamide Tablets USP 50mg
Brand Name:Bicalutamide
Strength:50mg, 150mg
Dosage Form:Film-coated Tablet
Packing:10s, 28s, 30s, 50s
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: Bicalutamide is used together with a luteinizing hormone releasing hormone (LHRH) analogue to treat stage D2 metastatic prostate cancer (cancer that has spread in men).
Storage:Store protected from moisture at a temperature not exceeding 30°C. Do not refrigerate.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Bicalutamide Tablets USP 50mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Bicalutamide Tablets USP 50mg
    Each film-coated tablet contains:
    Bicalutamide USP……………..50mg
    Excipients…………………………q.s.
    Colours: Titanium Dioxide USP

THERAPEUTIC INDICATIONS:

Bicalutamide is used together with a luteinizing hormone releasing hormone (LHRH) analogue to treat stage D2 metastatic prostate cancer (cancer that has spread in men).

CAUTION & WARNING:

Caution: It is dangerous to take this preparation except under medical supervision.
Warning: Cytotoxic Agent: To be sold by retail on the prescription of an oncologist/ Cancer Hospital/ Institution only.
Warning: Cytotoxic: To be supplied against demand from Cancer Hospitals, Institutions and against prescription of a Cancer Specialist only.
Keep out of reach and sight of children.
Keep container tightly closed.
Dispense in original container.
Swallow complete tablet, do not crush or chew.

STORAGE & DOSAGE:

Storage: Store protected from moisture at a temperature not exceeding 30°C. Do not refrigerate.
Dosage: As directed by Oncologist.
For Oral use. Read the package insert before use.

Why Taj Pharmaceuticals?

Taj Pharmaceuticals has established itself as a beacon of pharmaceutical excellence, with a proud history of delivering high-quality medications to patients worldwide. Our dedication to maintaining the highest standards of quality and safety is reflected in every Bicalutamide Tablet we produce. Bicalutamide Tablets are a critical component in the treatment of prostate cancer, a condition that affects countless individuals and their families. We understand the importance of reliability in such circumstances, and our commitment to consistency in manufacturing ensures that you can trust us with your healthcare needs. At Taj Pharmaceuticals, our mission transcends mere medication production. We aim to improve lives and enhance health outcomes. Bicalutamide Tablets are a testament to this commitment, offering hope and effective treatment options to those battling prostate cancer. Our global presence ensures that patients and healthcare providers around the world have access to our pharmaceutical solutions. We invite you to experience the Taj Pharmaceuticals difference and entrust us with your healthcare needs. With Bicalutamide Tablets, you’re choosing a partner dedicated to your well-being. Your health is our priority, and we are honored to be your pharmaceutical provider on your journey to improved health and quality of life.

What is Bicalutamide Tablets and its uses:

Bicalutamide Tablets are a vital medication in the fight against prostate cancer, a condition that predominantly affects the male population. These tablets contain the active ingredient bicalutamide, classified as an antiandrogen. Prostate cancer is often fueled by androgens, male sex hormones, and bicalutamide’s role is to counteract these hormones’ influence, specifically testosterone, in the treatment of prostate cancer. At the core of their mechanism of action, Bicalutamide Tablets inhibit the binding of testosterone to prostate cancer cells. By doing so, they disrupt the essential growth signals that androgens provide to these cells, ultimately slowing down the proliferation of cancerous cells within the prostate gland. This critical function makes bicalutamide an integral part of prostate cancer management. The primary application of Bicalutamide Tablets is in the treatment of prostate cancer, particularly in cases where the disease has advanced and potentially spread to other parts of the body. When combined with other therapies or medications, bicalutamide contributes significantly to controlling the progression of prostate cancer. It may also provide relief from associated symptoms, enhancing the patient’s quality of life. It is crucial to emphasize that the use of Bicalutamide Tablets is not a standalone treatment but a crucial component of a comprehensive prostate cancer treatment plan. This plan is customized by healthcare providers based on individual factors, including the stage and severity of the cancer. Bicalutamide Tablets are often integrated into a multimodal approach that may include surgical interventions, radiation therapy, or other hormonal treatments like luteinizing hormone-releasing hormone (LHRH) agonists. Patients undergoing treatment with Bicalutamide Tablets are strongly advised to adhere to their healthcare provider’s recommendations diligently and to maintain regular follow-up appointments for continuous monitoring of their prostate cancer treatment progress.

How does Bicalutamide Tablets work?

Bicalutamide Tablets, featuring the active ingredient bicalutamide, play a crucial role in the management of prostate cancer by disrupting the influence of androgens, specifically testosterone. Prostate cancer is notorious for its dependence on androgens for growth, making the actions of these tablets essential in curbing its progression. At the heart of their mechanism of action lies the inhibition of androgen binding. Prostate cancer cells possess androgen receptors on their surface, which serve as docking sites for hormones like testosterone. These hormones, when bound to the receptors, trigger a cascade of signals that stimulate the unchecked growth of cancer cells. Bicalutamide acts as a competitive inhibitor, meaning it competes with testosterone for binding to these receptors. However, it takes a different approach. Rather than activating the receptors like testosterone, bicalutamide binds to them without activating them. This critical action effectively blocks the androgen signals responsible for fueling the growth and division of prostate cancer cells. The result of this antagonistic action is a notable slowdown in cancer cell growth and a reduction in the spread of prostate cancer within the prostate gland. By disrupting the androgen-dependent pathways crucial for cancer progression, Bicalutamide Tablets act as a formidable force against this prevalent cancer type. It is vital to recognize that these tablets are not a standalone treatment but a vital component of a comprehensive prostate cancer treatment plan. Healthcare providers customize treatment plans based on individual factors, including the stage and severity of the cancer. Bicalutamide Tablets are often integrated into a broader therapeutic strategy that may encompass surgical interventions, radiation therapy, or other hormonal treatments such as luteinizing hormone-releasing hormone (LHRH) agonists. Patients undergoing treatment with Bicalutamide Tablets are encouraged to diligently follow their healthcare provider’s recommendations and maintain regular follow-up appointments to monitor the progress of their prostate cancer treatment.

Benefits of Bicalutamide Tablets:

Bicalutamide Tablets offer a range of significant benefits, primarily in the realm of prostate cancer management. These tablets are particularly effective in the treatment of prostate cancer, a condition where androgens, notably testosterone, play a pivotal role in driving cancer cell growth. The key advantage of Bicalutamide Tablets lies in their ability to inhibit the binding of testosterone to prostate cancer cells. By doing so, they impede the signals that fuel the uncontrolled proliferation of cancer cells within the prostate gland. This vital action results in a notable slowdown in the progression of prostate cancer, making these tablets an invaluable tool in the fight against this prevalent cancer.

Crucially, Bicalutamide Tablets are not a standalone treatment but a crucial component of a comprehensive prostate cancer management plan. They are frequently integrated with other therapeutic interventions, such as surgery, radiation therapy, or hormonal treatments like luteinizing hormone-releasing hormone (LHRH) agonists. This multimodal approach ensures a more comprehensive and effective approach to treating prostate cancer, particularly in advanced cases. Additionally, Bicalutamide Tablets may provide relief from symptoms associated with prostate cancer, including urinary difficulties, pain, and discomfort.

Side Effects of Bicalutamide Tablets:

While Bicalutamide Tablets offer substantial benefits, it’s essential to be aware of potential side effects that may accompany their use. Common side effects include hot flashes, gastrointestinal symptoms like nausea or diarrhea, breast changes such as enlargement or tenderness, and fatigue. These side effects can vary in severity from person to person and may require various management strategies, from lifestyle adjustments to medications.

Additionally, monitoring liver function is crucial during Bicalutamide treatment, as the medication can affect liver enzymes. Regular liver function tests are typically recommended to ensure safety. Some individuals may also experience a decrease in libido or sexual desire while taking these tablets.

It’s important to emphasize that not all individuals will experience these side effects, and their impact can differ. Healthcare providers carefully assess the benefits and potential risks of Bicalutamide Tablets in each patient’s unique case, tailoring treatment plans accordingly. Patients are encouraged to communicate any unusual or severe side effects to their healthcare provider promptly. Adherence to recommended monitoring and follow-up appointments is vital to ensure the safe and effective management of prostate cancer.

Frequently Asked Questions About Bicalutamide Tablets:

Certainly, here are some frequently asked questions (FAQs) about Bicalutamide Tablets:

  1. What are Bicalutamide Tablets used for?

Bicalutamide Tablets are primarily used in the treatment of prostate cancer. They work by inhibiting the effects of androgens, such as testosterone, which play a key role in promoting the growth of prostate cancer cells.

  1. How do Bicalutamide Tablets work?

These tablets function as antiandrogens, blocking the binding of testosterone to prostate cancer cells. By interrupting the androgen dependent growth signals, they slow down the proliferation of cancer cells within the prostate gland.

  1. Are Bicalutamide Tablets a standalone treatment for prostate cancer?

No, Bicalutamide Tablets are typically part of a comprehensive treatment plan for prostate cancer. They are often used in combination with other therapies such as surgery, radiation therapy, or hormonal treatments, depending on the patient’s specific condition and needs.

  1. What are the common side effects of Bicalutamide Tablets?

Common side effects may include hot flashes, gastrointestinal symptoms (nausea, diarrhea), breast changes (enlargement or tenderness), fatigue, and decreased libido. It’s important to discuss any side effects with your healthcare provider.

  1. How long do I need to take Bicalutamide Tablets?

The duration of treatment with Bicalutamide Tablets varies depending on the individual patient’s condition and treatment plan. Your healthcare provider will determine the appropriate course of treatment.

  1. Can women or children take Bicalutamide Tablets?

No, Bicalutamide Tablets are specifically intended for the treatment of prostate cancer in adult men and should not be used by women or children.

  1. Are there any dietary restrictions while taking Bicalutamide Tablets?

There are no specific dietary restrictions associated with Bicalutamide Tablets. However, maintaining a balanced diet and staying hydrated can help manage some of the side effects, such as gastrointestinal symptoms.

  1. How often should I have liver function tests while taking Bicalutamide Tablets?

Regular monitoring of liver function is typically recommended during Bicalutamide treatment, as the medication can affect liver enzymes. The frequency of these tests will be determined by your healthcare provider.

  1. What should I do if I miss a dose of Bicalutamide Tablets?

If you miss a dose, take it as soon as you remember. However, if it’s close to the time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not double the dose to make up for a missed one.

  1. How can I manage hot flashes while taking Bicalutamide Tablets?

Hot flashes are a common side effect. Lifestyle adjustments such as staying cool, wearing lightweight clothing, and avoiding triggers like spicy foods or caffeine may help manage hot flashes. In some cases, medications can also be prescribed.

These FAQs provide essential information about Bicalutamide Tablets, but it’s crucial to consult with your healthcare provider for personalized guidance and to address specific questions or concerns related to your treatment.

As Bicalutamide Tablets Exporters; We can cater to export business queries from the following geographies. We are exporting our Bicalutamide 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

Bicalutamide 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  Bicalutamide 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
Fax No: +91 22 2634 1274

GENERIC NAME OF THE MEDICINAL PRODUCT:

a) Bicalutamide Tablets USP 50mg
b) Bicalutamide Tablets USP 150mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Bicalutamide Tablets USP 50mg
Each film-coated tablet contains:
Bicalutamide USP……………..50mg
Excipients…………………………q.s.
Colours: Titanium Dioxide USP


b) Bicalutamide Tablets USP 150mg
Each film-coated tablet contains:
Bicalutamide USP……………150mg
Excipients……………………….q.s.
Colours: Iron Oxide Red

THERAPEUTIC INDICATIONS:

Bicalutamide is used together with a luteinizing hormone releasing hormone (LHRH) analogue to treat stage D2 metastatic prostate cancer (cancer that has spread in men).

CAUTION & WARNING:

Caution: It is dangerous to take this preparation except under medical supervision.
Warning: Cytotoxic Agent: To be sold by retail on the prescription of an oncologist/ Cancer Hospital/ Institution only.
Warning: Cytotoxic: To be supplied against demand from Cancer Hospitals, Institutions and against prescription of a Cancer Specialist only.
Keep out of reach and sight of children.
Keep container tightly closed.
Dispense in original container.
Swallow complete tablet, do not crush or chew.

STORAGE & DOSAGE:

Storage: Store protected from moisture at a temperature not exceeding 30°C. Do not refrigerate.
Dosage: As directed by Oncologist.
For Oral use. Read the package insert before use.