GENERIC NAME OF THE MEDICINAL PRODUCT:

a) Capecitabine Tablets USP 150mg
b) Capecitabine Tablets USP 500mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

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


b) Capecitabine Tablets USP 500mg
Each film-coated tablet contains:
Capecitabine USP ……………….500mg
Excipients…………………………….q.s.
Colours: Titanium Dioxide USP

THERAPEUTIC INDICATIONS:

Capecitabine is used to help treat patients with Dukes' C colon cancer (colon cancer that has spread to lymph nodes in the area close to the colon), after having surgery. This medicine is also used to treat metastatic colorectal cancer (cancer of the colon or rectum that has spread to other parts of the body).

CAUTION & WARNING:

CAUTION: It is dangerous to take this preparation except under medical supervision.
CAUTION: Potent cytotoxic agent handle with great care. Use only after reading the directions on pack insert.
Procedures for safe handling of cytotoxic drugs should be followed.
WARNING: Cytotoxic Agent: To be sold by retail on the prescription of Oncologist/ Cancer Hospital/ Institution only.
WARNING: To be supplied against demand from Cancer Hospitals, Institutions and against prescription of a Cancer Specialist only.
PHARMACIST: PLEASE DISPENSE WITH MEDICATION GUIDE PROVIDED SEPARATELY.
Aluminium-aluminium blister - The medical product does not require any special storage condition. PVC/PVdc-aluminium blister.
Swallow capecitabine tablets whole with water within 30 minutes of a meal.
Do not crush or cut capecitabine tablets.
Keep out of reach and sight of children.

STORAGE & DOSAGE:

Storage: Store at 20°C to 25°C (68° to 77° F) [see USP Controlled Room Temperature].
Do not refrigerate.
Dosage: As directed by the Physician.
For dosage recommendations and other important prescribing information, read accompanying insert.

Capecitabine Tablets USP 150mg Technical Specification:

Product Name:Capecitabine Tablets USP 150mg
Brand Name:Xlotabin
Strength:150mg, 500mg
Dosage Form:Film-coated tablets
Packing:10s, 30s, 100s Blisters
30 Tab Bottle, 60 Tab Bottle, 120 Tab Bottle
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, Cytotoxic Agent, Breast cancer
Indication: Capecitabine is used to help treat patients with Dukes’ C colon cancer (colon cancer that has spread to lymph nodes in the area close to the colon), after having surgery. This medicine is also used to treat metastatic colorectal cancer (cancer of the colon or rectum that has spread to other parts of the body).
Storage:Store at 20°C to 25°C (68° to 77° F) [see USP Controlled Room Temperature]. Do not refrigerate.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Capecitabine Tablets USP 150mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Capecitabine Tablets USP 150mg
    Each film-coated tablet contains:
    Capecitabine USP ……………….150mg
    Excipients…………………………….q.s.
    Colours: Red Oxide of Iron

THERAPEUTIC INDICATIONS:

Capecitabine is used to help treat patients with Dukes’ C colon cancer (colon cancer that has spread to lymph nodes in the area close to the colon), after having surgery. This medicine is also used to treat metastatic colorectal cancer (cancer of the colon or rectum that has spread to other parts of the body).

CAUTION & WARNING:

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

CAUTION: Potent cytotoxic agent handle with great care. Use only after reading the directions on pack insert.

Procedures for safe handling of cytotoxic drugs should be followed.

WARNING: Cytotoxic Agent: To be sold by retail on the prescription of Oncologist/ Cancer Hospital/ Institution only.

WARNING: To be supplied against demand from Cancer Hospitals, Institutions and against prescription of a Cancer Specialist only.

PHARMACIST: PLEASE DISPENSE WITH MEDICATION GUIDE PROVIDED SEPARATELY.

Aluminium-aluminium blister – The medical product does not require any special storage condition. PVC/PVdc-aluminium blister.

Swallow capecitabine tablets whole with water within 30 minutes of a meal.

Do not crush or cut capecitabine tablets.

Keep out of reach and sight of children.

STORAGE & DOSAGE:

Storage: Store at 20°C to 25°C (68° to 77° F) [see USP Controlled Room Temperature].

Do not refrigerate.

Dosage: As directed by the Physician.

For dosage recommendations and other important prescribing information, read accompanying insert.

Why Taj Pharmaceuticals?

Leadership in Cancer Treatment: Taj Pharmaceuticals has established itself as a distinguished leader in the realm of cancer treatment. This reputation is exemplified through our dedication to innovation and excellence, notably embodied by Capecitabine Tablets. With a proven track record of providing effective oncology medications, we are committed to advancing cancer care by ensuring that healthcare professionals have access to the highest quality pharmaceuticals.

Patient-Centric Approach: At Taj Pharmaceuticals, we recognize that cancer treatment transcends the realm of medications; it’s fundamentally about the patients and their overall well-being. This patient-centric ethos propels us to perpetually refine and develop medications like Capecitabine Tablets. Our objective is to enhance treatment outcomes while minimizing potential side effects. Through these efforts, we aim to significantly contribute to the improved quality of life for cancer patients worldwide.

Adherence to High-Quality Manufacturing Standards: Our state-of-the-art manufacturing facilities are steadfast in adhering to the most stringent quality standards. We take immense pride in leveraging cutting-edge technology and a cadre of highly skilled professionals to produce Capecitabine Tablets. Every facet of the manufacturing process is subject to rigorous scrutiny, ensuring that each tablet meets the highest benchmarks for purity, potency, and uniformity.

Global Accessibility of Capecitabine Tablets: Cancer is a universal challenge, and in kind, our commitment to providing Capecitabine Tablets spans the globe. We are resolute in our mission to make this indispensable medication accessible to cancer patients and healthcare providers across the world. Regardless of geographic location, Taj Pharmaceuticals remains unwavering in our determination to ensure that patients have unimpeded access to this pivotal cancer therapy.

Collaboration and Support for Cancer Care: Taj Pharmaceuticals doesn’t merely supply pharmaceuticals; we forge enduring partnerships. We extend continuous support and actively collaborate with healthcare providers and institutions. This empowers them to administer the highest standard of care to cancer patients. Our commitment extends beyond the product, as we work hand-in-hand with healthcare professionals to advance cancer treatment and research.

In choosing Taj Pharmaceuticals for Capecitabine Tablets, you are selecting a partner deeply rooted in quality, innovation, and patient-centric care. We stand resolutely at the forefront of cancer treatment, delivering hope and healing to patients and healthcare providers alike.

What is Capecitabine Tablets and its uses:

Capecitabine Tablets are a vital component in the arsenal against cancer, primarily used in the treatment of breast cancer and colorectal cancer. These tablets belong to the class of antimetabolite drugs and contain capecitabine as their active ingredient. What sets Capecitabine apart is its unique mechanism – within the body, it is converted into another powerful compound called 5-fluorouracil (5-FU). This conversion unleashes a targeted attack on cancer cells, disrupting their growth and replication processes, ultimately leading to their destruction.

Treatment of Breast Cancer: One of the foremost applications of Capecitabine Tablets is in the treatment of breast cancer. This medication is often prescribed when breast cancer has metastasized, spreading to other parts of the body, or when other treatment options have proven ineffective. It can be used as a standalone chemotherapy drug or in combination with other cancer medications, offering a versatile approach to breast cancer therapy.

Colorectal Cancer: Capecitabine Tablets also play a pivotal role in the management of colorectal cancer, encompassing both colon and rectal cancer cases. They are deployed as part of comprehensive chemotherapy regimens, aiding in the battle against colorectal malignancies.

Other Cancer Types: Beyond breast and colorectal cancers, Capecitabine Tablets may find application in the treatment of gastric (stomach) cancer and, in certain cases, other cancer types like pancreatic and esophageal cancer. Their usage in these instances is generally guided by healthcare providers, who consider individual patient factors and the specifics of the cancer diagnosis.

The uniqueness of Capecitabine lies in its prodrug nature, where it remains inactive until transformed into its active form, 5-FU, inside the body. This compound, 5-FU, acts as a chemotherapy agent, disrupting the growth and replication of cancer cells. What sets Capecitabine apart is its propensity to convert into 5-FU primarily within tumor cells, thereby delivering targeted therapy with reduced side effects compared to direct 5-FU administration.

The utilization of Capecitabine Tablets, including dosage and duration, is tailored to the type and stage of cancer, as well as the overall health of the patient. Typically overseen by experienced oncologists or specialized healthcare providers, the treatment plan is meticulously crafted to maximize its effectiveness while minimizing potential side effects.

How does Capecitabine Tablets Work:

Capecitabine Tablets employ a distinctive mechanism of action, distinguished by their transformation into an active chemotherapy agent within the body. The pivotal component of this mechanism is the conversion of capecitabine into 5-fluorouracil (5-FU), a potent chemotherapy drug. This conversion occurs via enzymatic processes, primarily within cancer cells. Here is a breakdown of how Capecitabine Tablets function:

Prodrug Activation: Capecitabine starts as an inactive prodrug, devoid of chemotherapy activity. Once ingested, it embarks on a journey through the bloodstream, making its way to tumor sites.

Conversion to 5-FU: Within the body, specific enzymes, both in the liver and within tumor cells themselves, transform capecitabine into its active state, 5-FU. This conversion process is notably robust within cancer cells, leading to a higher concentration of 5-FU within the tumor, thereby concentrating its therapeutic impact.

Interfering with DNA Synthesis: The active agent, 5-FU, exerts its anticancer effects by disrupting the synthesis of DNA, the fundamental genetic material within cells. It integrates itself into the DNA of rapidly dividing cancer cells, disrupting the regular DNA replication process.

Inhibition of Cell Growth: Through its incorporation into DNA, 5-FU hinders the formation of new DNA strands. This impediment effectively curtails the growth and multiplication of cancer cells, a crucial step in curbing the disease’s progression.

Induction of Cell Death: 5-FU also triggers cell death, a process known as apoptosis, within cancer cells. It initiates a series of events within the cell, ultimately leading to its self-destruction.

Targeted Action: A notable advantage of Capecitabine Tablets is their propensity to preferentially convert into 5-FU within tumor cells. This targeted activation enables a more focused assault on cancer cells while sparing healthy ones to some extent. As a result, it holds the potential to mitigate the side effects commonly associated with chemotherapy.

The effectiveness of Capecitabine Tablets hinges on numerous variables, including the type of cancer being treated, its stage, and the individual patient’s response to the medication. Oncologists meticulously design treatment plans involving Capecitabine to optimize its therapeutic benefits while minimizing side effects. Regular monitoring and adjustments to the treatment regimen are common practices to ensure the best possible outcomes for cancer patients.

Benefits of Capecitabine Tablets:

Capecitabine Tablets offer significant advantages in cancer treatment. Firstly, they have proven effectiveness in combating various cancer types, including breast cancer and colorectal cancer. Whether used as a standalone chemotherapy drug or in combination therapy, Capecitabine plays a pivotal role in halting the progression of these malignancies. Moreover, the convenience of oral administration, in the form of tablets, can enhance patient comfort and reduce the necessity for frequent hospital visits, ultimately contributing to an improved quality of life during treatment.

Another key advantage lies in Capecitabine’s targeted action. As a prodrug, it is converted into its active form, 5-fluorouracil (5-FU), primarily within cancer cells. This selective activation allows for a focused assault on cancer cells, potentially minimizing damage to healthy tissues and thereby reducing the likelihood and severity of side effects. Furthermore, oncologists can tailor treatment regimens with Capecitabine to align with each patient’s unique requirements, encompassing variables such as cancer type, stage, and overall health.

Common Side Effects:

Alongside its benefits, Capecitabine Tablets can also be accompanied by certain side effects. Hand-Foot Syndrome, characterized by redness, swelling, tenderness, and, in some cases, peeling or blistering on the palms and soles, is a notable side effect. Effective hand and foot care can aid in managing this condition. Nausea and vomiting are possible side effects, which can be alleviated with the prescription of antiemetic medications.

Capecitabine may lead to diarrhea, and in some instances, it can be severe. Adequate hydration and medications to control diarrhea may be required. Fatigue is a common occurrence during cancer treatment and may be exacerbated by Capecitabine. Rest and gentle exercise can help mitigate this symptom. The medication can also reduce blood cell counts, increasing the risk of anemia, infections, and bleeding. Regular blood tests are typically conducted to monitor these levels.

Liver toxicity is another potential side effect, necessitating vigilant monitoring of liver function. Mouth sores, or stomatitis, can develop with Capecitabine treatment, but maintaining proper oral hygiene and using prescribed mouthwashes can help manage this discomfort. Finally, while less common than with some other chemotherapy drugs, Capecitabine may cause hair thinning or loss.

Patient experiences with side effects can vary, emphasizing the importance of open communication with healthcare providers. Many side effects can be effectively managed with supportive care and adjustments to the medication regimen. The benefits of Capecitabine in treating cancer often outweigh the potential side effects, especially when administered under the expert supervision of healthcare professionals.

Frequently Asked Questions About Capecitabine Tablets:

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

  1. What is Capecitabine, and what is it used for?

Capecitabine is a chemotherapy medication used in the treatment of various types of cancer, including breast cancer and colorectal cancer.

  1. How does Capecitabine work?

Capecitabine is a prodrug that gets converted into an active chemotherapy drug, 5fluorouracil (5FU), within the body. 5FU interferes with the growth and replication of cancer cells.

  1. Is Capecitabine the same as 5fluorouracil (5FU)?

No, Capecitabine is a prodrug that is converted into 5FU in the body. They have a similar mechanism of action, but Capecitabine has the advantage of being administered orally.

  1. What types of cancer can Capecitabine treat?

Capecitabine is commonly used in the treatment of breast cancer and colorectal cancer. It may also be considered for other types of cancer, depending on the individual patient’s condition.

  1. Is Capecitabine administered orally?

Yes, Capecitabine is available in tablet form and is taken orally. This is often more convenient for patients compared to intravenous chemotherapy.

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

Common side effects may include hand foot syndrome, nausea, vomiting, diarrhea, fatigue, low blood cell counts, liver toxicity, mouth sores, and hair loss. However, the severity and occurrence of side effects can vary among individuals.

  1. How is the dosage of Capecitabine determined?

The dosage of Capecitabine is determined by the patient’s oncologist and is based on factors such as the type and stage of cancer, the patient’s overall health, and their individual response to the medication.

  1. Can Capecitabine be used during pregnancy and breastfeeding?

Capecitabine may pose risks to a developing fetus, so its use during pregnancy should be carefully considered and discussed with a healthcare provider. It is generally not recommended during breastfeeding.

  1. Are there any interactions with other medications?

Capecitabine can interact with other medications, so it’s essential to inform your healthcare provider about all the drugs you are taking, including over the counter and herbal supplements.

  1. How often is Capecitabine taken, and for how long is it typically prescribed?

The dosing schedule and duration of Capecitabine treatment vary depending on the specific cancer being treated and the patient’s response to therapy. It is typically administered in cycles with rest periods in between.

Patients and caregivers should consult with their healthcare providers for personalized information and guidance regarding Capecitabine Tablets in their specific medical situations.

Capecitabine Tablets Exporters; We can cater to export business queries from the following geographies. We are exporting our Capecitabine Tablets product in 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

Capecitabine 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 Capecitabine 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