Major Ingredients

Each film coated tablet contains Capecitabine USP 500 mg.

Major Functionality

Colorectal Cancer: Capecitabine is indicated as a single agent for adjuvant treatment in patients with Dukes' C colon cancer who have undergone complete resection of the primary tumor when treatment with fluoropyrimidine therapy alone is preferred. Capecitabine was non-inferior to 5- flourouracil and Calcium folinate for disease-free survival (DFS). Although neither Capecitabine nor combination chemotherapy prolongs overall survival (OS), combination chemotherapy has been demonstrated to improve disease-free survival compared to 5-fluorouracil or Calcium folinate. Capecitabine is indicated as first-line treatment of patients with metastatic colorectal carcinoma when treatment with fluoropyrimidine therapy alone is preferred. Combination chemotherapy has shown a survival benefit compared to 5-fluorouracil or Calcium folinate alone. A survival benefit over 5 fluorouracil or Calcium folinate has not been demonstrated with Capecitabine monotherapy.Use of Capecitabine instead of 5-fluorouracil or Calcium folinate in combinations has not been adequately studied to assure safety or preservation of the survival advantage. Breast Cancer: Capecitabine in combination with Docetaxel is indicated for the treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing chemotherapy. Capecitabine monotherapy is also indicated for the treatment of patients with metastatic breast cancer resistant to both Paclitaxel and an anthracycline-containing chemotherapy regimen or resistant to Paclitaxel and for whom further anthracycline therapy is not indicated eg, patients who have received cumulative doses of 400mg/m2 of Doxorubicin or Doxorubicin equivalents. Resistance is defined as progressive disease while on treatment, with or without an initial response, or relapse within 6 months of completing treatment with an anthracycline- containing adjuvant regimen

Manufacture Information

Drug International Limited was incorporated under the Registrar of Joint Stock Companies in 1974 as a Private Limited Company. The company commenced formulation and production in 1983 and emerged as a pioneer in Bangladesh for adding a state of the art oral solid dosage plant. Since inception, Drug International Limited's primary objective has been to meet guidelines provided by major global regulatory bodies such as the World Health Organization Good Manufacturing Practices (WHO cGMP) guidelines.