| Generic Name |
Capecitabine Tablets |
| Strength |
500mg |
| Packing |
12 Tablets/box |
| Origin |
China |
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Product name:
Capecitabine Tablets
Character:
0.5g: double convex, rectangular, peach coated sheet, white after removing the coating. XELODA on one side, 500 on the other.
Indications:
Capecitabine tablets, indicated as adjuvant chemotherapy for colon cancer: capecitabine for Dukes' Monotherapeutic adjuvant therapy for stage C patients with colon cancer who received only fluoropyrimidines after radical primary tumor resection. The disease-free survival (DFS) of the treatment was comparable to that of the 5-fluorouracil and formyltetrahydrofolate combination regimen (5-FU/LV). Neither capecitabine alone nor chemotherapy combined with other drugs can prolong overall survival (OS), but existing trial data suggest that capecitabine can improve disease-free survival compared with 5-FU/LV in combination chemotherapy regimens. Physicians prescribe capecitabine monotherapy for Dukes' These findings may be considered for adjuvant treatment of stage C colon cancer. The data used to support this indication came from foreign clinical studies (see section [Clinical trials]). Colorectal cancer: Capecitabine can be used as first-line chemotherapy when fluorouracil monotherapy is preferred in patients with metastatic colorectal cancer. When capecitabine was combined with other drugs, survival was better than 5-FU/LV monotherapy. There is no evidence to support the survival advantage of capecitabine monotherapy. The safety and survival benefits of capecitabine as a substitute for 5-FU/LV in combination chemotherapy need further study. Breast cancer combination chemotherapy: Capecitabine may be used in combination with docetaxel for the treatment of metastatic breast cancer that has failed chemotherapy with anthracycline-containing regimens. Breast cancer single-agent chemotherapy: Capecitabine can also be used alone to treat patients with metastatic breast cancer who are resistant to both paclitaxel and anthracycline-containing chemotherapy regimens or who are resistant to paclitaxel and cannot be treated with anthracyclines (e.g., who have received a cumulative dose of 400 mg/m2 adriamycin or a doxorubicin equivalent). Resistance was defined as continued disease progression (with or without initial remission) during treatment, or relapse within 6 months after completion of adjuvant chemotherapy containing anthracyclines. Gastric cancer: Capecitabine is indicated for the first-line treatment of inoperable advanced or metastatic gastric cancer.
Drug overdose:
Acute drug overdose presents with: nausea, vomiting, diarrhea, mucositis, gastrointestinal irritation, bleeding, and bone marrow suppression.
Medical management of drug overdose should include: conventional treatment, supportive care (aimed at correcting clinical manifestations), and prevention of complications.
Pharmacology and toxicology:
Pharmacological action
Both normal and tumor cells metabolize 5-FU to 5-fluoro-2-deoxyuridylate monophosphate (FdUMP) and 5-fluoruridylate triphosphate (FUTP). These metabolites cause cell damage through two different mechanisms. First, FdUMP and folate cofactor N5, 10-methylenetetrahydrofolate bind to thymidylate synthase (TS) to form a covalently bound triple complex. This binding inhibits 2' -deoxyuridine from forming thoracic nucleotides. Thoracic nucleotide is an essential precursor to thymidine riboside triphosphate, which is required for DNA synthesis, so deficiencies of this compound inhibit cell division. Second, the nucleotranscriptase may mistakenly encode FUTP at the site of uridine triphosphate (UTP) during RNA synthesis. This metabolic error interferes with RNA processing and protein synthesis.
Toxicological study
At present, there are not enough studies to evaluate the carcinogenicity of capecitabine. Capecitabine did not cause mutations in bacteria (Ames test) or mammalian cells (Chinese hamster V79/HPRT gene mutation analysis) in vitro. Capecitabine can fracture human peripheral blood lymphocytes in vitro, but not in mouse bone marrow (micronucleus test). Fluorouracil causes mutations in bacteria and yeast, and also causes chromosomal abnormalities in micronucleus tests in mice.
In a study of fertility and total reproductive performance in mice, an oral capecitabine dose of 760mg/kg/ day disrupted the estrus period and led to decreased fertility. In pregnant mice, no embryos survived at this dose. The disruption of estrus is reversible. The dose caused degenerative changes in the males in this trial, including a reduction in the number of spermatocytes and sperm cells. Separate pharmacokinetic studies showed that the dose corresponding to this 5'-DFUR AUC value in mice was approximately 0.7 times the recommended daily dose for patients.
Storage:
Closed storage at 25ºC, acceptable between 15-30ºC. Drugs should be kept out of reach of children.
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