| Dossier: | Ctd |
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| GMP: | Chinese GMP |
| Transport Package: | Free |
| Specification: | 500mg |
| Trademark: | Sinolead |
| Origin: | China |
| Samples: |
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| Customization: |
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| Generic Name | Capecitabine Tablets 500mg |
| Strength | 500mg |
| Packing | 12tabs/blister,1blistrer/box |
| Origin | China |
Double convex, rectangular, peach coated sheet, white after removing the coating.
Indications for 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.
Usage and dosage:
The recommended dose of capecitabine is 1250mg/m2 orally, twice a day (once in the morning and once in the evening; Equal to the total daily dose of 2500mg/m[sup]2[/sup]), after 2 weeks of treatment, stop the drug for 1 week, 3 weeks for a course of treatment. Capecitabine tablets should be swallowed with water within 30 minutes after a meal. When used in combination with docetaxel, the recommended dose of capecitabine is 1250 mg/m2, twice daily, discontinued after 2 weeks of treatment for 1 week, and the recommended dose of docetaxel in combination is 75 mg/m2, once every 3 weeks, for 1 hour of intravenous infusion. According to docetaxel's prospectus, some chemotherapeutic adjuvant drugs should be routinely administered before docetaxel is used in patients receiving combination chemotherapy with capecitabine and docetaxel.
Table 1 lists the total daily dose of capecitabine by body surface area and the number of tablets to be taken for each dose.
When used as adjuvant therapy for patients with Dukes 'C stage colon cancer, the recommended treatment time is 6 months, that is, capecitabine 1250 mg/m2 orally, twice a day, 2 weeks after treatment for 1 week, 3 weeks as a course of treatment, a total of 8 courses (24 weeks).
Matters needing attention:
Diarrhea: Capecitabine can cause diarrhea, sometimes severe. Patients who develop severe diarrhea should be closely monitored, and fluids and electrolytes should be replaced immediately if the patient begins to become dehydrated. Standard antidiarrheal drugs (such as loperamide) should be started early in the range of rational use. Dosage should be reduced if necessary (see Usage and dosage).
Dehydration: Dehydration should be prevented and corrected when starting treatment with capecitabine. Patients who develop anorexia, weakness, nausea, vomiting, or diarrhea can quickly become dehydrated. When symptoms of grade 2 (or above) dehydration appear, treatment with this product must be stopped immediately while dehydration is corrected. Treatment should not be resumed until the symptoms of dehydration have disappeared and the immediate cause of dehydration has been corrected and controlled. In response to adverse events, it is necessary to adjust the dosage.
Cardiotoxicity of capecitabine similar to fluorouracil has been observed, including myocardial infarction, angina pectoris, arrhythmia, cardiac arrest, heart failure, and electrocardiogram changes. These adverse events may be more common in patients with a prior history of coronary artery disease.
Rare, unpredictable and severe toxicities (such as oral inflammation, diarrhea, neutropenia, and neurotoxicity) associated with 5-fluorouracil have occurred in the past due to dihydropyrimine dehydrogenase deficiency (DPD). Therefore, the possibility of an association between reduced DPD levels and enhanced potential lethal toxic effects of 5-fluorouracil cannot be ruled out.
Capecitabine can cause hand-foot syndrome (palm-plantar numbness or chemotherapy-induced acroerythema), a skin toxicity. In patients with metastatic cancer treated with capecitabine monotherapy, the median onset time of hand-foot syndrome was 79 days (ranging from 11 to 360 days) and the severity was grade 1 to 3.
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