Capecitabine Taro 500 mg

/ Taro

This product should only be prescribed by a qualified physician experienced in the utilisation of anti-neoplastic medicinal products. Careful monitoring during the first cycle of treatment is recommended for all patients.
Standard dose: The dosage is determined based on a measurement called body surface area. Your body surface area is calculated from your weight and height. The standard dose for adults is 1250 mg per m² of body surface area, taken twice a day (morning and evening).
Please refer to the license holder for further details.

Adjuvant Colon Cancer: for the adjuvant treatment of patients following surgery of stage III (Dukes stage C) colon cancer.
Colorectal Cancer: for the treatment of patients with advanced or metastatic colorectal cancer.
Advanced gastric cancer: for first line treatment of advanced gastric cancer in combination with chemotherapy.
Breast Cancer Combination Therapy: in combination with docetaxel is indicated for the treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing chemotherapy.
Breast Cancer Monotherapy: indicated for the treatment of advanced or metastatic breast cancer after failure of standard therapy including a taxane unless therapy with a taxane is clinically contraindicated.

History of severe and unexpected reactions to fluoropyrimidine therapy. Hypersensitivity to capecitabine or to any of the excipients, or fluorouracil. In patients with known dihydropyrimidine dehydrogenase (DPD) deficiency. During pregnancy and lactation. In patients with severe leukopenia, neutropenia, or thrombocytopenia. In patients with severe hepatic impairment. In patients with severe renal impairment (creatinine clearance below 30 ml/min). Treatment with sorivudine or its chemically related analogues, such as brivudine If contraindications exist to any of the medicinal products in the combination regimen, that medicinal product should not be used.

Please refer to the license holder for further details.

Herpes viral infection, nasopharyngitis, lower respiratory tract infection, neutropenia, anaemia, headache, lethargy dizziness, parasthesia, dysgeusia. Please refer to the license holder for further details.

Interaction studies have only been performed in adults.
Cytochrome P-450 2C9 substrates: Other than warfarin, no formal drug-drug interaction studies between it and other CYP2C9 substrates have been conducted. Care should be exercised when capecitabine is co-administered with 2C9 substrates (e.g., phenytoin).
Coumarin-derivative anticoagulants: Altered coagulation parameters and/or bleeding have been reported in patients taking this drug concomitantly with coumarin-derivative anticoagulants such as warfarin and phenprocoumon. These reactions occurred within several days and up to several months after initiating therapy and, in a few cases, within one month after stopping it.
Phenytoin: Increased phenytoin plasma concentrations resulting in symptoms of phenytoin intoxication in single cases have been reported during concomitant use with phenytoin. Patients taking phenytoin concomitantly with it should be regularly monitored for increased phenytoin plasma concentrations.
Folinic acid: a combination study with this drug and folinic acid indicated that folinic acid has no major effect on the pharmacokinetics of it and its metabolites.
Please refer to the license holder for further details.

Pregnancy: Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with capecitabine. If the patient becomes pregnant while receiving capecitabine, the potential hazard to the foetus must be explained. An effective method of contraception should be used during treatment. There are no studies in pregnant women using capecitabine.
Lactation: It is not known whether capecitabine is excreted in human breast milk.

Please refer to the license holder for further details.

Food: no later than 30 minutes after a meal.
Storage: Store below 25°C.
Do not discard the medicine via household waste or wastewater. Ask the pharmacist how to discard the medicine in order to protect the environment.