Hetero Labs


Medicell Pharma
Concise Prescribing Info
Single agent for adjuvant treatment in patients w/ Duke's C colon cancer who have undergone complete resection of the primary tumor when treatment w/ fluoropyrimidine therapy alone is preferred. 1st-line treatment of patients w/ metastatic colorectal carcinoma when treatment w/ fluoropyrimidine therapy alone is preferred. Metastatic breast cancer after failure of prior anthracycline-containing chemotherapy; metastatic breast cancer resistant to both paclitaxel & an anthracycline-containing chemotherapy regimen or resistant to paclitaxel & for whom further anthracycline therapy is not indicated.
Dosage/Direction for Use
Monotherapy for colon, colorectal or breast cancer Initially 1,250 mg/m2 bd for 2 wk, followed by a 7-day rest period. Adjuvant treatment w/ stage III colon cancer is recommended for a total of 6 mth. Combination therapy for breast cancer w/ docetaxel Initially 1,250 mg/m2 bd for 2 wk, followed by a 7-day rest period plus docetaxel 75 mg/m2 given as 1-hr IV infusion every 3 wk. Combination therapy for colon & colorectal cancer Initially 1,000 mg/m2 bd for 2 wk, followed by a 7-day rest period. Adjuvant treatment w/ stage III colon cancer is recommended for a total of 6 mth.
Should be taken with food: Take w/in 30 min after meals.
Hypersensitivity. History of severe & unexpected reactions to fluoropyrimidine therapy or known hypersensitivity to fluorouracil. Dihydropyrimidine dehydrogenase deficiency. Severe leukopenia, neutropenia or thrombocytopenia. Concomitant use w/ sorivudine or its chemically related analogues eg, brivudine. Severe hepatic or renal impairment (CrCl <30 mL/min).
Special Precautions
Discontinue use if severe skin reactions occur. Monitor patients w/ severe diarrhea. Potentially fatal acute renal failure secondary to dehydration. Preexisting compromised renal function or concomitantly using known nephrotoxic agents. History of significant cardiac disease, arrhythmias & angina pectoris. Preexisting hypo- or hypercalcaemia. Central or peripheral nervous system disease (eg, brain metastasis or neuropathy). DM or electrolyte disturbances. Decreased dihydropyrimidine dehydrogenase levels. May induce severe skin reactions eg, Stevens-Johnson syndrome & toxic epidermal necrolysis, cutaneous toxicity eg, hand-foot syndrome (palmar-plantar erythrodysesthesia or chemotherapy-induced acral erythema) & hyperbilirubinemia. Ensure adequate fluid & electrolyte replacement in dehydrated patients due to severe diarrhea. Concomitant use w/ warfarin & oral coumarin-derivative anticoagulant therapy. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. May affect ability to drive & use machines. Moderate renal impairment (CrCl 30-50 mL/min). Hepatic impairment. Woman of childbearing potential. Not to be used during pregnancy & lactation. Childn. Elderly.
Adverse Reactions
GI disorders eg, diarrhea, nausea, vomiting, abdominal pain, stomatitis; palmar-plantar erythrodysesthesia; fatigue, asthenia; anorexia; cardiotoxicity; increased renal dysfunction; thrombosis/embolism.
Drug Interactions
Altered coagulation parameters &/or bleeding w/ coumarin-derivative anticoagulants eg, warfarin & phenprocoumon. Co-administration w/ other CYP450 2C9 metabolized drugs. Increased phenytoin plasma conc. Decreased absorption rate w/ food. Increased plasma conc w/ Al or Mg hydroxide-containing antacids. Reduced max tolerated dose w/ leucovorin (folinic acid), interferon-2α; radiotherapy. Increased fluoropyrimidine toxicity w/ sorivudine & analogues. Decreased efficacy of 5-fluorouracil w/ allopurinol.
ATC Classification
L01BC06 - capecitabine ; Belongs to the class of antimetabolites, pyrimidine analogues. Used in the treatment of cancer.
Capetero tab 150 mg
Capetero tab 500 mg
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