Capetero 500

Capetero 500



Hetero Labs


Full Prescribing Info
Each Film-Coated Tablet contains: Capecitabine 500 mg.
Pharmacology: Pharmacokinetics: Capecitabine is readily absorbed from the gastrointestinal tract, with peak plasma concentrations occurring at about 1.5 hours. Food reduces the rate and extent of absorption. Plasma protein binding of Capecitabine is less than 60%. Capecitabine is hydrolysed in the liver to 5'-deoxy-5-fluorocytidine (5'-DFCR), which is then converted to 5'-deoxy-5-fluorouridine (5'-DFUR; doxifluridine) and subsequently to 5-fluorouracilin body tissues. 5-fluorouracil is further metabolised. About 3 % of a dose of capecitabine is excreted in the urine unchanged.
Capecitabine is a prodrug that is converted to fluorouracil in body tissue. It is given orally for the treatment of metastatic colorectal cancer and is also used for the adjuvant treatment of patients after surgery for Dukes C colon cancer. Capecitabine is given with docetaxel for the treatment of locally advanced or metastatic breast cancer after failure of anthracycline-containing chemotherapy. It may be given after monotherapy after failure or taxanes and anthracycline-containing regimens for patients with breast cancer and for whom further anthracycline-containing therapy is not indicated. Capecitabine with lapatinib is used for treatment of patients with advanced or metastatic breast cancer whose tumours overexpress human epidermal receptor type 2 (HER2). Capecitabine is also used with platinum-based regimen for the first-line treatment of gastric cancer.
Dosage/Direction for Use
For monotherapy in colon, colorectal, or in breast cancer, the recommended initial dose is 1.25 g/m2 given twice daily; doses are given for 14 days, followed by a 7-day rest period. Adjuvant treatment for colon cancer is recommended for a total of 6 months.
For combination therapy in breast cancer, when given with docetaxel, Capecitabine is given in the same dose as listed previously; Docetaxel is given at 75 mg/m2 as a 1 hour intravenous infusion every 3 weeks. However, when used with Lapatinib tosilate, a different regimen is used.
In combination therapy in colorectal or gastric cancer, the recommended initial dose of Capecitabine is 0.8 to 1 g/m2 twice daily for 14 days, followed by a 7-day rest period. Alternatively, Capecitabine 625 mg/m2 twice daily is given continuously.
Capecitabine tablet should be swallowed with water within 30 minutes after a meal. Doses should be modified in subsequent cycles according to toxicity. Capecitabine doses should be reduced in patients with renal impairment.
Mild renal impairment, CC 51 to 80 mL/minute: no dosage adjustment requirement.
Moderate renal impairment, CC 30 to 50 mL/minute: when the starting dose is 1.25 g/L2 twice daily, a dose reduction of 25%, to about 950 mg/m2 twice daily is recommended; however, when the starting dose is 1 g/m2 twice daily, no dose reduction is required.
Severe renal impairment, CC below 30 mL/minute: Capecitabine is contraindicated.
Capecitabine is contraindicated in patients with severe renal impairment.
Special Precautions
Renal impairment increases systemic exposure to 5'-deoxy-5-fluorouridine, a metabolite of Capecitabine. An increased in the severity of adverse effects appears to correlate with decreased renal function and increased exposure to its metabolites.
Adverse Reactions
Diarrhoea (which may be severe), nausea and vomiting, abdominal pain, stomatitis, and palmar-plantar erythrodysesthesia syndrome (erythema and desquamation of hands and feet) occur commonly with Capecitabine, and may be dose-limiting. Other common adverse effects include fatigue, asthenia, and anorexia. Rashes, alopecia, erythema, dryness of the skin, pruritus, skin pigmentation disorders, and nail disorders can occur. Other adverse effects are fever, pain, arthralgia, constipation, dyspepsia, paraesthesia, headache, dizziness, insomnia, hypo or hypercalcaemia, and dehydration. Dermatitis, cardiotoxicity, and bone-marrow depression have all been reported. Hyperbilirubinaemia has occurred. Doses should be reduced in patients with moderate renal impairment.
Severe hypertriglyceridaemia has been reported with oral Capecitabine; patients had high baseline triglyceride concentrations at the start of Capecitabine. Despite the introduction of lipid-lowering therapy, triglyceride concentrations remained above baseline, and only decreased several weeks after stopping Capecitabine.
Drug Interactions
Altered coagulation parameters and bleeding have occurred in patients on Warfarin or phenprocoumon given Capecitabine. Increased phenytoin plasma concentrations and symptoms of toxicity during use with Capecitabine. Capecitabine must not be given with Sorivudine or its analogues as fatal fluoropyrimidine toxicity may occur. Antacids containing Aluminum or Magnesium hydroxides cause a small increase in capecitabine plasma concentration. The maximum tolerated dose of Capecitabine is reduced when it is given with either Folinic Acid or Interferon alfa.
Store at temperatures not exceeding 30°C.
ATC Classification
L01BC06 - capecitabine ; Belongs to the class of antimetabolites, pyrimidine analogues. Used in the treatment of cancer.
FC tab 500 mg x 100's.
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