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BRAND : Xeloda
COUNT : 60 Tablets

Description of Xeloda

Xeloda is an anti-cancer drug which is brand of Capecitabine, which is orally administered prodrug of 5 deoxy-5-fluorouridine is converted to 5-FU Xeloda is a biconvex, oblong film coated tablet Brand name: Xeloda Active ingredient: Capecitabine Strength: 150mg & 500mg Mfg: Roche Pack: 150mg-60 tablets in a carton; 500mg-120 tablets in a carton Category: Anti-neoplastic drug

Pharmacology of Xeloda

Mechanism of action: In-vivo, Capecitabine is changed to 5-FU with the help of enzymes Further, 5-FU is again converted to 5-fluoro 2 deoxyuridine monophosphates and 5-fluorouridine triphosphate These metabolites lead to cell injury Cell injury causes by; folate cofactor and FdUMP, merged to thymidylate synthase to form ternary complex by covalently bound This merging inhibits the production of thymidylate from deoxyuridylate Thymidylate essential for DNA synthesis Lack of this compound leads to inhibit cell division Nuclear transcriptional enzymes wrongly inserted to FUTP due to uridine triphosphate in RNA synthesis This leads to interfere with RNA and protein synthesis Pharmacokinetics: Absorption: Xeloda reaches the peak plasma level at about 1.5 hours Food diminished both the rate and duration of absorption of Xeloda tablet with mean Cmax and AUC0 reduced by 60% and 35% respectively Distribution: The human plasma protein bound to Xeloda tablet is occurs in less than 60% Bio-activation and metabolism: Xeloda is largely metabolized to 5-FU enzymatically. In liver, 60 kDa carboxylesterase hydrolyses to 5 deoxy-5-fluorocytidine. Cytidine deaminase is an enzyme which converts 5-DFCR to 5-DFUR. Thymidine phosphorylase is also an enzyme which involved in the conversion of 5-DFUR to 5-FU active drug Excretion: The route of elimination of Xeloda is occurred through urine 95.5% The mean terminal half life period of Xeloda tablet is 0.75 hour

Indication of Xeloda

Xeloda tablets are mainly indicated for; Colon-rectal cancer Xeloda is used as adjuvant therapy in Duke colon cancer Metastatic colon-rectal cancer: Xeloda is first line treatment Breast cancer: Xeloda in combination with docetaxel in metastatic condition

Dose & Dosage's of Xeloda

Duke colon cancer: Adjuvant therapy: Xeloda 1250mg/m2 should be taken orally as twice daily given as 3 cycles for total 8 cycles Colorectal cancer: Xeloda 1250mg/m2 should be given as twice daily for 2 weeks q21 days Breast cancer: In metastatic, resistant to paclitaxel and anthracycline Monotherapy: 1250mg/m2 should be taken twice daily orally for 3 weeks Combination: 1250mg/m2 Xeloda with 75mg/m2 of docetaxel for 3 weeks as twice daily Xeloda should be administered within 30 minutes after a meal Creatinine clearance: <30ml/min should be contraindicated Creatinine clearance: 30-50ml/min dose should be reduced to 25% Missed dose: If patient fail to take the dose of Xeloda, must consult with medical oncologist and follow the suggestions Do not self medicate. The missed dose must be skipped and follow the regular dosing schedule Do not double the dose.

Side Effects of Xeloda

Stomatitis, diarrhea, vomiting, abdominal pain, nausea, dyspepsia, hand and foot syndrome, alopecia, rashes, Erythema, fatigue, pyrexia, asthenia, dizziness, headache, eye disorders, conjunctivitis, neutropenia, Epistaxis, elevated ALAT, increased in calcium levels, anemia, decreased platelets, weakness, edema, chest pain

Contraindication of Xeloda

Xeloda is contraindicated in patients having severe renal impairment Hypersensitivity reaction occurs

Drug Interaction of Xeloda

Xeloda with anti-coagulant: altered coagulation problem and bleeding occurs to control this adverse effect; monitored the prothrombin time frequently Xeloda with phenytoin: level of phenytoin should be monitored for reducing the toxicity of phenytoin Leucovorin with Xeloda: 5-FU concentration should be increased and toxicity elevated by Leucovorin. It may cause death due to diarrhea, enterocolitis, and dehydration in elder patients CYP2C9 substrates: care should be taken while concomitant with Xeloda tablets Food drug interaction occurs in Xeloda tablets, food may interfere with absorption of Xeloda. Reduce the rate and duration of absorption of Xeloda occurs. Xeloda should be taken within 30minutes after meal

Precaution of Xeloda

Risk of severe bleeding; Xeloda increase the anti-coagulant effect of warfarin, it may elevate bleeding Diarrhea Cardiomyopathy occurs; acute decrease in LVEF Increased risk of fatal reactions in patients having low or absence of Dihydropyrimidine dehydrogenase activity Dehydration Fetal harm Hyperbilirubinaemia Neutropenia and thrombocytopenia occurs

Usage & Safety profile of Xeloda Pregnancy & Lactation

Pregnancy category of Xeloda tablets: D Xeloda tablets are not recommended in pregnancy conditions Breast feeding is also not recommended

Storage of Xeloda

Xeloda tablets should be stored at 20oC to 25oC (68oF to 77oF)