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capecitabine-150mg

PRODUCT DETAILS

Generic : Capecitabine
Strength : 150mg
Packing : 60 tablets in a carton

for MORE INFORMATION !!!

Xeloda 150mg is known as fluoropyrimidine carbamate who having the anti-cancer activity. The drug supplied as oblong and film coated tablet for oral administration.
Xeloda 150mg is a systemic prodrug of 5’-deoxy-5-fluorouridine (5’-DFUR) which is changed to 5 fluoro uracil
Xeloda 150mg is also have anti-metabolite activity and the activity of Xeloda 150mg tablet will inhibits the growth of tumor cells and slows their spread in the body.
Xeloda 150mg is prescription drugs sold under the proper guidance of medical oncologist and pharmacist.

INDICATION

Colorectal cancer :
Adjuvant treatment in Duke’s colon cancer
First line therapy in colon-rectal cancer metastasis
Breast cancer :
In metastatic breast cancer: used in combination with docetaxel after failure of anthracycline containing chemotherapy

DOSAGE

Monotherapy:
First line therapy of patients with advanced colorectal cancer:
The usual dose of Xeloda is 1250mg/m2 should be taken orally as twice daily (morning and evening dose 2500mg/m2); therapy continue for 2 weeks followed by 1-week rest period given as 3 weeks cycle
Adjuvant therapy for Duke’s colon cancer:
The usual dose of Xeloda is 1250mg/m2 orally as twice daily (morning and evening dose 2500mg/m2); for 2 weeks followed by 1 week given as 3 weeks for total 8 cycles (24 weeks)
Breast cancer:
Monotherapy:
Recommended dose: 1250mg/m2 should be taken as orally for twice daily
In combination with docetaxel;
1250mg/m2 of Xeloda with 75mg/m2 of docetaxel for 3 weeks
After a meal the drug Xeloda should be given within 30 minutes
In pediatric:
The safety and efficacy of the Xeloda tablets in pediatric patients has not been established

MECHANISM OF ACTION

Enzymes changes capecitabine to 5-fluorouracil (5-FU) in vivo. Both normal and cancer cells metabolize 5-FU to 5-fluoro-2’-deoxyuridine monophosphate (FdUMP) and 5-fluorouridine triphosphate (FUTP).
These metabolites lead to cell damage by two different mechanisms.
First, FdUMP and the folate cofactor, N5-10-methylenetetrahydrofolate, link to thymidylate synthase (TS) and form a complex of covalently bound ternary. This bounding prohibits the thymidylate from 2’-deoxyuridylate formation. Thymidylate is the required precursor of thymidine triphosphate, which is specifically used for the synthesis of DNA, so that an inadequacy of this mixture can prevent cell division.
Second, during the synthesis of RNA the nuclear transcriptional enzymes can mistakenly fused FUTP in place of uridine triphosphate (UTP). This metabolic error can prevent RNA processing and synthesis of protein.

PHARMACOKINETICS

Absorption:
The time to peak plasma level at about 1.5 hours
Food reduced both the rate and duration of absorption of Xeloda with mean Cmax and AUC0-∞ reduced by 60% and 35% respectively
Distribution:
The human plasma protein bound to Xeloda is occurred 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. An enzyme which converts 5’-DFCR to 5’-DFUR known as Cytidine deaminase. another an enzyme which involved in the conversion of 5’-DFUR to 5-FU active drug is Thymidine phosphorylase
Excretion:
The route of elimination of Xeloda is occurred through urine 95.5%
The mean terminal half-life period of Xeloda is 0.75 hour

PRECAUTION

Cardio toxicity: while taking Xeloda 150mg, cardio toxicity occurs like; myocardial infarction, angina, dyshythmias, cardiac arrest sudden death, Cardiomyopathy
Diarrhea: patients with severe diarrhea should be monitored
Dihydropyrimidine dehydrogenase deficiency
Dehydration and renal failure
Embryo fetal toxicity
Mucocutaneous and dermatologic toxicity
Hyperbilirubinemia
Hematological problems
Care should be taken while using in geriatric patients
Hepatic insufficiency
Coagulopathy: concomitant with warfarin, anti-coagulant response should be monitored

DRUG INTERACTION

Xeloda 150mg interaction with warfarin and phenprocoumon, bleeding occurs. These events occurred within several days and even a month also
Interaction of phenytoin with Xeloda 150mg, toxicity related to elevation of phenytoin levels
Concomitant use of Leucovorin: the toxicity and concentration of 5-FU increased by Leucovorin. In elderly patients, phenytoin and Leucovorin is administered weekly which may cause; diarrhea, dehydration, enterocolitis which may causes death.
other than warfarin, there is no drug interaction occurs while concomitant with CYP2C9 substrates
While combination of Xeloda 150mg with CYP2C9 substrates Care should be taken.

DRUG-FOOD INTERACTION

In case of administering Xeloda 150mg with food, it leads to reduce the rate and duration of absorption of Xeloda 150mg.
Xeloda 150mg tablets should be administered within 30 minutes after food

CONTRAINDICATION

Known hypersensitivity to bendamustine and its metabolites

STORAGE

Xeloda 150mg should be stored at 20℃ to 25℃ (68℉ to 77℉)

MISSED DOSE

If dose is missed then take the dose of Xeloda 150mg, must consult with medical oncologist and follow the suggestions
Avoid taking self-medicate.
Or missed dose must be skipped and continue the regular dosing schedule
Do not double the dose

SIDE EFFECTS

Most common side effects :
Diarrhea, nausea, anemia, Lymphopenia, head and foot syndrome, edema, fatigue, fever, headache, pain, paresthesia, alopecia, dermatitis, abdominal pain, anorexia, loss of appetite, constipation, dyspepsia, stomatitis, vomiting, neutropenia, thrombocytopenia, dyspnea, bilirubin decreased, eye irritation
Common side effects :
Dermatitis, rash, dizziness, headache, Chest pain, weakness, dehydration, dry mouth, dyspepsia, Pruritus, taste disturbance, back pain
Post marketing reports:
Toxic leukoencephalopathy

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