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capegard-500mg

PRODUCT DETAILS

Brand name : Capegard
Active ingredient : Capecitabine
Strength : 500mg
Manufactured by : Cipla
Pack : 500mg-120 tablets in a carton
Category : Anti-neoplastic drug

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

DOSAGE

Monotherapy:
First line therapy of patients with advanced colorectal cancer:
The usual dose of Capegard 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 Capegard 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 Capegard with 75mg/m2 of docetaxel for 3 weeks After a meal the drug Capegard should be given within 30 minutes
In pediatric:
The safety and efficacy of the Capegard tablets in pediatric patients has not been established

PHARMACOKINETICS

Absorption:
The time to peak plasma level at about 1.5 hours Food reduced both the rate and duration of absorption of Capegard with mean Cmax and AUC0-∞ reduced by 60% and 35% respectively
Distribution:
The human plasma protein bound to Capegard is occurs in less than 60%
Bio-activation and metabolism:
Capegard 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 Capegard is occurred through urine 95.5% The mean terminal half life period of Capegard is 0.75 hour

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 leads 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 a 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.

PRECAUTION AND WARNING

Cardio toxicity: while taking Capegard, 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 Hyperbilirubinaemia 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

Capegard interaction with warfarin and phenprocoumon, bleeding occurs. These events occurred within several days and even a month also Interaction of phenytoin with Capegard, 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 Capegard with CYP2C9 substrates Care should be taken

DRUG-FOOD INTERACTION

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

CONTRAINDICATION

Excretion Renal impairment patients. Patients with hypersensitivity to Capegard or other components.

PREGNANCY

Pregnancy category: D Capegard may cause harm to the fetus. Generally Capegard should not be recommended in pregnancy or women who are become pregnant

STORAGE

Capegard should be stored at 20℃ to 25℃ (68℉ to 77℉)

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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