Capegard 150mg

Capegard 150mg - (fluoropyrimidine carbamate) with anti-tumor activity
Capegard 150mg is a prodrug of 5’-deoxy-5-fluorouridine (5’-DFUR) which is changed to 5 fluoro uracil.
Capegard 150mg is generally administered orally.
Capegard 150mg is also have anti-metabolite activity

Capecitabine

Capegard

150mg

Cipla Ltd




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

Mechanism of action

Capecitabine is a prodrug, it is metabolizing to 5-FU. In both non-cancer and cancer cells, 5-FU is metabolized in to 5-fluoro-2-deoxyuridine monophosphate (FdUMP) and 5-fluorouridine triphosphate (FUTP)
These two metabolites cause injury to the tumor cells by two major ways :
FdUMP and the folate cofactor (N5-10-methylenetetrahydrofolate), which binds to thymidylate synthase (TS) to form covalently bound ternary complex.
This binding prohibits the production of thymidylate from 2’-deaxyuridylate
Thymidylate an important messenger of thymidylate triphosphate.
It is essential for DNA synthesis; therefore, insufficiency of this compound leads to inhibit cell division
Nuclear transcriptional enzymes can falsely inserted FUTP alternative to uridine triphosphate during RNA synthesis. This metabolic failure can hinder with RNA conversion and protein synthesis via assembly of counterfeit RNA



Pharmacokinetics

Capecitabine reaches the peak plasma level at about 1.5 hours
Food decreased both the rate and duration of absorption of Capegard 150mg with mean Cmax and AUC0-∞ reduced by 60% and 35% respectively

The human plasma protein bound to Capecitabine is occurs in less than 60%

Capecitabine 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

The route of elimination of Capecitabine is occurred through urine 95.5%
The mean terminal half-life period of Capecitabine is 0.75 hour


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drug
Brand Capegard
Ingredients Capecitabine
Strength 150mg
Manufactured Cipla Ltd
Rating

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
Capegard should be administered within 30 minutes after a meal
In pediatric:
The safety and efficacy of the Capegard tablets in pediatric patients has not been established

10%:
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
1-10%:
Chest pain, dermatitis, Pruritus, rash, dizziness, headache, weakness, dehydration, dry mouth, dyspepsia, taste disturbance, back pain
Post marketing reports:
Toxic leukoencephalopathy

Precaution

Coagulopathy: concomitant with warfarin, anti-coagulant response should be monitored
Diarrhea: patients with severe diarrhea should be monitored
Cardio toxicity: while taking Capegard 150mg, cardio toxicity occurs like; myocardial infarction, angina, dyshythmias, cardiac arrest sudden death, Cardiomyopathy
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.

DRUG INTERACTION

  • Anticoagulant: Capegard 150mg concomitant with warfarin and phenprocoumon, bleeding occurs. These events occurred within several days and even a month also

  • Phenytoin: combination of phenytoin and Capegard 150mg, toxicity related to elevation of phenytoin levels

  • 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.

  • CYP2C9 substrate: other than warfarin, there is no drug interaction occurs while concomitant with CYP2C9 substrates

  • Care should be taken while combination of Capegard 150mg with CYP2C9 substrates

  • DRUG - FOOD INTERACTION


  • In case of administering Capegard 150mg with food, it leads to reduce the rate and duration of absorption of Capegard 150mg.

  • Capegard 150mg tablets should be administered within 30 minutes after food

Contraindication

Capegard 150mg is contraindicated to renal impairment patients
Capegard 150mg is contraindicated in patients with hypersensitivity to Capegard 150mg or other components



Pregnancy category: D
Capegard 150mg may cause harm to the fetus
Generally, Capegard 150mg should not be recommended in pregnancy or women who are become pregnant
Breast feeding is not recommended

Capegard 150mg should be stored at 20°C to 25°C (68°F to 77°F).

If patient fail to take the dose of Capegard 150mg, 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

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