CAPNAT - 500mg



Capnat 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

Capnat pharmacology


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







Mechanism of action


Capnat is a prodrug, it is metabolizes 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 causes 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

Pharmacokinetic


Absorption:
Capnat reaches the peak plasma level at about 1.5 hours Food decreased both the rate and duration of absorption of Capnat with mean Cmax and AUC0-∞ reduced by 60% and 35% respectively
Distribution:
The human plasma protein bound to Capnat is occurs in less than 60%
Bio-activation and metabolism:
Capnat is largely metabolized to 5-FU enzymatically. In liver, 60 kDa carboxylesterase hydrolyses to 5’-deoxy-5-fluorocytidine. An enzyme Cytidine deaminase which converts 5’-DFCR to 5’-DFUR. Another an enzyme Thymidine phosphorylase is also that involved in the conversion of 5’-DFUR to 5-FU active drug
Excretion:
The route of elimination of Capnat is occurred through urine 95.5% The mean terminal half life period of Capnat is 0.75 hour

Drug interaction


Anticoagulant: Capnat concomitant with warfarin and phenprocoumon, bleeding occurs. These events occurred within several days and even a month also Phenytoin: combination of phenytoin and Capnat, 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 Capnat with CYP2C9 substrates
Drug-food interaction:
In case of administering Capnat with food, it leads to reduce the rate and duration of absorption of Capnat. Capnat tablets should be administered within 30 minutes after food

Precaution and warning


Coagulopathy: concomitant with warfarin, anti-coagulant response should be monitored Diarrhea: patients with severe diarrhea should be monitored Cardio toxicity: while taking Capnat, 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, Hyperbilirubinaemia, Hematological problems, Care should be taken while using in geriatric patients, Hepatic insufficiency.

Pregnancy and lactation


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

Precaution and warning


Coagulopathy: concomitant with warfarin, anti-coagulant response should be monitored Diarrhea: patients with severe diarrhea should be monitored Cardio toxicity: while taking Capnat, 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, Hyperbilirubinaemia, Hematological problems, Care should be taken while using in geriatric patients, Hepatic insufficiency.

Storage


Capnat should be stored at 200C to 250 F(680F to 770F)

Side effects


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 Post marketing reports: Toxic leukoencephalopathy



Missed dose


The patient missed to take a single dose of Capnat, should consult with medical oncologist and follow the suggestions


Missed dose


Do not self medicate. Or missed dose should be swapped and continue the regular dosing schedule Do not double the dose


Contraindication


Capnat is contraindicated to renal impairment patients Capnat is contraindicated in patients with hypersensitivity to Capnat or other components


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