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Zecyte-250MG

PRODUCT DETAILS

Brand name : Zecyte
Active ingredient : Abiraterone acetate
Strength :250MG
Manufactured by : Cipla
Pack : 250MG-120 tablets in a carton
Category : Anti-neoplastic drug

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

Monotherapy:
First line therapy of patients with advanced colorectal cancer:
The usual dose of Zecyte is 1250mg/m2 should be taken orally as twice daily (morning and evening dose 2250MG/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 Zecyte is 1250mg/m2 orally as twice daily (morning and evening dose 2250MG/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 Zecyte with 75mg/m2 of docetaxel for 3 weeks After a meal the drug Zecyte should be given within 30 minutes

In pediatric

The safety and efficacy of the Zecyte tablets in pediatric patients has not been established

PHARMACOKINETIC

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

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

DRUG-FOOD INTERACTION

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

CONTRAINDICATION

Renal impairment patients.Patients with hypersensitivity to Zecyte or other components.

MISSED DOSE

If dose is missed then take the dose of Zecyte, 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

STORAGE

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

PREGNANCY

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

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