Absorption: Readily absorbed. Food decrease rate and extent of absorption. peak plasma concentration is 1.5hr. Distribution: Plasma protein binding: <60%, mainly to albumin. Metabolism: capecitabine hydrolysed in the liver into 5'-deoxy-5-fluorocytidine (5'-DFCR) then to 5'-deoxy-5-fluorouridine (5'-DFUR), and subsequently in body tissues into 5-fluorouracil by thymidine phosphorylase enzyme. Excretion: Via urine (96%, (<3% as unchanged drug) and faeces (<3%). Elimination half-life is 0.75 hr.
Brand : Capegard
Ingredients : Capecitabine
Strength : 500mg
Manufactured : Cipla
Package : 120 Tablets
Capegard tablets should be administered on an empty stomach, taken within 30 minutes after the meals.Dosage regimens of Capegard
The prescribed dose of Capegard tablets are 1250mg/m2 should be administered orally as two times a day for the period of 2 weeks pursued by a one week rest time given as 3 weeks cycle. In combination of Capegard with docetaxel, the prescribed dose is 1250mg/m2 of Capegard as two times day and the dose of docetaxel are 75mg/m2 given as intravenous infusion over the period of 1 hour for every 3 weeks. Premedication should be provided, based on the docetaxel labeling it should be initiated before starting the docetaxel therapy for the patients getting both Capegard plus docetaxel. The supporting therapy for the Duke’s C colon cancer patients, the prescribed treatment duration period is 6 months. The usual dose of Capegard 1250mg/m2 should be taken orally for 2 weeks which is follows as one week rest period and the duration of therapy should be continue for 3 weeks cycle as total cycle is 8 (24 weeks). In case of toxicity occurs due to Capegard therapy, treatment should be interrupt or discontinue. On the other way, dose adjustment should be suggested to reduce the adverse effect related to toxicity. In any drugs that should be combined with Capegard , must require dose alteration such as Phenytoin, coumarin derivatives are combined with Capegard tablets, must undergo dosage adjustment. Depending on the toxicity grade of patients therapy should be followed; At first, patients suspected with grade II toxicity at the time of 14 days of Capegard therapy; the treatment should be postponed. Therapy should be interrupted until grade changed to I; then therapy with Capegard should be continuing as same dose. Supporting therapy should be provided if possible, in case of toxicity.
Grade II toxicity sustains in case of combinational therapy of Capegard with docetaxel; interrupts the therapy and toxicity decreases as grade 1 then continue the treatment at 100% original dose of Capegard . In grade I toxicity: continue the dose of CapegardIn grade II
1st appearance: Post pone the treatment until resolved to grade I and continue the therapy with 100% dose of Capegard 2nd appearance: Post pone the treatment until resolved to grade I and continue the therapy with 75% dose of Capegard 3rd appearance: Post pone the treatment until resolved to grade I and continue the therapy with 50% dose of Capegard . 4th appearance: stop the treatment of CapegardIn grade III
1st appearance: Post pone the treatment until resolved to grade I and continue the therapy with 75% dose of Capegard . 2nd appearance: Post pone the treatment until resolved to grade I and continue the therapy with 50% dose of Capegard . 3rd appearance: stop the treatment.In grade IV
1st appearance: stop the treatment or if toxicity resolved to grade I, then resume the therapy with 50% dose of Capegard . For hepatic damage patients: No dosage adjustment should be recommended. For renal damage patients: In moderate renal damage, the dose of Capegard reduced to 75% in both monotherapy & combinational therapy with docetaxel By using Cockroft & Gault equation; 140-age of patients x body weight in Kg used to analysis the kidney function to obtain creatinine clearance value.
Stomatitis, diarrhea, vomiting, abdominal pain, nausea, dyspepsia, hand and foot syndrome, alopecia, rashes, Erythema, fatigue, pyrexia, asthenia, dizziness, headache, eye disorders, conjunctivitis, neutropenia, Epistaxis, elevated ALAT, increased in calcium levels, anemia, decreased platelets, weakness, edema, chest pain
Cardio toxicity: monitor cardiac toxicity like myocardial infarction, ischemic conditions, or any other cardiac problems during the therapy with Capegard . Hand foot syndrome: the dose of Capegard should be reduced to reduce the toxicity. Dihydropyrimidine dehydrogenase insufficiency: adverse reactions related to 5-FU is contributed to this deficiency. Liver insufficiency: mild or moderate liver damage patients administered Capegard carefully and monitor the adverse effects. Hematological problems: check the blood cell counts regularly before or after the treatmentEmbryo fetal toxicity
Capegard causes fetal harm, which may causes death. Pregnancy: Capegard is contraindicated; produce carcinogenesis, mutagenesis, and fertility impairments. Diarrhea: anti-diarrheal therapy should be provided.Coagulopathy
During the co administration of Capegard with warfarin, the anti-coagulant response rate should be monitored frequently. This combination may cause severe bleeding effect which leads to death also. By increasing the prothrombin time & INR values, bleeding may occur. This event may appear within several days & also several months after initiation of therapy. In some cases after stopping the therapy of Capegard , may occurs