HENPLATIN (Oxaliplatin)Henplatin for Injection 50mg
Each vial contains Oxaliplatin
(Lyophilized powder) - 50mg
It is used for the treatment of metastatic colorectal cancer in patients who were previously on fluorouracil. It may be used singly or in combination with fluorouracil.
Dosage and Administration
In monotherapy or combination therapy, the suggested dosage is 130mg/? of body surface area, add into 250 to 500 ml 5% of glucose solution and infuse 2 to 6 hours. If no major toxicity appears, repeat every 3 weeks. Adjust dosage according to safety, particularly safety of neurology.
Pharmacology and Toxicology
It has toxicities commonly seen platinum compounds, and exhibits category-specific cardiac toxicity. No renal toxicity of cisplatin or bone marrow toxicity was observed. A relatively new platinum compound, it acts on DNA by producing alkylation conjugate, and forms inter- and intra-strand Pt-DNA crosslinks, consequently, inhibits synthesis and replication of DNA. It rapidly combines with DNA, at most 15 minutes. Combination of cisplatin and DNA is divided into phases, which includes a delay phase after 48 hours [In vivo, an hour after administration, determine presence of conjugate of adduct of leukocyte. DNA synthesis during replication, DNA separation after replication, synthesis of RNA and cell protein is inhibited]. It is effective for some cell lines resistant to cisplatin.
After 2 hours of continuous infusion at a dose of 130mg/m2, the total plasma platinum reaches peak value of 5.1±0.8mg/ml/h, the stimulant AUC is 189±45mg/ml/h. After infusion, 50% of platinum combine with erythrocyte; and the other 50% of platinum is present in plasma. 25% of plasma platinum is in free form; the other 75% plasma platinum combine with protein. Protein-combined platinum increases gradually and reaches stable level of 95%, 5 days after administration. The clearance is divided into tow phases; the half-life of clearance phase is about 40 hours. Up to 50% of platinum is eliminated via urine within 48 hours (55% of platinum is cleared in 6 days). Fecal excretion is limited (only 5% of platinum is eliminated through feces in 11 days). In patients with renal failure, only clearance of filterable platinum decreases, and thus no dosage adjustment is necessary.
At 22nd day after administration, the level of erythrocyte-bonded platinum is 56% of plasma peak value, while at same time, most plasma platinum have been eliminated. During latter administration periods, no significant increase in the levels of total or plasma platinum was observed while erythrocyte-bonded platinum cumulative evidence.
No antidote is available. When overdosage occurs, adverse reactions will aggravate, hematologic monitoring should be performed, and take expectant treatment according to its toxicity.
Store at room temperature not exceeding 25oC
Foods, Drugs and Cosmetics Act prohibits dispensing without prescription.
Pregnancy And Lactation
It may cause harm and damage to the fetus and should not therefore be given to pregnant women. No study is performed about whether the product is excreted in human milk; it should not be administrated during lactation.
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