|Composition : || Each vial contains: |
Each vial contains:
Oxaliplatin -------------------25mg, 50mg, 100mg
Water for injection -----------q.s.
|Indications : || oxaliplatin used in combination with infusional 5-fluorouracil/leucovorin, is indicated for: |
adjuvant treatment of stage III colon cancer in patients who have undergone complete resection of the primary tumor.
treatment of advanced colorectal cancer.
|Contraindications : || Oxaliplatin should not be administered to patients with a history of known allergy to oxaliplatin or other platinum compounds . |
|Adverse Effects : || Serious adverse reactions including anaphylaxis and allergic reactions, neuropathy,pulmonary toxicities and hepatotoxicities can occur.. |
|Dosage : || oxaliplatin 85 mg/m² intravenous infusion in 250-500 mL 5% Dextrose injection, USP and leucovorin 200 mg/m² intravenous infusion in 5% Dextrose Injection, USP both given over 120 minutes at the same time in separate bags using a Y-line, followed by 5-fluorouracil 400 mg/m² intravenous bolus given over 2-4 minutes, followed by 5-fluorouracil 600 mg/m² intravenous infusion in 500 mL 5% Dextrose Injection, USP (recommended) as a 22-hour continuous infusion. |
Day 2: Leucovorin 200 mg/m² intravenous infusion over 120 minutes, followed by 5-fluorouracil 400 mg/m² intravenous bolus given over 2-4 minutes, followed by 5-fluorouracil 600 mg/m² intravenous infusion in 500 mL 5% Dextrose Injection, USP (recommended) as a 22-hour continuous infusion.
| Pharmacological action : || Oxaliplatin is a neoplastic drug used in metastatic colorectal cancer where fluropyrimidines therapy or alone chemotherapy have failed, also used along with fluropyrimidines. |
Precautions : Oxaliplatin may rarely cause a severe (possibly fatal) allergic reaction within minutes after a dose. Tell your doctor immediately if you develop any signs of an allergic reaction (e.g., rash, itching, swelling, trouble breathing, dizziness)..
| Drug interaction: || No pharmacokinetic interaction between 85 mg/m² of Oxaliplatin and infusional 5-fluorouracil has been observed in patients treated every 2 weeks, but increases of 5-fluorouracil plasma concentrations by approximately 20% have been observed with doses of 130 mg/m² of Oxaliplatin administered every 3 weeks. In vitro, platinum was not displaced from plasma proteins by the following medications: erythromycin, salicylate, sodium valproate, granisetron, and paclitaxel. In vitro, oxaliplatin is not metabolized by, nor does it inhibit, human cytochrome P450 isoenzymes. No P450-mediated drug-drug interactions are therefore anticipated in patients.. |
| Precautions: || Oxaliplatin may rarely cause a severe (possibly fatal) allergic reaction within minutes after a dose.|