Daxotel

Docetaxel Anhydrous USP

Composition: Each Vial Contains Docetaxel Anhydrous USP 80mg /2ml.

Indications: Breast Cancer: Docetaxel is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy. Docetaxel in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with operable node-positive breast cancer. Non-Small Cell Lung Cancer: Docetaxel as a single agent is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior platinum-based chemotherapy. Prostate Cancer: Docetaxel in combination with prednisone is indicated for the treatment of patients with metastatic castration-resistant prostate cancer. Gastric Adenocarcinoma: Docetaxel in combination with cisplatin and fluorouracil is indicated for the treatment of patients with advanced gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction.

Dosage and Administration: Breast Cancer: For locally advanced or metastatic breast cancer after failure of prior chemotherapy, the recommended dose of Docetaxel is 60 mg/m2 to 100 mg/m2 administered intravenously over 1 hour every 3 weeks. Non-Small Cell Lung Cancer: For treatment after failure of prior platinum-based chemotherapy, Docetaxel was evaluated as monotherapy, and the recommended dose is 75 mg/m2 administered intravenously over 1 hour every 3 weeks. Non-Small Cell Lung Cancer: For treatment after failure of prior platinum-based chemotherapy, Docetaxel was evaluated as monotherapy, and the recommended dose is 75 mg/m2 administered intravenously over 1 hour every 3 weeks. Prostate Cancer: For metastatic castration-resistant prostate cancer, the recommended dose of Docetaxel is 75 mg/m2 every 3 weeks as a 1 hour intravenous infusion. Gastric Adenocarcinoma: For gastric adenocarcinoma, the recommended dose of Docetaxel is 75 mg/m2 as a 1 hour intravenous infusion, followed by cisplatin 75 mg/m2, as a 1 to 3 hour intravenous infusion (both on day 1 only), followed by fluorouracil 750 mg/m2 per day given as a 24-hour continuous intravenous infusion for 5 days, starting at the end of the cisplatin infusion. Treatment is repeated every three weeks. Head and Neck Cancer: The recommended dose of Docetaxel is 75 mg/m2 as a 1 hour intravenous infusion followed by cisplatin 75 mg/m2 intravenously over 1 hour, on day one, followed by fluorouracil as a continuous intravenous infusion at 750 mg/m2 per day for five days. Or, as directed by the registered physician.

Use in Pregnancy and Lactation: It can cause fetal harm when administered to a pregnant woman. Docetaxel caused embryo fetal toxicities including intrauterine mortality when administered to pregnant rats and rabbits during the period of organogenesis. Embryo fetal effects in animals occurred at doses as low as 1/50 and 1/300 the recommended human dose on a body surface area basis.

Packing: Each vial contains 1 vial of 2ml solution containing Docetaxel Anhydrous USP 80 mg.

Prescribing Description

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