देश: संयुक्त राज्य
भाषा: अंग्रेज़ी
स्रोत: NLM (National Library of Medicine)
DEXRAZOXANE HYDROCHLORIDE (UNII: 5346058Q7S) (DEXRAZOXANE - UNII:048L81261F)
Cumberland Pharmaceuticals Inc.
DEXRAZOXANE HYDROCHLORIDE
DEXRAZOXANE 500 mg
INTRAVENOUS
PRESCRIPTION DRUG
Totect® is indicated for the treatment of extravasation resulting from intravenous anthracycline chemotherapy. None. Risk Summary Based on findings from animal studies and its mechanism of action, Totect can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1)] . Limited available data with Totect use in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes. In animal reproduction studies, intravenous administration of dexrazoxane to pregnant rats and rabbits during organogenesis resulted in teratogenicity at maternal doses that were approximately 0.1 and 0.2 times, respectively, the human dose of 1000 mg/m². Advise pregnant women of the potential risk to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of ma
Each Totect carton contains 1 single dose vial of Totect (dexrazoxane for injection) 500 mg as a sterile, pyrogen-free lyophilized powder. NDC 66220-110-01: Carton of 1 vial of Totect Store at 25ºC (77ºF); excursions permitted between 15-30ºC (59-86ºF) [see USP Controlled Room Temperature]. Protect from light. Keep vial in carton until ready for use. Follow special handling and disposal procedures [see Dosage and Administration (2.3)] .1
New Drug Application
TOTECT- DEXRAZOXANE HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION CUMBERLAND PHARMACEUTICALS INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE TOTECT SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TOTECT. T O TE C T (DEXRAZOXANE) FOR INJECTION, FOR INTRAVENOUS USE INITIAL U.S. APPROVAL: 2007 RECENT MAJOR CHANGES Dosage and Administration (2.3) 11/2018 Warnings and Precautions (5.1) 02/2018 Warnings and Precautions (5.2) 02/2018 Warnings and Precautions (5.3) 02/2018 INDICATIONS AND USAGE Totect is a cytoprotective agent indicated for the treatment of extravasation resulting from intravenous anthracycline chemotherapy. (1) DOSAGE AND ADMINISTRATION Reconstitute and further dilute Totect before use. (2.3) Administer Totect by intravenous infusion over 1 to 2 hours once daily for 3 consecutive days. (2.1, 2.4) Initiate the first infusion as soon as possible and within the first six hours after extravasation. (2.1) Recommended doseMaximum daily dose Day one: 1000 mg/m 2000 mg Day two: 1000 mg/m 2000 mg Day three: 500 mg/m 1000 mg Reduce dose by 50% for patients with creatinine clearance < 40 mL/min. (2.2) DOSAGE FORMS AND STRENGTHS For Injection: 500 mg as a sterile, pyrogen-free lyophilized powder in a single dose vial for reconstitution. (3) CONTRAINDICATIONS None. (4) WARNINGS AND PRECAUTIONS Myelosuppression: Dexrazoxane is associated with leukopenia, neutropenia, and thrombocytopenia. Perform hematological monitoring. (5.1) Anaphylactic/Hypersensitivity Reactions: Monitor for signs and symptoms. Permanent treatment discontinuation should be considered for severe hypersensitivity reactions. (5.2) Embryo-Fetal Toxicity: Can cause fetal harm. Advise patients of reproductive potential of the risk to a fetus and to use effective contraception (5.3, 8.1, 8.3) ADVERSE REACTIONS The most common adverse reactions (≥15%) are nausea, pyrexia, injection site pain, vomiting, and postoperative infection. (6.1) TO REPORT SUSPECTE पूरा दस्तावेज़ पढ़ें