late matter and discoloration prior to administration, whenever solution and container permit.
HOW SUPPLIED
Methotrexate Injection, USP (preservative free) is supplied in a single-dose vial containing 25 mg/mL of methotrexate as the base in the following package strengths:
|
NDC 66758-040-02 |
50 mg in 2 mL (packaged in 10's) |
|
NDC 66758-040-08 |
250 mg in 10 mL (packaged in 10's) |
|
NDC 66758-041-01 |
1 gram in 40 mL (individually packaged) |
Store at USP controlled room temperature 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). See USP controlled room temperature. Protect from light.
For Parenta Customer Service, call 1-800-898-9948.
REFERENCES
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Recommendations for the Safe Handling of Parenteral Antineoplastic Drugs. NIH Publication No. 83-2621. For sale by the Superintendent of Documents, U.S. Government Printing Office, Washington, D.C. 20402
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AMA Council Report. Guidelines for Handling Parenteral Antineoplastics. JAMA, March 15, 1985.
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National Study Commission on Cytotoxic Exposure-Recommendations for Handling Cytotoxic Agents. Available from Louis P. Jeffrey, Sc.D., Chairman, National Study Commission on Cytotoxic Exposure, Massachusetts College of Pharmacy and Allied Health Sciences, 179 Longwood Ave., Boston, Massachusetts 02115.
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Clinical Oncological Society of Australia; Guidelines and Recommendations for Safe-Handling of Antineoplastic Agents. Med J Australia 1: 426-428, 1983.
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Jones RB et al. Safe Handling of Chemotherapeutic Agents: A Report from the Mount Sinai Medical Center. CA-A Cancer Journal for Clinicians: Sept/Oct, 258-263, 1983.
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American Society of Hospital Pharmacists Technical Assistance Bulletin on Handling Cytotoxic and Hazardous Drugs. Am J Hosp Pharm 47:1033-1049, 1990.
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Controlling occupational exposure to hazardous drugs (OSHA Work-Practice Guidelines). AM J Health Syst Pharm 1996: 53: 1669-1685.
Manufactured for:
Parenta Pharmaceuticals
an Ebewe Pharma Company
West Columbia, SC 29169
Manufactured by:
EBEWE Pharma Ges.m.b.H. Nfg.KG
A-4866 Unterach, AUSTRIA
March 2009
‡LEUCOVORIN RESCUE SCHEDULES FOLLOWING TREATMENT WITH HIGHER DOSES OF METHOTREXATE
|
Clinical Situation |
Laboratory Findings |
Leucovorin Dosage and Duration |
|
Normal Methotrexate Elimination |
Serum methotrexate level approximately 10 micromolar at 24 hours after administration, 1 micromolar at 48 hours, and less than 0.2 micromolar at 72 hours. |
15 mg PO, IM, or IV q 6 hours for 60 hours (10 doses starting at 24 hours after start of methotrexate infusion). |
|
Delayed Late Methotrexate Elimination |
Serum methotrexate level remaining above 0.2 micromolar at 72 hours, and more than 0.05 micromolar at 96 hours after administration. |
Continue 15 mg PO, IM, or IV q 6 hours, until methotrexate level is less than 0.05 micromolar. |
|
Delayed Early Methotrexate Elimination and/or Evidence of Acute Renal Injury |
Serum methotrexate level of 50 micromolar or more at 24 hours, or 5 micromolar or more at 48 hours after administration, OR; |
