Doxorubicin Hydrochloride for Injection, USP, a sterile red-orange lyophilized powder for intravenous use only, is available in 10, 20 and 50 mg single dose vials and a 150 mg multidose vial. Each 10 mg single dose vial contains 10 mg of doxorubicin HCl, USP, 50 mg of lactose, NF (hydrous) and 1 mg of methylparaben, NF (added to enhance dissolution). Each 20 mg single dose vial contains 20 mg of doxorubicin HCl, USP, 100 mg of lactose, NF (hydrous) and 2 mg of methylparaben, NF (added to enhance dissolution). Each 50 mg single dose vial contains 50 mg of doxorubicin HCl, USP, 250 mg of lactose, NF (hydrous) and 5 mg of methylparaben, NF (added to enhance dissolution). Each 150 mg multidose vial contains 150 mg of doxorubicin HCl, USP, 750 mg of lactose, NF (hydrous) and 15 mg of methylparaben, NF (added to enhance dissolution). Doxorubicin Hydrochloride for Injection, USP is available as: Sterile single use only: NDC 0013-1086-91 10 mg single dose vial, 10 vial packs
NDC 0013-1096-91 20 mg single dose vial, 10 vial packs
NDC 0013-1106-79 50 mg single dose vial, single packs Multidose vial: NDC 0013-1116-83 150 mg multidose vial, single packs Store at controlled room temperature, 15º to 30ºC (59º to 86ºF). Protect from light. Retain in carton until time of use. Discard unused portion. Reconstituted Solution Stability After adding the diluent, the vial should be shaken and the contents allowed to dissolve. The reconstituted solution is stable for 7 days at room temperature and under normal room light (100 foot-candles) and 15 days under refrigeration (2º to 8ºC). It should be protected from exposure to sunlight. Discard any unused solution from the 10 mg, 20 mg and 50 mg single dose vials. Unused solutions of the multiple dose vial remaining beyond the recommended storage times should be discarded. Doxorubicin Hydrochloride Injection, USP is a sterile parenteral, isotonic, available in 5 mL (10 mg), 10 mL (20 mg), 25 mL (50 mg), and 37.5 mL (75 mg) single dose vials and a 100 mL (200 mg) multidose vial. Each mL contains doxorubicin HCI and the following inactive ingredients: sodium chloride 0.9% and water for injection q.s. Hydrochloric acid is used to adjust the pH to a target pH of 3.0. Doxorubicin Hydrochloride Injection, USP is available as: SINGLE DOSE GLASS VIALS: NDC 0013-1136-91 10 mg vial, 2 mg/mL, 5 mL, 10 vial packs
NDC 0013-1146-91 20 mg vial, 2 mg/mL,10 mL, 10 vial packs
NDC 0013-1156-79 50 mg vial, 2 mg/mL, 25 mL, single vial packs
NDC 0013-1176-87 75 mg vial, 2 mg/mL, 37.5 mL, single vial packs MULTIDOSE VIALS, in Cytosafe™ vial packs: NDC 0013-1286-83 150 mg, 2 mg/mL, 75 mL
NDC 0013-1266-83 200 mg, 2 mg/mL, 100 mL Store refrigerated, 2º to 8ºC (36º to 46ºF). Protect from light. Retain in carton until contents are used. Contains no preservative. Discard unused portion. REFERENCES 1. 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, DC 20402. 2. AMA Council Report. Guidelines for Handling Parenteral Antineoplastics. JAMA 1985; 2.53(11):1590-1592. 3. National Study Commission on Cytotoxic Exposure-Recommendations for Handling of Cytotoxic Agents. Available from Louis P. Jeffrey, ScD., Chairman, National Study Commission on Cytotoxic Exposure, Massachusetts College of Pharmacy and Allied Health Sciences, 179 Longwood Avenue, Boston, MA 02115. 4. Clinical Oncology Society of Australia, Guidelines and Recommendations for Safe Handling of Antineoplastic Agents. Med J Australia 1983; 1:426-428. 5. Jones RB, et al. Safe Handling of Chemotherapeutic Agents: A Report from the Mount Sinai Medical Center. CA-A Cancer Journal for Clinicians 1983; (Sept/Oct): 258-263. 6. American Society of Hospital Pharmacists Technical Assistance Bulletin on Handling Cytotoxic and Hazardous Drugs. Am J Hosp Pharm 1990; 47:1033-1049. 7. Controlling Occupational Exposure to Hazardous Drugs (OSHA Work-Practice Guidelines). Am J Health-Syst Pharm 1996; 53:1669-1685. 8. ONS Clinical Practice Committee. Cancer Chemotherapy Guidelines and Recommendations for Practice. Pittsburgh, PA: Oncology Nursing Society; 1999: 32-41. Distributed by: Pharmacia and Upjohn Company, Division of Pfizer Inc, NY, NY 10017. Revised October 2006. FDA Rev date: 5/8/2003 Last reviewed on RxList: 9/11/2008
This monograph has been modified to include the generic and brand name in many instances.