make sure that [2000:<25,000 50% No repeat dosage should be given until leukocyte count has returned to 4000/mm 3 and a platelet count to 100,000/mm 3 . When mitomycin is used in combination with other myelosuppressive agents, the doses should be adjusted accordingly. If the disease continues to progress after two courses of mitomycin, the drug should be stopped since chances of response are minimal. STABILITY Unreconstituted mitomycin stored at room temperature is stable for the lot life indicated on the package. Avoid excessive heat (over 40 C, 104 F). Reconstituted with Sterile Water for Injection to a concentration of 0.5 mg per mL, mitomycin is stable for 14 days refrigerated or 7 days at room temperature. Diluted in various I.V. fluids at room temperature, to a concentration of 20 to 40 micrograms per mL: I.V. Fluid Stability 0.9% Sodium Chloride Injection 12 hours Sodium Lactate Injection 24 hours The combination of mitomycin (5 mg to 15 mg) and heparin (1,000 units to 10,000 units) in 30 mL of 0.9% Sodium Chloride Injection is stable for 48 hours at room temperature. Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published. 1-8 There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate. How is Mutamycin Supplied Mutamycin (Mitomycin) for Injection USP NDC 69448-001-05 Each amber vial contains 5 mg mitomycin, individually packed in single carton. NDC 69448-002-11 Each amber vial contains 20 mg mitomycin, individually packed in single carton. NDC 69448-003-38 Each amber vial contains 40 mg mitomycin, individually packed in single carton. Storage: Store dry powder at 25 C, excursion permitted between 15 C and 30 C, protected from light. Avoid excessive heat, over 40 C (104 F). Protect reconstituted solution from light. Store solution under refrigeration 2 to 8 C (36 to 46 F), discard after 14 days. If unrefrigerated, discard after 7 days. References ONS Clinical Practice Committee. Cancer Chemotherapy Guidelines and Recommendations for Practice Pittsburgh, PA: Oncology Nursing Society; 1999:32-41. Recommendations for the safe handling of parenteral antineoplastic drugs. Washington, DC: Division of Safety, National Institutes of Health; 1983. US Dept of Health and Human Services, Public Health Service publication NIH 83-2621. AMA Council on Scientific Affairs. Guidelines for handling parenteral antineoplastics. JAMA. 1985;253:1590-1591. National Study Commission on Cytotoxic Exposure. Recommendations for handling cytotoxic agents. 1987. Available from Louis P. Jeffrey, Chairman, National Study Commission on Cytotoxic Exposure. Massachusetts College of Pharmacy and Allied Health Sciences, 179 Longwood Avenue, Boston, MA 02115. Clinical Oncological Society of Australia. Guidelines and recommendations for safe handling of antineoplastic agents. Med J Australia. 1983;1:426-428. Jones RB, Frank R, Mass T. Safe handling of chemotherapeutic agents: a report from the Mount Sinai Medical Center. CA-A Cancer J for Clin. 1983;33:258-263. American Society of Hospital Pharmacists. ASHP technical assistance bulletin on handling cytotoxic and hazardous drugs. Am J Hosp Pharm. 1990;47:1033-1049. Controlling Occupational Exposure to Hazardous Drugs. (OSHA Work-Practice Guidelines.). Am J Health SystPharm. 1996;53:1669-1685. Manufactured for : Accord BioPharma Inc. 1009 Slater Road, Suite 210-B, Durham, NC 27703. USA Manufactured by : Intas Pharmaceuticals Limited, Ahmedabad 380 009, India. 10 0823 0 668295 Issued - September, 2016 Carton Label-Mutamycin (Mitomycin) for injection USP 40 mg/vial NDC 69448- 003 -38 Mutamycin (Mitomycin) For Injection USP 40 mg Rx only WARNING: MUST BE ADMINISTERED IV TO AVOID TISSUE DAMAGE Carton Label-Mutamycin (Mitomycin) for injection USP 20 mg/vial NDC 69448- 002 -11 Mutamycin (Mitomycin) For Injection USP 20 mg Rx only WARNING: MUST BE ADMINISTERED IV TO AVOID TISSUE DAMAGE Carton Label-Mutamycin (Mitomycin) for injection USP 5 mg/vial NDC 69448- 001 -05 Mutamycin (Mitomycin) For Injection USP 5 mg Rx only WARNING: MUST BE ADMINISTERED IV TO AVOID TISSUE DAMAGE Mutamycin mitomycin injection, powder, lyophilized, for solution Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:69448-003 Route of Administration INTRAVENOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MITOMYCIN (MITOMYCIN) MITOMYCIN 40 mg in 80 mL Inactive Ingredients Ingredient Name Strength MANNITOL 80 mg in 80 mL Packaging # Item Code Package Description 1 NDC:69448-003-38 1 VIAL in 1 BOX, UNIT-DOSE 1 80 mL in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA064144 07/25/2017 Mutamycin mitomycin injection, powder, lyophilized, for solution Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:69448-002 Route of Administration INTRAVENOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MITOMYCIN (MITOMYCIN) MITOMYCIN 20 mg in 40 mL Inactive Ingredients Ingredient Name Strength MANNITOL 40 mg in 40 mL Packaging # Item Code Package Description 1 NDC:69448-002-11 1 VIAL in 1 BOX, UNIT-DOSE 1 40 mL in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA064144 07/25/2017 Mutamycin mitomycin injection, powder, lyophilized, for solution Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:69448-001 Route of Administration INTRAVENOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MITOMYCIN (MITOMYCIN) MITOMYCIN 5 mg in 10 mL Inactive Ingredients Ingredient Name Strength MANNITOL 10 mg in 10 mL Packaging # Item Code Package Description 1 NDC:69448-001-05 1 VIAL in 1 CARTON 1 10 mL in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA064144 07/25/2017 Labeler - Accord BioPharma Inc. (079636487) Registrant - Accord Healthcare Inc. (604222237) Establishment Name Address ID/FEI Operations Intas Pharmaceuticals Limited 725927649 manufacture(69448-003, 69448-002, 69448-001), analysis(69448-003, 69448-002, 69448-001) Establishment Name Address ID/FEI Operations Intas Pharmaceuticals Limited 915837971 manufacture(69448-003, 69448-002, 69448-001), analysis(69448-003, 69448-002, 69448-001) Revised: 08/2017 Accord BioPharma Inc. Next Interactions Print this page Add to My Med List More about Mutamycin (mitomycin) Side Effects During Pregnancy Dosage Information Drug Interactions Support Group En Español 0 Reviews Add your own review/rating Drug class: antibiotics/antineoplastics Consumer resources Mutamycin Mutamycin (Advanced Reading) Professional resources Mutamycin (AHFS Monograph) Mitomycin (FDA) Related treatment guides Bladder Cancer Pancreatic Cancer Stomach Cancer> ] Antibiotics 101 Everything you need to know about antibiotics: List of Common Antibiotics & Types Antibiotics & Drinking Alcohol - Is it Safe? Antibiotics For UTI - What Are My Options? FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only N Pregnancy Category Not classified N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Drug Class Antibiotics / antineoplastics Related Drugs antibiotics / antineoplastics Adriamycin , doxorubicin , mitomycin , Doxil , Valstar , epirubicin Bladder Cancer cisplatin , Adriamycin , doxorubicin , mitomycin , Tecentriq , atezolizumab , thiotepa , Platinol , More... Pancreatic Cancer fluorouracil , Tarceva , gemcitabine , Gemzar , Abraxane , Afinitor , Sutent , mitomycin , More... Stomach Cancer fluorouracil , Adriamycin , doxorubicin , mitomycin , Cyramza , ramucirumab , Adrucil , More... Mutamycin Rating No Reviews - Be the first! No Reviews - Be the first! Not Rated - Be the first! every body
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