most well known [0.02):3 mg% 50% >3 mg% 50% Representative Dose Schedules and Combination for the Approved Indication of Remission Induction in Adult Acute Nonlymphocytic Leukemia In Combination For patients under age 60, Daunorubicin Hydrochloride for Injection USP 45 mg/m 2 /day IV on days 1, 2, and 3 of the first course and on days 1, 2 of subsequent courses AND cytosine arabinoside 100 mg/m 2 /day IV infusion daily for 7 days for the first course and for 5 days for subsequent courses. For patients 60 years of age and above, Daunorubicin Hydrochloride for Injection USP 30 mg/m 2 /day IV on days 1, 2, and 3 of the first course and on days 1, 2 of subsequent courses AND cytosine arabinoside 100 mg/m 2 /day IV infusion daily for 7 days for the first course and for 5 days for subsequent courses. This Daunorubicin Hydrochloride for Injection USP dose-reduction is based on a single study and may not be appropriate if optimal supportive care is available. The attainment of a normal-appearing bone marrow may require up to three courses of induction therapy. Evaluation of the bone marrow following recovery from the previous course of induction therapy determines whether a further course of induction treatment is required. Representative Dose Schedule and Combination for the Approved Indication of Remission Induction in Pediatric Acute Lymphocytic Leukemia In Combination Daunorubicin Hydrochloride for Injection USP 25 mg/m 2 IV on day 1 every week, vincristine 1.5 mg/m 2 IV on day 1 every week, prednisone 40 mg/m 2 PO daily. Generally, a complete remission will be obtained within four such courses of therapy; however, if after four courses the patient is in partial remission, an additional one or, if necessary, two courses may be given in an effort to obtain a complete remission. In children less than 2 years of age or below 0.5 m2 body surface area, it has been recommended that the Daunorubicin Hydrochloride for Injection USP dosage calculation should be based on weight (1 mg/kg) instead of body surface area. Representative Dose Schedules and Combination for the Approved Indication of Remission Induction in Adult Acute Lymphocytic Leukemia In Combination Daunorubicin Hydrochloride for Injection USP 45 mg/m 2 /day IV on days 1, 2, and 3 AND vincristine 2 mg IV on days 1, 8, and 15; prednisone 40 mg/m 2 /day PO on days 1 through 22, then tapered between days 22 to 29; L-asparaginase 500 IU/kg/day x 10 days IV on days 22 through 32. The contents of a vial should be reconstituted with 4 mL of Sterile Water for Injection and agitated gently until the material has completely dissolved. The sterile vial contents provide 20 mg of Daunorubicin, with 5 mg of Daunorubicin per mL. The desired dose is withdrawn into a syringe containing 10 mL to 15 mL of 0.9% Sodium Chloride Injection, USP and then injected into the tubing or sidearm in a rapidly flowing IV infusion of 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP. Daunorubicin Hydrochloride for Injection USP should not be administered mixed with other drugs or heparin. Storage and Handling Store unreconstituted powder between 20 to 25 C (68 to 77 F); [See USP Controlled Room Temperature]; Excursions permitted to 15 to 30 C (59 to 86 F). The reconstituted solution is stable for 24 hours at controlled room temperature and 48 hours under refrigeration. It should be protected from exposure to sunlight. Protect from light. Retain in carton until time of use. If Daunorubicin Hydrochloride for Injection USP contacts the skin or mucosae, the area should be washed thoroughly with soap and water. Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published. 1-7 There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate. How is Daunorubicin Supplied Daunorubicin Hydrochloride for Injection, is available in butyl-rubber-stoppered vials, each containing 21.4 mg Daunorubicin hydrochloride (equivalent to 20 mg of Daunorubicin) and 100 mg of mannitol, as a sterile reddish lyophilized powder. When reconstituted with 4 mL of Sterile Water for Injection, USP, each mL contains 5 mg Daunorubicin activity. NDC 42658-007-01 20 mg, single dose vials, single dose vials; one vial in one inner carton and ten inner cartons in one outer carton. REFERENCES 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. AMA Council Report. Guidelines for Handling Parenteral Antineoplastics. JAMA , March 15,1985. National Study Commission on Cytotoxic Exposure Recommendations for Handling Cytotoxic Agents. Available from Louis R Jeffrey, Sc.D., Chairman, National Study Commission on Cytotoxic Exposure, Massachusetts College of Pharmacy and Allied HealthSciences, 179 Longwood Avenue, Boston, Massachusetts 02115. Clinical Oncological Society of Australia: Guidelines and recommendations for safe handling of antineoplastic agents. Med J Australia 1:426-428, 1983. Jones RB, et al: Safe handling of chemotherapeutic agents: A report from the Mount Sinai Medical Center, Ca A Cancer Joumal for Clinicians Sept/Oct, 258-263, 1983. American Society of Hospital Pharmacists technical assistance bulletin on handling cytotoxic and hazardous drugs. Am J Hosp Pharm 47:1033-1049, 1990. Controlling Occupational Exposure to Hazardous Drugs. (OSHA Work-Practice Guidelines), Am J Health-Syst Pharm , 15:1669-1685, 1996. Distributed by: Halison Pharmaceuticals USA, Inc. Princeton, NJ 08540 USA Manufactured in China Issued: 07/2014 VIAL LABEL Vial Label 20 mg BASE Daunorubicin HYDROCHLORIDE Daunorubicin hydrochloride injection, powder, for solution Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:42658-007 Route of Administration INTRAVENOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Daunorubicin HYDROCHLORIDE (Daunorubicin) Daunorubicin 20 mg in 4 mL Inactive Ingredients Ingredient Name Strength MANNITOL 100 mg in 4 mL Packaging # Item Code Package Description 1 NDC:42658-007-01 1 VIAL in 1 BOX 1 4 mL in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 10/01/2016 Labeler - Halison Pharmaceuiticals USA, Inc (961628505) Establishment Name Address ID/FEI Operations Hisun Pharmaceutical(Hangzhou) Co., Ltd. 421250870 manufacture(42658-007), api manufacture(42658-007), analysis(42658-007), pack(42658-007), label(42658-007) Revised: 11/2015 Halison Pharmaceuiticals USA, Inc Next Interactions Print this page Add to My Med List More about daunorubicin Side Effects During Pregnancy Dosage Information Drug Interactions Support Group Pricing & Coupons En Español 0 Reviews Add your own review/rating Drug class: antibiotics/antineoplastics Consumer resources Daunorubicin Daunorubicin (Conventional) Daunorubicin Intravenous (Advanced Reading) Professional resources Daunorubicin citrate (AHFS Monograph) Daunorubicin hydrochloride (AHFS Monograph) DAUNOrubicin (Conventional) (Wolters Kluwer) Other brands: Cerubidine Related treatment guides Acute Lymphocytic Leukemia Acute Myeloid Leukemia Acute Nonlymphocytic Leukemia] 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 D Pregnancy Category Positive evidence of risk N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Manufacturer Teva Pharmaceuticals USA, Inc. Drug Class Antibiotics / antineoplastics Related Drugs antibiotics / antineoplastics Adriamycin , doxorubicin , mitomycin , Doxil , Valstar , epirubicin Acute Nonlymphocytic Leukemia cyclophosphamide , Cytoxan , cytarabine , mitoxantrone , thioguanine , Novantrone , Cytoxan Lyophilized , More... Acute Myeloid Leukemia vincristine , cytarabine , Mylotarg , Idhifa , idarubicin , Vyxeos , Rydapt , midostaurin , More... Acute Lymphocytic Leukemia prednisone , methotrexate , Deltasone , cyclophosphamide , Cytoxan , vincristine , Trexall , More... Daunorubicin Rating No Reviews - Be the first! No Reviews - Be the first! Not Rated - Be the first! remedies
likely Daunorubicin exercise session
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