Nchi: Marekani
Lugha: Kiingereza
Chanzo: NLM (National Library of Medicine)
Fluorouracil (UNII: U3P01618RT) (Fluorouracil - UNII:U3P01618RT)
Sandoz Inc
Fluorouracil
Fluorouracil 50 mg in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
Fluorouracil is effective in the palliative management of carcinoma of the colon, rectum, breast, stomach and pancreas. Fluorouracil therapy is contraindicated for patients in a poor nutritional state, those with depressed bone marrow function, those with potentially serious infections or those with a known hypersensitivity to Fluorouracil.
NDC 66758-054-01: 50 mg/mL in a 50 mL flip-top Pharmacy Bulk Package vial, individually packaged. NDC 66758-054-02: 50 mg/mL in a 100 mL flip-top Pharmacy Bulk Package vial, individually packaged. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. DO NOT FREEZE. PROTECT FROM LIGHT. Vial stoppers do not contain natural rubber latex. For Sandoz Inc. Customer Service, call 1-800-525-8747. Manufactured for: SANDOZ Princeton, NJ 08540 Manufactured by: Ebewe PHARMA A-4866 Unterach, AUSTRIA April 2011
Abbreviated New Drug Application
FLUOROURACIL- FLUOROURACIL INJECTION, SOLUTION SANDOZ INC ---------- FLUOROURACIL INJECTION, USP RX ONLY PHARMACY BULK PACKAGE - NOT FOR DIRECT INFUSION WARNING It is recommended that FLOUROURACIL be given only by or under the supervision of a qualified physician who is experienced in cancer chemotherapy and who is well versed in the use of potent antimetabolites. Because of the possibility of severe toxic reactions, it is recommended that patients be hospitalized at least during the initial course of therapy. DESCRIPTION Fluorouracil Injection, USP an antineoplastic antimetabolite, is a colorless to yellow aqueous sterile, nonpyrogenic injectable solution for intravenous administration. Each mL contains: 50 mg of fluorouracil; pH is adjusted to approximately 9.2 with sodium hydroxide. Chemically, fluorouracil, a fluorinated pyrimidine, is 5-fluoro-2,4 (1_H_,3_H_)-pyrimidinedione. It is a white to practically white crystalline powder which is sparingly soluble in water. The molecular weight is 130.08 and the structural formula is: C H FN O . A _pharmacy bulk package_ is a container of a sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for intravenous infusion or the filling of empty sterile syringes for patients with individualized dosing requirements. CLINICAL PHARMACOLOGY There is evidence that the metabolism of fluorouracil in the anabolic pathway blocks the methylation reaction of deoxyuridylic acid to thymidylic acid. In this manner, fluorouracil interferes with the synthesis of deoxyribonucleic acid (DNA) and to a lesser extent inhibits the formation of ribonucleic acid (RNA). Since DNA and RNA are essential for cell division and growth, the effect of fluorouracil may be to create a thymine deficiency which provokes unbalanced growth and death of the cell. The effects of DNA and RNA deprivation are most marked on those cells which grow more rapidly and which take up fl Soma hati kamili