Држава: Сједињене Америчке Државе
Језик: Енглески
Извор: NLM (National Library of Medicine)
FLOXURIDINE (UNII: 039LU44I5M) (FLOXURIDINE - UNII:039LU44I5M)
Hikma Pharmaceuticals USA Inc.
FLOXURIDINE
FLOXURIDINE 100 mg in 1 mL
INTRA-ARTERIAL
PRESCRIPTION DRUG
Floxuridine for Injection, USP is effective in the palliative management of gastrointestinal adenocarcinoma metastatic to the liver, when given by continuous regional intra-arterial infusion in carefully selected patients who are considered incurable by surgery or other means. Patients with known disease extending beyond an area capable of infusion via a single artery should, except in unusual circumstances, be considered for systemic therapy with other chemotherapeutic agents. Floxuridine therapy is contraindicated for patients in a poor nutritional state, those with depressed bone marrow function or those with potentially serious infections.
Floxuridine for Injection, USP, 500 mg, lyophilized, in a 5 mL vial, is supplied in individual cartons. NDC 0143-9270-01. This is to be reconstituted with 5 mL sterile water for injection. The sterile powder should be stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Reconstituted vials should be stored under refrigeration 2° to 8°C (36° to 46°F) for not more than 2 weeks. To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. For Product Inquiry call 1-877-845-0689.
Abbreviated New Drug Application
FLOXURIDINE- FLOXURIDINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION HIKMA PHARMACEUTICALS USA INC. ---------- FLOXURIDINE FOR INJECTION USP FOR INTRA-ARTERIAL INFUSION ONLY RX ONLY WARNING It is recommended that floxuridine be given only by or under the supervision of a qualified physician who is experienced in cancer chemotherapy and intra-arterial drug therapy and is well versed in the use of potent antimetabolites. Because of the possibility of severe toxic reactions, all patients should be hospitalized for initiation of the first course of therapy. DESCRIPTION Floxuridine for Injection, USP, an antineoplastic antimetabolite, is available as a sterile, nonpyrogenic, lyophilized powder for reconstitution. Each vial contains 500 mg of floxuridine which is to be reconstituted with 5 mL of sterile water for injection. An appropriate amount of reconstituted solution is then diluted with a parenteral solution for intra-arterial infusion (see DOSAGE AND ADMINISTRATION section). Floxuridine is a fluorinated pyrimidine. Chemically, floxuridine is 2'-Deoxy-5-fluorouridine, with a molecular formula of C H FN O . It is a white to off-white odorless solid which is freely soluble in water. The 2% aqueous solution has a pH of between 4.0 and 5.5. The molecular weight of floxuridine is 246.20 and the structural formula is: CLINICAL PHARMACOLOGY When floxuridine is given by rapid intra-arterial injection it is apparently rapidly 9 11 2 5 When floxuridine is given by rapid intra-arterial injection it is apparently rapidly catabolized to 5-fluorouracil. Thus, rapid injection of floxuridine produces the same toxic and antimetabolic effects as does 5-fluorouracil. The primary effect is to interfere with the synthesis of deoxyribonucleic acid (DNA) and to a lesser extent inhibit the formation of ribonucleic acid (RNA). However, when floxuridine is given by continuous intra-arterial infusion its direct anabolism to floxuridine-monophosphate is enhanced, thus increasing the inhibition of DNA. Floxuridine is metabolized in the liver Прочитајте комплетан документ