देश: संयुक्त राज्य
भाषा: अंग्रेज़ी
स्रोत: NLM (National Library of Medicine)
FLOXURIDINE (UNII: 039LU44I5M) (FLOXURIDINE - UNII:039LU44I5M)
Fresenius Kabi USA, LLC
FLOXURIDINE
FLOXURIDINE 500 mg in 5 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.
The container closure is not made with natural rubber latex. 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.
Abbreviated New Drug Application
FLOXURIDINE - FLOXURIDINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION FRESENIUS KABI USA, LLC ---------- FLOXURIDINE FOR INJECTION, USP FOR INTRA-ARTERIAL INFUSION ONLY WARNING It is recommended that Floxuridine for Injection, USP 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_). Floxuridine is a fluorinated pyrimidine. Chemically, floxuridine is 2’-deoxy-5-fluorouridine. 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 structural formula is: CLINICAL PHARMACOLOGY: 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. The drug is excreted intact and as urea, fluorouracil, α-fluoro- β-ureidopropionic acid, dihydrofluorouracil, α-fluoro-β-guanidopropionic acid and α-fluoro-β-alanine i पूरा दस्तावेज़ पढ़ें