Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/965
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FDUR (Injection, Powder, Lyophilized, For Solution)
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| dailymed-instance:dosage |
Each vial must be reconstituted
with 5 mL of sterile Water for Injection to yield a solution containing
approximately 100 mg of floxuridine /mL. The calculated daily dose(s)
of the drug is then diluted with 5% dextrose or 0.9% sodium chloride
injection to a volume appropriate for the infusion apparatus to be
used. The administration of FUDR is best achieved with the use of
an appropriate pump to overcome pressure in large arteries and to
ensure a uniform rate of infusion. Parenteral drug products should be inspected visually for particulate
matter and discoloration prior to administration whenever solution
and container permit. The recommended therapeutic dosage schedule of FUDR by continuous
arterial infusion is 0.1 to 0.6 mg/kg/day. The higher dosage ranges
(0.4 mg to 0.6 mg) are usually employed for hepatic artery infusion
because the liver metabolizes the drug, thus reducing the potential
for systemic toxicity. Therapy can be given until adverse reactions
appear . When these side effects
have subsided, therapy may be resumed. The patient should be maintained
on therapy as long as response to FUDR continues. Procedures for proper handling and disposal of anticancer drugs should
be considered. Several guidelines on this subject have been published.There is no general agreement that all of the procedures
recommended in the guidelines are necessary or appropriate.
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| dailymed-instance:clinicalP... |
When FUDR is given by rapid
intra-arterial injection it is apparently rapidly catabolized to 5-fluorouracil.
Thus, rapid injection of FUDR 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
FUDR is given by continuous intra-arterial infusion its direct anabolism
to FUDR-monophosphate is enhanced, thus increasing the inhibition
of DNA. Floxuridine
is metabolized in the liver. The drug is excreted intact and as urea,
fluorouracil, a-fluoro-bureidopropionic acid, dihydrofluorouracil,
a-fluoro-b-guanidopropionic acid and a-fluoro-b-alanine in the urine;
it is also expired as respiratory carbon dioxide. Pharmacokinetic
data on intra-arterial infusion of FUDR are not available.
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| dailymed-instance:activeIng... | |
| dailymed-instance:supply |
NDC 61703-331-09 - 500 mg Sterile FUDR
(floxuridine) powder in a 5 mL vial packaged individually. This is to be reconstituted with
5 mL sterile water for injection. The sterile powder should be stored
at 15��C to 30��C (59��F to 86��F). Reconstituted
vials should be stored under refrigeration 2��C to 8��C (36��F
to 46��F) for not more than 2 weeks.
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| dailymed-instance:genericDr... | |
| dailymed-instance:boxedWarn... |
WARNING: It is recommended that FUDR
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.
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| dailymed-instance:activeMoi... | |
| dailymed-instance:genericMe... |
Floxuridine
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| dailymed-instance:fullName |
FDUR (Injection, Powder, Lyophilized, For Solution)
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| dailymed-instance:adverseRe... |
Adverse reactions to the
arterial infusion of FUDR are generally related to the procedural
complications of regional arterial infusion. The more common adverse reactions to the drug are nausea, vomiting,
diarrhea, enteritis, stomatitis and localized erythema. The more common
laboratory abnormalities are anemia, leukopenia, thrombocytopenia
and elevations of alkaline phosphatase, serum transaminase, serum
bilirubin and lactic dehydrogenase. Other adverse reactions are: Gastrointestinal: duodenal ulcer, duodenitis, gastritis, bleeding,
gastroenteritis, glossitis, pharyngitis, anorexia, cramps, abdominal
pain; possible intra- and extrahepatic biliary sclerosis, as well
as acalculous cholecystitis. Dermatologic: alopecia, dermatitis, nonspecific skin toxicity, rash. Cardiovascular: myocardial ischemia. Miscellaneous Clinical Reactions: fever,
lethargy, malaise, weakness. Laboratory
Abnormalities: BSP, prothrombin, total proteins, sedimentation
rate and thrombopenia. Procedural Complications of Regional Arterial Infusion: arterial
aneurysm; arterial ischemia; arterial thrombosis; embolism; fibromyositis;
thrombophlebitis; hepatic necrosis; abscesses; infection at catheter
site; bleeding at catheter site; catheter blocked, displaced or leaking. The following adverse reactions
have not been reported with FUDR but have been noted following the
administration of 5-fluorouracil. While the possibility of these occurring
following FUDR therapy is remote because of its regional administration,
one should be alert for these reactions following the administration
of FUDR because of the pharmacological similarity of these two drugs:
pancytopenia, agranulocytosis, myocardial ischemia, angina, anaphylaxis,
generalized allergic reactions, acute cerebellar syndrome, nystagmus,
headache, dry skin, fissuring, photosensitivity, pruritic maculopapular
rash, increased pigmentation of the skin, vein pigmentation, lacrimal
duct stenosis, visual changes, lacrimation, photophobia, disorientation,
confusion, euphoria, epistaxis and nail changes, including loss of
nails.
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| dailymed-instance:indicatio... |
FUDR 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.
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| dailymed-instance:routeOfAd... | |
| dailymed-instance:name |
FDUR
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