FLUOROURACIL- fluorouracil injection, solution

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

Fluorouracil (UNII: U3P01618RT) (Fluorouracil - UNII:U3P01618RT)

Disponibil de la:

Sandoz Inc

Calea de administrare:

INTRAVENOUS

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

Fluorouracil Injection, USP 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.

Rezumat produs:

Fluorouracil Injection, USP is available for intravenouse use in 10 mL vials. Each mL contains 50 mg (available as 500 mg/10 mL) of fluorouracil in a colorless to faint yellow aqueous solution. Sodium hydroxide may have been added to adjust the pH to approximately 9.2 during manufacture. NDC 66758-044-03: Carton of 10 × 10 mL single use vials Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Do not refrigerate or freeze. Protect from light. Retain in carton until contents are used. Discard any unused portion. For Sandoz Inc. Customer Service, call 1-800-525-8747. Manufactured for: SANDOZ Princeton, NJ 08540 Manufactured by: Ebewe PHARMA A-4866 Unterach, AUSTRIA October 2009

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

FLUOROURACIL- FLUOROURACIL INJECTION, SOLUTION
SANDOZ INC
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FLUOROURACIL INJECTION,
USP
RX ONLY
WARNING
It is recommended that Fluorouracil Injection 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.
These instructions should be thoroughly reviewed before administration
of Fluorouracil
Injection, USP.
DESCRIPTION
Fluorouracil Injection, USP an antineoplastic antimetabolite, is a
sterile, nonpyrogenic injectable
solution for intravenous administration. Each mL contains 50 mg of
fluorouracil and water for injection.
Sodium hydroxide may be added to adjust pH to approximately 9.2 during
manufacture.
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 of fluorouracil is 130.08.
Molecular formula of fluorouracil is: C H FN O .
The structural formula is:
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 fluorouracil at a more rapid rate.
Following intravenous injection,fluorouracil distributes into tumors,
intestinal mucosa, bone marrow,
liver and other tissues throughout the body. In spite of its limited
lipid solubility