FLUOROURACIL- fluorouracil injection, solution

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Sandoz Inc

INN (International ime):

Fluorouracil

Sastav:

Fluorouracil 50 mg in 1 mL

Administracija rute:

INTRAVENOUS

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

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.

Proizvod sažetak:

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

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

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