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Basic Drug Info
Drug Name:Fluorouracil
Manufacturer:GeneraMedix, Inc.
Other Info:



Clinical Trials:


Indications and Usage
Fluorouracil Injection, USP is effective in the palliative management of carcinoma of the colon, rectum, breast, stomach and pancreas.
Carcinoma -- A malignant neoplasm made up of epithelial cells tending to infiltrate the surrounding tissues and give rise to metastases. It is a histological type of neoplasm but is often wrongly used as a synonym for "cancer." (From Dorland, 27th ed)

Contraindications
Fluorouracil Injection, USP 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 Injection.
Infection -- Invasion of the host organism by microorganisms that can cause pathological conditions or diseases.

Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Warnings

( see boxed WARNING) THE DAILY DOSE OF FLUOROURACIL INJECTION, USP IS NOT TO EXCEED 800 MG.

IT IS RECOMMENDED THAT PATIENTS BE HOSPITALIZED DURING THEIR FIRST COURSE OF TREATMENT.Fluorouracil Injection, USP should be used with extreme caution in poor risk patients with a history of high-dose pelvic irradiation or previous use of alkylating agents, those who have a widespread involvement of bone marrow by metastatic tumors or those with impaired hepatic or renal function.Rarely, unexpected, severe toxicity (e.g., stomatitis, diarrhea, neutropenia and neurotoxicity) associated with 5-fluorouracil has been attributed to deficiency of dipyrimidine dehydrogenase activity.

A few patients have been rechallenged with 5-fluorouracil and despite 5-fluorouracil dose lowering, toxicity recurred and progressed with worse morbidity.

Absence of this catabolic enzyme appears to result in prolonged clearance of 5-fluorouracil.
Branded Drugs
The following US Branded drugs contain Fluorouracil


CARAC -- SANOFI AVENTIS US LLC

EFUDEX -- VALEANT PHARMACEUTICALS INTERNATIONAL

FLUOROPLEX -- ALLERGAN HERBERT SKIN CARE DIV ALLERGAN INC

ADRUCIL -- PHARMACIA AND UPJOHN CO

ADRUCIL -- TEVA PARENTERAL MEDICINES INC

FLUOROPLEX -- ELORAC INC


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