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Brand Name: Adrucil Trade Name: fluorouracil, 5-FU
FDA Approved For: ADRUCIL Injection is effective in the palliative management of carcinoma of the colon, rectum, breast, stomach and pancreas. Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
Carcinogen: Longterm studies in animals to evaluate the carcinogenic potential of fluorouracil have not been conducted. However, there was no evidence of carcinogenicity in small groups of rats given fluorouracil orally at doses of 0.01, 0.3, 1 or 3 mg per rat 5 days per week for 52 weeks, followed by a six-month observation period. Also, in other studies, 33 mg/kg of fluorouracil was administered intravenously to male rats once a week for 52 weeks followed by observation for the remainder of their lifetimes with no evidence of carcinogenicity. Female mice were given 1 mg of fluorouracil intravenously once a week for 16 weeks with no effect on the incidence of lung adenomas. On the basis of the available data, no evaluation can be made of the carcinogenic risk of fluorouracil to humans. Mutagen: Oncogenic transformation of fibroblasts from mouse embryo has been induced in vitro by fluorouracil, but the relationship between oncogenicity and mutagenicity is not clear. Fluorouracil has been shown to be mutagenic to several strains of Salmonella typhimurium, including TA 1535, TA 1537 and TA 1538, and to Saccharomyces cerevisiae, although no evidence of mutagenicity was found with Salmonella typhimurium strains TA 92, TA 98 and TA 100. In addition, a positive effect was observed in the micronucleus test on bone marrow cells of the mouse, and fluorouracil at very high concentrations produced chromosomal breaks in hamster fibroblasts in vitro.
Manufacturer and/or Distributor: ICN Puerto Rico    

Adverse Reactions:
Stomatitis and esophagopharyngitis (which may lead to sloughing and ulceration), diarrhea, anorexia, nausea and emesis are commonly seen during therapy. Leukopenia usually follows every course of adequate therapy with fluorouracil. The lowest white blood cell counts are commonly observed between the 9th and 14th days after the first course of treatment, although uncommonly the maximal depression may be delayed for as long as 20 days. By the 30th day the count has usually returned to the normal range. Alopecia and dermatitis may be seen in a substantial number of cases. The dermatitis most often seen is a pruritic maculopapular rash usually appearing on the extremities and less frequently on the trunk. It is generally reversible and usually responsive to symptomatic treatment. Other adverse reactions are: Hematologic: pancytopenia, thrombocytopenia, agranulocytosis, anemia. Cardiovascular: myocardial ischemia, angina. Gastrointestinal: gastrointestinal ulceration and bleeding. Allergic reactions: anaphylaxis and generalized allergic reactions. Neurologic: acute cerebellar syndrome (which may persist following discontinuance of treatment), nystagmus, headache. Dermatologic: dry skin, fissuring, photosensitivity, as manifested by erythema or increased pigmentation of the skin; vein pigmentation; palmar-plantar erythrodysesthesia syndrome, as manifested by tingling of the hands and feet following by pain, erythema, and swelling. Ophthalmic: Lacrimal duct stenosis, visual changes, lacrimation, photophobia. Psychiatric: disorientation, confusion, euphoria. Miscellaneous: thrombophlebitis, epistaxis, nail changes (including loss of nails).


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