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5-FLUOROURACIL

Package(a):
VIAL: 1 x 1,000 mg/20 ml.
Dosage(a):
Depends on the condition of the patient, the type of carcinoma being treated and whether it is to be administered alone or in combination with another therapy. 
I.V. administration: Initial treatment should be given in hospital and the total daily dose should not exceed 800 mg. Daily monitoring of platelet and W.B.C. counts is recommended and treatment should be interrupted if platelets fall below 100,000/mm³ or the W.B.C. count falls below 3,000/mm³. Dose should be calculated according to the patient’s actual weight, unless there is obesity, edema or some other form of abnormal fluid retention such as ascites. In this case, ideal weight should be used as the basis for the calculation. 
I.V. infusion: A daily dose of 15 mg/kg body weight (600 mg/m²), but not more than 1 G per infusion, is diluted in 300-500 ml of 5% glucose solution or in 300-500 ml of 0.9% sodium chloride solution and given over 4 hours. This dose is given on consecutive days until toxicity occurs or a total dose of 12-15 G has been reached. Alternatively, 5-Fluorouracil may be given as a continuous infusion over 24 hours. 
I.V. injection: 12 mg/kg body weight (480 mg/m²) may be given daily for 3 days. If there are no signs of toxicity, 6 mg/kg body weight (240 mg/m² on days, 5, 7 and 9 should be administered. Maintenance therapy: 5-10 mg/kg (200-400 mg/m²) by I.V. injection once weekly. 
Breast cancer: May be used in combination, e.g. with methotrexate and cyclophosphamide or with doxorubicin and cyclophosphamide. In this schedule, 10-15 mg/kg (400-600 mg/m²) is administered I.V. on days 1 and 8 of a 28-day therapy course. May also be given by 24 hour continuous infusion; the usual dose is 8.25 mg/kg (350 mg/m²). In all cases, toxic side effects must disappear before maintenance therapy is started. See prescribing information for full details.
Prescribing Restrictions:  None

Package(b):
VIAL: 1 x 5,000 mg/100 ml.
Dosage(b):
Depends on the condition of the patient, the type of carcinoma being treated and whether it is to be administered alone or in combination with another therapy. 
I.V. administration: Initial treatment should be given in hospital and the total daily dose should not exceed 800 mg. Daily monitoring of platelet and W.B.C. counts is recommended and treatment should be interrupted if platelets fall below 100,000/mm³ or the W.B.C. count falls below 3,000/mm³. Dose should be calculated according to the patient’s actual weight, unless there is obesity, edema or some other form of abnormal fluid retention such as ascites. In this case, ideal weight should be used as the basis for the calculation. 
I.V. infusion: A daily dose of 15 mg/kg body weight (600 mg/m²), but not more than 1 G per infusion, is diluted in 300-500 ml of 5% glucose solution or in 300-500 ml of 0.9% sodium chloride solution and given over 4 hours. This dose is given on consecutive days until toxicity occurs or a total dose of 12-15 G has been reached. Alternatively, 5-Fluorouracil may be given as a continuous infusion over 24 hours. 
I.V. injection: 12 mg/kg body weight (480 mg/m²) may be given daily for 3 days. If there are no signs of toxicity, 6 mg/kg body weight (240 mg/m² on days, 5, 7 and 9 should be administered. Maintenance therapy: 5-10 mg/kg (200-400 mg/m²) by I.V. injection once weekly. 
Breast cancer: May be used in combination, e.g. with methotrexate and cyclophosphamide or with doxorubicin and cyclophosphamide. In this schedule, 10-15 mg/kg (400-600 mg/m²) is administered I.V. on days 1 and 8 of a 28-day therapy course. May also be given by 24 hour continuous infusion; the usual dose is 8.25 mg/kg (350 mg/m²). In all cases, toxic side effects must disappear before maintenance therapy is started. See prescribing information for full details.
Prescribing Restrictions:  None


Indications:
Palliative management of carcinoma of the colon, rectum, breast, stomach and pancreas in selected patients considered incurable by surgery or other means. As leucovorin-fluorouracil chemotherapy combination for cancer treatment.
Contra-Indications:
Hypersensitivity, bone marrow depression, especially after radiation. Severe changes in blood counts, hemorrhage, stomatitis, ulcerations in the mouth and GI tract. Severe diarrhea, severe hepatic and/or renal dysfunction, severe infectious diseases. Serious debility, plasma bilirubin greater than 85 mcg/liter.
Special Precautions:
Should only be administered under the strict supervision of a qualified physician who is experienced in the use of antineoplastic therapy. All patients should be admitted to hospital for initial treatment. Adequate treatment is usually followed by leucopenia, the lowest W.B.C. count commonly being observed between days 7 and 14 of the first course, but occasionally being delayed for as long as 20 days. The W.B.C. count usually returns to normal by day 30. Daily monitoring of platelet and W.B.C. counts is recommended and treatment should be interrupted if platelets fall below 100,000/mm³ or the W.B.C. count falls below 3,000/mm³. If the totally W.B.C. count is less than 2,000 mm³, and especially if there is granulocytopenia, it is recommended that the patient should be hospitalized. Treatment should also be interrupted at the first sign of stomatitis or oral ulceration, severe diarrhea, G.I. ulceration, G.I. bleeding or hemorrhage at any site. This drug is not intended as an adjuvant to surgery. 
Pregnancy and lactation: Not recommended during pregnancy, especially during the first semester. Expected benefits of treatment should be weighed against potential risks to the fetus in each individual case. Nursing mothers should stop. Appropriate contraceptive measures are to be taken in men and women up to 3 months after stopping treatment. 
In all instances, toxic side effects must disappear before maintenance therapy is started.
Side Effects:
Leucopenia, thrombocytopenia. Diarrhea, nausea, vomiting. Anorexia, mucositis, stomatitis, esophagitis, pharyngitis, proctitis, G.I. ulceration and bleeding. Isolated cases of chest pain, ischemia, ECG abnormalities, left ventricular dysfunction and rarely myocardial infarction have been reported. Alopecia, dermatitis, dry skin, fissure, erosion, erythema, rash, pruritis, photosensitivity, allergic skin reactions. Pigmentations, streaky hyperpigmentation or depigmentation near the veins, changes in the nails or loss of nails. Palmar-Plantar Erythrodysesthesia Syndrome. A transient reversible cerebellar syndrome, including ataxia, a reversible confusional state and extrapyramidal motor and cortical disturbances. Anaphylaxis, generalized allergic reactions. Disorientation, confusion, euphoria. See prescribing information for full details.
Drug Interactions:
Calcium folinate (folinic acid). Both the efficacy and toxicity may be increased when used in combination with other cytotoxic drugs (interferon-alfa, cyclophosphamide, vincristine, methotrexate, cisplatin, doxorubicin). In combination with other myelosuppressive substances. Aminophenazone, phenylbutazone, sulfonamides, allopurinol. Vaccines, leucoverin calcium. See prescribing information for full details.