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  • Fluorouracil “Ebewe” 50 mg/ml
    / Pharmalogic


    Active Ingredient
    Fluorouracil 50 mg/ml

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Vial

    1 X 1,000 mg / 20 ml

    partial basket chart 61068 6376

    Vial

    1 X 5,000 mg / 100 ml

    partial basket chart 61079 6377

    Related information


    Dosage

    Selection of an appropriate dose and treatment regimen depends upon the condition of the patient, the type of carcinoma being treated and whether 5-fluorouracil (5-FU) is to be administered alone or in combination with another therapy.
    Fluorouracil should be administered intravenously, avoiding extravasation.
    Initial treatment should be given in hospital and the total daily dose should not exceed 800 mg.
    Daily monitoring of platelet and white blood cell (WBC) counts is recommended and treatment should be interrupted if platelet count falls below 100,000/mm3 or the WBC count falls below 3,000/mm³.
    It is customary to calculate the dose in accordance with the patient’s actual weight unless there is obesity, oedema 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.
    The following dosages are intended as a guideline only.
    The initial treatment may be in the form of an infusion or injection, the former usually being preferred because of lesser toxicity.
    Intravenous infusion: A daily dose of 15 mg/kg body weight (600 mg/m²), but not more than 800 mg per infusion, is diluted in 300-500 ml of 5% glucose solution or in 300-500 ml of 0.9% sodium chloride solution and administered over 4 hours.
    This dose is given on consecutive days until toxicity occurs or a total dose of 12-15 g has been reached. Some patients have received up to 30 g at the maximum rate of 1 g daily.
    Treatment should be interrupted until haematological and gastrointestinal toxicities resolve.
    Alternatively 5-FU may be given as a continuous infusion over 24 hours.
    Intravenous injection: 12 mg/kg body weight (480 mg/m²) may be given daily for 3 days by intravenous injection. If there are no signs of toxicity, 6 mg/kg body weight (240 mg/m²) should be administered on days 5, 7 and 9.
    Maintenance therapy consists of 5-10 mg/kg (200-400 mg/m²) by intravenous injection once weekly.
    In all instances, toxic side effects must disappear before maintenance therapy is started!
    Breast cancer: For treatment of breast cancer, 5-FU 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 intravenously on days 1 and 8 of a 28-day therapy course.
    5-FU may also be given by 24-hour continuous infusion; the usual dose is 8.25 mg/kg (350 mg/m²).
    Pediatric Patients: There are no dosage recommendations for 5-FU use in children.
    Elderly: 5-FU dosage is similar to that used in younger adults.


    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.


    Pregnancy and Lactation

    Pregnancy: There is insufficient information about the effects of 5-FU on pregnancy in the absence of concomitant treatment (cytotoxic drugs, radiation therapy). After administration of 5-FU during pregnancy – always in combination with other potentially damaging forms of treatment – there have been reports of children born with anomalies as well as reports of children born healthy even after administration of 5-FU in the first trimester of pregnancy.
    In animal studies 5-FU has been shown to be teratogenic and fetotoxic in various animal species.
    Furthermore, animal studies have produced evidence of fertility-damaging effects.
    The use of 5-FU is not recommended during pregnancy, especially during the first trimester.
    Expected benefits of treatment should be weighed against potential risks to the fetus in each individual case.
    Lactation: It is not known if 5-FU is excreted in human milk.
    Nursing mothers should stop breastfeeding during treatment with 5-FU.


    Overdose

    Symptoms: Acute: Psychotic reactions, somnolence, increased effectiveness of sedative drugs, increased alcohol toxicity.
    If sedation is necessary, diazepam can be administered i.v. in small doses (e.g., starting with 5 mg) with cardiovascular and pulmonary monitoring.
    Chronic: Bone marrow depression to the point of agranulocytosis and critical thrombocytopenia, haemorrhagic tendency, ulcerations in the gastrointestinal tract, diarrhoea, alopecia.
    Therapy: There is no known specific antidote. Infusions of leukocyte or platelet concentrates should be administered prophylactically. Attention is to be paid to adequate hydration and diuresis; electrolyte imbalances should be corrected. Haemodialysis is not usually necessary. The patient should be observed carefully to detect late haematologic and gastrointestinal complications as early as possible. Further treatment should be symptomatic.


    Manufacturer
    Ebewe Pharma
    Licence holder
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