DBL Fluorouracil

DBL Fluorouracil





Zuellig Pharma


Concise Prescribing Info
As mono- or in combination therapy for the palliative treatment of malignant tumours, particularly of the breast, colon or rectum; & treatment of gastric, primary hepatic, pancreatic, uterine (cervical particularly), ovarian & bladder carcinomas.
Dosage/Direction for Use
IV infusion 15 mg/kg diluted in 300-500 mL of 5% glucose given over a period of 4 hr daily. Max: 1 g/day. IV inj 12 mg/kg daily for 3 consecutive days. May give 6 mg/kg on the 5th, 7th & 9th days, if toxic effects do not appear. Maintenance: 5-10 mg/kg once a wk.
Hypersensitivity. Patients who are debilitated; suffering from poor nutritional state, potentially serious infection or bone marrow depression following radiotherapy or therapy w/ other antineoplastic agents (leucocyte count <5,000/mm3, platelet count <100,000/mm3). Do not take w/in 4 wk of treatment w/ brivudine, sorivudine & their analogues. Pregnancy & lactation.
Special Precautions
Do not re-administer after a documented CV reaction (arrhythmia, angina, ST segment changes). Monitor platelets & WBC counts daily; discontinue if platelet count is <100,000/mm3 or WBC count is <3,500/mm3. Regularly test patients concomitantly taking phenytoin. Discontinue promptly if leucopenia, thrombocytopenia, stomatitis, oesophagopharyngitis, intractable vomiting, diarrhoea, melena haemorrhage, oral ulceration, evidence of GI ulceration or bleeding appear. Myelosuppression. Patients who experience chest pain during treatment or w/ a history of heart disease. Patients who have had high dose pelvic irradiation or been previously treated w/ alkylating agents; concomitant use of other chemotherapeutic agents may depress bone marrow function & increase the toxicity. Dihydropyrimidine dehydrogenase deficiency. Avoid prolonged exposure to sunlight. Avoid administration of live or live-attenuated vaccines in patients immunocompromised by chemotherapeutic agents. Continuous infusion may increase the incidence & severity of palmar-plantar erythrodysesthesia. May interfere w/ thyroid function diagnostic tests. Patients w/ reduced renal or liver function, jaundice or heart disease. Childn. Elderly.
Adverse Reactions
Nausea & vomiting, stomatitis, diarrhoea, proctitis, melaena & oesophagitis; reversible alopecia, partial loss of nails, dermatitis, hyperpigmentation, skin rashes, palmar-plantar erythrodysestheia syndrome, thrombophlebitis, asymptomatic hyperpigmentation; leucopenia (primarily granulocytopenia); chest pain, tachycardia, breathlessness, arrhythmia & ECG changes (ST segment changes), angina pectoris, myocardial ischaemia, MI, cardiac shock & failure, myocarditis, cardiomyopathy & pericarditis, thrombophlebitis; multifocal inflammatory leukoencephalopathy (MILE); disorientation, confusion, euphoria, ataxia, nystagmus, headache, slurred speech, dizziness, unsteadiness, muscular weakness, acute cerebellar syndrome; septic shock, sepsis, neutropenic sepsis, pneumonia, superinfection, UTI, catheter related infection, cellulitis, pharyngitis & other infections; local inj site reaction.
Drug Interactions
Increased hematotoxicity w/ all myelosuppresive drugs (eg, cytotoxic agents used in combination chemotherapy). Increased GI toxicity w/ folinic acid. May cause (MILE. Increased plasma conc w/ cimetidine pretreatment. Increased plasma conc of phenytoin. Increased exposure w/ brivudine & sorivudine, & their related analogues. Bone marrow effects may be potentiated by radiation therapy on the bone marrow, especially to the area of the chest & mediastinum. Elevated INR levels & occasional bleeding episodes w/ warfarin. Increased total serum thyroxine conc.
ATC Classification
L01BC02 - fluorouracil ; Belongs to the class of antimetabolites, pyrimidine analogues. Used in the treatment of cancer.
DBL Fluorouracil inj 50 mg/mL
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