DBL Fluorouracil

DBL Fluorouracil





Zuellig Pharma


Concise Prescribing Info
Alone or in combination for palliative treatment of malignant tumours, particularly of breast, colon or rectum. Gastric, primary hepatic, pancreatic, uterine (cervical) ovarian & bladder carcinomas.
Dosage/Direction for Use
IV infusion 15 mg/kg in 300-500 mL of 5% glucose over 4 hr, may be continued daily until 1st GI side effects occur. Discontinue treatment until side effects recede then place on maintenance therapy. IV inj 12 mg/kg for 3 consecutive days. Then 6 mg/kg on 5th, 7th & 9th day, then place on maintenance therapy. Maintenance: 5-10 mg/kg IV inj once wkly.
Hypersensitivity. Bone marrow depression following radiotherapy or other antineoplastic agents (leucocyte <5,000/mm3 & platelet <100,000/mm3), potentially serious infection, poor nutritional state, debilitated. Pregnancy.
Special Precautions
Not to be readministered after documented CV reaction (arrhythmia, angina, ST segment changes). Discontinue use if leucopenia, thrombocytopenia, stomatitis, oesopharyngitis, intractable vomiting, diarrhoea, melena, haemorrhage, oral ulceration, GI ulceration or bleeding occurs. Heart disease; bone marrow depression, additional stress due to therapy, interfered nutritional uptake. Myelosuppression, viral, bacterial, fungal &/or parasitic infections. Daily monitoring of platelets & WBC counts. Concomitant use w/ other chemotherapeutic agents. Dihydropyrimidine dehydrogenase deficiency. Renal & hepatic impairment; jaundice. Women of childbearing potential should use adequate contraception. May impair fertility in men. Not to be used during pregnancy & lactation. Elderly ≥70 yr.
Adverse Reactions
Nausea, vomiting, stomatitis, diarrhoea, proctitis, oesophagitis; dermatological reactions, skin rashes, photosensitivity; leucopenia, granulocytopenia; chest pain, tachycardia, breathlessness, arrhythmia, ECG changes, angina, myocardial ischaemia, MI, cardiomyopathy; ocular toxicity; neurological, neurotoxicity effects; infections; local inj site reaction, fever.
Drug Interactions
Increased hematotoxicity w/ myelosuppressive drugs. Increased GI toxicity by folinic acid (leucovorin). Decreased bone marrow depression degree w/ allopurinol. Biochemically modulated antitumour efficacy w/ methotrexate, metronidazole & folinic acid. Multifocal inflammatory leukoencephalopathy w/ levamisole. Increased plasma conc by cimetidine. Increased phenytoin plasma conc w/ concomitant capecitabine. Avoid use w/ live or live attenuated vaccines. Interfered w/ thyroid function diagnostic tests.
MIMS Class
Cytotoxic Chemotherapy
ATC Classification
L01BC02 - fluorouracil ; Belongs to the class of antimetabolites, pyrimidine analogues. Used in the treatment of cancer.
DBL Fluorouracil inj 50 mg/mL
10 mL x 5 × 1's;20 mL x 5 × 1's;50 mL x 1's
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