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 daily for 3 consecutive days, followed by 6 mg/kg on 5th, 7th & 9th day. Then place on maintenance therapy: 5-10 mg/kg IV inj once wkly.
Hypersensitivity. Bone marrow depression following RT or other antineoplastic agents (leucocyte <5,000/mm3 & platelet <100,000/mm3), suffering from potentially serious infection, known complete dihydropyrimidine dehydrogenase deficiency, poor nutritional state, debilitated. Not to be taken w/in 4 wk of brivudine, sorivudine or chemically-related analogues. Pregnancy.
Special Precautions
Not to be re-administered 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, multifocal inflammatory leucoencephalopathy occurs. Myelosuppression; cardiotoxicity, history of heart disease; bone marrow depression, high-dose pelvic irradiation, previous treatment w/ alkylating agents; palmar-plantar erythrodysesthesia syndrome. Monitor platelets & WBC counts daily. Dihydropyrimidine dehydrogenase deficiency. Avoid prolonged exposure to sunlight. Interference w/ diagnostic thyroid function tests. Avoid use w/ live or live-attenuated vaccine. Concomitant use w/ phenytoin, other chemotherapeutic agents, folinic acid. Renal & hepatic impairment; jaundice. Women of childbearing potential & male partners should use adequate contraception. Not to be used during pregnancy & lactation. Elderly ≥70 yr.
Adverse Reactions
Nausea, vomiting, diarrhoea, stomatitis, proctitis, malaena, GI haemorrhage & ulcer, oesophagitis; dehydration, decreased appetite; anaphylactic reaction, hypersensitivity; alopecia, nail disorders, dermatitis, hyperpigmentation, skin rashes & fissures, palmar-plantar erythrodysaesthesia syndrome, photosensitivity; leucopenia, granulocytopenia; chest pain, tachycardia, breathlessness, arrhythmia, ECG changes, angina pectoris, myocardial ischaemia, MI, cardiac shock & failure, myocarditis, cardiomyopathy, pericarditis, thrombophlebitis, haemorrhage; ocular toxicity; neurological, neurotoxicity effects; infections; local inj site reaction, fever.
Drug Interactions
Increased hematotoxicity w/ myelosuppressive drugs. Increased GI toxicity w/ folinic acid (leucovorin). Decreased bone marrow depression degree w/ allopurinol. Biochemically modulated antitumour efficacy or toxicity w/ MTX. Reduced clearance by metronidazole. Multifocal inflammatory leukoencephalopathy w/ levamisole. Increased plasma conc by cimetidine. Increased phenytoin plasma conc w/ concomitant capecitabine. Increased exposure w/ brivudine, sorivudine or chemically-related analogues. Potentiated bone marrow effects w/ radiation therapy. Elevated INR & bleeding episodes w/ warfarin. Serious fatal infections w/ live or live-attenuated vaccines. Increased total serum thyroxine conc.
MIMS Class
Cytotoxic Chemotherapy
ATC Classification
L01BC02 - fluorouracil ; Belongs to the class of antimetabolites, pyrimidine analogues. Used in the treatment of cancer.
DBL Fluorouracil soln for 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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