Ildong Pharm


International Apex
Concise Prescribing Info
Palliative treatment of malignant tumours, particularly of the breast, colon or rectum; treatment of gastric, primary hepatic, pancreatic, uterine (cervical), ovarian & bladder carcinomas, as monotherapy or combination therapy.
Dosage/Direction for Use
Adult Single agent: 15 mg/kg (max: 1 g) IV infusion daily, diluted in 300 to 500 mL of glucose 5% given over a period of 4 hr. WBC count has risen to 3,000-4,000/mm3 or platelet count to 80,000-100,000/mm3 Maintenance: 12 mg/kg daily IV inj for 3 consecutive days. If toxic effects do not appear, patient may be given 6 mg/kg IV on the 5th, 7th & 9th days. If there are still no signs of toxicity, the patient may be placed on maintenance therapy of 5-10 mg/kg by IV inj once a wk. In combination w/ other cytostatic agents or w/ radiotherapy: 5-7 mg/kg daily as a 24-hr intra-arterial continuous drip infusion. Suggested regimens w/ folinic acid include: 200 mg/m2 of folinic acid (as Ca folinate) by slow IV inj followed immediately by an IV bolus of fluorouracil 370 mg/m2 for 5 consecutive days & may be repeated every 4-5 wk. The Mayo regimen: Lower doses of folinic acid (20 mg/m2) followed by fluorouracil 425 mg/m2 for 5 consecutive days, repeated every 4-5 wk. The de Gramont regimen: Initial dose of 200 mg/m2 of folinic acid, followed by fluorouracil 400 mg/m2 as an initial IV bolus inj & then 600 mg/m2 by continuous IV infusion given for 2 consecutive days every 2 wk.
Hypersensitivity. Patients who are in a poor nutritional state; depressed bone marrow function (leukocyte count of <5,000/mm3 &/or platelet count of <100,000/mm3); potentially serious infections; major surgery w/ in the previous mth; seriously debilitated patients; management of non-malignant disease. Do not give in combination w/ brivudin, sorivudin & analogues. Pregnancy & lactation.
Special Precautions
Weak or malnourished patients, patients w/ history of heart disease or hepatic or renal insufficiency; history of high-dose pelvic irradiation or treatment w/ alkylating agents & widespread metastases to the bone marrow. Do not use in patients w/ dihydropyrimidine dehydrogenase (DPD) enzyme deficiency.
Adverse Reactions
Palmar-plantar erythrodysesthesia syndrome (erythema & painful desquamation of the hands & feet); GI toxicity; leucopenia, thrombocytopenia, stomatitis, GI ulceration & bleeding, diarrhoea or haemorrhage from any site; anaemia; nausea & vomiting, rashes, alopecia; ocular irritation, central neurotoxicity (cerebellar ataxia) & myocardial ischaemia; local inflammatory & photosensitivity reactions; dermatitis, erythema multiforme.
Drug Interactions
Modified actions w/ other drugs including allopurinol, cimetidine, folinic acid, methotrexate & metronidazole.
ATC Classification
L01BC02 - fluorouracil ; Belongs to the class of antimetabolites, pyrimidine analogues. Used in the treatment of cancer.
Fluoroxil soln for inj 50 mg/mL
10 mL x 10 × 1's;5 mL x 10 × 1's
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