5-Fluorouracil Sandoz

5-Fluorouracil Sandoz





Zuellig Pharma
Concise Prescribing Info
Palliative treatment of several carcinomas, as monotherapy & in combination therapy in colorectal & mammacarcinoma as well. In malignant tumours of the oesophagus, stomach, pancreatic glands, in hepatocellular carcinoma, in liver metastasis, anal carcinomas, urinary bladder, prostate as well as in head & neck tumours.
Dosage/Direction for Use
IV infusion 15 mg/kg or 600 mg/m2 over 2-4 hr daily. IV inj 12 mg/kg or 480 mg/m2 slow IV (2-3 min) on day 1, 2 & 3: If no toxic signs appear, administer 6 mg/kg or 240 mg/m2 on days 5, 7 & 9. Starting therapy in wkly use: 15 mg/kg or 600 mg/m2 once wkly slow IV. 24-hr continuous infusion: 5-7 mg/kg/day or 200 mg/m2/day. Maintenance therapy: When remission is achieved ie, after a decrease of side effects, re-increase of leucocytes to 3,000-4,000 microliter & of the thrombocytes to 80,000-100,000 microliter: 5-10 mg/kg or 200-400 mg/m2 IV once wkly. Max daily dose: 1 g.
Large liver metastasis (decreased metabolism). Pregnancy & lactation.
Special Precautions
Blood count controls every 2-3 days upon initial therapy. Regularly control blood count, liver function & renal function during maintenance therapy. In combination w/ methotrexate, administer methotrexate 24 hr before fluorouracil.
Adverse Reactions
Myelosuppression w/ leucopenia & neutropenia, anemia, immunosuppression. Anorexia, mucositis, stomatitis, neck pain, pharyngitis, oesophagitis, enteritis, ulcer (including oral cavity), bleedings, malabsorption: Nausea, vomiting & diarrhea. Dermatitis, dry skin, transient exantherma, urticarial, pruritus, photosensibility, alopecia, hyperpigmentation, acne. Precordialgia, ischaemia, transient ECG-changes, cardiac infarction. Seldom confusion, somnolence, ataxia, euphoria, photophobia.
Drug Interactions
Cytostatic agents (interferon-α, cyclophosphamide, vincristine, methotrexate, cisplatin, doxorubicin), folinic acid, aminophenazone, phenylbutazone, sulphonamide, allopurinol, chlorodiazepoxide, disulfiram, griseofulvin & INH.
ATC Classification
L01BC02 - fluorouracil ; Belongs to the class of antimetabolites, pyrimidine analogues. Used in the treatment of cancer.
5-Fluorouracil Sandoz soln for inj 1000 mg/20 mL
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