5-Fluorouracil Ebewe

5-Fluorouracil Ebewe Dosage/Direction for Use



EBEWE Pharma




Mega Lifesciences
Full Prescribing Info
Dosage/Direction for Use
Treatment with fluorouracil should be administered only by physicians with extensive experience in tumour therapy. Initial treatment in hospital should be considered.
Fluorouracil is used in mono-chemotherapy and as a component of poly-chemotherapy. Since the method of application and dose recommendation for fluorouracil vary significantly, only general reference values can be given.
The exact dose should be taken from treatment protocols that have proved successful in the particular disease.
Posology: Initial therapy in daily use: As IV infusion: 15 mg/kg or 600 mg/m2 over 4 hours daily; till the onset of side effects.
As IV injection: Slow IV (2 to 3 minutes) administration of 12 mg/kg or 480 mg/m2 on the 1st, 2nd and 3rd day.
If no signs of toxicity are observable: administration of 6 mg/kg or 240 mg/m2 on day 5, 7 and 9.
Initial therapy in weekly use: Slow IV administration of 15 mg/kg or 600 mg/m2 once weekly.
Maintenance therapy: Once remission has been achieved or rather after the resolution of side effects, the further increase in leucocytes up to 3,000 to 4,000/μl, in thrombocytes up to 80,000 to 100,000/μl: 5-10 mg/kg or 200-400 mg/m2 IV once weekly.
The maximum daily dose of 1 g must not be exceeded.
All doses apply to normal weight, i.e. in adiposities, ascites or oedema, an adequate standardisation must be conducted.
The duration of treatment depends on nature and progress of the disease and is determined by an experienced specialist or in accordance with the treatment protocol.
When fluorouracil is combined with other cytostatic agents with a similar side effect profile or with radiotherapy the dose must be reduced accordingly. The administration can take place in the form of a 24-hour continuous intravenous drip infusion.
Method of administration: Fluorouracil must be applied strictly by intravenous infusion. It can be injected or infused after dilution with 0.9% sodium chloride or glucose 5%.
Extravascular application should be avoided.
Special dose instructions: The recommended doses should be reduced by one third to one half in patients with poor nutritional condition, after a major surgical intervention, in myelosuppression (leucocytes <4,000/μl, thrombocytes <100,000/μl) and severely impaired hepatic and renal function.
Renal or hepatic dysfunction: In patients with renal or hepatic dysfunction, caution should be exercised and the dose reduced if necessary.
Elderly persons (aged 65 or more): No dose adjustment of the initial dose is required. However, a thorough medical monitoring of elderly patients is recommended.
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