DBL Fluorouracil Injection BP 50mg/mL

INJECTION

**4.2 Dose and method of administration** **Dosage** The dosage being based on the patient’s actual weight. Ideal weight is used only if the patient is obese or if there has been a spurious weight gain due to oedema, ascites or other forms of abnormal fluid retention. Prior to treatment each patient is to be carefully evaluated in order to estimate the optimum initial dosage of fluorouracil. **The total daily dose of fluorouracil should not exceed 1 gram.** The following regimens have been recommended for use of fluorouracil as a single agent in adults: _**Intravenous infusion**_ 15 mg/kg bodyweight (to a maximum of 1 g) daily diluted in 300 to 500 mL of 5% glucose given over a period of 4 hours. Infusion may be continued daily until the first gastrointestinal side effects occur, i.e. stomatitis, diarrhoea, leucopenia and thrombocytopenia, treatment must be discontinued until the side effects have receded (until the WBC count has risen to 3,000 to 4,000 per mm3 or platelet count to 80,000 to 100,000 per mm3), the patient may then be placed on a maintenance therapy program. _**Intravenous injection**_ 12 mg/kg bodyweight daily for 3 consecutive days. If toxic effects do not appear, the patient may then be given 6 mg/kg intravenously on the 5th, 7th and 9th days. If there are still no signs of toxicity, the patient may be placed on maintenance therapy, otherwise regression of toxic side effects must be awaited before continuing therapy. _**Maintenance therapy**_ 5 to 10 mg/kg bodyweight by intravenous injection once a week. Toxic symptoms seldom occur during maintenance therapy. If, however, they do appear, therapy must be discontinued until the symptoms resolve. **Dosage adjustments** The initial recommended doses should be reduced by one third to a half if any of the following conditions are present: 1. poor nutritional state; 2. after major surgery (within previous 30 days); 3. inadequate bone marrow function (WBC count less than 5,000 per mm3; platelet count less than 100,000 per mm3); 4. impaired hepatic and/or renal function. **Method of administration** DBL Fluorouracil Injection BP may be administered by intravenous infusion or intravenous injection. Fluorouracil may be used in combination with other cytotoxic agents or with radiotherapy. In such cases doses should be correspondingly reduced. DBL Fluorouracil Injection BP may also be administered as a 24 hour intra-arterial continuous drip infusion (5 to 7.5 mg/kg bodyweight daily).