Fluorouracil Injection

Therapeutic class 治療性藥物
Anticancer 抗癌
Composition
Fluorouracil Injection 25 mg/ml
Each ml contains: 5-Fluorouracil 25 mg
Fluorouracil Injection 50 mg/ml
Each ml contains: 5-Fluorouracil 50 mg

Indications
Palliative management of carcinoma of the colon, rectum, breast, stomach, and pancreas, in selected patients in whom the disease is considered not manageable by surgery or other means.

Contraindications
Fluorouracil is contraindicated in:
-Patients with a known hypersensitivity to fluorouracil.
-Patients in a poor nutritional state.
-Patients with depressed bone marrow function.
-Patients with potentially serious infections.

Dosage and Adminstration
Parenteral drug products should be inspected visually for particulate matter and discoloration, prior to administration, whenever solution and container permit (see Pharmaceutical Precautions). Fluorouracil Injection does not contain any antimicrobial preservative and is intended for single dose administration only.

The daily dose of fluorouracil is not to exceed 800 mg. It is recommended that patients be hospitalized during their first course of treatment.

Fluorouracil Injection is intended for intravenous administration only. Intra-arterial administration has also been used. Extravasation should be avoided. Dosage must be individualized and is based on the patient s actual weight, using the lean body weight (dry weight) if the patient is obese or if there has been a spurious weight gain due to edema, ascites or other abnormal fluid retention.

It is recommended that prior to treatment each patient be carefully evaluated in order to estimate as accurately as possible the optimum initial dosage of fluorouracil.

Fluorouracil Injection may be diluted with 0.9% Sodium Chloride Injection or 5% Dextrose Injection. The resulting solution is stable for 48 hours when stored at room temperature.

Initial Dosage
12 mg/kg intravenously once daily for 4 successive days. The daily dosage should not exceed 800 mg. If no toxicity is observed, 6 mg/kg are given on the 6th, 8th, 10th and 12th days, unless toxicity occurs. No therapy is given on the 5th, 7th, 9th or 11th days. Therapy should be discontinued at the end of the 12th day, even if no toxicity is apparent (see Warnings and Precautions).

Poor risk patients or those not in an adequate nutritional state (see Contraindications and Warnings) should receive 6 mg/kg/day for 3 days. If no toxicity is observed, 3 mg/kg is given on the 5th,7th and 9th days, unless toxicity occurs. No therapy is to be given on the 4th, 6th or 8th days. The daily dose should not exceed 400 mg.

A sequence of injections on either schedule constitutes a "course of therapy". Therapy should be discontinued promptly when any signs of toxicity appear.

Maintenance Therapy
Where toxicity has not been a problem, therapy is continued using either of the following schedules:

1. Repeat the dosage of the first course every 30 day after the last day of the previous course of treatment.

2. When toxic signs resulting from the initial course of therapy have subsided, administer a maintenance dosage of 10-15 mg/kg/week as a single dose. Do not exceed 1 g/week. Use reduced doses for poor risk patients. Consider the patient's reaction to the previous course and adjust dosage accordingly. Some patients have received from 9 to 45 courses of treatment over 12-60 months.

Infusion
A daily dose of 15 mg/kg, but not more than 1 g per infustion, to be diluted in 500ml 5% Dextrose Injection or 500 ml 0.9% Sodium Chloride Injection and administered by intravenous infusion at the rate of 40 drops per minute over 4 hours. Alternatively, the daily dose may be infused over 30-60 minutes, or given as a continuous infusion over 24 hours. This daily dose is given on successive days until toxicity occurs or until 12-15 g has been given. This sequence of injections constitutes a "course" of therapy. Some patients have received up to 30 g at a maximum rate of 1 g daily. The daily dose should never exceed 1 g. An interval of 4-6 weeks should be allowed between any 2 "courses".

Dilution of Fluorouracil Injection
Fluorouracil Injection may be diluted with 0.9% Sodium Chloride Injection or 5% Dextrose Injection. The resulting solution is stable for 48 hours when stored at room temperature, protected from light.

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