Fluorouracil Dosage

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Usual Adult Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for Colorectal Cancer

For palliative management of colorectal cancer:

Initial Dose: 12 mg/kg intravenously once daily for 4 successive days.
Maximum Dose: 800 mg/day.
If no toxicity is observed, 6 mg/kg may be administered on the 6th, 8th, 10th, and 12th day. (No therapy is given on days 5, 7, 9, or 11.) Discontinue at the end of day 12, even with no apparent toxicity.

Poor risk patients and those who are not in an adequate nutritional state:
Initial Dose: 6 mg/kg/day for 3 days.
Maximum Dose: 400 mg/day.
If no toxicity is observed, 3 mg/kg may be administered on days 5, 7, and 9. (No therapy is to be administered on days 4, 6, or 8.) Discontinue at the end of day 9, even with no apparent toxicity.

Maintenance Therapy: In instances where toxicity has not been a problem, it is recommended that therapy be continued using either of the following schedules:

1) Repeat the dosage of the first course every 30 days after the last day of the previous course, or

2) When the toxic signs resulting from the initial course of therapy have subsided, administer a maintenance dose of 10 to 15 mg/kg/week as a single dose.
Maximum Dose: 1 g/week

The reaction by the patient to the previous course of therapy should be taken into account and the dosage should be adjusted accordingly.

Usual Adult Dose for Stomach Cancer

For palliative management of stomach cancer:

Initial Dose: 12 mg/kg intravenously once daily for 4 successive days.
Maximum Dose: 800 mg/day.
If no toxicity is observed, 6 mg/kg may be administered on the 6th, 8th, 10th, and 12th day. (No therapy is given on days 5, 7, 9, or 11.) Discontinue at the end of day 12, even with no apparent toxicity.

Poor risk patients and those who are not in an adequate nutritional state:
Initial Dose: 6 mg/kg/day for 3 days.
Maximum Dose: 400 mg/day.
If no toxicity is observed, 3 mg/kg may be administered on days 5, 7, and 9. (No therapy is to be administered on days 4, 6, or 8.) Discontinue at the end of day 9, even with no apparent toxicity.

Maintenance Therapy: In instances where toxicity has not been a problem, it is recommended that therapy be continued using either of the following schedules:

1) Repeat the dosage of the first course every 30 days after the last day of the previous course, or

2) When the toxic signs resulting from the initial course of therapy have subsided, administer a maintenance dose of 10 to 15 mg/kg/week as a single dose.
Maximum Dose: 1 g/week

The reaction by the patient to the previous course of therapy should be taken into account and the dosage should be adjusted accordingly.

Usual Adult Dose for Pancreatic Cancer

For palliative management of pancreatic cancer:

Initial Dose: 12 mg/kg intravenously once daily for 4 successive days.
Maximum Dose: 800 mg/day.
If no toxicity is observed, 6 mg/kg may be administered on the 6th, 8th, 10th, and 12th day. (No therapy is given on days 5, 7, 9, or 11.) Discontinue at the end of day 12, even with no apparent toxicity.

Poor risk patients and those who are not in an adequate nutritional state:
Initial Dose: 6 mg/kg/day for 3 days.
Maximum Dose: 400 mg/day.
If no toxicity is observed, 3 mg/kg may be administered on days 5, 7, and 9. (No therapy is to be administered on days 4, 6, or 8.) Discontinue at the end of day 9, even with no apparent toxicity.

Maintenance Therapy: In instances where toxicity has not been a problem, it is recommended that therapy be continued using either of the following schedules:

1) Repeat the dosage of the first course every 30 days after the last day of the previous course, or

2) When the toxic signs resulting from the initial course of therapy have subsided, administer a maintenance dose of 10 to 15 mg/kg/week as a single dose.
Maximum Dose: 1 g/week

The reaction by the patient to the previous course of therapy should be taken into account and the dosage should be adjusted accordingly.

Usual Adult Dose for Breast Cancer

For palliative management of carcinoma of the breast:

Initial Dose: 12 mg/kg intravenously once daily for 4 successive days.
Maximum Dose: 800 mg/day.
If no toxicity is observed, 6 mg/kg may be administered on the 6th, 8th, 10th, and 12th day. (No therapy is given on days 5, 7, 9, or 11.) Discontinue at the end of day 12, even with no apparent toxicity.

Poor risk patients and those who are not in an adequate nutritional state:
Initial Dose: 6 mg/kg/day for 3 days.
Maximum Dose: 400 mg/day.
If no toxicity is observed, 3 mg/kg may be administered on days 5, 7, and 9. (No therapy is to be administered on days 4, 6, or 8.) Discontinue at the end of day 9, even with no apparent toxicity.

Maintenance Therapy: In instances where toxicity has not been a problem, it is recommended that therapy be continued using either of the following schedules:

1) Repeat the dosage of the first course every 30 days after the last day of the previous course, or

2) When the toxic signs resulting from the initial course of therapy have subsided, administer a maintenance dose of 10 to 15 mg/kg/week as a single dose.
Maximum Dose: 1 g/week

The reaction by the patient to the previous course of therapy should be taken into account and the dosage should be adjusted accordingly.

Usual Adult Dose for Cervical Cancer

(In combination with cisplatin)
1000 mg/m2 IV on day 1
The cycle is repeated every 21 days.

Usual Pediatric Dose for Malignant Disease

The manufacturer has reported that the safety and effectiveness of fluorouracil have not been established in children. However, the drug has been used in children following adult guidelines.

Initial Dose: 12 mg/kg intravenously once daily for 4 successive days.
Maximum Dose: 800 mg/day.
If no toxicity is observed, 6 mg/kg may be administered on the 6th, 8th, 10th, and 12th day. (No therapy is given on days 5, 7, 9, or 11.) Discontinue at the end of day 12, even with no apparent toxicity.

Poor risk patients and those who are not in an adequate nutritional state:
Initial Dose: 6 mg/kg/day for 3 days.
Maximum Dose: 400 mg/day.
If no toxicity is observed, 3 mg/kg may be administered on days 5, 7, and 9. (No therapy is to be administered on days 4, 6, or 8.) Discontinue at the end of day 9, even with no apparent toxicity.

Maintenance Therapy: In instances where toxicity has not been a problem, it is recommended that therapy be continued using either of the following schedules:

1) Repeat the dosage of the first course every 30 days after the last day of the previous course, or

2) When the toxic signs resulting from the initial course of therapy have subsided, administer a maintenance dose of 10 to 15 mg/kg/week as a single dose.
Maximum Dose: 1 g/week

The reaction by the patient to the previous course of therapy should be taken into account and the dosage should be adjusted accordingly.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

Avoid extravasation.

Fluorouracil should be used with extreme caution in poor risk patients with a history of pelvic irradiation or previous use of alkylating agents, those who have widespread involvement of bone marrow by metastatic tumors or impaired hepatic or renal function.

Dialysis

Data not available

Other Comments

All dosages are based on patient's actual body weight. However, the estimated lean body weight is used if the patient is obese or if there has been a spurious weight gain due to ascites or other forms of abnormal fluid retention.

Use of fluorouracil is contraindicated in patients who are in a poor nutritional status, have depressed bone marrow function, and those with potentially serious infections.

Fluorouracil is a highly toxic drug with a narrow margin of safety.

It is recommended that patients be hospitalized during treatment with fluorouracil.

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