Fluorouracil 500 mg/10 ml

Indonesia • Ferron Par Pharmaceuticals

Indication

For palliative treatment of carcinoma of the colon, rectum, breast, stomach and pancreas in patients who are considered incurable by surgery or other means.

Composition

Fluorouracil 500 mg

Package

1 vial of 10 ml

Dosage Forms

Injection

ATC Classification

L01B

Warning

Alcohol
Consult Your Doctor
Safety of this item for use with alcohol has not been established. Please consult your doctor.
Machinery
Caution
This item may not be safe for use while operating heavy machinery. Use with caution and after consultation with your doctor.
Pregnancy
Not Recommended
This item is not safe for use during pregnancy.
Lactation
Not Recommended
This item is not safe for use during lactation.

Dosage

18 Years Old and Above

Usual dosage:
12 mg/kg i.v once daily for 4 successive days. The maximum daily dose of fluorouracil is 800 mg. If no toxicity is observed, 6 mg/kg are given on days 6, 8, 10 and 12 (no therapy is given on days 5, 7, 9 and 11).Therapy is discontinued at the end of day 12, even if no toxicity is observed.

Poor Risk Patients or Those with Inadequate Nutritional State

6 mg/kg/day for 3 days. If no toxicity is observed, 3 mg/kg are given on day 5, 7 and 9 (no therapy on day 4, 6 and 8). The maximum daily dose is 400 mg. The above sequence of injections constitutes a course of therapy.

Maintenance Therapy

When toxicity has not been a problem, it is recommended to continue therapy using either of the following schedules:

  • Repeat dosage of first course every 30 days after the last day of the previous course of treatment.
  • When toxic signs resulting from the initial course of therapy have subsided, administer a maintenance dosage of 10 to 15 mg/kg/week as a single dose. Do not exceed 1 g per week.

The amount of the drug to be used may vary from 9 to 45 courses of treatment during periods which ranged from 12 to 60 months.

Other Details

Fluorouracil injection is for i.v use only and no dilution is required. Actual body weight is used for dosage calculation, except in obese patients and in the presence of abnormal fluid retention (edema, ascites), the estimated ideal body weight is used.