Fluorouracil USP
Composition:
Fluracil-250:
Each vial (10ml) contains Fluorouracil USP 250mg (25mg/ml) Solution for IV
injection.
Fluracil-500:
Each vial (10ml) contains Fluorouracil USP 500mg (50mg/ml) solution for IV
injection.
Indications
:
Fluorouracil is indicated alone or in combination for-
1. Carcinoma of the colon or rectum
2. Carcinoma of the stomach and
exocrine pancreas
3. Carcinoma of the liver
4. Carcinoma of the breast
5. Carcinoma of the bladder
6. Carcinoma of the lung
7. Epithelial ovarian carcinoma
8. Cervical carcinoma
Dosage
and Administration:
Intravenous 5-fluorouracil can be delivered by rapid intravenous bolus
injection or slow infusion. The vial contents can rapidly be injected directly
into a peripheral vein, the commonest schedules being: 12-13.5 mg/kg (500
mg/m2) daily for 5 days repeated at 4- weekly intervals. Slow intravenous
infusion requires the drug, to be diluted in 500 ml of dextrose 5% solution,
then infused over 2-3 h on 5 successive days. Usual Adult Dose: For
palliative management of cancer: Initial Dose: 12 mg/kgintravenously 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. or, as direceted by the registered physicians.
Use
in pregnancy and lactation: Fluorouracil is contraindicated
throughout pregnancy. The literature pertaining to pregnancy and cytotoxic
drugs is necessarily limited but it appears in general that risk of
teratogenesis diminishes with the advancement of pregnancy. Therefore most
cytotoxic drugs are absolutely contraindicated in the first trimester and
5-fluorouracil, used in the
first trimester has been reported to cause multiple congenital abnormalities.
There are many case reports, however, of pregnancy being conducted successfully
with combination chemotherapy being given to the mother during the second and
third trimesters. Because of the age of the population and the natural history
of the tumors treated, most of the data on long-term follow-up
pertain to therapy for leukemias. More data need to be accrued on the
subsequent development of neonates before it is certain that any of these
compounds are free of late effects. Lactating
mother: It is not known whether Fluorouracil is excreted in human milk.
Because Fluorouracil inhibits DNA, RNA and protein synthesis, mothers should
not nurse while receiving this drug.
Packing:
Fluracil-250:
Each box contains one vial of 250mg Fluorouracil solution for IV injection.
Fluracil-500: Each box contains one
vial of 500mg Fluorouracil solution for IV injection.