Fluracil

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.

Prescribing Description

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