Fluorouracil Injection, USP is effective in the palliative management of carcinoma of the colon, rectum,
breast, stomach and pancreas.
DOSAGE AND ADMINISTRATION
Fluorouracil Injection, USP should be administered only intravenously, using care to avoid
extravasation. No dilution is required.
All dosages are based on the patient's actual weight. However, the estimated lean body mass (dry
weight) is used if the patient is obese or if there has been a spurious weight gain due to edema, ascites
or other forms of 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 Injection, USP.
Twelve mg/kg are given intravenously once daily for four successive days. The daily dose 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 is to be discontinued at the
end of the 12th day, even if no toxicity has become apparent. (See WARNINGS and PRECAUTIONS.)
Poor risk patients or those who are not in an adequate nutritional state (see CONTRAINDICATIONS
and WARNINGS) should receive 6 mg/kg/day for three days. If no toxicity is observed, 3
mg/kg may be given on the 5th, 7th and 9th days unless toxicity occurs. No therapy is 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."
In instances where toxicity has not been a problem, it is recommended that therapy be continued 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 patient's reaction to the previous course of therapy should be taken into account in determining the
amount of the drug to be used, and the dosage should be adjusted accordingly. Some patients have
received from 9 to 45 courses of treatment during periods which ranged from 12 to 60 months.
Handling And Disposal
Procedures for proper handling and disposal of anticancer drugs should be considered. Several
guidelines on this subject have been published.1-7 There is no general agreement that all of the
procedures recommended in the guidelines are necessary or appropriate.
Note: Parenteral drug products should be inspected visually for particulate matter and discoloration
prior to administration, whenever solution and container permit. Although the fluorouracil solution may
discolor slightly during storage, the potency and safety are not adversely affected. If a precipitate
occurs due to exposure to low temperatures, resolubilize by heating to 140°F and shaking vigorously;
allow to cool to body temperature before using.
For intravenous use. Fluorouracil Injection, USP is available as follows:
SINGLE DOSE VIALS
||Fluorouracil Injection, USP
||500 mg/10 mL vial
||1 g/20 mL vial
10 mL vials are packaged 10 vials per shelf pack with NDC 16729-276-68.
20 mL vials are packaged 10 vials per shelf pack with NDC 16729-276-67.
Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light.
Retain in carton until time of use.
Also available in two pharmacy bulk vials as follows:
PHARMACY BULK PACKAGES
||Fluorouracil Injection, USP
||2.5 g/50 mL vial
||5 g/100 mL vial
1. Recommendations for the Safe Handling of Parenteral Antineoplastic Drugs. Washington, DC, U.S.
Government Printing Office (NIH Publication No. 83-2621).
2. AMA Council Report. Guidelines for Handling Parenteral Antineoplastics. JAMA, Mar 15, 1985;
3. National Study Commission on Cytotoxic Exposure: Recommendations for Handling Cytotoxic
Agents. Available from Louis P. Jeffrey, ScD, Director of Pharmacy Services, Rhode Island
Hospital, 593 Eddy Street, Providence, Rhode Island 02902.
4. Clinical Oncological Society of Australia: Guidelines and Recommendations for Safe Handling of
Antineoplastic Agents. Med J Aust. Apr 30, 1983; 1:426–428.
5. Jones RB, Frank R, Mass T: Safe Handling of Chemotherapeutic Agents: A Report from the Mount
Sinai Medical Center. Sept–Oct 1983; 33:258–263.
6. American Society of Hospital Pharmacists Technical Assistance Bulletin on Handling Cytotoxic
Drugs in Hospitals. Am J Hosp Pharm. Jan 1985; 42:131–137.
7. OSHA Work-Practice Guidelines for Personnel Dealing with Cytotoxic (Antineoplastic) Drugs. Am
J Hosp Pharm. 1986; 43:1193–1204.
Manufactured By: Intas Pharmaceuticals Limited, Plot No.: 457, 458, Village - Matoda, Bavla Road, Ta.- Sanand, Dist. – Ahmedabad – 382 210. India. Revised: March 2014