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Adrucil (Fluorouracil) - Indications and Dosage



ADRUCIL Injection is effective in the palliative management of carcinoma of the colon, rectum, breast, stomach and pancreas.


General Instructions

ADRUCIL Injection 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 ADRUCIL.


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 sections.)

Poor risk patients or those who are not in an adequate nutritional state (see CONTRAINDICATIONS and WARNINGS sections) should receive 6 mg/kg/day for three days. If no toxicity is observed, 3 mg/kg may be given on the 5th, 7 th and 9 th days unless toxicity occurs. No therapy is given on the 4 th, 6 th or 8 th days. The daily dose should not exceed 400 mg.

A sequence of injections on either schedule constitutes a "course of therapy."

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 dosage of first course every 30 days after the last day of the previous course of treatment.
  2. 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. 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.

Directions for proper use of pharmacy bulk package

(Not for Direct Infusion)

The 50 mL and 100 mL Pharmacy Bulk Packages are for use in a Pharmacy Admixture Service only. They should be inserted into a plastic hanging device and suspended as a unit in a laminar flow hood. Use only if clear and seal is intact and undamaged.

Use of this product is restricted to a suitable work area, such as a laminar flow hood. Use only if clear and seal is intact and undamaged. Prior to entering the vial, remove the flip-off seal and cleanse the rubber closure with a suitable antiseptic agent. The container closure may be penetrated only one time, utilizing a suitable sterile transfer device or dispensing set which allows measured distribution of the contents. The date and time the vial was initially opened should be recorded in the space provided on the vial label. Transfer individual dose(s) to appropriate intravenous infusion solutions. Use of a syringe with a needle is not recommended. Multiple entries increase the potential of microbial and particulate contamination.

The withdrawal of container contents should be accomplished without delay using aseptic technique.However, should this not be possible, a maximum time of 4 hours from initial closure entry is permitted to complete fluid transfer operations. It is recommended that the transferred fluids be used promptly.

Recommended Storage Conditions After Opening

Keep under laminar flow hood at room temperature.


ADRUCIL® Injection (fluorouracil Injection, USP) is available in two pharmacy bulk vials as follows:

NDC Number ADRUCIL Volume
0703-3018-12 50 mg/mL 2.5 g/50 mL vial
0703-3019-12 50 mg/mL 5 g/100 mL vial

The 50 mL and 100 mL pharmacy bulk packages are packaged 5 vials per shelf pack.

Store at room temperature 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from light. Retain in carton until time of use.

NOTE: Although fluorouracil solution may discolor slightly during storage, the potency and safety are not adversely affected.

Also available as follows:

NDC Number ADRUCIL Volume
0703-3015-13 50 mg/mL 500 mg/10 mL

The 10 mL vials are packaged 10 vials per shelf pack.

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