Consumer medicine information

1. Why am I being treated with DBL Fluorouracil Injection BP?

DBL Fluorouracil Injection BP contains the active ingredient fluorouracil. DBL Fluorouracil Injection BP is used to treat some types of cancer.
For more information, see Section 1. Why am I being treated with DBL Fluorouracil Injection BP? in the full CMI.

2. What should I know before treatment with DBL Fluorouracil Injection BP?

Do not use if you have ever had an allergic reaction to fluorouracil or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, have an infection or high temperature, take any other medicines, or if you are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use DBL Fluorouracil Injection BP? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with DBL Fluorouracil Injection BP and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How is DBL Fluorouracil Injection BP given?

Your doctor will decide what dose you will receive. This depends on your medical condition and other factors. Fluorouracil must only be given by a doctor or nurse.
More instructions can be found in Section 4. How do I use DBL Fluorouracil Injection BP? in the full CMI.

5. What should I know during treatment with DBL Fluorouracil Injection BP?

There are many important things to consider while you are taking this medicine. The most common and serious considerations are summarised below (see the full CMI for more details).

6. Are there any side effects?

Side effects of this medicine may include nausea; vomiting; diarrhoea; yellowing of the skin or eyes, loss of appetite; hair or nail loss; changes in skin or nails; euphoria; tiredness; headache; dizziness; fatigue; irritability; restlessness; sore mouth; mouth ulcers; sore rectum or anus; unsteady walking; muscle weakness or muscle cramp; changes in vision; jerky eye movements; excess tears; sensitivity of eyes to light or skin to sunlight; fever; pain, stiffness or swelling in joints; tingling and pain of the hands and feet; redness and swelling; slurred speech; memory loss; confusion; swelling, redness or pain near the injection site; chest pain; irregular and/or rapid heart-beat; loss of consciousness; infection; unusual bleeding or bruising; severe abdominal pain; difficulty swallowing; fits; coma; allergic reaction (shortness of breath, wheezing or difficulty breathing; swelling; rash, itching or hives on the skin). For more information, see Section 6. Are there any side effects? in the full CMI

1 Name of Medicine

Fluorouracil.

2 Qualitative and Quantitative Composition

Each mL of DBL Fluorouracil Injection BP contains fluorouracil 25 mg or 50 mg.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Solution for injection.
DBL Fluorouracil Injection BP is a sterile, colourless, preservative free solution containing 5-fluorouracil in water for injections, prepared with the aid of sodium hydroxide. The pH of the solution is approximately 8.9. DBL Fluorouracil Injection BP is a clear, colourless to slightly yellow solution.

4 Clinical Particulars

4.9 Overdose

Signs and symptoms. The possibility of overdosage with fluorouracil is unlikely in view of the mode of administration. High dosages or prolonged treatment with fluorouracil can result in life-threatening intoxication symptoms; the anticipated manifestations would be nausea, vomiting, diarrhoea, gastrointestinal ulcers and haemorrhage and myelosuppression (include thrombocytopenia, leucopenia and granulocytopenia).
Treatment. Uridine triacetate is a specific antidote for the treatment of 5-fluorouracil overdose or the treatment of severe early-onset toxicities. It should be administered within 96 hours after end of 5-fluorouracil infusion. In the event uridine triacetate is not available, treatment is symptomatic and supportive. Patients who have been exposed to an overdose of fluorouracil should be monitored haematologically for at least 4 weeks. Should abnormalities appear, appropriate therapy should be utilised.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Fluorouracil was genotoxic in the majority of the in vitro studies in bacteria (Salmonella typhimurium and Saccharomyces cerevisiae) or in vivo studies performed. Oncogenic transformation of fibroblasts from mouse embryo has been induced in vitro by fluorouracil, but the relationship between oncogenicity and mutagenicity is not clear. A positive effect was observed in the micronucleus test on bone marrow cells of the mouse, and fluorouracil at very high concentrations produced chromosomal breaks in hamster fibroblasts in vitro.
Carcinogenicity. Insufficient evidence of carcinogenicity was found in long-term studies in rats and mice. Conventional long-term studies in animals to determine the carcinogenic potential of fluorouracil have not been performed. Insufficient evidence of carcinogenicity was found in long-term studies following oral or intravenous administration in rats and mice for up to 1 year. Nevertheless, the risk of carcinogenicity cannot be totally excluded.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Fluorouracil is a white to almost white, practically odourless, crystalline powder. It is sparingly soluble in water, slightly soluble in alcohol and practically insoluble in chloroform and ether.
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSFLUORO.gif Molecular formula: C₄H₃FN₂O₂.
Molecular weight: 130.1.
CAS number. 51-21-8.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/DBLFLCST.gif