Registered South Africa · SAHPRA

FLORACOR 50 mg/ ml INJECTION

FLUROURACIL

41/26/0246 antineoplastic and immunomodulating agents

What it does

Flurouracil is a medication used to treat certain types of cancer, especially skin cancer.

Commonly used for: skin cancer (basal cell carcinoma), breast cancer, colorectal cancer

Read more in plain English ↓

Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

Ask about this medicine

Answers come only from this medicine's registration record, BNF monograph and interaction data - not medical advice.

Medicine sourcing is available in Kenya only. We don't sell or dispense medicines - licensed pharmacies do.

Sourcing - Kenya only

Registration & product details

Registration no.
41/26/0246
Registration date
2008/04/18
Expiry date
-
Status
Registered
Active ingredient
FLUROURACIL
Dosage form
-
Strength
-
Pack size
-
Therapeutic class
-
ATC class (WHO)
L01BC - Pyrimidine analogues
RxNorm RxCUI
4492
Manufacturer / MAH
-
Applicant / LTR
Accord Healthcare (Pty) Ltd
Country of origin
-

Source: South African Health Products Regulatory Authority · fetched 2026-04-15 21:30:04 · updated 2026-10-21 04:02:22

Disclaimer: This information is sourced from South African Health Products Regulatory Authority (South Africa). Always consult a qualified healthcare professional before using any medication.

About this medicine

Flurouracil is a medication used to treat certain types of cancer, especially skin cancer.

What it treats

  • skin cancer (basal cell carcinoma)
  • breast cancer
  • colorectal cancer

How it works

Flurouracil works by stopping the growth of cancer cells in the body.

Who it's for

It is for patients diagnosed with specific cancers who need treatment to help manage their condition.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: flurouracil

Fluorouracil is an antimetabolite chemotherapy agent that is primarily used in the treatment of various cancers, including colorectal, breast, stomach, and pancreatic cancers. It is a pyrimidine analogue that inhibits DNA and RNA synthesis, making it effective in targeting rapidly dividing cancer cells.

Indications

  • Colorectal cancer
  • Breast cancer
  • Stomach cancer
  • Pancreatic cancer
  • Head and neck cancers
  • Basal cell carcinoma

Dosage

Children: Refer to the BNF for Children for appropriate paediatric dosing information.

Adults: Refer to the BNF for specific dosing guidelines as they vary depending on the treatment regimen and cancer type.

Mechanism of action

Fluorouracil works by inhibiting thymidylate synthase, an enzyme critical for the synthesis of thymidine, a nucleotide required for DNA replication and repair. By depleting thymidine levels, fluorouracil interferes with DNA synthesis, leading to cell death. It also incorporates into RNA, disrupting RNA functions.

Pharmacodynamics

Fluorouracil exhibits dose-dependent cytotoxicity, primarily affecting rapidly proliferating cells. Its effects can be enhanced by leucovorin, which stabilizes the binding of fluorouracil to thymidylate synthase, increasing its efficacy. The drug has a short half-life and its cytotoxic effects are more pronounced in tumor tissues due to higher proliferation rates.

Pharmacokinetics

Fluorouracil is administered intravenously and is rapidly metabolized in the liver, primarily by dihydropyrimidine dehydrogenase (DPD) to inactive metabolites. The elimination half-life ranges from 8 to 20 minutes, with a significant amount of the drug being excreted in urine. The volume of distribution is approximately 0.5–1 L/kg, indicating extensive tissue distribution.

Contra-indications

  • Hypersensitivity to flurouracil or any of its excipients
  • Severe bone marrow suppression
  • Pregnancy
  • Lactation

Adverse effects

  • Nausea
  • Vomiting
  • Diarrhea
  • Stomatitis
  • Hand-foot syndrome
  • Myelosuppression
  • Alopecia
  • Dermatologic reactions
  • Fatigue

Interactions

  • Increased toxicity when used with other myelosuppressive agents
  • May enhance the effects of anticoagulants, leading to increased bleeding risk
  • Caution when used with agents that can cause renal impairment

Precautions

  • Monitor blood counts regularly due to risk of myelosuppression
  • Caution in patients with liver impairment
  • Assess hydration status and renal function before treatment
  • Use with caution in elderly patients

Pregnancy

Flurouracil is contraindicated in pregnancy due to potential teratogenic effects.

Breast-feeding

Flurouracil is not recommended during breastfeeding as it may be excreted in breast milk.

Storage

Store flurouracil in a cool, dry place away from light. Protect from moisture.

Formulations

  • Topical cream
  • Injection solution

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.