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EFUDEX is a brand name for Fluorouracil, supplied as a cream. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: EFUDEX is recommended for the topical treatment of premalignant keratoses and superficial basal cell carcinoma. 1.1 Pediatrics (≥ 18 years of age) Based on the data submitted and reviewed by Health Canada, the safety and efficacy of EFUDEX in pediatric patients has not been established; therefore, Health Canada has…
Verbatim from this product's HC label. Tap a section to expand.
2 Recommended Dose and Dosage Adjustment EFUDEX should be applied twice daily with a non-metal applicator or suitable glove in an amount of the cream sufficient to cover the lesion. When EFUDEX is applied to a lesion, a response occurs with the following sequence: erythema, usually followed by vesiculation, erosion, ulceration, necrosis and epithelization.
The lower frequency and intensity of activity in adjacent normal skin indicate a selective cytotoxic property. Medication should be continued until the inflammatory reaction reaches the erosion, ulceration, and necrosis stage, at which time use of the drug should be terminated.
The usual duration of therapy is from two to four weeks. Complete healing of the lesion may not be evident for one to two months following cessation of EFUDEX therapy. While the patient is undergoing EFUDEX therapy, consideration can be given to curettage, wound excision and removal of pathological tissue.
Health Canada has not authorized an indication for pediatric use. 4 Administration EFUDEX is preferably applied with a non-metal applicator or suitable glove; if it is applied with the fingertips, the hands should be washed immediately afterward.
EFUDEX should be applied with care near the eyes, nostrils and mouth. To rule out the presence of a f rank neoplasm, a biopsy should be made of those lesions failing to respond to treatment or recurring after treatment. 5 Missed Dose If you miss a dose of EFUDEX, apply it as soon as you remember.
However, if more than a few hours have passed, skip the missed dose and go back to your regular dosing schedule. If you miss more than one dose, check with your doctor. 7 Instructions for Preparation and Use a. Wash the affected area with soap and water.
b. Carefully dry the affected area and wait until it is completely dry. c. Apply a thin layer of EFUDEX enough to cover the entire area. It is recommended that a cotton-tipped swab or a suitable glove is used to apply EFUDEX. However, if you have to use your fingertips, wash your hands immediately after use.
Note:
Be careful if you are applying EFUDEX to your face and avoid getting any into your eyes, nostrils, or mouth. d. Wash your hands thoroughly immediately after using EFUDEX. PrEFUDEX® Product Monograph Page 6 of 16
2 Clinical Trial Adverse Reactions Because clinical trials are conducted under very specific conditions, the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. The most frequently encountered local reactions are pain, pruritus, hyperpigmentation and burning at the site of application.
Other local reactions include dermatitis, scarring, soreness and tenderness. Insomnia, stomatitis, suppuration, scaling, swelling, irritability, medicinal taste, photosensitivity and lacrimation have also been reported. 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data Clinical Trial Findings Laboratory abnormalities reported include leucocytosis, thrombocytopenia, toxic granulation and eosinophilia.
PrEFUDEX® Product Monograph Page 8 of 16
03/2020 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ..................................................................................... 2 TABLE OF CONTENTS ..........................................................................................................
2 PART I: HEALTH PROFESSIONAL INFORMATION............................................................... 4 1 INDICATIONS.............................................................................................................. 4 2 CONTRAINDICATIONS ...............................................................................................
4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX...................................................... 4 4 DOSAGE AND ADMINISTRATION .............................................................................. 2 Recommended Dose and Dosage Adjustment ....................................................
4 Administration..................................................................................................... 5 Missed Dose.......................................................................................................
7 Instructions for Preparation and Use ................................................................... 5 5 OVERDOSAGE ........................................................................................................... 6 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ........................
6 7 WARNINGS AND PRECAUTIONS .............................................................................. 1 Special Populations ............................................................................................ 1 Pregnant Women ............................................................................................
EFUDEX is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
2 Breast-feeding). EFUDEX is contraindicated in patients with known dihydropyridine dehydrogenase (DPD) enzyme deficiency (see 7 WARNINGS AND PRECAUTIONS). EFUDEX must not be used in conjunction with brivudine*, sorivudine* and analogues.
2 Drug-Drug Interactions). *Not authorized for sale in Canada
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Fluorouracil in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
2 Breast-feeding................................................................................................. 3 Pediatrics (≥ 18 years of age) .......................................................................... 7 8 ADVERSE REACTIONS ..............................................................................................
2 Clinical Trial Adverse Reactions .......................................................................... 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data Clinical Trial Findings........................................................................
7 9 DRUG INTERACTIONS ............................................................................................... 4 Drug-Drug Interactions........................................................................................ 5 Drug-Food Interactions .......................................................................................
6 Drug-Herb Interactions........................................................................................ 7 Drug-Laboratory Test Interactions ....................................................................... 8 10 CLINICAL PHARMACOLOGY .....................................................................................
1 Mechanism of Action ....................................................................................... 2 Pharmacokinetics............................................................................................ 8 11 STORAGE, STABILITY AND DISPOSAL ....................................................................
9 12 SPECIAL HANDLING INSTRUCTIONS ....................................................................... 9 PrEFUDEX® Product Monograph Page 3 of 16 PART II: SCIENTIFIC INFORMATION ..................................................................................
10 13 PHARMACEUTICAL INFORMATION ........................................................................ 10 14 CLINICAL TRIALS .................................................................................................... 11 15 MICROBIOLOGY.......................................................................................................
11 16 NON-CLINICAL TOXICOLOGY ................................................................................. 11 PATIENT MEDICATION INFORMATION .............................................................................. 12 PrEFUDEX® Product Monograph Page 4 of 16 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS EFUDEX is recommended for the topical treatment of premalignant keratoses and superficial basal cell carcinoma.
1 Pediatrics (≥ 18 years of age) Based on the data submitted and reviewed by Health Canada, the safety and efficacy of EFUDEX in pediatric patients has not been established; therefore, Health Canada has not authorized an indication for pediatric use 2 CONTRAINDICATIONS EFUDEX is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. 2 Breast-feeding). EFUDEX is contraindicated in patients with known dihydropyridine dehydrogenase (DPD) enzyme deficiency (see 7 WARNINGS AND PRECAUTIONS).
EFUDEX must not be used in conjunction with brivudine*, sorivudine* and analogues. 2 Drug-Drug Interactions). *Not authorized for sale in Canada 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions Life-threatening systemic toxicity has been reported with the topical use of […]