Fluorouracil with salicylic acid
- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Cutaneous solution containing fluorouracil 5mg/g and salicylic acid 100mg/g.
Topical treatment of slightly palpable and/or moderately thick hyperkeratotic actinic keratosis (grade I/II) in immunocompetent adults.
Grade I/II intensity is based on the 4-point scale of Olsen et al.
Apply to actinic keratoses once a day for a maximum of 12 weeks. If severe side effects occur, reduce the frequency of drug application to three times per week until the side effects improve.
Response can be seen as early as in 6 weeks. The level of response increases over time, the optimal effects may not be evident for up to 8 weeks after treatment cessation.
Up to 10 actinic keratoses lesions can be treated at the same time, although the total area of skin that can be treated at one time should not exceed 25 cm squared. The solution should only come into contact with the affected area and a rim of max. 0.5 cm of healthy skin surrounding the lesion.
The treated area should be left to dry to form a film over the applied area. The treated area should not be covered.
Before reapplying fluorouracil and salicylic acid the existing film coating should be removed.
(See Dosage; Adult)
Not recommended as no clinical data available.
Patients with Renal Impairment
Contraindicated in renal impairment.
For topical application.
The solution should not be used if crystals occur.
Fluorouracil is cytostatic.
Pregnancy - see Pregnancy section
Breastfeeding - see Lactation section
Dihydropyrimidine dehydrogenase deficiency
Children under 18 years of age
Precautions and Warnings
Dihydropyrimidine dehydrogenase (DPD) enzyme plays an important role in breaking down fluorouracil. Inhibition, deficiency or decreased activity of this enzyme can result in the accumulation of fluorouracil.
If applicable, DPD enzyme activity should be indicated before treatment with fluorouracil or other fluoropyrimidines.
Close monitoring of the affected area is required in patients with sensory disturbances e.g. diabetes mellitus.
The solution should be applied less frequently to areas of skin with thin epidermis, and treatment should be monitored more often.
There has been clinical experience with the use of fluorouracil and salicylic acid on the face, forehead and bald scalp. The thickness of the epidermis on other parts of the body such as the upper trunk, arms or legs should be taken into consideration when deciding on treatment.
Fluorouracil and salicylic acid should not come into contact with eyes or mucous membranes.
Avoid contact with textiles or acrylics (e.g. acrylic bathtubs) as fluorouracil and salicylic acid may cause permanent stains.
Patients should be counseled to protect the skin against further excessive or cumulative exposure to UV/sunlight, especially in the area being actively treated.
Pregnancy and Lactation
Fluorouracil with salicylic acid cutaneous solution is contraindicated in pregnancy.
There are no data from the use of topical fluorouracil in pregnant women. The amount of fluorouracil absorbed systemically when applied topically in patients with actinic keratoses is approximately 6%.
Animal studies have not been conducted with topical fluorouracil. However, fluorouracil was embryotoxic and teratogenic in mice, rats, and hamsters given parenteral doses equivalent to the human dose.
The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14-17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Fluorouracil with salicylic acid cutaneous solution is contraindicated in breastfeeding.
It is not known if fluorouracil is excreted in breast milk after topical application. The low molecular weight (about 130) probably indicates that the drug is excreted into milk.
Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1
Effects on Ability to Drive and Operate Machinery
No influence on the ability to drive or operate machinery.
Inflammation (application site)
Irritation (application site)
Burning (application site)
Ulceration (application site)
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Shelf Life and Storage
Store below 25 degrees C
Do not freeze or refrigerate
Keep the bottle tightly closed
Caution flammable: keep away from fire or flames
Last Full Review Date: June 2011
British National Formulary, 61st Edition (2011) Pharmaceutical Press, London.
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 8th edition (2008) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.
Summary of Product Characteristics: Actikerall 5mg/g + 100mg/g Cutaneous Solution. Almirall Ltd. Revised May 2014.
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