Note: Avoid prolonged exposure to sunlight or UV irradiation during treatment; reaction intensity may be increased.
Actinic keratosis, hyperkeratotic: Topical: Apply once daily until lesions have cleared or up to a maximum duration of 12 weeks. May treat up to 10 lesions at the same time; however, the total treatment area should not exceed 25 cm². Larger areas should be treated at different periods with the most symptomatic area treated first. Less frequent application may be required when used on areas of thin epidermis (eg, around eyes and temples). Optimal therapeutic response may not be observed for up to 8 weeks after treatment discontinuation.
Missed doses: In case of a missed dose, do not apply an extra dose, but continue treatment according to the regular schedule.
Use is contraindicated.
No dosage adjustment necessary.
Dihydropyrimidine dehydrogenase enzyme deficiency: If symptoms of dihydropyrimidine dehydrogenase enzyme deficiency develop (symptoms may include nausea, vomiting, diarrhea, stomatitis, esophagopharyngitis, GI ulceration and bleeding, hemorrhage [from any site], thrombocytopenia, and agranulocytosis), discontinue fluorouracil and salicylic acid use immediately and wash treated area with warm water. Evaluate promptly.
Local adverse reaction, severe: Reduce application frequency to 3 times per week.
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults. Also see individual agents.
>10%: Local: Application-site reaction (application-site burning [≤86%], application-site edema [<1%], application-site eczema [<1%], application-site erosion [7%; severe: 1%], application-site dermatitis [<1%], application-site scaling [<1%], application-site erythema [11%; severe: 2%], application-site irritation [≤86%; severe: 21%], application-site pain [25%; severe: 4%], application-site pruritus [45%; severe: 5%], dermal ulcer [application site: ≤1%], local inflammation [application site: 73%; severe 16%])
1% to 10%: Dermatologic: Crusted skin (3%; scab), desquamation (2%)
<1%:
Dermatologic: Pruritus, skin erosion
Gastrointestinal: Gastroenteritis
Infection: Influenza
Ophthalmic: Dry eye syndrome, eye pruritus, increased lacrimation
Postmarketing:
Dermatologic: Cicatrix of skin (application site), contact dermatitis
Hypersensitivity: Hypersensitivity reaction
Hypersensitivity to fluorouracil, capecitabine, salicylic acid or other salicylates, or any component of the formulation; use in eyes or mucous membranes; patients who are or may become pregnant; breastfeeding; renal insufficiency; concomitant use with dihydropyrimidine dehydrogenase (DPD) enzyme inhibitors; patients with known DPD deficiency.
Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Concerns related to adverse effects:
• Local skin reactions: Localized skin reactions such as erythema, inflammation, irritation (including burning), pain, pruritus, bleeding, and erosion may occur. Reactions are typically mild or moderate but severe reactions have been observed. Increased absorption through skin with a thin epidermis is possible and may lead to an increase in incidence and frequency of adverse reactions. Concurrent use with topical products with drying, peeling, desquamating, or abrasive properties may result in cumulative irritant/drying effect.
Disease-related concerns:
• Dihydropyrimidine dehydrogenase enzyme deficiency: Dihydropyrimidine dehydrogenase enzyme deficiency may result in increased cytotoxic activity and severe toxicity with topical fluorouracil; signs/symptoms of toxicity may include nausea, vomiting, diarrhea, stomatitis, esophagopharyngitis, GI ulceration and bleeding, hemorrhage (from any site), thrombocytopenia, and agranulocytosis.
Dosage form specific issues:
• Dimethylsulfoxide: Product may contain dimethylsulfoxide, which can cause skin irritation.
Other warnings/precautions:
• Appropriate use: Safety and efficacy have not been evaluated in the treatment of recurring lesions or on body parts other than the face, forehead, and bald scalp; fluorouracil and salicylic acid have not been evaluated for treatment in basal cell carcinoma or in Bowen disease.
Not available in the United States.
No
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, External:
Actikerall: Fluorouracil 0.5% and salicylic acid 10% (25 mL) [contains alcohol, usp]
Topical: For external use only. Not intended for oral, ophthalmic, intranasal, intravaginal, intra-auditory canal, or intra-anal use. Apply solution to the face, forehead, and/or bald scalp with the provided brush applicator connected to the closure cap. To avoid overloading the brush with solution, wipe the brush on the neck of the bottle before application. Do not cover treated area after application. Allow solution to dry to form a film over the treated area. Just prior to each reapplication, remove any remaining film coating by peeling it off; warm water may be used if needed. Avoid contact with healthy skin (allow contact with lesion and a maximum rim of 0.5 cm only of surrounding healthy skin); avoid application to mucous membranes due to potential for local inflammation and ulceration. Do not apply to bleeding lesions.
Hazardous agent (NIOSH 2016 [group 1]).
Fluorouracil is a hazardous agent. Use appropriate precautions for receiving, handling, storage, preparation, dispensing, transporting, administration, and disposal. Follow NIOSH and USP 800 recommendations and institution-specific policies/procedures for appropriate containment strategy (NIOSH 2016; USP-NF 2020).
Note: Not approved in the United States.
Actinic keratosis, hyperkeratotic: Treatment of slightly palpable and/or moderately thick hyperkeratotic actinic keratosis (grade I/II) of the face, forehead, and balding scalp in immunocompetent adults.
Fluorouracil may be confused with flucytosine.
This medication is in a class the Institute for Safe Medication Practices (ISMP) includes among its list of drug classes that have a heightened risk of causing significant patient harm when used in error.
KIDs List: Salicylates, when used in pediatric patients <18 years of age with suspicion of viral illness (influenza, chickenpox), are identified on the Key Potentially Inappropriate Drugs in Pediatrics (KIDs) list and should be used with caution due to risk of Reye syndrome (weak recommendation; very low quality of evidence) (PPA [Meyers 2020]).
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Aminolevulinic Acid (Systemic): Photosensitizing Agents may enhance the photosensitizing effect of Aminolevulinic Acid (Systemic). Risk X: Avoid combination
Aminolevulinic Acid (Topical): Photosensitizing Agents may enhance the photosensitizing effect of Aminolevulinic Acid (Topical). Risk C: Monitor therapy
Brivudine: May enhance the adverse/toxic effect of Fluorouracil (Topical). Risk X: Avoid combination
Calcipotriene: Salicylic Acid may diminish the therapeutic effect of Calcipotriene. Management: Monitor for reduced calcipotriene efficacy if combined with salicylic acid. Consider separating the administration of these agents by 10 to 12 hours to minimize the risk of this potential interaction. Risk C: Monitor therapy
Methoxsalen (Systemic): Photosensitizing Agents may enhance the photosensitizing effect of Methoxsalen (Systemic). Risk C: Monitor therapy
Porfimer: Photosensitizing Agents may enhance the photosensitizing effect of Porfimer. Risk C: Monitor therapy
Verteporfin: Photosensitizing Agents may enhance the photosensitizing effect of Verteporfin. Risk C: Monitor therapy
Evaluate pregnancy status prior to use. Use is contraindicated in patients who can become pregnant if pregnancy cannot be excluded.
Use is contraindicated in patients who are pregnant.
Refer to individual monographs for additional information.
Use is contraindicated in patients who are breastfeeding.
Refer to individual monographs for additional information.
Refer to individual agents.
Onset: Response may be observed as early as 6 weeks; complete healing may not be evident for up to 8 weeks after treatment cessation.
Absorption: Fluorouracil: Minimal percutaneous absorption (0.035%) through intact skin; also see individual agents.
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