Actikerall (Fluorouracil and Salicylic acid) - Uses, Dose, Side effects

Actikerall is a combination of topical fluorouracil and salicylic acid that is used to treat hyperkeratotic actinic keratosis of the skin.

Actikerall (Fluorouracil and salicylic acid) Uses:

  • Hyperkeratotic actinic keratosis:

    • Immunocompetent adults with Grade I or Grade II (slightly perceptible and/or moderately thick) hyperkeratotic actinic keratosis of the face, forehead, and balding scalp are eligible for treatment.

Actikerall dose in Adults

Actikerall dose in the treatment of Hyperkeratotic actinic keratosis:

  • Apply topically once a day until the lesions have cleared or for a maximum duration of 12 weeks.
  • The drug may be used to treat up to ten lesions at the same time; however, avoid exceeding the total treatment area of 25 cm².
  • If the disease affects a larger area of the body, try to treat it at the different periods with the most symptomatic lesions treated first.
  • When applying the medicine over skin that is sensitive and thin such as around the eyes and temple, or in patients who develop drug-related adverse events, a less frequent application may be more suitable (thrice a week).
  • It may take up to 8 weeks(after treatment discontinuation) for optimal therapeutic response to be seen.
  • Missed doses:

    • If the dose is missed, avoid applying an extra dose.
    • The treatment may be continued at the regularly scheduled time.

Use in Children:

Not indicated.

Actikerall Pregnancy Risk Category: X

  • Pregnant women and women at risk of becoming pregnant are advised to not use this medication.

Use of fluorouracil or salicylic acid during breastfeeding

  • Breastfeeding women should not use this product.

Dose in Kidney Disease:

Use is contraindicated.

Dose in Liver disease:

No dosage adjustment is necessary.

Common Side Effects of Actikerall (Fluorouracil and salicylic acid):

  • Local:

    • Application-Site Pruritus
    • Application Site Pain
    • Application Site Irritation
    • Local Inflammation
    • Application Site Erythema

Less Common Side Effects of Actikerall (Fluorouracil and salicylic acid):

  • Dermatologic:

    • Crusted skin
    • Desquamation
  • Local:

    • Skin erosion

Contraindications to Actikerall (Fluorouracil and salicylic acid):

  • Allergy reactions to fluorouracil or capecitabine, salicylic acids or other salicylates or any component of this formulation
  • Use in the eyes and mucous membranes
  • Pregnant or potentially pregnant women
  • Women who are lactating
  • Patients with severe renal impairment
  • Use with dihydropyrimidine (DPD), enzyme inhibitors in conjunction
  • Patients with a DPD deficiency.

Warnings and precautions

  • Local skin reactions

    • Localized skin reactions may occur in patients with itching, inflammation, redness or burning.
    • Patients usually experience mild to moderate skin reactions. However, patients may develop ulcerated lesions or thin epidermis, which can lead to increased incidences of toxic effects.
    • Avoid applying to bleeding lesions.
    • The local adverse effects of drugs that can cause skin peeling, irritation, desquamation, and irritation may be increased if they are used in combination.
  • Photosensitivity

    • Photosensitivity may be caused by the drug. It is important to avoid prolonged exposure to ultraviolet radiation or sunlight during treatment.
  • Dihydropyrimidine dehydrogenase enzyme deficiency:

    • People who lack the enzyme activity of dihydropyrimidine deshydrogenase (DPD) may experience severe drug-related toxicities when they use topical fluorouracil.
    • Patients can experience nausea, vomiting and stomatitis.
    • If there is suspicion of toxicity, it should be stopped immediately. The area should be washed with warm soapy water.
    • Patients with a known DPD deficiency are not advised to use it.

Fluorouracil and salicylic acid (topical): Drug Interaction

Risk Factor C (Monitor therapy)


The serum levels of fosphenytoin may increase when fluorouracil (Topical) is used.


Fluorouracil serum concentration might rise (Topical).

Leucovorin Calcium-Levoleucovorin

may intensify the negative or harmful effects of fluorouracil (Topical).


The serum concentration of phenytoin may rise when fluorouracil (Topical) is administered.

Vitamin K Antagonists (eg, warfarin)

The serum concentration of Vitamin K antagonists may rise in response to fluorouracil (Topical).


Monitoring Parameters:

None mentioned.

How to administer Actikerall (Fluorouracil and salicylic acid)?

  • It is intended for topical use only.
  • Administration into the eyes, nasal cavity, intravaginal, ears, oral cavity, or inside the anal canal should be avoided.
  • The solution may be applied over the face, forehead, and/or scalp via the brush applicator that is connected to the cap.
  • Avoid the use of the excessive application by wiping the brush with the neck of the bottle before applying the drug.
  • To create a protective film over the treated area, the solution should be allowed to dry.
  • The treated area should not be covered after applying the drug.
  • Before applying for the medicine, peel off any remaining coating over the area.
  • If needed, use warm water to peel off the medicine.
  • Avoid contact with healthy skin and over ulcerated lesions or over-bleeding areas of the skin.

Mechanism of action of Fluorouracil and salicylic acid:

Refer to individual agents (fluorouracil, Salicylic acid).


  • Although treatment can be seen as soon as six weeks after the treatment is completed, full healing may take up to 8 weeks.


  • Fluorouracil is minimally absorbed through intact skin (0.035%).
  • Contact individual agents.

International Brand Names of Fluorouracil and salicylic acid:

  • Actikerall
  • Verrucare
  • Verruma Hermal
  • Verrumal

Fluorouracil and salicylic acid Brand Names in Pakistan:

No Brands Available in Pakistan.


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