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)
Fosphenytoin	The serum levels of fosphenytoin may increase when fluorouracil (Topical) is used.
Gemcitabine Hair Removing Hard Beans Wax Painless Beauty Wax Beans For All Skins Wax Beans For Face Body Legs	Fluorouracil serum concentration might rise (Topical).
Leucovorin Calcium-Levoleucovorin	may intensify the negative or harmful effects of fluorouracil (Topical).
Phenytoin	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).

Initial:

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

Absorption:

• 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.