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For application to the skin:
In general Verrumal is applied to each wart two to three times daily.
Verrumal must only come into contact with the wart and not with the healthy skin surrounding the wart; if necessary, the surrounding skin should be covered with a paste or ointment. It is advisable to wipe off the brush on the neck of the bottle before application. In the case of very small warts the medicinal product can be more accurately applied by a toothpick or similar item instead of with the brush.
Each time Verrumal is reapplied the existing film coating should be removed beforehand by simply peeling it off.
In the case of periungual warts and – in particular – subungual warts care should be taken that the nail matrix is not damaged and Verrumal is not allowed to enter the nail bed.
The area to be treated should not be larger than 25 cm².
The average length of application is 6 weeks. Consistent application on a daily basis should be ensured.
Once the therapy has proved to be successful, treatment should be continued for approximately 1 week.
Experience has shown that in many cases, e.g. where there are very prominent common warts and warts on the soles of the feet, it is advantageous if the tissue that has died as a result of the Verrumal treatment is removed by a doctor.
Common warts (special form: plantar warts, on areas of the sole of the foot that are subjected to pressure), plane juvenile warts of the extremities.
Hypersensitivity to the active substances or to any other ingredients.
Verrumal may not be used during lactation, an existing pregnancy or by women for whom pregnancy cannot be excluded with certainty.
Verrumal should not be used to treat infants or patients with renal insufficiency.
Verrumal should not be used in patients with dihydropyrimidine dehydrogenase (DPD) enzyme deficiency. A large percentage of fluorouracil is catabolized by the DPD enzyme. DPD enzyme deficiency can result in shunting of fluorouracil to the anabolic pathway, leading to cytotoxic activity and potential toxicities.
Verrumal may not be used in conjunction with brivudine, sorivudine and analogues. Brivudine, sorivudine and analogues are potent inhibitors of the fluorouracil-degrading enzyme dihydropyrimidine dehydrogenase (DPD).
Verrumal is not intended for use to large surfaces of the skin (skin area not greater than 25 cm²).
Verrumal must not be allowed to come into contact with the eyes or mucous membranes.
Patients should discontinue therapy with Verrumal if symptoms of DPD enzyme deficiency develop.
Rarely, life-threatening toxicities such as stomatitis, diarrhea, neutropenia, and neurotoxicity have been reported with intravenous administration of fluorouracil in patients with DPD enzyme deficiency. One case of lifethreatening systemic toxicity has been reported with the topical use of Verrumal in a patient with DPD enzyme deficiency. Symptoms included severe abdominal pain, bloody diarrhea, vomiting, fever, and chills. Physical examination revealed stomatitis, erythematous skin rash, neutropenia,thrombocytopenia, inflammation of the esophagus, stomach, and small bowel. A similiar case was observed with the use of a topical product containing 5% fluorouracil.
If applicable, the determination of DPD enzyme activity is indicated before starting treatment with fluoropyrimidines.
Nucleoside analogues such as brivudine and sorivudine may lead to a drastic increase in plasma concentrations of fluorouracil or other fluoropyrimidines and thus an associated increase in toxicity. For this reason, an interval of at least 4 weeks between the use of fluorouracil and brivudine, sorivudine and analogues should be observed. In case of an accidental administration of brivudine to patients who are being treated with fluorouracil, effective measures for reducing fluorouracil toxicity should be taken. Admission to a hospital may be indicated. All necessary measures for protection from systemic infections and dehydration should be introduced. Patients who take phenytoin concomitantly with fluorouracil should be regularly tested for elevated plasma levels of phenytoin.
The other active ingredient dimethyl sulphoxide may induce skin irritation.
If areas of skin with a thin epidermis are afflicted by warts, Verrumal should be applied less frequently and the course of the therapy monitored more often, as the strong softening effect of the salicylic acid contained in Verrumal on the corneal layer may result in the formation of scars. With warts that have a very strong tendency to cornification it is sometimes expedient to pre-treat the warts with salicylic acid plasters.
For full details see prescribing information.
Common: burning, particularly during application.
Uncommon: erosive skin reactions.
In rare cases an intense burning sensation may lead to the therapy being discontinued.
As the medicinal product has a very strong softening effect on the corneal layer, whitish discolorations and defurfuration of the skin may occur, particularly in the surroundings of the wart.
Due to its salicylic acid content, use of this medicinal product may cause slight signs of irritation, such as dermatitis and contact allergic reactions, in patients of a corresponding disposition. Such irritation may be manifested in the form of itching, reddening and small blisters even outside the area of contact (so-called scatter reactions).
The enzyme dihydropyrimidine dehydrogenase (DPD) plays an important role in the breakdown of fluorouracil. Nucleoside analogues such as brivudine and sorivudine may lead to a drastic increase in plasma concentrations of fluorouracil or other fluoropyrimidines and thus an associated increase in toxicity. For this reason, an interval of at least 4 weeks between the use of fluorouracil and brivudine, sorivudine and analogues should be observed. If applicable, the determination of DPD enzyme activity is indicated before starting treatment with fluoropyrimidines. Elevated plasma levels of phenytoin leading to symptoms of phenytoin intoxication have been reported with the concomitant administration of phenytoin and fluorouracil. Absorbed salicylic acid may interact with methotrexate and sulphonylureas.
Pregnancy and Lactation
Verrumal is contraindicated in pregnancy and lactation.
During the application of Verrumal to a 25 cm² area of skin a quantity of 0.2 g of Verrumal and therefore 1 mg of fluorouracil (FU) is applied.
For an individual weighing 60 kg 1 mg of FU corresponds to a dose of 0.017 mg per kilgram of body weight. Systemic intoxications occur in the case of intravenous doses of 15 mg per kilogram of body weight and can therefore be excluded due to the thousand-fold safety margin. Furthermore, the safety margin is also considerably increased by the fact that there is no significant percutaneous absorption of FU from Verrumal Due to the fact that after the percutaneous absorption of salicylic acid serum levels above 5 mg/dl are hardly ever reached, salicylate intoxications are practically excluded when Verrumal is applied in accordance with instructions.
Early symptoms of salicylate intoxication only occur at serum levels of more than 30 mg/dl. These manifest themselves in the form of ringing in the ears, tinnitus with hardness of hearing, epistaxis, nausea, vomiting, irritability as well as a feeling of dryness of the mucous membranes.