Keravort, cream 5% 0,25 g 12 pcs

Pharmacodynamics

Imiquimod is an immune response modifier. Imiquimod does not exhibit direct antiviral activity, its action is due to the induction of synthesis of interferon-alpha (IFNα) and other cytokines.

Pharmacokinetics

Less than 0.9% of imiquimod labeled with the radioactive isotope is absorbed through the skin after a single dose.

A small amount of the drug entered the systemic bloodstream is excreted without delay by the kidneys and through the intestine at a ratio of approximately 3:1. Serum concentrations of the drug did not reach quantifiable levels (> 5 ng/mL) after single or multiple topical applications.

Indications

Active ingredient

Composition

100 g of cream for external use contains:

The active ingredient:

Imihimod 5.0 g.

Auxiliary Substances:

Isostearic acid;

Cetyl alcohol,;

Stearyl alcohol;

White soft paraffin;

Polysorbate 60;

Sorbitan stearate;

Methyl parahydroxybenzoate;

Propyl parahydroxybenzoate;

Glycerin;

Xanthan gum;

Benzyl alcohol;

Purified water.

How to take, the dosage

Externally.

Keravort cream should be used before going to bed. Before applying the cream, wash the affected areas of the skin with soap and water and let them dry. The cream is applied to the affected areas and gently rubbed into the skin. The cream should remain on the skin for 6-10 hours. Water should be avoided on the affected area, you must postpone showers and other water procedures for 8 hours. At the end of this time, the cream should be washed with soap and warm water. One sachet of cream is enough to cover a 20 cm area of skin2.

The cream in the opened sachet must not be used again! Before and after applying the cream, wash your hands with warm water and soap. When treating genital/perianal warts, the cream should be used after sexual intercourse.

Genital and perianal warts (condyloma acuminata) in adults.

Keravort cream should be applied three times a week (i.e. Monday, Wednesday and Friday or Tuesday, Thursday and Saturday) prior to bedtime and left on the skin for 6-10 hours. The cream is applied in a thin layer and rubbed into the clean surface of areas affected by condylomas until completely absorbed.

Limited superficial basal cell carcinoma in adults.

Apply Keravort cream consecutively 5 days a week for 6 weeks (e.g., Monday through Friday) before bedtime and leave on the skin for approximately 8 hours.

The response of the treated tumor to the cream should be evaluated after 12 weeks of treatment. If the treated tumor does not respond well, another treatment should be applied.

If a local cutaneous reaction to the cream causes increased discomfort to the patient or if there is an infection of the treated surface, treatment must be interrupted for a few days.

Actinic keratoses in adults.

The treatment is prescribed and monitored by a doctor. Keravort cream should be applied 3 times a week (e.g., Monday, Wednesday and Friday or Tuesday, Thursday and Saturday) prior to bedtime for 4 weeks and left on the skin for 8 hours. A sufficient amount of cream is applied to the entire affected surface. Four weeks after stopping treatment, the presence of actinic keratosis should be evaluated. If any manifestations remain, treatment should be continued for another four weeks. The maximum recommended dose is one sachet. The maximum recommended treatment is 8 weeks.

If there is a local acute inflammatory reaction or if infection of the treated surface occurs, treatment should be suspended. In the latter case, appropriate measures should be taken. Each treatment period should not exceed 4 weeks due to missed doses or rest periods.

If the lesions do not respond sufficiently to treatment at follow-up 4-8 weeks after the second treatment period, another treatment should be applied.

If a dose is missed, the patient should apply the cream as soon as he or she remembers it, then treatment should continue on the usual schedule. Remember, however, that you may not apply the cream more than once a day.

Interaction

Not established.

Because Keravort cream stimulates the immune system, it should be used with caution in patients receiving immunosuppressants.

Special Instructions

The cream is not recommended for use in the eyes, mouth, nose and ears, or at the same time as a hermetic dressing.

Keravort cream should be used with caution in patients who have had organ transplants and in patients with reduced immunity, since a worsening of the existing condition or the development of a graft rejection reaction is possible.

In actinic keratoses, it is recommended to avoid natural or artificial ultraviolet irradiation of the eyes, lips, and nostrils.

The cream should be applied within 1 cm of the hairline, the edge of the eyes, the ear canals, the mouth or nose when treating basalioma. The cream is not meant for treating internal – genital, urethral, intravaginal, rectal or intraanal warts.

Keravort cream may weaken the effect of condoms or vaginal diaphragms.

Keravort cream should be washed off the skin before sexual intercourse.

Perhaps with caution when applying Keravort cream in the vaginal fornix, as the development of local cutaneous reactions on the mucosal surface may cause difficulty in urination.

Therapeutic use of Keravort cream is not recommended if the skin has not healed from previous use or surgical treatment. Use on damaged skin may lead to increased absorption of Keravort cream, which may cause a greater risk of adverse reactions.

Keravort cream may exacerbate inflammatory skin reactions.

In rare cases there may be a local acute inflammatory reaction, including mottling or erosion, even after several applications of Keravort Cream. Local acute inflammatory reactions may accompany, or even precede, systemic flu-like signs and symptoms, including malaise, fever, nausea, muscle pain and chills. In this case, it is recommended to take a break from treatment for a few days.

At the time of treatment, caution should be exercised when driving motor vehicles or operating other machinery, as well as when performing work that requires increased attention, due to the possible occurrence of weakness and dizziness.

Contraindications

Side effects

Overdose

In topical application of Keravort cream, total overdose is unlikely due to the low cutaneous absorption of the drug.

A persistent overdose with topical application of the cream may cause severe local skin reactions. If local side effects occur, the cream should be removed by washing with soap and water. Treatment can be resumed after the skin reaction has subsided.

Symptoms:After accidentally swallowing one 200 mg dose of Keravort cream, which corresponds to the contents of approximately 16 sachet bags, nausea, vomiting, headache, muscle pain and fever may occur. The most serious adverse event observed after multiple oral doses of 200 mg was arterial hypotension, which is controlled by oral and intravenous fluid administration.

Treatment:drug withdrawal, gastric lavage, symptomatic therapy.

Pregnancy use

No research has been done.

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