Instruction for use: Keravort

Dosage form: Cream for external use

Active substance: Imiquimodum

ATX

D06BB10 Imichimod

Pharmacological groups:

Immunomodulating agent [Other immunomodulators]

Immunomodulating agent [Antiviral (excluding HIV) means]

The nosological classification (ICD-10)

A63.0 Anogenital (venereal) warts: Anogenital warts; Venereal warts; Condylomata genital; Condyloma pointed; Externally pointed genital warts; Externally pointed condyloma; Pointed Condyloma; Flat condyloma

Composition and release form

Cream for external use 100 g

active substance: Imiquimod 5 g

Auxiliary substances: isostearic acid (Emersol 874) - 25 g; Cetyl alcohol (Speziol C16 Pharma) 2.2 g; Stearic alcohol (Speziol C18 Pharma) 3.1 g; Myristyl alcohol (Speziol C14) - 7 g; Paraffin soft white - 3 g; Polysorbate 60 (Tween 60) 3.4 g; Sorbitan stearate (Montane 60 PHA) - 0.6 g; Methyl parahydroxybenzoate 0.2 g; Propyl parahydroxybenzoate 0.02 g; Glycerol - 2 g; Gum xanthan (Xantural 75) - 0.5 g; Benzyl alcohol - 2 g; Purified water - up to 100 g

Description of dosage form

Cream: white or almost white smooth.

Pharmachologic effect

Mode of action - immunomodulating.

Pharmacodynamics

Imichimod - the active substance of the Keravort preparation - is a compound-modifier of the immune response. Imiximod does not have a direct antiviral effect, its effect is due to the induction of interferon alpha (IFN-α) and other cytokines.

Pharmacokinetics

Less than 0.9% of the radiolabeled imiquimod is absorbed through the human skin after a single dose.

A small amount of the drug that enters the systemic bloodstream is excreted from the body by the kidneys and through the intestine at a ratio of approximately 3: 1 without delay. Concentration of the drug in the blood serum after a single or multiple external application did not reach the level that can be quantified (> 5 ng / ml).

Indication of the Keravort

Treatment of external genital warts in the place of localization on the external genitalia or in the perianal region in adults.

Contraindications

Hypersensitivity to imichimod or other components of the cream;

Children under 18 years of age (due to lack of data).

Application in pregnancy and breastfeeding

Application in pregnancy is possible by strict indications if the intended benefit to the mother exceeds the potential risk to the fetus.

If you need to use the drug during lactation, breastfeeding should be discontinued.

Side effects

The incidence of side effects is defined as follows: very often - ≥1 / 10; Often - ≥1 / 100, 1/10; Infrequently - ≥1 / 1000, <1/100; Rarely - ≥1 / 10000, <1/1000; Very rarely - <1/10000.

Local skin reactions: very often - itching and pain in the place of application of the cream; Often - infection, erythema, erosion, excoriation / scaling and edema; Infrequently - skin itching, dermatitis, folliculitis, erythematous rash, eczema, urticaria; Rarely - induration, ulceration, scabbing and the appearance of blisters, local hypopigmentation and hyperpigmentation.

From the digestive system: infrequently - pain in the anus, lesions of the rectum.

From the genitourinary system: infrequently - fungal and bacterial infection, herpes simplex, vaginitis, vulvitis, painful intercourse, pain in the penis, vagina, atrophic vaginitis.

When there are local side effects, the cream should be removed by washing it off with soap and water. Treatment can be resumed after a skin reaction has been stopped.

Interaction

The interaction of imiquimod with other drugs, including immunosuppressants, has not been studied.

Dosing and Administration

Outwardly. Apply a thin layer on the previously cleaned surface of the affected skin and gently rub until completely absorbed. Cream should be applied only to the affected area, avoiding contact with internal surfaces. Keravort Cream should be applied 3 times a week before bedtime and left on the skin for 6-10 hours, during this time you should not take a shower or bath. On the site of application of the cream should not be applied bandage. After the specified time, the cream should be washed off with warm water and soap. Treatment should continue until the disappearance of visible genital or perianal condylomas, but no more than 16 weeks.

The cream is packed in disposable sachets containing the required amount of cream to apply to the affected area of the skin in 20 cm2.

If the patient forgot to apply the cream on schedule, you should apply the missed dose as soon as it was remembered, then follow the usual schedule.

Do not use the cream more than once a day.

Do not use excess cream.

Overdose

It is unlikely because of low absorption of the drug.

Symptoms: if you randomly ingest 200 mg of imiquimod, which corresponds to the contents of about 16 sachets, nausea, vomiting, headache, myalgia, and fever may occur. The most serious from the clinical point of view, the side effect of ingesting several doses of 200 mg is a decrease in blood pressure.

Treatment: immediate medical attention is required; Symptomatic therapy.

Special instructions

The cream is applied only to the affected areas.

Avoid getting the cream on the mucous membranes, contacting the cream with the eyes. In case of contact with eyes, rinse with water.

Keravort cream is applied before bedtime.

The use of excessive amounts of cream or a prolonged contact of the cream with the skin can cause a pronounced local reaction.

You cannot reuse the cream from a previously opened sachet.

Before and after applying the cream, you should wash your hands with warm water and soap.

Men who did not have circumcision, when treating genital warts, located under the foreskin, should daily rinse the affected area, pulling the foreskin. It is recommended to immediately stop treatment if early signs of phimosis are detected.

If a local reaction to the drug causes serious discomfort for the patient or an infection occurs in the area of the cream application, it is allowed to take a break for several days. In the event of infection, the necessary measures are taken.

Keravort Cream can cause an exacerbation of inflammatory skin diseases.

It is not recommended to use Keravort cream before healing of the skin after other types of medicamentous or surgical treatment.

Do not start treatment with Keravort cream on areas with open sores or wounds before healing.

Fillers methyl parahydroxybenzoate, propyl parahydroxybenzoate, cetyl alcohol and stearyl alcohol can cause an allergic reaction. When detecting a hypersensitivity reaction, it is recommended to stop therapy.

It is not recommended to use an occlusive dressing during treatment with Keravort.

The use of imiquimod in doses exceeding the recommended levels may lead to an increased risk of developing severe local reactions.

During application of the Keravort cream, avoid exposure to sunlight (including sunlight), as there is a risk of sunburn.

Since imiquimod does not have direct antiviral and cytotoxic effects, after the treatment, new genital warts and perianal areas may develop.

Based on the currently available knowledge, the treatment of urethral, intravaginal, cervical, rectal or intranal genital warts with Keravort cream is not recommended.

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

Keravort Cream can weaken the effect of condoms or vaginal diaphragms, so it is not recommended to use these contraceptives when using Keravort cream. You should choose an alternative method of contraception.

In patients with immunodeficiency it is not recommended to use Keravort cream repeatedly.

Influence on the ability to drive vehicles and work with machinery. Studies of the effect of the drug on the ability to drive a car and work with mechanisms have not been carried out.

Release form

Cream for external use, 5%. In the built-in bags of laminate, separated by perforations, 0.25 g. 12 or 24 pack. In a cardboard box.

Manufacturer

Glenmark Pharmaceuticals Ltd., India.

Name and address of the legal entity to which the registration certificate was issued: Glenmark Pharmaceuticals Ltd., India.

Conditions of supply of pharmacies

On prescription.

Storage conditions of the drug Keravort

In the dark place at a temperature of 2-25 ° C.

Keep out of the reach of children.

Shelf life of the drug Keravort

2 years.

Do not use after the expiry date printed on the package.