Keravort (Keravort)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceImihimodImihimod
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  • ALDARA
    cream externally 
    R-PHARM, CJSC     Russia
  • Keravort
    cream externally 
    Glenmark Pharmaceuticals Co., Ltd.     India
    • Dosage form: & nbspcream for external use
    Composition:

    In 100 g of cream contains:

    Active substance: imiquimod - 5.0 g;

    Auxiliary substances:

    isostearic acid (Emersol 874) -25.00 g, cetyl alcohol (Speziol C16 Pharma) - 2.20 g, stearyl alcohol (Speziol C18 Pharma) - 3.10 g, paraffin soft white - 3.0 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 2.0 g, xanthan gum (Hantural 75) - 0.5 g, benzyl alcohol - 2.0 g, purified water - up to 100 g.

    Description:

    White or almost white homogeneous soft cream.

    Pharmacotherapeutic group:Antiviral for topical use
    ATX: & nbsp

    D.06.B.B.10   Imihimod

    Pharmacodynamics:

    Imichimod, the active substance of Keravort, is a compound that modifies the immune response. Imihimod has no direct antiviral effect, its effect is due to the induction of interferon alfa (IFNα) 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 (> 5ng / ml).

    Indications:

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

    Contraindications:

    Keravort Cream is contraindicated in persons with hypersensitivity to imichimod or other components of the cream.

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

    Pregnancy and lactation:

    Use 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.

    Dosing and Administration:

    Outwardly. The cream is applied a thin layer on the previously cleaned surface of the affected areas of the skin and gently rubbed 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, do not use 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 be continued 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 you forget to apply the cream on schedule, apply the missed dose as soon as you remember it, then follow the usual schedule.

    Do not use the cream more than once a day.

    Do not use excess cream.

    Side effects:

    The incidence of side effects is defined as follows:

    Very often:> 1/10;

    Often: <1/10> 1/100;

    Infrequently: <1/100> 1/1000;

    Rarely: <1/1000> 1/10000;

    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.

    Infrequent: itchy skin, dermatitis, folliculitis, erythematous rash, eczema, hives.

    Rarely: induration, ulceration, scab formation and the appearance of vesicles, local hypopigmentation and hyperpigmentation.

    Disorders of the digestive system:

    Infrequent: pain in the anus, lesions of the rectum.

    Disorders of the genitourinary system:

    Infrequently: fungal and bacterial infection, herpes simplex, vaginitis, vulvitis, painful intercourse, pain in the penis, vagina, atrophic vaginitis.

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

    Overdose:

    Overdose is unlikely because of low absorption of the drug.

    If you randomly ingest 200 mg of imiquimod, which corresponds to the contents of approximately 16 sachets, nausea, vomiting, headache, myalgia, and fever may occur. The most serious from a clinical point of view, the side effect of ingesting several doses of 200 mg is to lower blood pressure. It is necessary to immediately consult a doctor and choose symptomatic therapy.

    Interaction:

    Studies of the interaction of imiquimod with other drugs, including immunosuppressants, have not been conducted.

    Special instructions:

    The cream is applied only to the affected areas.

    Avoid getting the cream on the mucous membranes.

    Avoid contact with 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 can not 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 in the area of ​​application of the cream there is an infection, you can take a break in the treatment for several days. In the event of infection, the necessary measures are taken.

    Keravort Cream can cause 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 spitter 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 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 the application period Keravort cream should avoid or minimize exposure to sunlight (including sunlight), since there is a danger of getting sunburn.

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

    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, therefore 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.

    Effect on the ability to drive transp. cf. and fur:

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

    Form release / dosage:

    Cream for external use, 5%.

    Packaging:

    For 0.25 g of cream for single use in the laminated sachets, separated by perforations.

    For 12 or 24 bags together with instructions for use in a cardboard pack.

    Storage conditions:

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

    Keep out of the reach of children.

    Shelf life:

    2 years.

    Do not use the drug after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-002245
    Date of registration:23.09.2013 / 06.12.2016
    Expiration Date:23.09.2018
    The owner of the registration certificate:Glenmark Pharmaceuticals Co., Ltd.Glenmark Pharmaceuticals Co., Ltd. India
    Manufacturer: & nbsp
    Representation: & nbspGLENMARK IMPEX LLCGLENMARK IMPEX LLCRussia
    Information update date: & nbsp02.01.2018
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