ALDARA (Aldara)

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:

    100 mg of the preparation contains:

    active substance: imiquimod 5.0 mg;

    Excipients: isostearic acid 25.0 mg, cetyl alcohol 2.2 mg, stearic alcohol 3.1 mg, paraffin soft white 3.0 mg, polysorbate 60 60 mg, sorbitan stearate 0.6 mg, benzyl alcohol 2.0 mg , methylparahydroxybenzoate 0.2 mg, propyl parahydroxybenzoate 0.02 mg, glycerol 2.0 mg, xanthan gum 0.5 mg, purified water 52.98 mg.

    Description:

    Homogeneous cream from white to light yellow color.

    Pharmacotherapeutic group:immunostimulating agent
    ATX: & nbsp

    D.06.B.B.10   Imihimod

    Pharmacodynamics:

    Imichimod - the active substance of the drug Aldara - is a compound-modifier of the immune response. Imihimod has no direct antiviral effect, its effect is due to the induction of interferon-alpha (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 blood stream is excreted without delay from the body by the kidneys and through the intestine in a ratio of approximately 3:1. 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).

    Indications:

    Treatment of external genital warts at the site of localization on the external genital organs or in the perianal area in adults.

    Contraindications:

    Hypersensitivity to imichimod or any other components of the cream.

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

    Pregnancy and lactation:

    Use during pregnancy is possible by strict indications, in case if The estimated benefit to the mother exceeds the potential risk to the fetus.

    If it is necessary to use the drug during lactation, breastfeeding should be discontinued.

    Dosing and Administration:

    Outwardly. The cream is applied in a thin layer on a previously cleaned surface condylomas and gently rubbed into the skin until completely absorbed. The cream should be applied Only on the affected area, avoiding hitting the inner surfaces.

    Cream Aldara is applied 3 times a week (for example: Monday, Wednesday and Friday or Tuesday, Thursday and Saturday), before going to bed, and left on the skin for about 6-10 hours; During this time, do not take a shower or bath.

    On the site of application of the cream should not be applied bandage.

    After this period, the cream should be washed off with mild soap and water.

    Treatment should continue until the disappearance of visible genital or perianal condylomas, but no more than 16 weeks.

    The Aldara Cream is packaged in disposable sachets containing the required amount of cream to apply to the affected area of ​​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, urticaria.

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

    Violations of the central and peripheral nervous system:

    Often: headache, dizziness.

    Infrequently: insomnia, depression, irritability, paresthesia, migraine, drowsiness, ringing in the ears.

    Disorders of the digestive system:

    Often: nausea.

    Infrequent: abdominal pain, diarrhea, vomiting, anorexia, pain in the anus, lesions rectum.

    Disorders of the genitourinary system:

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

    Violations of the hematopoiesis system:

    Very rarely: a decrease in hemoglobin, leukopenia, absolute neutropenia and thrombocytopenia.

    Musculoskeletal system:

    Infrequent: back pain, arthralgia.

    Respiratory system:

    Infrequently: pharyngitis, rhinitis.

    Systemic manifestations:

    Often: infection, myalgia, fever, flu-like symptoms, fatigue.

    Infrequent: increased sweating, lymphadenopathy.

    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:

    In the case of external use, the probability of a systemic overdose of Aldara cream is low due to low absorption of the drug through the skin.

    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 clinical side effect of oral administration of several doses of 200 mg is arterial hypotension, which is stopped by the introduction of fluid inside or intravenously.

    Interaction:

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

    Minimal absorption of the imichimode through the skin should limit interaction with the drugs of systemic action.

    Special instructions:

    Cream Aldara 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.

    Aldar's 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.

    Do not re-use the opened sachet.

    Wash hands thoroughly before and after applying the cream.

    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 if an infection occurs in the area of ​​the cream, it is allowed to take a break for several days. In the event of infection, the necessary measures are taken.

    Cream Aldara can cause an exacerbation of inflammatory skin diseases.

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

    Do not start treatment with Aldar cream on sites with open sores or wounds before healing.

    Fillers methyl parahydroxybenzoate, propyl parahydroxybenzoate, cetyl alcohol and stearic 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 Aldara.

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

    During the period of application of Aldar's cream, sunlight exposure (including sunlight) should be avoided or minimized, as there is a risk of 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 current knowledge, treatment of urethral, ​​intravaginal, cervical, rectal or intra-anal genital warts with Aldar cream is not recommended.

    Before sexual intercourse, Aldara Cream should be washed off the surface of the skin.

    Aldara's cream can reduce the effectiveness of a condom or vaginal diaphragm, so it is not recommended to use these contraceptives when using Aldar's cream. You should choose an alternative method of contraception.

    In patients with immunodeficiency it is not recommended to use Aldar's 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:

    250 mg of cream in a bag of multilayer film consisting of polyethylene film, polyester film and aluminum foil; sealed with heat seal.

    12 bags together with instructions for use are placed in a cardboard box.

    Storage conditions:

    At a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Do not re-use opened sachets.

    Shelf life:

    2 years.

    Do not use after expiry date.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-001612
    Date of registration:28.03.2012
    Date of cancellation:2017-03-28
    The owner of the registration certificate:R-PHARM, CJSC R-PHARM, CJSC Russia
    Manufacturer: & nbsp
    3M Health Care Limited United Kingdom
    Representation: & nbspR-PHARM, JSC R-PHARM, JSC Russia
    Information update date: & nbsp12.10.2015
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