Active substanceClobetasolClobetasol
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  • Dermovate®
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    ointment externally 
  • Cloveit®
    cream externally 
    VALEANT, LLC     Russia
  • Cloveit®
    ointment externally 
    VALEANT, LLC     Russia
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  • Dosage form: & nbspointment for external use
    Composition:

    In 1 g of ointment contains:

    active substance: clobetasol propionate 0.5 mg;

    Excipients: propylene glycol 50.0 mg, sorbitan sesquioleate 5.0 mg, white petrolatum up to 1.0 g.

    Description:

    White, translucent, oily, soft, homogeneous mass.

    Pharmacotherapeutic group:Glucocorticosteroid for topical application
    ATX: & nbsp

    D.07.A.D.01   Clobetasol

    Pharmacodynamics:

    Glucocorticosteroid for external use. It prevents the accumulation of neutrophils boundary, reduces the inflammatory exudation and production of lymphokines inhibits the migration of macrophages, reduces the intensity of infiltration and granulation processes, has a local anti-inflammatory, antipruritic, anti-allergic and anti-exudative effects.

    Pharmacokinetics:

    The mean maximum concentration of clobetasol propionate is reached in plasma through13 hours after the first application and 8 hours after repeated application to the healthy skin of 30 g clobetasol propionate in the form of 0.05% ointment and is 0.63 ng / ml. 10 hours after the application of the second dose (30 g) of clobetasol propionate in the form of a cream, its average maximum concentration in the plasma slightly exceeds that of the ointment. After 3 hours after a single application of 25 g of 0.05% clobetasol propionate ointment in patients with psoriasis and eczema, the average maximum plasma concentration in the plasma is 2.3 ng / ml and 4.6 ng / ml, respectively.

    When applied to large areas of the skin, absorption is possible (damage to the integrity or inflammation of the skin builds up absorption) and the manifestation of a systemic effect. Metabolized mainly in the liver, a small part - in the kidneys. It is excreted by the kidneys.
    Indications:

    - Psoriasis (with the exception of pustular and extensive plaque psoriasis);

    - eczema (various forms);

    - red flat lichen;

    - discoid lupus erythematosus;

    - Skin diseases resistant to therapy with less active glucocorticosteroids for topical application.

    Contraindications:

    - Pink acne;

    - Acne vulgaris;

    - skin cancer;

    - nodular pruritus of Gaida;

    - perioral dermatitis;

    - perianal and genital itching;

    - cutaneous manifestations of syphilis, diaper rash;

    - bacterial, viral and fungal skin diseases (including herpes simplex, chicken pox, skin tuberculosis, actinomycosis);

    - common plaque and pustular psoriasis;

    - hypersensitivity to the active and auxiliary substances of the drug;

    - age up to 1 year;

    - lactation period;

    - pregnancy.

    Pregnancy and lactation:

    Glucocorticosteroids for topical application should not be used during pregnancy for a long time in large doses.

    The safety of the use of clobetasol during lactation is not established.

    Dosing and Administration:

    Outwardly. Ointment is applied a thin layer on the affected skin 1-2 times a day. The duration of a continuous course of treatment is limited to 3-4 weeks.

    In particularly resistant cases, especially in the presence of hyperkeratosis, the anti-inflammatory effect of Cloveit® ointment can be enhanced by applying a bandage of polyethylene film overnight for the use of the drug, which is usually accompanied by a positive effect. When changing the occlusive dressing, the skin should be cleaned.In the future, the achieved effect can be maintained without the use of an occlusive dressing.

    Side effects:

    Burning, itching, steroid acne, dry skin.

    With prolonged use: weakening of the barrier function of the skin.

    When applied to large surfaces, it is possible to develop systemic side effects (gastritis, ulceration of the gastrointestinal mucosa, increased intraocular pressure, symptoms of hypercorticism).

    Long-term administration of glucocorticosteroids for topical application in large doses or applying them to large areas of the skin can be accompanied by systemic absorption with the subsequent development of symptoms of hypercorticoidism. The risk of developing this complication is increased in children, especially when using occlusive bandages, while the diaper can serve as a bandage.

    Given the appointment of Cloveit® to adult patients in a dosage of not more than 50 g per week, the suppression of the pituitary and adrenal glands function is transient in nature with their rapid recovery immediately after the end of the course of treatment.

    Long-term treatment with high-activity glucocorticosteroids for topical application in large doses can cause atrophic changesskin, in particular, its thinning, the appearance of atrophic bands (striae), the expansion of the superficial blood vessels, especially with the application of occlusive dressings and when applying the drug to areas of the skin with folds. Skin pigmentation and hypertrichosis may develop. In rare cases, treatment of psoriasis with glucocorticosteroids for topical application (or their withdrawal) provokes the development of pustular psoriasis.

    In rare cases, the drug Kloveit® can cause an exacerbation of the symptoms of the disease.

    Overdose:

    The development of acute overdose is unlikely. However, in case of chronic overdose or misuse, symptoms of hypercorticism may develop, which requires a gradual discontinuation of the drug under the supervision of a physician.

    Interaction:

    No data.

    Special instructions:

    The drug Kloveit® ointment is recommended for use in skin lesions, accompanied by its dryness, hyperkeratosis, thickening.

    The drug is recommended for short-term use.

    It should avoid the appointment of glucocorticosteroids for local use for a long time, especially in the treatment of young children,since this can lead to suppression of adrenal function. The use of Cloveit® in children requires the supervision of a doctor at least once a week.

    On the face more often than in other parts of the body, atrophic changes in the skin can occur as a result of prolonged use of local glucocorticosteroids.

    Do not apply the drug in the eye area, because the use of the drug in the peri-orbital region can cause the development of glaucoma. Treatment of psoriasis with glucocorticosteroids for topical use can be accompanied by the development of relapses of the disease, tolerance to the drug, generalized pustular form of the disease, local or systemic toxic reactions due to violation of the barrier function of the skin, so careful monitoring of the patient is especially important.

    When attaching a secondary infection, appropriate antibiotic therapy should be carried out. With any signs of generalization of the infection, it is necessary to stop the local use of glucocorticosteroids and conduct appropriate treatment with antibacterial drugs.

    Warm moist conditions created by the application of an occlusive dressing, contribute to the emergence of a bacterial infection,therefore, it is necessary to cleanse the skin before applying a new dressing.

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

    Does not affect.

    Form release / dosage:

    Ointment for external use, 0.05%.

    Packaging:

    By 25 grams of ointments into lithographed aluminum tubes with a lacquered inner surface.

    The tube is placed in a lithographed cardboard box with instructions for use.

    Storage conditions:

    Store at a temperature not exceeding 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    2 years.

    Do not use after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:LSR-000767/10
    Date of registration:05.02.2010 / 18.10.2013
    Expiration Date:Unlimited
    The owner of the registration certificate:VALEANT, LLC VALEANT, LLC Russia
    Manufacturer: & nbsp
    Representation: & nbspVALEANT LLC VALEANT LLC Russia
    Information update date: & nbsp29.01.2018
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