Etreex (Etrivex)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceClobetasolClobetasol
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  • Etreex
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    Galderma S.A.     Switzerland
    • Dosage form: & nbspshampoo
    Composition:

    In 1 g of shampoo contains:

    active substance: clobetasol propionate 500 μg;

    Excipients: ethanol 96% 100.00 mg, coco betaine 60.00 mg, sodium lauryl sulfate 170.00 mg, polyquaternium 10 20.00 mg, sodium citrate 26.00 mg, citric acid monohydrate 2.40 mg, purified water 621.10 mg.

    Description:Viscous translucent from colorless to faintly yellow liquid with the smell of alcohol.
    Pharmacotherapeutic group:glucocorticosteroid for topical application
    ATX: & nbsp

    D.07.A.D.01   Clobetasol

    Pharmacodynamics:

    Like other glucocorticosteroids for external use, clobetasol has anti-inflammatory, antipruritic and vasoconstrictive properties. The mechanism of anti-inflammatory activity of local glucocorticosteroids is not fully understood. However, it is believed that glucocorticosteroids act by inducing lipocortins - proteins, which in turn are inhibitors of phospholipase A2. Inhibition of phospholipase A2 in turn, leads to suppression of the release of arachidonic acid, which is the precursor of such powerful mediators of inflammation as prostaglandins and leukotrienes. In this way clobetasol due to the induction of lipocortins leads to a decrease in the biosynthesis of the main inflammatory mediators and, consequently, has an anti-inflammatory effect.

    Pharmacokinetics:

    Pharmacokinetics data indicate that the likelihood of systemic effects after the clinical use of the Etryvex shampoo is extremely low due to the low systemic bioavailability of clobetasol.

    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; is excreted by the kidneys.

    Indications:

    Treatment and prevention of relapses of psoriasis of the scalp in adults (with the exception of pustular and extensive plaque psoriasis).

    Contraindications:

    - Hypersensitivity to the active ingredient or to any of the ingredients of the drug;

    - skin diseases caused by mycobacterial, viral, fungal or parasitic infections;

    - children under 18;

    - Do not allow the shaving of EtriVex shampoo 0.05% in the eyes and eyelids (risk of glaucoma, cataracts) or on ulcerated skin surfaces.

    Pregnancy and lactation:

    Contraindicated use during pregnancy and the period of breastfeeding.

    Dosing and Administration:

    Outwardly.

    It is applied only to the scalp.

    The main course of treatment with daily application of shampoo Shampoo Etireeks 0.05% should be applied daily on dry scalp, carefully rubbing into affected areas. For one application on the entire scalp, approximately 7.5 ml (half a tablespoon) is sufficient for any number of affected areas.

    The applied Etryvex shampoo 0.05% should be left on the head for 15 minutes (without covering the head) and then washed off. After application, hands should be thoroughly washed.

    After 15 minutes, shampoo should be washed off with water and / or washed with normal shampoo. Then dry the hair, as usual.

    The duration of the main course of treatment with daily application of the drug should not exceed 4 weeks.If no improvement occurs in four weeks, review the diagnosis and therapy.

    Maintenance therapy with shampoo twice a week

    After cleansing the foci, and also after 4 weeks of the main course, the patient has a small amount of psoriatic scales, the Etrivex shampoo 0.05% should be applied twice a week to maintain therapeutic effect and prevent relapses. Such maintenance therapy is effective for 6 months.

    For prevention of exacerbations it is possible to conduct repeated courses of treatment with daily applying Etrevex shampoo 0.05%. The course should be conducted in the presence of a doctor.

    Side effects:

    If signs of hypersensitivity appear, treatment should be stopped immediately.

    The frequency of side effects is distributed in the following order: often (in 1% - 10% of cases); infrequently (in 0.1% -1% of cases); rarely (in 0.01% - 0.1% of cases); very rarely (less than 0.01% of cases), including reports of single side effects.

    From the skin and subcutaneous fat:

    infrequently: a feeling of discomfort, folliculitis, acne (in places of application), skin edema, telangiectasia,psoriasis (exacerbation), soreness of the skin, itching, urticaria, skin atrophy, dry skin, alopecia, skin irritation, skin tightening, erythema, rash, allergic contact dermatitis.

    From the side of the organ of vision (in case of accidental contact with eyes):

    infrequently: eye irritation.

    Co the sides of the nervous system:

    infrequently: headache

    Because the clobetasol refers to the class of glucocorticosteroids for external use, prolonged daily use, application to large areas of the skin or application of large amounts can lead to systemic absorption sufficient for the development of characteristic signs of hypercorticism (Cushing's syndrome) or suppression of the hypothalamic-pituitary-adrenal system that carries Transient (short-term) and rapidly reversible. However, since the Etreex shampoo 0.05% is applied only for 15 minutes, systemic absorption is observed only in rare cases and therefore the risk of suppression of the hypothalamic-pituitary-adrenal system when using shampoo is much lower than when applied, powerful glucocorticosteroids.

    During the clinical trials of the Etreeve shampoo, 0.05% of cases of suppression of the hypothalamic-pituitary-adrenal system were not reported.

    Prolonged and / or intensive treatment with potent glucocorticosteroids can cause local atrophic changes, such as local skin atrophy, striae, telangiectasia, erythema, purpura, contact dermatitis. When ingested, very powerful glucocorticosteroids can cause perioral dermatitis, skin atrophy, or rosacea exacerbation.

    There are reports of a change in pigmentation, the appearance of acne, pustular eruptions and hypertrichosis in the external application of potent glucocorticosteroids.

    Overdose:

    Acute overdose is very unlikely, but with chronic overdose or improper application, signs of hypercorticism may appear. In this situation, treatment should be gradually eliminated. However, because of the risk of acute suppression of the adrenal gland this must be done under the supervision of a doctor.

    Interaction:

    Drug interactions are not known.

    Special instructions:

    Glucocorticosteroids for external use should be used with caution for several reasons, including because of the possibility of relapse after discontinuation of treatment, development of resistance (tachyphylaxis) and local or systemic toxicity.

    In rare cases, under vigorous or prolonged treatment of psoriasis glucocorticosteroids such treatment or cancellation glucocorticosteroids provokes flash generalized pustular psoriasis.

    In very rare cases, there are reactions of hypersensitivity to glucocorticosteroids. The possibility of a hypersensitivity reaction should be considered in the case of resistance to treatment.

    In general, long-term continuous therapy with daily application of corticosteroids, use of occlusive dressings on the head is associated with an increased risk of systemic effects. In such cases it is necessary to strengthen medical supervision and regularly examine the patient for suppression of the hypothalamic-pituitary system. Such systemic effects disappear after discontinuation of treatment. However, with rapid cancellation, acute adrenal insufficiency may develop.

    Shampoo Etreex 0.05% is intended only for the treatment of psoriasis of the scalp and should not be applied to other parts of the body. In particular, shampoo Etrivex 0.05% is not recommended for application to the skin of the face, eyelids, folded skin areas (axillary cavities,genital and anal areas) and on eroded skin areas, as this increases the risk of local adverse events such as atrophic skin changes, telangiectasia, or dermatitis.

    The drug is recommended for short-term use; If necessary, it is possible to conduct short repeated courses.

    If you get Etrevex Shampoo 0.05% in the eyes, immediately wash them with plenty of water.

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

    As a glucocorticosteroid for topical use, Etryvex shampoo 0.05% does not affect the ability to drive vehicles and engage in other potentially hazardous activities requiring increased concentration and speed of psychomotor reactions.

    Form release / dosage:

    Shampoo, 0.05%.

    Packaging:

    30 ml, 60 ml, 125 ml in a high density polyethylene bottle with a screw cap (for bottles of 30 ml) or with a cap (for bottles of 60 ml and 125 ml).

    One bottle together with the instruction for use is placed in a cardboard box.

    Storage conditions:

    At a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use after expiry date.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-001131
    Date of registration:03.11.2011
    The owner of the registration certificate: Galderma S.A. Galderma S.A. Switzerland
    Manufacturer: & nbsp
    Representation: & nbspGALDERMA, LLCGALDERMA, LLCRussia
    Information update date: & nbsp29.07.2015
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