Etrivex shampoo 0.05%, 60ml

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

Outwardly.
Apply only to the scalp.

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

The applied shampoo Etrivex 0.05% should be left on the scalp for 15 minutes (without covering the scalp) and then washed off. Wash hands thoroughly after application.

After 15 minutes, the shampoo should be rinsed off with water and / or washed with regular 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 there is no improvement within four weeks, reconsider the diagnosis and therapy.

Supportive therapy with shampoo twice a week
After cleansing the lesions, as well as in the case when after 4 weeks of the main course the patient has a small amount of psoriatic scales, Etrivex 0.05% shampoo should be applied twice a week to maintain the therapeutic effect and prevent relapses. This maintenance therapy is effective for 6 months.

For the prevention of exacerbations, repeated courses of treatment can be carried out with daily application of Etrivex 0.05% shampoo. The course must be carried out in the presence of a doctor.

1 g of shampoo contains:
Active substance:

Clobetasol propionate - 500 micrograms
Excipients:
Ethanol 96% - 100.00 mg
Cocobetaine - 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

• Hypersensitivity to the active substance 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 Etrivex 0.05% shampoo to get into the eyes and eyelids (risk of developing glaucoma, cataracts) or on ulcerated skin surfaces.

Trade name of the drug:

Etrivex

International Non-Proprietary Name (INN):

clobetasol

Dosage form:

shampoo

Composition:

1 g of shampoo contains:
Active substance:

Clobetasol propionate - 500 micrograms
Excipients:
Ethanol 96% - 100.00 mg
Cocobetaine - 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 slightly yellow liquid with the smell of alcohol.

Pharmacotherapeutic group:

Topical glucocorticosteroid

ATX code: D 07 AD 01

Pharmacological properties:

Pharmacodynamics

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

Pharmacokinetics

Pharmacokinetic data indicate that the likelihood of systemic effects after clinical use of Etrivex 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 increases absorption) and the manifestation of a systemic effect.

It is metabolized mainly in the liver, a small part in the kidneys; excreted by the kidneys.

Indications for use:

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

Contraindications:

• Hypersensitivity to the active substance 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 Etrivex 0.05% shampoo to get into the eyes and eyelids (risk of developing glaucoma, cataracts) or on ulcerated skin surfaces.

Pregnancy and lactation:

Use during pregnancy and breastfeeding is contraindicated.

Method of administration and dosage:

Outwardly.
Apply only to the scalp.

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

The applied shampoo Etrivex 0.05% should be left on the scalp for 15 minutes (without covering the scalp) and then washed off. Wash hands thoroughly after application.

After 15 minutes, the shampoo should be rinsed off with water and / or washed with regular 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 there is no improvement within four weeks, reconsider the diagnosis and therapy.

Supportive therapy with shampoo twice a week
After cleansing the lesions, as well as in the case when after 4 weeks of the main course the patient has a small amount of psoriatic scales, Etrivex 0.05% shampoo should be applied twice a week to maintain the therapeutic effect and prevent relapses. This maintenance therapy is effective for 6 months.

For the prevention of exacerbations, repeated courses of treatment can be carried out with daily application of Etrivex 0.05% shampoo. The course must be carried out 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 rare (less than 0.01% of cases), including reports of isolated side effects.

On the part of the skin and subcutaneous fat:
Uncommon: discomfort, folliculitis, acne (at the sites of application of the drug), skin edema, telangiectasia, psoriasis (exacerbation), skin soreness, itching, urticaria, skin atrophy, dry skin, alopecia, skin irritation, skin tightening, erythema, rash, allergic contact dermatitis.

On the part of the organ of vision (in case of accidental eye contact):
Uncommon: eye irritation

From the nervous system:
Uncommon: headache

Since clobetasol belongs 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 to develop the characteristic signs of hypercortisolism (Cushing's syndrome) or suppression of the hypothalamic-pituitary-adrenal system, which wears transient (short-term) and quickly reversible. However, since Etrivex 0.05% shampoo is applied for only 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 applying powerful glucocorticosteroids. During clinical trials of shampoo Etrivex 0,05% of cases of suppression of the hypothalamic-pituitary-adrenal system were not reported.

Long-term and / or intensive treatment with powerful glucocorticosteroids can cause local atrophic changes such as local skin atrophy, striae, telangiectasia, erythema, purpura, contact dermatitis. Very potent glucocorticosteroids in contact with the face can cause perioral dermatitis, skin atrophy, or exacerbation of rosacea.

There are reports of changes in pigmentation, the occurrence of acne, pustular eruptions and hypertrichosis with the external use of powerful glucocorticosteroids.

Overdose:

Acute overdose is very unlikely, however, with chronic overdose or improper use, signs of hypercortisolism may appear. In this situation, treatment should be gradually withdrawn. However, due to the risk of acute suppression of adrenal function, this must be done under medical supervision.

Interaction with other medicinal products:

Drug interactions are not known.

Special instructions:

Topical glucocorticosteroids should be used with caution for several reasons, including the possibility of recurrence of the disease after discontinuation of treatment, the development of resistance (tachyphylaxis), and local or systemic toxicity.

In rare cases, with intensive or long-term treatment of psoriasis with glucocorticosteroids, such treatment or withdrawal of glucocorticosteroids provokes an outbreak of generalized pustular psoriasis. In very rare cases, hypersensitivity reactions to glucocorticosteroids are observed.

The possibility of a hypersensitivity reaction should be considered in cases of resistance to treatment.

In general, long-term continuous therapy with daily glucocorticosteroids and the 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 withdrawal, acute adrenal insufficiency may develop.

Etrivex 0.05% Shampoo is intended only for the treatment of scalp psoriasis and should not be applied to other parts of the body. In particular, Etrivex 0.05% shampoo is not recommended for use on the face, eyelids, folded skin (armpits, genital and anal areas) and on eroded skin, 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 Etrivex 0.05% shampoo gets in your eyes, rinse immediately with plenty of water.

Influence on the ability to drive a car and other mechanisms:

As a glucocorticosteroid for external use, Etrivex 0.05% shampoo does not affect the ability to drive vehicles and engage in other potentially hazardous activities that require increased concentration and psychomotor speed.

Release form:

Shampoo 0.05% 30ml, 60ml, 125ml in a high density polyethylene bottle with a screw cap (for 30ml bottles) or with a cap (for 60ml and 125ml bottles).
1 bottle together with instructions for use is placed in a cardboard box.

Storage conditions:

At a temperature not higher than + 25 ? —
Keep out of the reach of children!

Shelf life:

3 years. Do not use after the expiration date.

Terms of dispensing from pharmacies:

On prescription.