Etrivex, shampoo 0,05% 60 ml

Glucocorticosteroid for topical use

ATX code: D 07 AD 01

Pharmacological properties:

Pharmacodynamics

Like other topical glucocorticosteroids, clobetasol has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of anti-inflammatory activity of topical glucocorticosteroids is not fully understood.

Pharmacokinetics

Pharmacokinetics 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 skin, absorption is possible (damage to the integrity or inflammation of the skin increases absorption) and systemic effects may occur.

Metabolized mainly in the liver, a small portion in the kidneys; 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).

Pharmacological effect

Glucocorticosteroid for local use

ATX code: D 07 AD 01

Pharmacological properties:

Pharmacodynamics

Like other glucocorticosteroids for external use, clobetasol has anti-inflammatory, antipruritic and vasoconstrictor properties. The mechanism of the anti-inflammatory activity of local glucocorticosteroids is not fully understood.

However, it is believed that glucocorticosteroids 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 to such powerful inflammatory mediators as prostaglandins and leukotrienes. Thus, clobetasol, due to the induction of lipocortins, leads to a decrease in the biosynthesis of the main inflammatory mediators, 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 a systemic effect.

Metabolized mainly in the liver, a small part in the kidneys; excreted by the kidneys.

Special instructions

Topical corticosteroids should be used with caution for several reasons, including the potential for disease relapse after treatment discontinuation, 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 case of resistance to treatment.

In general, long-term continuous therapy with daily glucocorticosteroids and the use of occlusive head dressings are 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 cessation of treatment. However, if discontinued quickly, acute adrenal insufficiency may develop.

Etrivex 0.05% shampoo is intended only for the treatment of psoriasis of the scalp 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, areas of folded skin (armpits, genital and anal area) and eroded areas of the skin, as this increases the risk of local adverse effects such as atrophic skin changes, telangiectasia or dermatitis.

The drug is recommended for short-term use; If necessary, short refresher courses are possible.

If Etrivex 0.05% shampoo gets into your eyes, rinse them immediately with plenty of water.

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

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

Active ingredient

Clobetasol

Active components

Clobetasol propionate – 500 micrograms

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

Pregnancy

Use during pregnancy and breastfeeding is contraindicated.

Contraindications

Fungal, bacterial or viral skin lesions (including herpes simplex, chicken pox, skin tuberculosis, actinomycosis);

rosacea, acne vulgaris, skin cancer, nodular prurigo of Hyde, perioral dermatitis, perianal and genital itching, skin manifestations of syphilis, diaper rash, widespread plaque and pustular psoriasis;

children under 1 year of age, pregnancy, lactation (breastfeeding);

hypersensitivity to clobetasol.

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.

From the skin and subcutaneous fat:
Uncommon: discomfort, folliculitis, acne (in areas where the drug was applied), skin edema, telangiectasia, psoriasis (exacerbation), skin soreness, itching, urticaria, skin atrophy, dry skin, alopecia, skin irritation, skin tightness, erythema, rash, allergic contact dermatitis.

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

From the nervous system:
Uncommon: headache

Because clobetasol belongs to the class of topical glucocorticosteroids, long-term daily use, application to large areas of skin, or application of large quantities may result in systemic absorption sufficient to develop the characteristic signs of hypercortisolism (Cushing’s syndrome) or suppression of the hypothalamic-pituitary-adrenal axis, which is 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 axis when using shampoo is much lower than when applying powerful glucocorticosteroids. During clinical trials of Etrivex shampoo 0.05%, no cases of suppression of the hypothalamic-pituitary-adrenal axis were reported.

Long-term and/or intensive treatment with powerful glucocorticosteroids can cause local atrophic changes, such as local skin atrophy, stretch marks, telangiectasias, erythema, purpura, contact dermatitis. When exposed to facial skin, very potent glucocorticosteroids 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 external use of powerful glucocorticosteroids.

Overdose

Acute overdose is very unlikely, but chronic overdose or misuse may cause signs of hypercortisolism. In such a situation, treatment should be gradually withdrawn. However, due to the risk of acute adrenal suppression, this must be done under medical supervision.

Storage conditions

At a temperature not higher than + 25 °C
Keep out of the reach of children!

Shelf life

3 years. Do not use after expiration date.

Manufacturer

Galderma Laboratories, France