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 recurrence of scalp psoriasis in adults (except for pustular and extensive plaque psoriasis).

Active ingredient

Clobetasol

Composition

1 g of shampoo contains:

The active ingredient:

• Clobetasol propionate – 500 micrograms

Additives:

• 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

How to take, the dosage

Externally.
Applied only on the scalp.

The basic course of treatment with daily application of the shampoo
Shampoo Etrivex 0,05% should be applied daily to dry scalp, rubbing thoroughly into the affected areas. About 7.5 ml (half tablespoon) is enough for one application on the entire scalp, for any number of affected areas.

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

After 15 minutes, the shampoo should be rinsed with water and/or rinse the hair with normal shampoo. Then hair should be dried as usual.

The duration of the main course of treatment with daily application of the product should not exceed 4 weeks. If there is no improvement in four weeks, reconsider the diagnosis and therapy.

Twice weekly maintenance therapy with shampoo
After clearing the lesions and if small amounts of psoriatic flakes remain after 4 weeks of basic treatment, apply Etrivex 0.05% shampoo twice weekly to maintain the therapeutic effect and prevent recurrence. This maintenance therapy is effective for 6 months.

Repeated courses of treatment with daily application of Etrivex 0.05% Shampoo may be used to prevent exacerbations. The course should be done in the presence of a physician.

Special Instructions

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

In rare cases of intensive or prolonged 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 have been observed.

The possibility of hypersensitivity reactions should be considered in case of resistance to treatment.

In general, prolonged continuous therapy with daily application of glucocorticosteroids, the use of occlusive head dressings is associated with an increased risk of systemic effects. In such cases, increased physician monitoring and regular evaluation of the patient for suppression of the hypothalamic-pituitary system are necessary. Such systemic effects disappear after discontinuation of treatment. However, acute adrenal insufficiency may develop if rapidly withdrawn.

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

The product is recommended for short-term use; short repeated courses may be used if necessary.

If you get Etrivex 0.05% Shampoo in your eyes, flush them immediately with copious amounts of water.

Impact on the ability to drive and operate motor vehicles and other mechanisms:

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

Synopsis

Etrivex is a GKS for external use.

Prevents marginal accumulation of neutrophils, reduces inflammatory exudation and production of lymphokines, inhibits macrophage migration, reduces the intensity of infiltration and granulation processes, has local anti-inflammatory, antipruritic, anti-allergic anti-exudative effects.

It is recommended for psoriasis (except for extensive plaque psoriasis), eczema, squamous lichen planus, discoid lupus erythematosus; skin diseases resistant to therapy with less active topical GCS.

Contraindications

Fungal, bacterial or viral skin lesions (including Herpes simplex, varicella, tuberculosis of the skin, actinomycosis);

Pink acne, acne vulgaris, skin cancer, Hyde’s nodular scabies, perioral dermatitis, perianal and genital itching, cutaneous manifestations of syphilis, diaper rash, common plaque and pustular psoriasis;

Children under 1 year of age, pregnancy, lactation (breast-feeding);

High sensitivity to clobetasol.

Side effects

In case of signs of hypersensitivity the treatment should be stopped immediately.
Frequency of side effects is distributed in the following order: frequently (1% – 10% of cases); infrequently (0.1% – 1% of cases); rarely (0.01% – 0.1% of cases); very rarely (less than 0.01% of cases), including reports of single side effects.

Skin and subcutaneous fatty tissue:
Infrequent: Feeling of discomfort, folliculitis, acne (where the drug is applied), skin edema, telangiectasia, psoriasis (exacerbation), skin soreness, itching, urticaria, skin atrophy, dry skin, alopecia, skin irritation, skin tightening, erythema, rash, allergic contact dermatitis.

Visually (in case of accidental eye contact):
Infrequent: eye irritation

Nervous system disorders:
Infrequent: Headache

Because clobetasol belongs to the class of glucocorticosteroids for external use, prolonged daily use, application to large areas of skin, or application of large amounts may lead to systemic absorption sufficient to develop characteristic signs of hypercorticism (Cushing’s syndrome) or suppression of the hypothalamic-pituitary-adrenal system, which is transient (short-term) and rapidly reversible.

However, because Etrivex 0.05% shampoo is only applied for 15 minutes, systemic absorption is only rarely observed, and therefore the risk of hypothalamic-pituitary-adrenal suppression with shampoo application is much lower than with powerful glucocorticosteroids. No cases of hypothalamic-pituitary-adrenal suppression have been reported in clinical trials of Etrivex 0.05% shampoo.

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

There have been reports of pigmentation changes, acne, pustular rashes, and hypertrichosis with external use of powerful glucocorticosteroids.

Overdose

Acute overdose is very unlikely, but signs of hypercorticism may occur with chronic overdose or improper use. In such a situation, treatment should be gradually withdrawn. However, because of the risk of acute suppression of adrenal function, this should be done under medical supervision.

Pregnancy use

It is contraindicated for use during pregnancy and the period of breast-feeding.

Similarities

Dermoveit, Powercourt, Cloveit