Etrivex^® (Shampoo) Instructions for Use

Marketing Authorization Holder

Galderma, SA (Switzerland)

Manufactured By

Laboratoires Galderma (France)

ATC Code

D07AD01 (Clobetasol)

Active Substance

Clobetasol (Rec.INN registered by WHO)

Dosage Form

Etrivex®

Shampoo 0.05%: bottle 60 ml or 125 ml

Dosage Form, Packaging, and Composition

Shampoo is a viscous, semi-transparent liquid from colorless to pale yellow with an odor of ethanol.

Excipients: ethanol 96% – 100 mg, cocobetaine (30% solution) – 60 mg, sodium lauryl sulfate (70% solution) – 170 mg, polyquaternium-10 – 20 mg, sodium citrate – 26 mg, citric acid monohydrate – 2.4 mg, purified water – 621.1 mg.

60 ml – high-density polyethylene bottles (1) – cardboard boxes.
125 ml – high-density polyethylene bottles (1) – cardboard boxes.

Clinical-Pharmacological Group

Topical corticosteroids for external use

Pharmacotherapeutic Group

Topical glucocorticosteroid

Pharmacological Action

Glucocorticosteroid for external use. Prevents marginal accumulation of neutrophils, reduces inflammatory exudation and lymphokine production, inhibits macrophage migration, reduces the intensity of infiltration and granulation processes, and exerts local anti-inflammatory, antipruritic, antiallergic, and anti-exudative effects.

Pharmacokinetics

After application of clobetasol in topical dosage forms to healthy skin, the mean C_max of the active substance is about 0.63 ng/ml and is reached in plasma approximately 8-13 hours later. In patients with psoriasis and eczema, the mean C_max is reached approximately 3 hours after application and is 2.3-4.6 ng/ml.

When applied to large areas of the skin, absorption is possible (impaired skin integrity or inflammation enhances absorption) and systemic effects may occur.

It is metabolized mainly in the liver, with a small part in the kidneys. Excreted in the urine.

Indications

Psoriasis (except for extensive plaque psoriasis), prevention and treatment of relapses of scalp psoriasis (except for extensive plaque psoriasis); eczema, lichen planus, discoid lupus erythematosus; skin diseases resistant to therapy with less potent topical glucocorticosteroids.

ICD codes

Dosage Regimen

Apply a small amount of shampoo to dry scalp. Gently massage into the affected areas until the entire scalp is covered.

Leave the shampoo on the scalp for 15 minutes. Avoid contact with eyes, eyelids, and other skin areas.

After 15 minutes, add a small amount of water to lather. Rinse thoroughly with water.

Use once daily. The maximum treatment duration is 4 weeks.

Do not use occlusive dressings or bandages. Discontinue use after symptoms resolve.

If no improvement occurs within 4 weeks, re-evaluate the diagnosis. Do not exceed the recommended dosage or duration of use.

Limit the weekly application amount to 50 grams or less to minimize systemic absorption.

Wash hands thoroughly after application. Avoid use on broken skin, skinfold areas, or areas prone to chafing.

Adverse Reactions

Dermatological reactions: burning, skin itching, steroid acne, dry skin, folliculitis, skin soreness, psoriasis (exacerbation), alopecia, allergic contact dermatitis, erythema; with long-term use – weakening of the skin barrier function; with long-term use in high doses – atrophic skin changes, in particular, thinning, appearance of atrophic striae, dilation of superficial blood vessels, especially when using occlusive dressings and when applying the product to skinfold areas (the risk of this complication is increased in young children, in which case a diaper can act as an occlusive dressing); skin pigmentation and hypertrichosis may develop.

Gastrointestinal system: when applied to large surfaces, gastritis, ulceration of the gastrointestinal mucosa are possible.

Endocrine system: when applied to large surfaces, symptoms of hypercortisolism, suppression of adrenal function, Cushing’s syndrome are possible.

Organ of vision: eye pain/burning, eye irritation, eye strain, glaucoma are possible.

Nervous system: headache.

Other: in rare cases – exacerbation of disease symptoms.

Contraindications

Hypersensitivity to clobetasol; rosacea, acne vulgaris, skin cancer, nodular prurigo of Hyde, perioral dermatitis, perianal and genital pruritus, skin manifestations of syphilis, diaper rash, bacterial, viral, and fungal skin diseases (including herpes simplex, chickenpox, skin tuberculosis, actinomycosis), extensive plaque and pustular psoriasis; application of the product to the eyes and eyelids (risk of glaucoma, cataract); pregnancy, lactation (breastfeeding); childhood – depending on the dosage form.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and lactation (breastfeeding).

Pediatric Use

Use in children is possible according to indications, in age-appropriate recommended doses and dosage forms. It is necessary to strictly follow the instructions in the clobetasol drug labels regarding contraindications for the use of specific clobetasol dosage forms in children of different ages.

Special Precautions

In rare cases, treatment of psoriasis with topical glucocorticosteroids (or their withdrawal) provokes the development of pustular psoriasis.

Long-term prescription of topical glucocorticosteroids in large doses or their application to extensive skin areas may be accompanied by systemic absorption with subsequent development of hypercortisolism symptoms. The risk of this complication is increased in children, especially when using an occlusive dressing, where a diaper can act as such a dressing. In such cases, medical supervision should be enhanced and the patient should be regularly examined for suppression of the hypothalamic-pituitary-adrenal axis. Provided that clobetasol is used in adults at a dose not exceeding 50 g per week, suppression of pituitary and adrenal function is transient with rapid recovery immediately after the end of the treatment course.

Clobetasol is preferably used for short periods.

Long-term use of topical glucocorticosteroids should be avoided, as this may lead to suppression of adrenal function.

Atrophic skin changes resulting from long-term use of topical glucocorticosteroid forms may appear on the face more often than on other parts of the body.

Clobetasol should not be applied to the periorbital area, as this may cause the development of glaucoma.

Treatment of psoriasis with topical glucocorticosteroids may be accompanied by the development of disease relapses, tolerance, generalized pustular form of the disease, local or systemic toxic reactions due to impaired skin barrier function, therefore patient monitoring is especially important.

In case of secondary infection, appropriate antibacterial therapy should be administered. If any signs of infection generalization appear, topical glucocorticosteroid application should be discontinued and appropriate treatment with antibacterial drugs should be initiated. The warm, moist conditions created by an occlusive dressing promote bacterial infection, so the skin must be thoroughly cleaned before applying a new dressing.

Clobetasol in the form of a shampoo is indicated only for the treatment of scalp psoriasis; it should not be applied to other parts of the body and skin areas prone to chafing (armpits, genital and anal areas) and to erosive skin areas, as this increases the risk of local adverse reactions such as atrophic skin changes, telangiectasias, or steroid-induced dermatitis. If shampoo gets into the eyes, rinse them immediately with plenty of water.

Use in pediatrics

The use of clobetasol in children requires medical supervision at least once a week. Long-term use of topical glucocorticosteroids in young children should be avoided, as this may lead to suppression of adrenal function.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.