Rederm^® fluid (Solution) Instructions for Use

Marketing Authorization Holder

Vertex, JSC (Russia)

ATC Code

D07XC01 (Betamethasone in combination with other drugs)

Active Substances

Salicylic acid (USP)

Betamethasone (Rec.INN)

Dosage Form

Rederm® fluid

Solution for external use 0.05%+2%: 100 ml bottle with a spray nozzle

Dosage Form, Packaging, and Composition

Solution for external use transparent colorless viscous with a characteristic odor.

Excipients: disodium edetate, hypromellose, sodium hydroxide, isopropanol (isopropyl alcohol), purified water.

100 ml – polyethylene bottles with a spray nozzle (1) – cardboard packs.

Clinical-Pharmacological Group

A drug with anti-inflammatory and keratolytic action for external use

Pharmacotherapeutic Group

Corticosteroids used in dermatology; corticosteroids in combination with other agents; high-potency corticosteroids in combination with other agents

Pharmacological Action

A combined drug for external use, the action of which is due to its constituent components. It has anti-inflammatory, anti-edematous, anti-allergic, vasoconstrictive, antiproliferative, immunosuppressive, keratolytic, antimicrobial, antifungal, and local hypothermic action.

It inhibits the release of inflammatory mediators, prevents the marginal accumulation of neutrophils, reduces inflammatory exudate and cytokine production, and decreases macrophage migration, leading to a reduction in infiltration and granulation processes.

Due to the presence of salicylic acid, it softens the skin, eliminates horny layers, and promotes deeper penetration of the corticosteroid.

The ointment has a water-repellent effect and forms a protective film that protects the skin from external moisture; having a deep fat-saturating effect, it is most suitable for treating patients with dry and fragile skin.

The lotion (solution in a fat-free base) spreads easily on the skin surface, does not stick or dry out hair, does not leave visible marks, and has a cooling effect on the skin.

Indications

Psoriasis; eczema (especially chronic); ichthyosis; localized prurigo with severe lichenification; atopic dermatitis; diffuse neurodermatitis; simple and allergic dermatitis; urticaria; multiform exudative erythema; lichen simplex chronicus (circumscribed neurodermatitis); dermatoses not amenable to treatment with other corticosteroids (especially lichen ruber verrucosus); lichen planus; skin dyshidrosis; seborrheic dermatitis.

ICD codes

Dosage Regimen

Apply a thin layer to the affected skin areas two to three times daily.

Gently rub the solution until fully absorbed.

Limit the treatment course to a maximum of three weeks for continuous application.

For conditions requiring longer therapy, transition to an intermittent dosing schedule.

Apply the solution every other day to minimize the risk of local and systemic adverse effects.

In the management of chronic dermatoses, continue treatment for several days after all clinical symptoms have resolved.

This proactive maintenance helps prevent disease relapse.

Do not use on large body surface areas, under occlusive dressings, or for extended periods without medical supervision.

Discontinue use and consult a physician if irritation or signs of atrophy develop.

Adverse Reactions

Local reactions burning, irritation, dryness, hypopigmentation, skin itching, folliculitis, hypertrichosis, acne.

When using occlusive dressings – skin maceration, striae, skin atrophy, secondary infection, miliaria.

With long-term use – skin atrophy, local hirsutism, telangiectasias, purpura, hypopigmentation, hypertrichosis.

Systemic reactions when applied to large areas, systemic manifestations of the side effects of corticosteroids (growth retardation, Cushing’s syndrome, benign increased intracranial pressure after treatment cessation, hyperglycemia, glucosuria, hypokalemia, increased blood pressure) or salicylates (pallor, increased fatigue, drowsiness, hyperventilation against the background of tachypnea, nausea, vomiting, hearing impairment, confusion) are possible.

Contraindications

Bacterial, viral, and fungal skin diseases (pyoderma, syphilis, skin tuberculosis, chickenpox, herpes, actinomycosis, blastomycosis, sporotrichosis); post-vaccination skin reactions; perioral dermatitis; rosacea; trophic ulcers due to chronic venous insufficiency; skin tumors (skin cancer, nevus, atheroma, epithelioma, melanoma, hemangioma, xanthoma, sarcoma); pregnancy; lactation period (do not apply to the skin of the breast before feeding); children under 1 year of age; hypersensitivity to betamethasone or salicylic acid.

With caution

Hepatic insufficiency, children (over 1 year of age), long-term therapy, especially with the use of occlusive dressings.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and lactation (do not apply to the skin of the breast before feeding).

Use in Hepatic Impairment

With caution : hepatic insufficiency.

Pediatric Use

Contraindication — children under 1 year of age.

With caution : children (over 1 year of age).

The use of the ointment in children should be as short as possible (danger of systemic absorption of a proportionally larger amount of active components due to the predominance of skin surface area over body weight and insufficient maturity of the epidermis).

Special Precautions

Avoid getting the drug into the eyes, do not apply to the skin near the eyes and on mucous membranes.

Long-term use on facial skin is not recommended – development of rosacea-like dermatitis, perioral dermatitis, skin atrophy, and acne is possible; avoid use in the anogenital area.

The use of the ointment in children should be as short as possible (danger of systemic absorption of a proportionally larger amount of active components due to the predominance of skin surface area over body weight and insufficient maturity of the epidermis).

If signs of allergic reactions or local irritation appear, treatment should be discontinued.

Drug Interactions

Simultaneous use of cosmetic and dermatological agents for acne therapy, products containing ethanol, or medical soap with a pronounced drying effect may, in certain cases, cause skin irritation.

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

Over-the-Counter

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.