Betanecin SK (Ointment) Instructions for Use

Marketing Authorization Holder

Tula Pharmaceutical Factory, LLC (Russia)

ATC Code

D07XC01 (Betamethasone in combination with other drugs)

Active Substances

Salicylic acid (USP United States Pharmacopeia)

Betamethasone (Rec.INN WHO registered)

Dosage Form

Betanecin SK

Ointment for external use 0.05%+3%: tubes 10 g, 15 g, 20 g, 25 g, 30 g, 35 g, 40 g, 50 g, 60 g, 70 g, 80 g, or 100 g

Dosage Form, Packaging, and Composition

Ointment for external use of almost white color, homogeneous, of soft consistency, without visible particles.

Excipients: liquid paraffin – 100.0 mg, white soft paraffin – 869.36 mg.

10 g – aluminum tubes (1) – cardboard packs with an insert.
15 g – aluminum tubes (1) – cardboard packs with an insert.
20 g – aluminum tubes (1) – cardboard packs with an insert.
25 g – aluminum tubes (1) – cardboard packs with an insert.
30 g – aluminum tubes (1) – cardboard packs with an insert.
35 g – aluminum tubes (1) – cardboard packs with an insert.
40 g – aluminum tubes (1) – cardboard packs with an insert.
50 g – aluminum tubes (1) – cardboard packs with an insert.
60 g – aluminum tubes (1) – cardboard packs with an insert.
70 g – aluminum tubes (1) – cardboard packs with an insert.
80 g – aluminum tubes (1) – cardboard packs with an insert.
100 g – aluminum tubes (1) – cardboard packs with an insert.

Clinical-Pharmacological Group

Topical corticosteroids + aminoglycoside antibiotic + antifungal agent

Pharmacotherapeutic Group

Topical glucocorticosteroid + keratolytic agent

Pharmacological Action

A combined medicinal product 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 glucocorticosteroid.

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; limited prurigo with severe lichenification; atopic dermatitis; diffuse neurodermatitis; simple and allergic dermatitis; urticaria; multiform exudative erythema; simple chronic lichen (limited neurodermatitis); dermatoses not amenable to treatment with other glucocorticosteroids (especially lichen ruber verrucosus); lichen planus; skin dyshidrosis; seborrheic dermatitis.

ICD codes

Dosage Regimen

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

Gently rub the ointment into the skin until fully absorbed.

The standard treatment course is up to three weeks.

For conditions requiring longer therapy, reduce application frequency to once every other day.

In chronic dermatoses, continue treatment for several days after symptoms resolve to prevent relapse.

Do not use on large body surface areas, under occlusive dressings, or for prolonged periods due to risk of systemic absorption.

Limit use on the face and avoid application in skin folds and the anogenital area.

In pediatric patients over one year of age, use the minimum amount necessary for the shortest effective duration.

Discontinue use and consult a physician if irritation or allergic reactions occur.

Do not apply to broken skin, open wounds, or mucous membranes.

Avoid contact with eyes; if contact occurs, rinse thoroughly with water.

Adverse Reactions

Local reactions: burning, irritation, dryness, hypopigmentation, skin itching, folliculitis, hypertrichosis, acneiform eruption.

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 glucocorticosteroids (growth retardation, Cushing’s syndrome, benign intracranial hypertension 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.