Betaderm^® A (Ointment) Instructions for Use

Marketing Authorization Holder

VALEA NT, LLC (Russia)

Manufactured By

Pharmaceutical Works Jelfa, S.A. (Poland)

ATC Code

D07XC01 (Betamethasone in combination with other drugs)

Active Substances

Salicylic acid (USP)

Betamethasone (Rec.INN)

Dosage Form

Betaderm® A

Ointment for external use 500 mcg+30 mg/1 g: tube 15 g

Dosage Form, Packaging, and Composition

Ointment for external use white or almost white, semi-transparent, greasy, soft.

Excipients: liquid paraffin – 100 mg, white soft paraffin – to 1 g.

15 g – aluminum tubes (1) – cardboard packs.

Clinical-Pharmacological Group

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

Pharmacotherapeutic Group

Topical glucocorticosteroid + keratolytic agent

Pharmacological Action

Combined drug for external use.Betamethasone is a synthetic glucocorticosteroid that has strong anti-inflammatory, antipruritic, antiallergic, and vasoconstrictive effects.

It reduces inflammatory processes by inhibiting the production of prostaglandins and leukotrienes due to the suppression of phospholipase A₂ activity and a decrease in the release of arachidonic acid from phospholipids of cell membranes, and also has an antiallergic effect.

Due to the local vasoconstrictive effect, it reduces exudative reactions. It accelerates protein biotransformation in the skin and weakens proliferative processes.

Salicylic acid is an NSAID that exhibits a moderate keratolytic property and promotes the penetration of betamethasone into the skin.

Pharmacokinetics

Absorption and Distribution

Due to the keratolytic action of salicylic acid, Betamethasone easily penetrates the stratum corneum of the epidermis, where it accumulates.

It may penetrate into the systemic circulation in small amounts when applied externally and exert a systemic effect.

Metabolism and Excretion

Betamethasone is practically not metabolized in the skin. After slight absorption into the body, it is metabolized mainly in the liver.

It is excreted by the kidneys and, to a lesser extent, with bile in the form of compounds with glucuronic acid, and also in small amounts unchanged.

Indications

Inflammatory skin diseases (dermatoses) sensitive to glucocorticosteroid therapy, occurring with keratosis and peeling

• Urticaria;
• Multiforme exudative erythema;
• Chronic atopic dermatitis;
• Simple and allergic dermatitis;
• Circumscribed prurigo with severe lichenification;
• Seborrheic dermatitis of the scalp;
• Simple chronic lichen;
• Lichen ruber verrucosus, lichen planus;
• Eczema (including nummular eczema, hand eczema, eczematous dermatitis);
• Psoriasis;
• Dyshidrosis;
• Ichthyosis and other ichthyosis-like conditions.

ICD codes

Dosage Regimen

The drug is used externally.

Apply a small amount of the ointment in a thin layer to the affected skin surface 2 times a day – in the morning and at night, completely covering the affected areas of the skin.

In some patients, a maintenance effect can be achieved with less frequent applications. If necessary, occlusive dressings are applied, which are changed every 24 hours.

The duration of treatment depends on the effectiveness and tolerability of therapy and is usually no more than 3-4 weeks.

If a longer course of therapy is necessary, it is recommended to use the drug less frequently, for example, every other day.

In the treatment of chronic diseases, therapy should be continued for some time after the disappearance of all symptoms to avoid relapse of the disease.

For children aged 2 to 12 years, the ointment should be applied in a thin layer to a small area of the skin 1-2 times a day for no more than 1 week.

Adverse Reactions

Local reactions: possible burning sensation, irritation, dry skin, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis.

With prolonged use, as well as with the use of occlusive dressings – skin maceration, secondary infection, skin atrophy, miliaria, purpura.

Systemic reactions with prolonged use and application to large body surfaces (mainly in children) – hypoglycemia, glucosuria, reversible suppression of adrenal cortex function, manifestation of Cushing’s syndrome.

The patient should be warned to inform the attending physician if any of the side effects listed in the instructions worsen, or if the patient notices any other side effects not listed in the instructions.

Contraindications

• Rosacea and juvenile acne;
• Perioral dermatitis;
• Bacterial, viral or fungal skin infection (pyoderma, syphilis, chickenpox, skin tuberculosis, infections caused by Herpes simplex, Varicella zoster, actinomycosis, blastomycosis, sporotrichosis);
• Trophic ulcers due to chronic venous insufficiency;
• Skin tumors (skin cancer, nevus, atheroma, epithelioma, melanoma, hemangioma, xanthoma, sarcoma);
• Post-vaccination skin reactions;
• Children under 2 years of age;
• Pregnancy;
• Lactation period (breastfeeding);
• Hypersensitivity to the components of the drug.

Use with caution in the presence of atrophic skin changes, in patients with hepatic insufficiency, if long-term treatment with application to large areas of the skin is necessary, with the use of occlusive dressings; in children aged 2 years and older, in elderly patients.

Use in Pregnancy and Lactation

The drug is contraindicated during pregnancy and lactation (breastfeeding). It is recommended to stop breastfeeding during treatment.

Use in Hepatic Impairment

Use with caution in patients with hepatic insufficiency.

Pediatric Use

Contraindicated for use in children under 2 years of age.

Since children have a larger skin surface area relative to body weight, and the epidermis is not sufficiently developed, with external use of the drug, a proportionally larger amount of active substances may be absorbed and, therefore, there is a greater risk of systemic side effects.

The drug should be used in children for the shortest possible time and with all precautions.

Geriatric Use

Use with caution in elderly patients.

Special Precautions

The drug should not be applied to the skin of the face due to the possibility of telangiectasia even after short-term use.

Avoid getting the drug into the eyes and the periorbital area.

Some areas of the body (groin folds, armpits and perianal area) are more at risk of striae. Therefore, the duration of application of the drug in these areas should be limited.

Do not use in the anogenital area, as well as on areas of extensive skin lesions, especially with impaired skin integrity, for example, with burns.

Avoid getting the drug on the mucous membranes.

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

With prolonged use of the drug, its withdrawal should be carried out gradually.

If there is an extreme need to apply a bandage, then an air-permeable bandage should be applied and a sealing, oilcloth bandage should not be used.

In case of associated infection, appropriate therapy should be prescribed.

Use in pediatrics

The use of the drug in children aged 2 years and older is allowed only for strict indications and under medical supervision.

Since children have a larger skin surface area relative to body weight, and the epidermis is not sufficiently developed, with external use of the drug, a proportionally larger amount of active substances may be absorbed and, therefore, there is a greater risk of systemic side effects.

The drug should be used in children for the shortest possible time and with all precautions.

Effect on the ability to drive vehicles and mechanisms

There are no data on the adverse effect of the drug on the ability to drive vehicles and mechanisms.

Overdose

Overdose is very rare. However, with prolonged use and the use of topical glucocorticosteroids on a large surface of the skin, suppression of adrenal function with the development of secondary adrenal insufficiency and symptoms of hypercortisolism, including Cushing’s syndrome, is possible.

Long-term use on a large surface of the skin of drugs containing salicylic acid can lead to salicylic acid poisoning.

Treatment: symptomatic therapy. Acute symptoms of hypercortisolism are usually reversible. If necessary, correction of the electrolyte balance is carried out.

In case of salicylate overdose, treatment is also symptomatic. Measures should be taken to remove salicylates from the body as soon as possible, for example, oral administration of sodium bicarbonate (to alkalinize the urine) and forced diuresis.

Drug Interactions

The interaction of the drug Betaderm^® A with other drugs has not been studied.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 2 years.

Dispensing Status

The drug is approved for use as an over-the-counter product.

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.