Diprosalic^® (Ointment) Instructions for Use

Marketing Authorization Holder

BAYER, JSC (Russia)

Manufactured By

Famar, A.V.E. (Greece)

ATC Code

D07XC01 (Betamethasone in combination with other drugs)

Active Substances

Salicylic acid (USP)

Betamethasone (Rec.INN)

Dosage Form

Diprosalic®

Ointment for external use 0.5 mg+30 mg/1 g: tube 30 g

Dosage Form, Packaging, and Composition

Ointment for external use of almost white color, soft consistency, homogeneous, does not contain visible particles.

Excipients: liquid paraffin – 100 mg, petrolatum – 869.36 mg.

30 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

Diprosalic^® ointment is a combined preparation based on two active substances – betamethasone dipropionate and salicylic acid.

Betamethasone dipropionate – a synthetic fluorinated glucocorticosteroid – has anti-inflammatory, antipruritic, and vasoconstrictive action.

When applied topically, Salicylic acid has a keratolytic, as well as a bacteriostatic and some fungicidal action.

Indications

Diprosalic^® ointment is indicated to reduce inflammatory manifestations of dry and hyperkeratotic dermatoses sensitive to glucocorticosteroid therapy, including:

• Psoriasis;
• Chronic atopic dermatitis;
• Neurodermatitis (chronic simple lichen);
• Lichen planus;
• Eczema (including nummular eczema, hand eczema, eczematous dermatitis);
• Dyshidrosis;
• Seborrheic dermatitis of the scalp;
• Ichthyosis and other ichthyosis-like conditions.

ICD codes

Dosage Regimen

Apply a thin layer of Diprosalic^® ointment to the affected skin areas twice daily, in the morning and at night.

Gently rub in the ointment until it is completely absorbed, ensuring the entire affected area is covered.

For scalp dermatoses, part the hair to apply the ointment directly to the lesions.

Use the minimum amount necessary to control symptoms. Avoid application under occlusive dressings unless specifically directed by a physician.

For pediatric patients (2 years and older), limit the duration of treatment and the total surface area treated to minimize systemic absorption.

After symptoms subside, discontinue use. Do not use continuously for longer than required.

If no improvement is observed within one to two weeks, re-evaluate the diagnosis.

For maintenance therapy, some patients may be controlled with less frequent application, such as once daily.

Avoid contact with the eyes, mucous membranes, and broken skin. If contact occurs, rinse thoroughly with water.

Wash hands thoroughly after application, unless the hands are the treated area.

Adverse Reactions

Undesirable phenomena that occurred with the use of topical glucocorticosteroids included burning, itching, irritation, dry skin, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis. The following phenomena occurred more often with the use of occlusive dressings: skin maceration, secondary infection, skin atrophy, striae, and miliaria.

Preparations of salicylic acid can cause dermatitis.

If adverse reactions not described in this instruction occur, a doctor should be consulted.

Contraindications

• History of hypersensitivity reactions to any component of the ointment.

Use in Pregnancy and Lactation

Since the safety of using topical glucocorticosteroids in pregnant women has not been established, the prescription of this class of drugs during pregnancy is justified only if the expected benefit to the mother outweighs the potential risk to the fetus.

Drugs of this class should not be used during pregnancy in large doses or for a prolonged time.

Since it has not yet been determined whether the level of systemic absorption of topical glucocorticosteroids is sufficient to produce detectable concentrations in breast milk, either breastfeeding should be discontinued or the drug should be used, considering how necessary it is for the mother.

Pediatric Use

The drug may be used with caution in children aged 2 years and older.

Special Precautions

If irritation or hypersensitivity develops during the use of Diprosalic^® ointment, treatment should be discontinued.

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

When glucocorticosteroids are applied topically, especially in children, side effects characteristic of systemic glucocorticosteroids may occur, including suppression of the hypothalamic-pituitary-adrenal system function.

Systemic absorption of glucocorticosteroids and salicylic acid during topical application will be higher when using occlusive dressings, as well as when applied to extensive body surfaces.

When discontinuing the drug after long-term treatment, it is recommended to do so gradually.

Diprosalic^® ointment is not intended for use in ophthalmology. Contact with eyes and mucous membranes should be avoided.

Use in pediatrics.

The drug may be used with caution in children aged 2 years and older.

Children are more susceptible to the risk of hypothalamic-pituitary-adrenal system function suppression due to the use of topical glucocorticosteroids than adults, due to their larger body surface area to weight ratio and, accordingly, increased absorption of the drug.

There have been reports of decreased hypothalamic-pituitary-adrenal system function, Cushing’s syndrome, growth retardation, insufficient weight gain, and increased intracranial pressure in children receiving topical glucocorticosteroids. Suppression of hypothalamic-pituitary-adrenal system function in children is determined by low plasma cortisol levels and lack of response to adrenocorticotropic hormone stimulation. Increased intracranial pressure is manifested by bulging fontanelle, headaches, and bilateral papilledema.

Overdose

Excessive and prolonged use of topical glucocorticosteroids can cause suppression of the pituitary-adrenal system function, leading to secondary adrenal insufficiency and manifestations of hypercortisolism, including Cushing’s syndrome.

Appropriate symptomatic treatment is indicated. Acute symptoms of hypercortisolism are usually reversible.

Storage Conditions

Store in a dark place, out of the reach of children, at a temperature from 2 to 30°C (86°F).

Shelf Life

The shelf life is 5 years from the date of production.

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.