Diprosalic^® lotion (Solution) Instructions for Use

Marketing Authorization Holder

BAYER, JSC (Russia)

Manufactured By

Schering-Plough (France)

ATC Code

D07XC01 (Betamethasone in combination with other drugs)

Active Substances

Salicylic acid (USP)

Betamethasone (Rec.INN)

Dosage Form

Diprosalic® lotion

Solution for external use 0.5 mg+20 mg/1 g: dropper bottle 30 ml

Dosage Form, Packaging, and Composition

Solution for external use colorless, semi-transparent, viscous, with a characteristic odor of isopropyl alcohol, and free of visible particles.

Excipients: disodium edetate – 0.3 mg, hypromellose – 5 mg, sodium hydroxide – 5 mg, isopropanol – 392 mg, purified water – q.s. to 1 g.

30 ml – plastic dropper bottles (1) – cardboard packages.

Clinical-Pharmacological Group

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

Pharmacotherapeutic Group

Topical glucocorticosteroid + keratolytic agent

Pharmacological Action

A combined drug, the action of which is due to its constituent components.

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

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

Indications

• Psoriasis of the scalp or other locations;
• Seborrhea of the scalp;
• Other dermatoses amenable to glucocorticosteroid therapy.

ICD codes

Dosage Regimen

Apply externally only.

Apply a thin layer to the affected skin areas twice daily, in the morning and at night.

Ensure the application completely covers all affected areas.

For some patients, a maintenance effect may be achieved with less frequent application after initial control is established.

Determine the duration of treatment based on therapeutic efficacy and patient tolerance.

Discontinue treatment if skin irritation or signs of hypersensitivity develop.

Avoid use on the face, in the anogenital area, and on open wounds or damaged skin.

Do not use occlusive dressings.

Exercise caution with long-term use, especially in children, due to increased risk of systemic absorption.

When discontinuing after prolonged therapy, taper use gradually.

Adverse Reactions

Burning, itching, skin irritation, dry skin, folliculitis, hypertrichosis, acne, hypopigmentation, perioral dermatitis, allergic contact dermatitis, skin maceration, secondary infection, skin atrophy, striae, miliaria, pain sensations, skin fissures, dermatitis, purpura, telangiectasias, local hirsutism.

When topical glucocorticosteroids are used for a long period and/or in increased doses, especially in children, side effects characteristic of systemic glucocorticosteroids may develop (including suppression of the hypothalamic-pituitary-adrenal system function, development of Cushing’s syndrome, growth retardation, insufficient weight gain, and increased intracranial pressure).

Salicylic acid preparations can cause dermatitis.

Contraindications

• Hypersensitivity to any component of the drug;
• Children under 2 years of age;
• Pregnancy;
• Lactation period;
• Rosacea;
• Perioral dermatitis;
• Bacterial, viral, or fungal skin infection (pyoderma, syphilis, skin tuberculosis, Herpes simplex, chickenpox, Herpes 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;

With caution children under 12 years of age; hepatic insufficiency; long-term therapy.

Use in Pregnancy and Lactation

The safety of topical glucocorticosteroid use in pregnant women has not been established.

Since it has not yet been clarified whether topical glucocorticosteroids penetrate into breast milk, the issue of discontinuing breastfeeding or using the drug should be decided.

Use in Hepatic Impairment

With caution hepatic insufficiency.

Pediatric Use

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 ratio of body surface area to weight and, accordingly, increased absorption of the drug.

Special Precautions

If skin irritation or increased sensitivity to the drug appears during the use of Diprosalic Lotion, treatment should be discontinued. In case of secondary infection, appropriate therapy should be prescribed.

Systemic absorption of glucocorticosteroids and salicylic acid during their topical application will be higher the larger the body surface area being treated. Appropriate precautions must be taken if long-term use of the drug is anticipated, especially in children.

Application of salicylic acid to an open wound or damaged skin is not allowed.

Occlusive dressings should not be used when applying Diprosalic Lotion.

If skin dryness or irritation occurs, treatment with the drug should be discontinued.

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

Diprosalic Lotion is not intended for use in ophthalmology. Avoid contact with eyes and mucous membranes.

Long-term use on facial skin is not recommended.

Use in the anogenital area should be avoided.

Use in pediatrics.

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 ratio of body surface area to weight and, accordingly, increased absorption of the drug.

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, bilateral papilledema.

Overdose

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

Prolonged use of topical salicylic acid preparations in increased doses can cause symptoms of salicylate poisoning (early symptoms – nausea and vomiting).

Treatment symptomatic.

In case of glucocorticosteroid overdose – if necessary – correction of electrolyte imbalance. In case of salicylic acid poisoning, measures must be taken to rapidly eliminate salicylic acid from the body, for example, oral administration of sodium bicarbonate – to alkalinize the urine and force diuresis.

Storage Conditions

Store out of the reach of children, at a temperature from 2 to 25°C (77°F).

Shelf Life

Shelf life – 2 years. Do not use the drug after the expiration date.

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.