Akriderm^® SK (Solution, Ointment) Instructions for Use

ATC Code

D07XC01 (Betamethasone in combination with other drugs)

Active Substances

Salicylic acid (USP)

Betamethasone (Rec.INN)

Clinical-Pharmacological Group

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

Pharmacotherapeutic Group

Glucocorticosteroid + keratolytic agent

Pharmacological Action

Akriderm^® SK is a combined preparation containing the active substances – micronized Betamethasone dipropionate and micronized salicylic acid.

Betamethasone dipropionate is a synthetic fluorinated glucocorticoid that has anti-inflammatory, antipruritic, and vasoconstrictive action.

Salicylic acid, possessing a keratolytic action, promotes the penetration of betamethasone into the skin. It has a bacteriostatic and some fungicidal action.

The combined action of the active components leads to a rapid reduction in the severity of symptoms such as itching, irritation, erythema, and pain.

Indications

Local treatment of dermatoses accompanied by hyperkeratosis:

• Psoriasis;
• Localized and diffuse neurodermatitis;
• Lichen planus;
• Eczema;
• Dyshidrotic dermatitis;
• Ichthyosis and ichthyosiform changes.

ICD codes

Dosage Regimen

Ointment

For external use.

Akriderm^® SK is applied in a thin layer to the affected area of the skin 2 times/day – in the morning and in the evening. Another frequency of application may be established by the doctor, based on the severity of the disease.

In mild cases, it is usually sufficient to apply the ointment 1 time/day; in more severe lesions, more frequent application may be necessary.

The course of treatment should not exceed 3 weeks.

For children aged 2 to 12 years – apply in a thin layer 1 or 2 times/day for no more than 5 days. The duration of treatment, features of the treatment regimen, and repeated courses of treatment must be agreed with the doctor.

The drug should be used only according to the method of application and in the doses indicated in the instructions. If necessary, the patient should consult a doctor before using the drug.

Solution

For external use, apply to the affected areas, rubbing lightly, in a thin layer 2-3 times/day.

The course of treatment is up to 3 weeks. If long-term treatment is necessary, apply less frequently – every other day. When treating chronic diseases, treatment should be continued for some time after the disappearance of all symptoms to avoid relapse of the disease.

Adverse Reactions

With external use, adverse reactions are usually reversible and are mild.

Classification of adverse reactions by organs and systems with an indication of their frequency: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1000, <1/100), rare (≥1/10000, <1/1000), very rare (<1/10000), including individual reports, frequency unknown (frequency cannot be estimated from the available data).

Skin and subcutaneous tissue disorders common – burning, itching, irritation, dry skin, folliculitis, hypertrichosis, acneiform eruptions, acne, hypopigmentation, telangiectasia, perioral dermatitis, allergic contact dermatitis, skin maceration, skin atrophy, miliaria, secondary infections.

Eye disorders blurred vision.

Endocrine system disorders with prolonged use and application to large areas of the skin, mainly in children, the occurrence of systemic side effects of glucocorticoids is possible – hypokalemia, glucosuria, reversible suppression of adrenal cortex function, manifestation of Cushing’s syndrome.

If the patient experiences side effects listed in the instructions, or if they worsen, or if any other side effects not listed in the instructions occur, the patient must inform the doctor.

Contraindications

• Hypersensitivity to betamethasone, salicylic acid, other components of the drug;
• Rosacea;
• Acne;
• Perioral dermatitis;
• Bacterial, viral, or fungal skin infections;
• Trophic ulcers due to chronic venous insufficiency;
• Wounds;
• Skin tumors;
• Post-vaccination skin reactions;
• Perianal and genital itching;
• Children under 2 years of age;
• Pregnancy (long-term treatment in large doses);
• Breastfeeding period.

With caution children under 12 years of age, hepatic insufficiency, long-term treatment, application to extensive areas of the skin, use of occlusive dressings.

Use in Pregnancy and Lactation

The safety of topical use of glucocorticoids in pregnant women has not been established; the prescription of drugs of this group during pregnancy is justified only if the potential benefit outweighs the possible risk. During pregnancy, drugs of this group should not be used in high doses or for a long time.

It has not been established whether topical use of glucocorticoids can lead to their appearance in breast milk, so the issue of discontinuing breastfeeding should be considered.

Use in Hepatic Impairment

The drug should be prescribed with caution in hepatic insufficiency.

Pediatric Use

Contraindicated for use in children under 2 years of age.

The drug should be prescribed with caution to children under 12 years of age.

Special Precautions

If skin irritation or signs of allergic reactions appear during the use of Akriderm^® SK, treatment should be discontinued. If a fungal or bacterial infection is added, appropriate therapy should be prescribed.

Avoid getting the drug into the eyes and on mucous membranes, as well as application in the anogenital area, on areas of extensive skin lesions, especially with impaired skin integrity.

Use in children under 12 years of age is possible only under medical supervision. Children are more susceptible than adults to the risk of suppression of the hypothalamic-pituitary-adrenal system function when using topical corticosteroids due to the larger ratio of body surface area to body weight and, consequently, increased absorption of the drug. There have been reports of decreased function of the hypothalamic-pituitary-adrenal system, Cushing’s syndrome, growth retardation, insufficient weight gain, and increased intracranial pressure in children receiving topical corticosteroids. Suppression of the hypothalamic-pituitary-adrenal system function in children is determined by low plasma cortisol levels and lack of response to ACTH stimulation. Increased intracranial pressure is manifested by bulging fontanelle, headaches, bilateral papilledema.

When using the drug in children or for the treatment of facial skin lesions, the duration of treatment should not exceed 5 days.

It is not recommended to use the drug under occlusive dressings. With prolonged treatment, when applied to large skin surfaces, or when using occlusive dressings, systemic absorption of the corticosteroid and salicylic acid is possible.

With long-term treatment with the drug, its withdrawal is recommended to be carried out gradually.

Akriderm^® SK is not intended for use in ophthalmology. With external use of corticosteroids, visual impairment may occur. If a patient experiences symptoms such as blurred vision or other visual disturbances, the patient should be referred to an ophthalmologist to assess the possible causes of visual impairment, which may include cataract, glaucoma, and rare diseases such as central serous chorioretinopathy (CSCR), which have been reported after systemic and topical use of corticosteroids.

Overdose

Symptoms acute overdose is unlikely, however, with excessive or prolonged use of the drug, chronic overdose is possible, accompanied by signs of hypercorticism – hyperglycemia, glucosuria, reversible suppression of adrenal cortex function, manifestation of Cushing’s syndrome.

Treatment appropriate symptomatic treatment is indicated. In case of chronic toxic action, gradual withdrawal of the drug is recommended.

Drug Interactions

No interactions with other medicinal products have been identified.

Storage Conditions

The drug should be stored out of the reach of children at a temperature from 15°C (59°F) to 25°C (77°F).

Shelf Life

The shelf life is 3 years. Do not use after the expiration date.

Dispensing Status

The drug is available without a prescription.

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.