Afloderm^® (Ointment, Cream) Instructions for Use

ATC Code

D07AB10 (Alclometasone)

Active Substance

Alclometasone (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Topical corticosteroids for external use

Pharmacotherapeutic Group

Corticosteroids used in dermatology; corticosteroids; corticosteroids with moderate activity (group II)

Pharmacological Action

A non-halogenated synthetic glucocorticosteroid for topical use. It has anti-inflammatory, anti-allergic, antipruritic, and antiproliferative effects.

When applied to the skin surface at the site of inflammation, it quickly and effectively reduces the severity of objective symptoms ( erythema, edema, lichenification) and subjective sensations ( itching, irritation, pain).

Indications

Dermatoses for which topical therapy with glucocorticosteroids is effective (including on the face and in the anogenital area): atopic dermatitis, eczema, psoriasis, allergic and contact dermatitis, solar dermatitis, allergic reactions to insect bites.

ICD codes

Dosage Regimen

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

Gently rub in the medication until it is fully absorbed. Do not bandage or cover the treated area unless specifically directed by a physician.

Adjust the application frequency based on the severity of the condition and the specific anatomical location. For milder cases or for use on the face and intertriginous areas, once-daily application may be sufficient.

For severe or resistant lesions, a more frequent application schedule may be initially required under medical supervision.

The total duration of treatment should not exceed two weeks for adult patients. Limit treatment in pediatric patients to seven days unless otherwise advised by a physician.

Discontinue use and consult a physician if no clinical improvement is observed within the recommended treatment period.

Use the minimum amount necessary to control symptoms. Avoid application to very large body surface areas, under occlusive dressings, or for prolonged periods to minimize systemic absorption.

Adverse Reactions

Possibleitching, burning, redness or dryness of the skin, irritation, rash.

Very rarelyacne-like changes, hypopigmentation, miliaria, folliculitis, striae, skin atrophy, hypertrichosis, allergic contact dermatitis, secondary skin infections.

Contraindications

Skin tuberculosis, cutaneous manifestations of syphilis, chickenpox, viral skin infections, skin reactions to vaccination, open wounds, trophic ulcers, rosacea, acne vulgaris, children under 6 months of age, hypersensitivity to alclometasone.

Use in Pregnancy and Lactation

Use during pregnancy is only possible if the intended benefit to the mother outweighs the potential risk to the fetus. In such cases, use should be short-term and limited to a small area of skin.

There are no data on teratogenic effects.

Use during lactation is possible, but in such cases, do not apply to the skin of the breast before feeding.

Pediatric Use

Contraindication: children under 6 months of age.

The drug can be used in young children.

It should be considered that in young children, skin folds and diapers can have an effect similar to that of an occlusive dressing and, accordingly, increase the systemic absorption of the active substance. Furthermore, children may have a greater degree of systemic absorption due to the ratio of skin surface area to body weight, as well as due to the immaturity of the epidermis. Therefore, long-term use in young children is only possible under medical supervision.

Special Precautions

Do not apply to the skin in the eye area (due to the possible development of glaucoma and cataracts), or to open wound surfaces.

If the course of the disease is complicated by the development of a secondary bacterial or fungal infection, it is necessary to add a specific antibacterial or antifungal agent.

Can be used in young children.

It should be considered that in young children, skin folds and diapers can have an effect similar to that of an occlusive dressing and, accordingly, increase the systemic absorption of the active substance. Furthermore, children may have a greater degree of systemic absorption due to the ratio of skin surface area to body weight, as well as due to the immaturity of the epidermis. Therefore, long-term use in young children is only possible under medical supervision.

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.