Dermosolon (Ointment) Instructions for Use

Marketing Authorization Holder

Gedeon Richter, Ltd. (Hungary)

ATC Code

D07BA01 (Prednisolone and antiseptics)

Active Substances

Prednisolone (Rec.INN registered WHO)

Clioquinol (Rec.INN registered WHO)

Dosage Form

Dermosolon

Ointment for external use 5 mg+30 mg/1 g: tube 5 g

Dosage Form, Packaging, and Composition

5 g – tubes (1) – carton packs.

Clinical-Pharmacological Group

A drug with antibacterial, antifungal, and anti-inflammatory action for external use

Pharmacotherapeutic Group

Glucocorticosteroid + antimicrobial agent

Indications

• Dermosolon ointment is indicated for the treatment of acute and chronic dermatoses that are complicated by a bacterial or fungal infection, or when there is a high risk of such an infection developing.
• This includes conditions such as infected eczema (including nummular eczema), contact dermatitis, seborrheic dermatitis, and atopic dermatitis when secondary infection is present or suspected.
• It is also used for intertrigo and other inflammatory skin conditions in skin folds where bacterial or fungal overgrowth is common.

The product is effective due to the combined action of its components: prednisolone suppresses the inflammatory and allergic components of the disease, while clioquinol provides antibacterial and antifungal activity against a broad spectrum of pathogens.

Contraindications

• Hypersensitivity to prednisolone, clioquinol, other corticosteroids, iodine, or any of the excipients of the ointment.
• Viral skin infections, such as herpes simplex, chickenpox (varicella), herpes zoster (shingles), and vaccinia.
• Bacterial skin infections not controlled by antimicrobial agents (e.g., impetigo, cellulitis).
• Fungal skin infections that are not responsive to clioquinol.
• Tuberculous and syphilitic lesions of the skin.
• Skin reactions following vaccination.
• Acne vulgaris and rosacea.
• Perioral dermatitis.
• Dermatoses in children under 2 years of age, due to the increased risk of systemic absorption and potential for adverse effects.
• Application to large areas of the body, under occlusive dressings, or on extensive, exuding surfaces for prolonged periods, as this significantly increases systemic absorption of corticosteroids.

Dosage Regimen

The dosage and duration of treatment should be individualized based on the severity of the condition and the patient’s response. Apply a thin layer of Dermosolon ointment to the affected skin areas two to three times daily.

Gently rub the ointment into the skin until it is evenly distributed. The frequency of application may be reduced to once daily or every other day as the condition improves. Treatment should not be continued for more than 2 weeks without medical reevaluation.

Long-term continuous use should be avoided. If no clinical improvement is observed within 3-5 days, the diagnosis should be reconsidered. Do not use the ointment in or near the eyes. Wash hands thoroughly after application, unless the hands are the area being treated.

Adverse Reactions

Adverse reactions are more likely to occur with prolonged use, application to large body surface areas, or use under occlusive dressings. Local skin reactions at the application site may include: burning sensation, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, allergic contact dermatitis, maceration of the skin, and secondary infection.

With prolonged or intensive treatment, systemic absorption of the corticosteroid may occur, leading to reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria. This risk is significantly higher in infants and children.

Clioquinol may cause skin discoloration (yellowish or brownish staining) of the skin, hair, or fabrics. In rare cases, systemic absorption of clioquinol has been associated with neurotoxicity, including optic neuritis and peripheral neuropathy.

Drug Interactions

Concomitant use of Dermosolon ointment with other topical corticosteroids may increase the risk of local adverse effects and systemic absorption. No specific pharmacokinetic drug interactions with systemically administered drugs have been reported for topical application.

However, caution is advised when using this product concurrently with other topical preparations that have a high potential for skin irritation or desquamation, as this may enhance the penetration of both active substances. The iodine contained in clioquinol may interfere with thyroid function tests (e.g., PBI, I-131 uptake), potentially leading to falsely decreased results.

Patients should inform their doctor about all medications they are using, including prescription, over-the-counter, and other topical products.

Overdose

Acute overdose from topical application is unlikely. However, chronic or excessive application can lead to significant systemic absorption of both prednisolone and clioquinol, resulting in adverse effects as described in the Adverse Reactions section.

Symptoms of systemic corticosteroid overdose include Cushingoid appearance (moon face, central obesity), hypertension, hyperglycemia, and HPA axis suppression. In case of suspected chronic overdose, treatment should be discontinued gradually to avoid acute adrenal insufficiency.

Symptoms of clioquinol systemic toxicity may include neuropathy, visual disturbances, and gastrointestinal upset. There is no specific antidote. Treatment is supportive and symptomatic. In case of accidental ingestion, gastric lavage and administration of activated charcoal may be considered if performed shortly after ingestion.

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

Rx Only

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.