Momederm^® (Solution, Ointment) Instructions for Use

ATC Code

D07AC13 (Mometasone)

Active Substance

Mometasone (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Topical corticosteroids for external use

Pharmacotherapeutic Group

Topical glucocorticosteroid

Pharmacological Action

Mometasone is a synthetic glucocorticosteroid (GCS).

It has anti-inflammatory, antipruritic, and anti-exudative effects.

GCS induce the release of proteins that inhibit phospholipase A2, collectively known as lipocortins, which control the biosynthesis of inflammatory mediators such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid.

Pharmacokinetics

Absorption of mometasone is low.

Approximately 0.4% of the dose is detected in the systemic circulation 8 hours after application to intact skin (without an occlusive dressing).

Absorption increases with skin inflammation and damage.

Indications

• Skin inflammation and itching in dermatoses (including psoriasis, atopic dermatitis, seborrheic dermatitis) where GCS therapy is indicated.

ICD codes

Dosage Regimen

Solution

For external use.

Adults

Apply a small amount of the solution to the affected skin area once a day.

Continuous treatment with the drug should not last more than 2 weeks.

Do not use on facial skin for more than 5 days.

Children

Do not use in children under 2 years of age.

In children over 2 years of age, the drug can only be used in case of absolute necessity on a small area of skin, once a day, for a maximum of 5 days.

In children, the drug should be used with great caution and should not be applied to facial skin.

Ointment

For external use.

The dosage regimen is set individually, depending on the indications, the patient’s age, and the dosage form used.

Adverse Reactions

Local reactions burning, itching, paresthesia, folliculitis, acneiform eruptions, skin atrophy, hypertrichosis, hypopigmentation, perioral dermatitis, allergic contact dermatitis, skin maceration, secondary infection, striae, miliaria.

The likelihood of these adverse events increases with the use of occlusive dressings.

Systemic action when using topical GCS forms for a long time and/or for treating large areas of skin (total application area larger than the patient’s palm), or with the use of occlusive dressings, especially in children and adolescents, side effects characteristic of systemic GCS may occur, including adrenal insufficiency and Cushing’s syndrome.

Contraindications

• Bacterial, viral (Herpes simplex, chickenpox, Herpes zoster) or fungal skin infection;
• Tuberculosis, syphilis;
• Post-vaccination reactions;
• Pregnancy (treatment of extensive skin areas, long-term treatment);
• Lactation period (use in large doses and/or for a long time);
• Children under 2 years of age;
• Rosacea, perioral dermatitis;
• Hypersensitivity to any component of the drug or to other GCS.

With caution application to facial skin and intertriginous skin surfaces, use of occlusive dressings, as well as treatment of large skin areas and/or long-term treatment (especially in children).

Use in Pregnancy and Lactation

The safety of mometasone use during pregnancy and lactation has not been studied.

GCS cross the placental barrier.

Long-term treatment and the use of large doses during pregnancy should be avoided due to the risk of negative effects on fetal development.

GCS are excreted in breast milk.

If the use of GCS in large doses and/or for a long time is anticipated, breastfeeding should be discontinued.

Pediatric Use

Do not use in children under 2 years of age.

Special Precautions

If there is no effect within 2 weeks of therapy with the drug, the diagnosis should be clarified.

When applied to large areas of skin for a long time, especially when using occlusive dressings, the development of systemic effects of GCS is possible.

Considering this, it is necessary to monitor the function of the hypothalamic-pituitary-adrenal system.

Avoid getting the drug into the eyes.

Propylene glycol, which is part of the drug, may cause irritation at the application site.

In such cases, the use of the drug should be discontinued and appropriate treatment prescribed.

It should be taken into account that GCS can alter the manifestations of some skin diseases, which may complicate diagnosis.

Furthermore, the use of GCS can cause delayed wound healing.

During long-term GCS therapy, sudden discontinuation of therapy may lead to the development of a rebound syndrome, manifested as dermatitis with intense skin redness and a burning sensation.

Therefore, after a long course of treatment, the drug should be discontinued gradually, for example, by switching to an intermittent treatment regimen before completely stopping it.

Overdose

Symptoms suppression of hypothalamic-pituitary-adrenal system function (including secondary adrenal insufficiency).

Treatment symptomatic.

If necessary – correction of electrolyte imbalance, discontinuation of the drug (with long-term therapy – gradual withdrawal).

Drug Interactions

There are no data on interactions with other medicinal substances with the topical use of GCS.

However, vaccination against chickenpox and other types of immunization should not be carried out in patients using this drug, especially with long-term use on a large skin surface, since there is a risk of failure to develop a normal immune response in the form of the appearance of appropriate antibodies.

The drug may enhance the effect of immunosuppressive drugs and weaken the effect of immunostimulating drugs.

Storage Conditions

At a temperature not exceeding 25°C (77°F).

Do not freeze.

Keep out of reach of children.

Shelf Life

Shelf life – 2 years.

Dispensing Status

By 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.