Momate (Ointment, Cream) 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

Glucocorticosteroid for external use. It has anti-inflammatory, antipruritic, and anti-exudative effects.

Glucocorticosteroids induce the release of proteins that inhibit phospholipase A₂, known collectively 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 the drug after topical application is minimal. Eight hours after application to intact skin (without an occlusive dressing), 0.7% of mometasone is detected in the systemic circulation.

Indications

Inflammatory reactions and itching in dermatoses amenable to glucocorticosteroid therapy.

ICD codes

Dosage Regimen

Apply a thin film of Momate ointment or cream to the affected skin areas once daily.

Gently rub in the medication until it is fully absorbed. Use the minimum amount necessary to control symptoms.

For adults and children 2 years and older, the standard application frequency is once daily. Do not use for more than two weeks continuously without medical supervision.

Avoid application under occlusive dressings unless specifically directed by a physician, as this increases systemic absorption.

Do not apply to large areas of the body or to areas with compromised skin integrity, such as open wounds or severe erosions.

When treating intertriginous areas (skin folds) or the face, use extreme caution and limit the duration of therapy to the shortest possible period.

Discontinue treatment once control is achieved. If no improvement is observed within one week, re-evaluate the diagnosis.

For pediatric patients, closely monitor for signs of hypothalamic-pituitary-adrenal (HPA) axis suppression due to a higher risk of systemic absorption.

Do not use in children under 2 years of age; safety and efficacy in this age group have not been established.

Adverse Reactions

Infections and infestations: Uncommon – folliculitis, secondary infection.

Skin and subcutaneous tissue disorders: Uncommon – skin irritation and dryness, burning sensation, itching, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin maceration, signs of skin atrophy, striae, miliaria, formation of papules, pustules.

Nervous system disorders: Frequency not known – paresthesia.

When topical glucocorticosteroid forms are used for a long time and/or for the treatment of large skin areas, or with the use of occlusive dressings, especially in children and adolescents, side effects characteristic of systemic glucocorticosteroids may occur, including adrenal insufficiency and Cushing’s syndrome.

Contraindications

Hypersensitivity to mometasone; rosacea; perioral dermatitis; bacterial, viral (Herpes simplex, Herpes zoster, chickenpox), fungal skin infections; tuberculosis; syphilis; post-vaccination reactions; pregnancy (application to extensive skin areas, long-term treatment); lactation period (use in high doses and/or for a long time); children under 2 years of age.

Use with caution when applying to the skin of the face and intertriginous skin, when using occlusive dressings, and when applying to large areas of the skin and/or for a long time (especially in children).

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy on extensive skin areas, for a long time; during breastfeeding.

Pediatric Use

Contraindication: children under 2 years of age.

Special Precautions

When applied to large areas of the skin for a long time, especially when using occlusive dressings, the development of systemic effects of glucocorticosteroids is possible. Given this, patients should be monitored for signs of suppression of the hypothalamic-pituitary-adrenal system function and the development of Cushing’s syndrome.

It should be considered that glucocorticosteroids can alter the manifestations of some skin diseases, which may complicate the diagnosis. Furthermore, the use of glucocorticosteroids may cause delayed wound healing.

During long-term glucocorticosteroid 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.

Any of the side effects described with the systemic use of glucocorticosteroids, including adrenal suppression, can also occur with topical application, especially in children.

Use in pediatrics

Because children have a larger surface area to body weight ratio than adults, they are at greater risk of suppression of the hypothalamic-pituitary-adrenal system function and the development of Cushing’s syndrome when using any topical glucocorticosteroids. Long-term use of glucocorticosteroids in children may lead to impairments in their growth and development.

In children, it should be used in the minimum effective dose.

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.