Avecort (Ointment) Instructions for Use

Marketing Authorization Holder

Patent-Pharm, JSC (Russia)

Manufactured By

Zelenaya Dubrava, CJSC (Russia)

ATC Code

D07AC13 (Mometasone)

Active Substance

Mometasone (Rec.INN registered by WHO)

Dosage Form

Avecort

0.1% ointment for external use: 15 g or 30 g tube

Dosage Form, Packaging, and Composition

15 g – aluminum tubes (1) – cardboard packs.
30 g – aluminum tubes (1) – cardboard packs.

Clinical-Pharmacological Group

Topical corticosteroids for external use

Pharmacotherapeutic Group

Corticosteroids used in dermatology; corticosteroids; high-potency corticosteroids (group III)

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 during external use is insignificant.

Eight hours after application to intact skin (without an occlusive dressing), 0.7% of mometasone is detected in the systemic bloodstream.

Indications

Inflammatory reactions and itching in dermatoses amenable to glucocorticosteroid therapy.

ICD codes

Dosage Regimen

Apply a thin layer of ointment to the affected skin area once daily.

Gently rub in the ointment until fully absorbed. Do not apply under occlusive dressings unless specifically directed by a physician.

The duration of treatment depends on the specific dermatosis and therapeutic response. Limit continuous use to two weeks for plaque psoriasis and three weeks for eczematous dermatoses unless otherwise prescribed.

For pediatric patients aged 2 years and older, use the minimum effective amount for the shortest duration necessary. Avoid long-term continuous therapy in children.

Discontinue treatment after control of symptoms is achieved. If no improvement is seen within one week, re-evaluate the diagnosis.

To prevent relapse, taper use gradually after prolonged therapy by applying the ointment less frequently before complete cessation.

Avoid application to the face, axillae, and groin unless prescribed. Do not use in the eyes or on mucous membranes.

Wash hands thoroughly after application unless the hands are the treated area.

Adverse Reactions

Infections and infestations – rarely – folliculitis, secondary infection.

Skin and subcutaneous tissue disorders – rarely – skin irritation and dryness, burning sensation, itching, hypertrichosis, acne, 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 established – paresthesia.

When using external forms of glucocorticosteroids for a long time and/or for treating large areas of the skin, or when using 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 infection; 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 taken into account that glucocorticosteroids can alter the manifestations of some skin diseases, which may complicate 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 for the systemic use of glucocorticosteroids, including adrenal suppression, can also occur with external use, 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 disturbances 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 30°C (86°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.