Mometasone-Akrikhin (Cream) Instructions for Use

Marketing Authorization Holder

Akrikhin Chemical and Pharmaceutical Plant, JSC (Russia)

ATC Code

D07AC13 (Mometasone)

Active Substance

Mometasone (Rec.INN registered by WHO)

Dosage Form

Mometasone-Akrikhin

Cream for external use 0.1%: tubes 15 g or 30 g

Dosage Form, Packaging, and Composition

Cream for external use white or almost white in color.

Excipients: hexylene glycol – 12 g, glyceryl monostearate 40-55 – 5.5 g, cetearyl alcohol – 5.5 g, peg cetearyl ether (macrogol 20 cetyl/stearyl ether) – 4 g, white beeswax – 5 g, titanium dioxide – 1 g, aluminum starch octenylsuccinate – 10 g, purified water – 1.8 g, diluted phosphoric acid or concentrated orthophosphoric acid as a 10% solution – 1.2 g, petrolatum – up to 100 g.

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

Topical corticosteroid. It has anti-inflammatory, antipruritic, and anti-exudative effects. Corticosteroids 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

The absorption of the drug when applied topically is insignificant. 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 corticosteroid therapy.

ICD codes

Dosage Regimen

Apply a thin layer of cream to the affected skin areas once daily.

Gently rub in the cream until it is fully absorbed. Avoid application to the eye area.

The duration of treatment depends on the specific dermatosis and patient response. Do not use for more than two weeks without medical supervision.

For pediatric patients aged 2 years and older, use the minimum effective amount for the shortest duration necessary. Limit application to the smallest possible skin area.

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

For severe or extensive conditions, initiate therapy under close medical supervision. Avoid occlusive dressings unless specifically directed by a physician.

When treating intertriginous areas or the face, use extreme caution and limit application to a few days.

To prevent recurrence, gradually reduce the frequency of application before complete discontinuation after prolonged use.

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 topical corticosteroids for a long time and/or for treating large areas of skin, or with the use of occlusive dressings, especially in children and adolescents, side effects characteristic of systemic corticosteroids 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 should be applied to the skin of the face and intertriginous skin, use occlusive dressings, and also apply to large areas of 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 skin for a long time, especially when using occlusive dressings, the development of systemic effects of corticosteroids 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 corticosteroids can alter the manifestations of some skin diseases, which may complicate the diagnosis. In addition, the use of corticosteroids can cause delayed wound healing.

During long-term corticosteroid therapy, sudden discontinuation of therapy can lead to the development of a rebound syndrome, manifested in the form of 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 corticosteroids, 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 corticosteroids. Long-term use of corticosteroids in children can lead to disturbances in their growth and development.

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

Storage Conditions

Store at 15°C (59°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.