Mometasone

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT MOMETASONE (MOMETASONE)

Composition:

Active substance: mometasone;

1 g of the preparation contains 1 mg of mometasone furoate;

Excipients: hexylene glycol, concentrated phosphoric acid, glycerol monostearate, white wax, white soft paraffin, purified water.

Pharmaceutical form. Ointment.

Main physico-chemical properties: white or almost white opaque ointment, free from foreign inclusions.

Pharmacotherapeutic group. Corticosteroids for topical use in dermatology. ATC code D07AC13.

Pharmacological properties.

Pharmacodynamics.

Mometasone furoate is a synthetic glucocorticosteroid for topical use with anti-inflammatory, antipruritic, and anti-exudative effects.

Pharmacokinetics.

Pharmacokinetic studies have shown that systemic absorption after topical application of 0.1% mometasone furoate is minimal; approximately 0.4% of the applied dose is excreted from the body within 72 hours after application. Identifying the nature of metabolites was nearly impossible due to the small quantities present in blood plasma and excreta.

Clinical characteristics.

Indications.

Inflammatory manifestations and pruritus in dermatoses amenable to corticosteroid therapy, including psoriasis (except generalized plaque psoriasis) and atopic dermatitis, in adults and children aged 2 years and older.

Contraindications.

Rosacea, vulgaris acne, skin atrophy, perioral dermatitis, perianal and genital pruritus, diaper rash, bacterial (e.g., impetigo, pyoderma), viral (e.g., herpes simplex, herpes zoster, varicella, common warts, genital warts, molluscum contagiosum), parasitic, and fungal (e.g., candidiasis or dermatophytosis) infections, tuberculosis, syphilis, or postvaccination reactions. The medicinal product should not be applied to wounds or ulcerated skin. The medicinal product is contraindicated in patients with hypersensitivity to any of its components or to other glucocorticosteroids.

Interaction with other medicinal products and other forms of interaction.

Not established.

Special precautions for use.

If irritation or sensitization occurs, the use of the medicinal product should be discontinued and appropriate treatment initiated.

In case of development of concomitant skin infection, appropriate antifungal or antibacterial agents should be used. If positive response is not achieved within a short period of time, application of the medicinal product should be discontinued until the infection is completely resolved.

Systemic absorption following topical application of various glucocorticosteroids may result in reversible suppression of the hypothalamic-pituitary-adrenal (HPA) axis, with potential glucocorticosteroid insufficiency after discontinuation of treatment. In some patients, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria may occur.

Patients receiving topical steroids over large areas of skin or under occlusive dressings should be monitored periodically for evidence of HPA axis suppression. Such monitoring may include performing an adrenocorticotropic hormone (ACTH) stimulation test, measuring plasma cortisol levels in the morning, and in other media except urine.

Any adverse reactions associated with systemic corticosteroid use, including suppression of adrenal cortex function, may also occur with topical application of glucocorticosteroids, especially in children.

Children should not be treated with this product under occlusive dressings. Occlusive dressings should not be applied to the face. The ointment must be avoided from contact with mucous membranes.

Topical steroids may be hazardous in psoriasis for several reasons, including relapses following development of tolerance, risk of generalized pustular psoriasis, and development of local or systemic toxicity due to impaired skin barrier function. When using the product in psoriasis, careful patient monitoring is essential.

Abrupt discontinuation after prolonged therapy may lead to rebound phenomenon presenting as dermatitis with intense redness, irritation, and burning. This can be prevented by gradual withdrawal of the drug, for example, intermittent treatment until complete cessation.

Glucocorticoids may alter the signs of some skin lesions and complicate diagnosis, thereby delaying recovery.

The medicinal product is not intended for ophthalmic use, particularly not for application on eyelids. Contact of the product with eyes must be avoided.

Visual disturbances may occur with both systemic and topical corticosteroids (including intranasal, inhaled, and intraocular administration). If symptoms such as blurred vision or other visual disturbances occur, the patient should be referred for ophthalmological examination to evaluate possible causes, including cataract, glaucoma, or rare conditions such as central serous chorioretinopathy, which has been reported after systemic and topical corticosteroid use.

Use during pregnancy or breastfeeding.

During pregnancy or breastfeeding, treatment with this product should be used only as directed by a physician. Even then, application over large areas of skin or for prolonged periods should be avoided. There are insufficient data on the safety of this product in pregnant women. As with other topical glucocorticosteroids, this medicinal product should be used in pregnant women only if the potential benefit to the mother outweighs the potential risk to the fetus.

It is not known whether topical application of corticosteroids results in sufficient systemic absorption to allow detection of the drug in breast milk. This medicinal product should be used during breastfeeding only after careful assessment of the benefit-risk ratio. If treatment with high doses or for prolonged periods is required, breastfeeding should be discontinued.

Ability to influence reaction rate while driving or operating machinery.

Not established.

Dosage and Administration.

Apply the ointment as a thin layer to affected skin areas once daily. The duration of treatment is determined individually, depending on the severity and course of the disease.

The use of topical corticosteroids in children and on the face should be limited to the minimum amount required to achieve therapeutic efficacy, and the treatment duration should not exceed 5 days.

Children.

The drug is indicated for children aged 2 years and older only under medical supervision.

Due to a higher surface area to body mass ratio in children compared to adults, they are more susceptible to suppression of the hypothalamic-pituitary-adrenal (HPA) axis and Cushing's syndrome when using any topical corticosteroids, especially when applied to areas exceeding 20% of the body surface.

It is recommended to use the smallest amount of glucocorticosteroids necessary to achieve the therapeutic effect, particularly in children. The treatment course should not exceed 5 days. Prolonged treatment with glucocorticosteroids may impair growth and development in children.

The safety of using the drug in children for longer than 6 weeks has not been established.

There are only limited data on the treatment of children under 2 years of age.

Mometasone should not be used for the treatment of diaper dermatitis.

The ointment should not be applied under occlusive dressings unless specifically directed by a physician, and should not be applied to areas under non-breathable diapers or pants.

Overdose.

Excessive prolonged use of topical corticosteroids may suppress the hypothalamic-pituitary-adrenal (HPA) axis function, potentially leading to secondary adrenal insufficiency, which is usually reversible.

In case of such suppression, the application interval should be increased, a less potent glucocorticosteroid should be used, or the drug should be discontinued.

The steroid content in each container is so small that in the unlikely event of accidental ingestion, the toxic effect would be negligible or absent.

Adverse Reactions

The adverse reactions reported in connection with the use of the medicinal product, by system organ class and frequency, are listed below: very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1000, < 1/100); rare (≥ 1/10,000, < 1/1000); very rare (< 1/10,000); frequency not known (cannot be estimated from the available data).

Infections and infestations: very rare – folliculitis; frequency not known – infections, furuncles.

Nervous system disorders: very rare – burning sensation; frequency not known – paraesthesia.

Skin and subcutaneous tissue disorders: very rare – pruritus; frequency not known – contact dermatitis, skin hypopigmentation, hypertrichosis, skin atrophic striae, acneiform dermatitis, skin atrophy.

Eye disorders: frequency not known – blurred vision (see also section "Dosage and Administration").

General disorders and administration site conditions: frequency not known – pain at application site, reactions at application site.

Local adverse reactions uncommonly reported with topical dermatological corticosteroids include: dryness and irritation of the skin, dermatitis, perioral dermatitis, maceration of the skin, enlargement of the affected area, exacerbation of allergic manifestations, erythema, striae, miliaria, and telangiectasias, papular, pustular eruptions, and sensation of pricking.

Shelf life. 2 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of the reach and sight of children.

Packaging.

15 g in a tube in a carton.

Prescription status. Prescription only.

Manufacturer. LIMITED LIABILITY COMPANY "CORPORATION "ZDOROVYA".

Manufacturer's address and location of manufacturing activities.

Ukraine, 61013, Kharkiv region, city of Kharkiv, Shevchenka Street, building 22

(all stages of manufacturing, quality control, batch release).

Ukraine, 08301, Kyiv region, city of Boryspil, Shevchenka Street, building 100, letter B-II (corpus 4)

(all stages of manufacturing, batch release).