Instruction for use: Momate

Active substance Mometasone

ATX Code D07AC13 Mometasone

Pharmacological group

Glucocorticosteroid for topical use [Glucocorticosteroids]

Nosological classification (ICD-10)

L29 Itching

Itching with partial obstruction of the biliary tract, Dermatitis itchy, Dermatosis with persistent itching, Other itching dermatoses, Itching dermatoses, Itching allergic dermatosis, Itching dermatitis, Itching itch, Excruciating itching, Severe itching, Endogenous itching, Skin itching with dermatosis, Limited itching dermatitis, Itching of the skin, Itchy scalp, Itching eczema

L30.9 Dermatitis, unspecified

Allergic dermatoses complicated by a secondary bacterial infection, Anal eczema, Bacterial maturation, Varicose Eczema, Venous dermatitis, Inflammation of the skin, Inflammation of the skin upon contact with plants, Inflammatory Skin Diseases, Inflammatory skin reactions, Inflammatory processes of the skin, Hypostatic dermatitis, Fungal Eczema, Fungal dermatosis, Dermatitis, Dermatitis is stagnant, Dermatitis and eczema in the anal area, Dermatitis acute contact, Perianal dermatitis, Dermatosis, Dermatosis of the scalp, Dermatosis of psoriasis, Dermatosis with persistent itching, Dermatoses, Dermatoses itchy, Other itching dermatoses, Significant eczematous manifestations, Itching with, dermatoses, Itching eczema, True eczema, Skin reaction to insect bites,Skin itching with dermatosis, Constitutional eczema, Weeping eczema, Drowsing inflammatory skin disease, Dying Infectious-Inflammatory Skin Disease, Non-allergic dermatitis, Nummular eczema, Acute contact eczema, Acute inflammatory skin disease, Acute dermatosis, Acute severe dermatosis, Perianal dermatitis, Superficial dermatosis, Subacute Contact Eczema, Simple dermatitis, Occupational dermatitis, Psychogenic dermatosis, Bubble dermatitis of newborns, Pustular eruptions, Irritation and redness of the skin, Low-flammable eczema, Dry atrophic eczema, Dry eczema, Toxic dermatitis, Ear eczema like dermatitis, Chronic eczema, Chronic dermatosis, Chronic common dermatosis, Scaly papular dermatosis, Eczema, Eczema anal region, Eczema of the hands, Eczema Contact, Eczema lichenized, Eczema Nummular, Eczema acute, Eczema acute contact, Eczema subacute, Eczematous dermatitis, Eczema-like rashes, Ecome exogenous, Endogenous eczema, Gluteal dermatitis, Restricted itchy dermatitis

Composition

Cream for external use 100 g

active substance:

Mometasone furoate 0.1 g

Auxiliary substances: paraffin (soft white); Beeswax white; Propylene glycol monostearate; Stearyl alcohol; Cetomacrogol; Propylene glycol; Methylparahydroxybenzoate; Propyl parahydroxybenzoate; purified water

Ointment for external use 100 g

active substance:

Mometasone furoate 0.1 g

Auxiliary substances: paraffin (soft white); Beeswax white; Propylene glycol monostearate

Description of dosage form

Cream: white.

Ointment: white.

pharmachologic effect

Pharmacological action - antipruritic, glucocorticoid, anti-inflammatory local.

Pharmacodynamics

Mometasone is a synthetic SCS (glucocorticosteroids), which possesses an anti-inflammatory, antipruritic and antiexudative action. SCS induces the release of proteins that inhibit phospholipase A2 and are known collectively as lipocortins that control the biosynthesis of inflammatory mediators such as PG (prostaglandins) and RT (leukotrienes) by inhibiting the release of their common precursor, arachidonic acid.

Pharmacokinetics

Absorption is negligible. After 8 hours after a single application on the intact skin (without occlusive dressing), about 0.4% (cream) and 0.7% (ointment) of the active substance are found in the systemic circulation. Mometasone is extensively metabolized in the liver, excreted mainly by the kidneys and in an insignificant amount with bile. T1 / 2 is approximately 5.8 hours (ointment).

Indications

Cream for external use

Inflammation and itching in dermatoses that respond to GCS (glucocorticosteroids) -therapy.

Ointment for external use

Inflammation and itching in dermatoses (psoriasis, atopic dermatitis, seborrheic dermatitis), amenable to GCS therapy in adults and children over 2 years.

Contraindications

Hypersensitivity to any component of the drug or SCS;

Pink acne, perioral dermatitis;

Bacterial, viral (Herpes simplex, chicken pox, Herpes zoster) or fungal skin infection;

Tuberculosis, syphilis;

Postvaccinal reactions;

Pregnancy (treatment of extensive skin areas, long-term treatment);

Lactation period (use in large doses and / and for a long time);

Children's age to 2 years (ointment).

With caution: apply to face and intertriginous skin, apply occlusive dressings, and also treat large areas of the skin and / or prolonged treatment (especially in children).

pregnancy and lactation

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

GCS penetrate the placental barrier. Long-term treatment and use of large doses during pregnancy should be avoided due to the threat of adverse effects on fetal development.

GCS is excreted in breast milk. In the event that the use of GCS is expected in large doses and / or for a long time, breastfeeding should be discontinued.

Side effects

Rarely - irritation and dry skin, burning sensation, itching, folliculitis, hypertrichosis, acne, hypopigmentation, perioral dermatitis, allergic contact dermatitis, skin maceration, secondary infection, signs of skin atrophy, striae, sweating. Less than 1% of cases - the formation of papules, pustules.

When external forms of SCS are used for a long time and / or for the treatment of large areas of the skin, or with the use of occlusive dressings, especially in children and adolescents, there may be side effects characteristic of SCS of systemic action, including adrenal insufficiency and Cushing's syndrome.

Interaction

Studies of interaction with other drugs have not been conducted.

Dosing and Administration

External, a thin layer of cream or ointment Momat put on the affected skin areas 1 time per day.

The duration of the course of treatment is determined by its effectiveness, as well as the patient's tolerance, the presence and severity of side effects.

Overdose

Symptoms: oppression of the hypothalamic-pituitary-adrenal system, including secondary adrenal insufficiency.

Treatment: symptomatic, if necessary - correction of electrolyte imbalance, drug withdrawal (with prolonged therapy - gradual abolition).

special instructions

When applied to large areas of the skin for a long time, especially when using occlusive dressings, it is possible to develop a systemic action of GCS. Given this, patients should be observed in terms of signs of suppression of the hypothalamic-pituitary-adrenal system and the development of Cushing's syndrome.

Avoid contact with the drug Momat in the eyes.

Propylene glycol, which is part of the preparation, may cause irritation at the site of application. In such cases, the use of the Momat drug should be stopped and appropriate treatment should be prescribed.

It should be borne in mind that the GCS can change the manifestations of certain skin diseases, which can make it difficult to diagnose. In addition, the use of GCS may be a cause of delayed wound healing.

With prolonged therapy with SCS, sudden discontinuation of therapy can lead to the development of a rebound syndrome, manifested in the form of dermatitis with intense reddening of the skin and a burning sensation. Therefore, after a long course of treatment, the drug should be canceled gradually, for example by switching to an intermittent scheme before the treatment is completely discontinued.

Application in pediatrics. Due to the fact that the ratio of surface area and body weight is greater in children than in adults, children are at greater risk of suppressing the function of the hypothalamic-pituitary-adrenal system and the development of Cushing's syndrome with any local GCS. Long-term GCS treatment of children can lead to disruption of their growth and development. Children should receive a minimum dose of the drug sufficient to achieve the effect.

Form of issue

Cream for external use, 0,1%. In an aluminum tube having a nozzle with a closed end, with a lid having a point for piercing, 5 or 15 g. Each tube is in a cardboard bundle.

Ointment for external use, 0.1%. In an aluminum tube having a nozzle with a closed end, with a lid having a point for piercing, 5 or 15 g. Each tube is in a cardboard bundle.

Terms of leave from pharmacies

On prescription.

storage Conditions

In dry, the dark place at a temperature of no higher than 25 ° C. Do not freeze.

Keep out of the reach of children.