Gistan-N cream 0.1%, 15 ml

Mometasone is a synthetic glucocorticosteroid (GCS). It has anti-inflammatory, antipruritic and anti-exudative effects.

The GCS induces the release of phospholipase A2 inhibitory proteins collectively known as lipocortins, which control the biosynthesis of inflammatory mediators such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid.

Prevents marginal accumulation of neutrophils, which reduces inflammatory exudate and cytokine production, inhibits macrophage migration, leads to a decrease in infiltration and granulation processes.

It reduces inflammation due to decrease in formation of chemotaxis substance (effect on “late” allergic reactions) and inhibits development of “immediate” allergic reaction (conditioned by inhibition of production of arachidonic acid metabolites and decrease in release of inflammatory mediators from mast cells).

In case of daily application of the cream in children over 2 years old with allergic dermatitis the therapeutic effect is seen within 3 weeks.

Indications

Active ingredient

Composition

Active substances:

mometasone furoate – 1 mg

Auxiliary substances:

emulsion wax – 0.095 g,

sodium citrate – 0.001 g,

liquid paraffin – 0.03566 g,

soft white paraffin – 0.18564 g,

propylene glycol – 0.06 g,

Chlorocresol – 0.001 g,

Cetomacrogol – 0.002 g,

water – up to 1 g.

How to take, the dosage

Externally

A thin layer of the drug is applied to the affected areas of the skin once a day.

The duration of treatment: 7-28 days, determined by the effectiveness of therapy, as well as the patient’s tolerance of the drug and the presence and severity of side effects.

Special Instructions

If there is no effect within 2 weeks of therapy with the drug, the diagnosis should be clarified.

The development of systemic GCS action is possible when applied to large areas of skin over long periods of time, especially when using occlusive dressings.

Hypothalamic-pituitary-adrenal function should be monitored. Eye contact with the drug should be avoided.

Propylene glycol in the product may cause irritation at the application site. In these cases, discontinue use and appropriate treatment should be administered.

Please note that GCS may change the expression of certain skin conditions, which may make it difficult to diagnose. In addition, use of GCS may delay healing of wounds.

Long-term use of GCS may cause rebound syndrome with intense redness and burning sensations in the form of dermatitis.

This is why withdrawal should be done gradually after a long course of treatment, e.g., by switching to an intermittent regimen before stopping treatment completely.

Pediatric use

. Because children have a greater surface area to body weight ratio than adults, they are at greater risk of suppression of hypothalamic-pituitary-adrenal function and development of Icenko-Cushing’s syndrome with any topical GCS. Prolonged treatment of children with GCS may result in impairment of their growth and development. The use of the drug in children for more than 3 weeks has not been studied.

Children should receive the minimum dose of the drug sufficient to achieve an effect.

Features

The absorption of Gistan-N cream is low.

In 8 hours after application on intact skin (without occlusive dressing) about 0.4% of the dose is found in the systemic bloodstream.

The absorption increases with inflammation and skin damage.

Contraindications

– pink acne, perioral dermatitis;

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

– tuberculosis, syphilis;

– post-vaccine reactions;

– pregnancy (treatment of large areas of skin, long-term treatment);

– lactation (use in high doses or/and over a long period of time);

– children under 2 years of age;

– hypersensitivity to any component of the drug or other GKS.

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

Side effects

Local reactions: burning, itching, paresthesias, folliculitis, acne, skin atrophy, hypertrichosis, hypopigmentation, perioral dermatitis, allergic contact dermatitis, skin maceration, accession of secondary infection, stretch marks, sweat.

The likelihood of these adverse events increases with the use of occlusive dressings.

Systemic effects: When external forms of GCS are used for prolonged periods and/or to treat large areas of skin (total application area greater than the patient’s palm area), or with the use of occlusive dressings, especially in children and adolescents, side effects characteristic of systemic GCS may occur, including adrenal insufficiency and Itzenko-Cushing’s syndrome.

Overdose

Symptoms: depression of hypothalamic-pituitary-adrenal system function (including secondary adrenal insufficiency).

Treatment:symptomatic. If necessary – correction of electrolyte imbalance, withdrawal of the drug (with prolonged therapy – gradual withdrawal).

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