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

Inflammation and itching of the skin due to dermatoses (including psoriasis, atopic dermatitis, seborrheic dermatitis), for which GCS therapy is indicated.

Pharmacological effect

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

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 the marginal accumulation of neutrophils, which reduces inflammatory exudate and cytokine production, inhibits the migration of macrophages, and leads to a reduction in the processes of infiltration and granulation.

Reduces inflammation by reducing the formation of a chemotaxis substance (impact on “late” allergy reactions), inhibits the development of an “immediate” allergic reaction (due to inhibition of the production of arachidonic acid metabolites and a decrease in the release of inflammatory mediators from mast cells).

With daily application of the cream to children over 2 years of age with allergic dermatitis, the therapeutic effect appears within 3 weeks.

Special instructions

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

When applied to large areas of skin for a long time, especially when using occlusive dressings, systemic action of GCS may develop.

Given this, it is necessary to monitor the function of the hypothalamic-pituitary-adrenal system. Avoid contact of the drug with the eyes.

Propylene glycol contained in the composition may cause irritation at the site of application. In such cases, use of the drug should be discontinued and appropriate treatment should be prescribed.

It should be borne in mind that GCS can change the manifestation of some skin diseases, which can complicate the diagnosis. In addition, the use of corticosteroids may cause a delay in wound healing.

With long-term therapy with GCS, sudden cessation of therapy can lead to the development of rebound syndrome, manifested in the form of dermatitis with intense redness of the skin and a burning sensation.

Therefore, after a long course of treatment, drug withdrawal should be carried out gradually, for example, by switching to an intermittent treatment regimen before stopping it completely.

Use in pediatrics

Due to the fact that in children the ratio of surface area to body weight is greater than in adults, children are at greater risk of suppressing the function of the hypothalamic-pituitary-adrenal system and developing Cushing’s syndrome when using any topical corticosteroids. Long-term treatment of children with GCS can lead to disruption 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.

Active ingredient

Mometasone

Composition

Active substances:

mometasone furoate – 1 mg

Excipients:

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.

Contraindications

– rosacea, perioral dermatitis;

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

– tuberculosis, syphilis;

— post-vaccination reactions;

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

– lactation period (use in large doses and/or for a long time);

– children under 2 years of age;

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

With caution: application to the facial skin and intertriginous skin surface, use of occlusive dressings, as well as treatment of large areas of skin and/or long-term treatment (especially in children).

Side Effects

Local reactions: burning, itching, paresthesia, folliculitis, acne, skin atrophy, hypertrichosis, hypopigmentation, perioral dermatitis, allergic contact dermatitis, skin maceration, secondary infection, striae, prickly heat.

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

Systemic action: when using external forms of GCS for a long time and/or for treating large areas of skin (the total area of ​​application is greater than the area of ​​the patient’s palm), or using occlusive dressings, especially in children and adolescents, side effects characteristic of systemic GCS may occur, including adrenal insufficiency and Cushing’s syndrome.

Overdose

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

Treatment: symptomatic. If necessary, correct electrolyte imbalance, discontinue the drug (with long-term therapy, gradual withdrawal).

Functional features

Absorption of Gistan-N cream is low.

8 hours after application to intact skin (without an occlusive dressing), about 0.4% of the dose is found in the systemic circulation.

With inflammation and damage to the skin, absorption increases.

Storage conditions

At a temperature not exceeding 25 °C.

Do not freeze.

Keep out of the reach of children.

Shelf life

3 years

Manufacturer

Oxford Laboratories Pvt. Ltd., India