Gistan-H (Cream) Instructions for Use

Marketing Authorization Holder

Oxford Laboratories, Pvt. Ltd. (India)

ATC Code

D07AC13 (Mometasone)

Active Substance

Mometasone (Rec.INN registered by WHO)

Dosage Form

Gistan-H

Cream for external use 0.1%: tubes 5 g or 15 g

Dosage Form, Packaging, and Composition

Cream for external use white, homogeneous.

Excipients : emulsifying wax – 0.095 g, sodium citrate – 0.001 g, liquid paraffin – 0.03566 g, white soft paraffin – 0.18564 g, propylene glycol – 0.06 g, chlorocresol – 0.001 g, cetomacrogol – 0.002 g, water – up to 1 g.

5 g – aluminum tubes (1) – cardboard packs.
15 g – aluminum tubes (1) – cardboard packs.

Clinical-Pharmacological Group

Topical corticosteroids for external use

Pharmacotherapeutic Group

Topical glucocorticosteroid

Pharmacological Action

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

GCS induces the release of proteins that inhibit phospholipase A₂ and are 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.

It prevents the marginal accumulation of neutrophils, which reduces inflammatory exudate and cytokine production, inhibits macrophage migration, and leads to a reduction in infiltration and granulation processes. It reduces inflammation by decreasing the formation of chemotaxis substances (affecting ‘late’ allergic reactions) and inhibits the development of an ‘immediate’ allergic reaction (due to inhibition of arachidonic acid metabolite production and reduced release of inflammatory mediators from mast cells).

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

Pharmacokinetics

The absorption of Gistan-H cream is low. Eight hours after application to intact skin (without an occlusive dressing), about 0.4% of the dose is detected in the systemic bloodstream. Absorption increases with inflammation and skin damage.

Indications

• Skin inflammation and itching in dermatoses (including psoriasis, atopic dermatitis, seborrheic dermatitis) where GCS therapy is indicated.

ICD codes

Dosage Regimen

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

The standard treatment duration is 7 to 28 days.

Adjust the duration based on therapeutic response and patient tolerance.

Do not use on large body surface areas or under occlusive dressings unless directed by a physician.

For pediatric patients (2 years and older), use the minimum effective dose for the shortest possible duration.

Avoid application on the face, intertriginous areas, and broken skin unless specifically indicated.

Discontinue treatment if skin irritation occurs.

If no clinical improvement is observed within two weeks, re-evaluate the diagnosis.

After prolonged use, withdraw the drug gradually to prevent rebound dermatitis.

Adverse Reactions

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

The likelihood of the listed adverse events 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 (total application area larger than the patient’s palm), or when using occlusive dressings, especially in children and adolescents, side effects characteristic of systemic GCS may occur, including adrenal insufficiency and Cushing’s syndrome.

Contraindications

• Rosacea, perioral dermatitis;
• Bacterial, viral (Herpes simplex, chickenpox, Herpes zoster) or fungal skin infection;
• Tuberculosis, syphilis;
• Post-vaccination reactions;
• Pregnancy (treatment of extensive skin areas, long-term treatment);
• Lactation period (use in large doses or/and for a long time);
• Children under 2 years of age;
• Hypersensitivity to any component of the drug or to other GCS.

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

Use in Pregnancy and Lactation

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

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

GCS are excreted in breast milk. If the use of GCS in large doses and/or for a long time is anticipated, breastfeeding should be discontinued.

Pediatric Use

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 development of Cushing’s syndrome with the use of any topical GCS. Long-term treatment of children with GCS may lead to impaired 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 the effect.

Special Precautions

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

When applied to large areas of the skin for a long time, especially when using occlusive dressings, the development of systemic effects of GCS is possible.

In view of this, it is necessary to monitor the function of the hypothalamic-pituitary-adrenal system. Avoid getting the drug into the eyes.

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

It should be borne in mind that GCS can change the manifestation of some skin diseases, which may complicate the diagnosis. Furthermore, the use of GCS can cause delayed wound healing.

With long-term GCS therapy, sudden discontinuation of therapy may 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.

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 development of Cushing’s syndrome with the use of any topical GCS. Long-term treatment of children with GCS may lead to impaired 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 the effect.

Overdose

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

Treatment symptomatic. If necessary – correction of electrolyte imbalance, discontinuation of the drug (with long-term therapy – gradual withdrawal).

Drug Interactions

Not identified.

Storage Conditions

At a temperature not exceeding 25°C (77°F). Do not freeze. Keep out of reach of children.

Shelf Life

Shelf life – 3 years.

Dispensing Status

By prescription.

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.