Description
Release form
Cream for external use, white, homogeneous.
Packaging
Aluminum tube 15 ml. Carton packaging.
Pharmacological action
Mometasone – a synthetic glucocorticosteroid (GCS). It has anti-inflammatory, antipruritic and antiexudative effects.
GCS induces the release of proteins that inhibit phospholipase A2 and are commonly 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, and reduces the rate of infiltration and granulation.
Reduces inflammation by reducing the formation of chemotaxis substance (effect 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 old with allergic dermatitis, the therapeutic effect is manifested in 3 weeks.
Indications
Inflammation and itching of the skin with dermatoses (including psoriasis, atopic dermatitis, seborrheic dermatitis), in which GCS therapy is indicated.
Contraindications
– rosacea, perioral dermatitis
– bacterial, viral (Herpes simplex, chickenpox, Herpes zoster) or fungal infection of the skin
– tuberculosis, syrdilis
– 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 old
– hypersensitivity to any either a component of the drug or to other corticosteroids.
Precautions: application to the skin of the face and the intertriginous surface of the skin, the use of occlusive dressings, as well as the treatment of large areas of skin and / or prolonged treatment (especially in children).
Use during pregnancy and lactation
The safety of the use of mometasone furoate 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 a negative effect on the development of the fetus.
GCS is excreted in breast milk. When, when the use of GCS in large doses and / or for a long time is expected, breast-feeding should be stopped.
Special instructions
If there is no effect within 2 weeks of drug therapy, 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 the systemic effect of corticosteroids is possible.
Given this, it is necessary to control the function of the hypothalamic-pituitary-adrenal system. Avoid contact with eyes.
Propylene glycol, which is part of the composition, may cause irritation at the site of application. In such cases, you should stop using the drug and prescribe the appropriate treatment.
It should be borne in mind that corticosteroids can alter the manifestation of certain skin diseases, which may complicate the diagnosis. In addition, the use of corticosteroids can be a reason for the delay in wound healing.
With prolonged treatment with corticosteroids, a sudden cessation of therapy can lead to the development of rebound syndrome, which manifests itself in the form of dermatitis with intense reddening of the skin and a burning sensation. Therefore, after a long course of treatment, discontinuation of the drug should be carried out gradually, for example, switching to an intermittent treatment regimen before it is completely discontinued.
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 the development of Itsenko-Cushing’s syndrome with the use of any local corticosteroids. Long-term treatment of children with corticosteroids can 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 a minimum dose sufficient to achieve the effect.
Ingredients
Active ingredients:
mometasone furoate – 1 mg
Excipients:
emulsion wax – 0.095 g,
sodium citrate – 0.001 g,
paraffin liquid – 0.03566 g, srdlplgpr 0.1 gpfp 0.06 gpp g,
chlorocresol – 0.001 g,
cetomacrogol – 0.002 g,
water – up to 1 g
Dosage and administration of
Outwardly
A thin layer of the drug is applied to the affected skin once a day.
Duration of treatment: 7-28 days, determined by the effectiveness of therapy, as well as patient tolerance, the presence and severity of side effects.
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 probability of the occurrence of these adverse events increases with the use of occlusive dressings.
Systemic effect: when applying external forms of corticosteroids for a long time and / or to treat large areas of the 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 for GCS systemic effects, including adrenal insufficiency and Itsenko-Cushing’s syndrome.
Drug Interactions
Not detected.
Overdose
Symptoms: Depression of function of hypothalamic-pituitary-adrenal system (incl. secondary adrenal insufficiency).
Treatment: symptomatic. If necessary – correction of electrolyte imbalance, withdrawal of the drug (with long-term therapy – gradual withdrawal).
Storage conditions
At a temperature not exceeding 25 ° C.
Do not freeze.
Keep out of the reach and sight of children.
Shelf life
3 years.
Active substance
Mometasone
Terms and conditions
prescription
dosage form
cream
Possible product names
GISTAN-N 0.1% CREAM TUBE 15 G
GISTAN-NRE 15% GERMAN-KRE 15% GDR-1 -H cream 15 ml
Oxford Laboratories Pvt. Ltd., India
