Composition
A 100 g ointment contains:
Active ingredient: mometasone furoate - 0.10 g;
Excipients: paraffin (soft white paraffin), white beeswax, propylene glycol monostearate.
Pharmacological action
Pharmacotherapeutic group: glucocorticosteroid for topical use.
Pharmacodynamics
Mometasone furoate is a synthetic glucocorticosteroid (GKS) with anti-inflammatory, antipruritic and antiexudative effects.
GCS induce 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.
Pharmacokinetics .
When applied topically there is little absorption of mometasone. About 0.7% of the glucocorticosteroid can be detected in the systemic blood flow 8 hours after application to intact skin (without an occlusive dressing).
Indications
Inflammatory phenomena and pruritus in dermatoses amenable to glucocorticosteroid therapy.
Administration during pregnancy and lactation
The safety of using mometasone during pregnancy has not been studied. External administration of glucocorticosteroids in pregnant animals may cause fetal abnormalities. No relevant data have been established in humans. The use of Momeyd during pregnancy is allowed only when the expected benefit to the mother outweighs the risk to the fetus. In such cases, the use of the drug should be of short duration, limited to small skin areas and under medical supervision.
It is not known whether topical GCS penetrate into the mother's milk. A decision should be taken to discontinue breastfeeding or to withdraw the drug, taking into account the need for its administration to the mother. Breast-feeding should be stopped if high doses and/or prolonged use of GCSs are suspected.
Contraindications
- Hypersensitivity to mometazone, to other glucocorticosteroids or to any component of the drug;
- Pink acne, perioral dermatitis;
- Bacterial, viral (herpes virus, chickenpox) or fungal skin infections;
- Tuberculosis, syphilis;
- Postvaccination reactions;
- Pregnancy (application to large areas of skin, prolonged treatment);
- Breastfeeding (high dose or/and prolonged use);
- Childhood under 2 years of age (due to insufficient data);
- Acne, skin atrophy, perianal and genital itching, do not apply to wounds, ulcers.
Caution
- Application to the face and intertriginous skin, application of occlusive dressings, as well as application to large areas of skin and/or prolonged treatment (especially in children);
- Prolonged treatment with GCS.
Side effects
Classification of adverse reactions by organs and systems with indication of the frequency of occurrence:
Very common (≥1/10); common (≥1/100, < 1/10); infrequent (≥1/1000, < 1/100); rare (≥1/10000, < 1/1000); very rare (< 1/10000), including individual reports, frequency unknown (frequency cannot be estimated from available data)
Infectious and parasitic diseases:
Very rare Folliculitis
Frequency unknown Secondary infection, furunculosis
Nervous system disorders:
Very rare Burning sensation
Frequency unknown Paresthesias
Skin and subcutaneous tissue disorders:
Very rare Urticaria
Frequently unknown Contact dermatitis, pigmentation changes, hypertrichosis, acneiform dermatitis, local skin atrophy
General disorders and disorders at the injection site: Frequency unknown Pain at the application site, skin reactions at the application site
Visual disturbances: Frequency unknown Blurred vision
Prolonged use of GCS for external application in high doses or application to large areas of skin may be accompanied by systemic absorption with development of symptoms: dry skin, dermatitis, perioral dermatitis, maceration of skin, atrophic skin changes, such as thinning of skin, appearance of atrophic strips (stretch marks), telangiectasia.
Compared to adult patients, children may have a higher degree of absorption of topical GCS and are therefore more at risk of systemic side effects. This is due to the fact that children have an immature skin barrier and a higher body surface area to body weight ratio. In children who have taken GCS for external use, the following side effects have been observed: suppression of hypothalamic-pituitary-adrenal system, Icenko-Cushing's syndrome, stunting, delayed weight gain, increased intracranial pressure.
Interaction
No interaction of the drug Momaid with other drugs has been registered.
How to take, course of treatment and dosage
Externally.
A thin layer of Momeyd is applied to the affected areas of skin once a day. The duration of treatment is determined by its effectiveness, as well as the patient's tolerability and the presence and severity of side effects. When using the drug on the face, on areas with thin skin, as well as in children, application of the drug should be in the minimum amount to ensure the therapeutic effect. The course of treatment should be limited to 5 days.
Overdose
Symptoms: suppression of hypothalamic-pituitary-adrenal system function, including secondary adrenal insufficiency.
Treatment: symptomatic, if necessary - correction of water-electrolyte balance, withdrawal of the drug (in case of long-term therapy - gradual withdrawal).
Special directions
When applied to large skin areas for a long time, especially when using occlusive dressings, systemic action of GKS may develop.
Patients should therefore be monitored for signs of hypothalamic-pituitary-adrenal system suppression and the development of Itzenko Cushing's syndrome.
Eye contact with Momeyd should be avoided.
Propylene glycol monostearate contained in the product may cause irritation at the application site. In such cases, the product should be discontinued and appropriate treatment should be prescribed.
It should be borne in mind that GCS may alter the appearance of some skin conditions, which may make it difficult to make a diagnosis. In addition, the use of GCS may delay wound healing.
With prolonged use of GCS, abrupt discontinuation of treatment may lead to ricochet syndrome, which manifests as dermatitis with intense redness and burning sensation of the skin. Therefore, after a long course of treatment, withdrawal should be done gradually, e.g. by changing to an intermittent regimen before stopping the treatment completely.
Visual disturbances may occur with systemic, external and local (including intranasal, inhalation and intraocular) use of GCS. If symptoms such as blurred vision or other visual disturbances are present, the patient should be advised to consult an ophthalmologist for possible causes of visual disturbances, including cataract, glaucoma or rare conditions such as central serous chorioretinopathy (CCS), which have been observed in some cases with systemic, external and topical use of GCS.
Any of the side effects described with systemic glucocorticosteroids, including suppression of adrenal function, may also occur with topical and topical use, especially in children.
GCS should be used with caution in the treatment of psoriasis, as relapses, drug tolerance, risk of generalised pustular psoriasis and local or systemic toxic reactions due to skin barrier failure have been reported in individual cases. In case of secondary infection, appropriate antibiotic therapy should be given. In case of any signs of spreading infection, the external application of GCS should be discontinued and appropriate antibacterial or antifungal treatment should be given. If signs of skin hypersensitivity or irritation associated with the use of the product are noted, treatment should be discontinued and a doctor consulted. On the face, more often than on other body surfaces, atrophic changes may occur after long-term treatment with topical GCS; the course of treatment in this case should not exceed 5 days. Use with caution in persons with existing atrophic skin changes, especially in the elderly. Caution must be exercised when applying to the face, folds, natural bends and areas of thin skin.
Application in paediatrics
Due to the fact that children have a greater surface area to body weight ratio than adults, children have a higher risk of hypothalamic-pituitary-adrenal suppression and development of Icenko-Cushing syndrome with any topical GCS. Prolonged treatment of children with GCSs may result in growth and developmental abnormalities.
Children should receive the minimum dose of the drug that is sufficient to achieve an effect.
Prolonged use in children should be supervised by a doctor. The course of treatment in children should not exceed 5 days. Occlusive dressings should not be used.
Effect of the drug on the ability to drive vehicles, mechanisms
No effect of the drug Momaid on the ability to drive vehicles or operate moving mechanisms has been observed.
Studies on the effect of mometazone on the ability to drive vehicles, mechanisms have not been carried out. Patients should be warned about the possibility of blurred vision. In case of the occurrence of the above undesirable phenomenon, it is necessary to refrain from such activities.
Form release
Ointment for external use 0.1% 15 g in aluminium tubes. Each tube, along with instructions for use, is placed in a cardboard box.
The storage condition
From 2℃ to 25℃.
Do not freeze.
Active ingredient
Mometasone
