Moleskin ointment 0.1% tube 15 g

Pharmacodynamics. Mometasone furoate is a synthetic glucocorticosteroid that has anti-inflammatory effects. Like other topical corticosteroids, mometasone furoate has antipruritic, antiexudative and vasoconstrictive effects. In general, the mechanism of anti-inflammatory action of topical corticosteroids has not been elucidated. It is assumed that corticosteroids induce the release of proteins that inhibit phospholipase A2 and are known under the general name lipocortins. These proteins control the biosynthesis of such potent inflammatory mediators as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid.

Pharmacokinetics. The extent of penetration of mometasone furoate through the skin depends on various factors, including the composition of the drug and the integrity of the epidermal barrier. Studies conducted in humans have shown that about 0.4% of a dose applied to intact skin (without occlusive dressing) of 0.1% mometasone furoate cream / ointment was contained in the circulatory system after 8 hours. Inflammatory and other processes occurring in the skin can lead to increased penetration of the drug through the skin.

Inflammatory phenomena and pruritus in dermatoses amenable to corticosteroid therapy, including psoriasis (except widespread plaque psoriasis) and atopic dermatitis, in adults and children aged 2 years and older.

Apply a thin layer of Moleskin cream/ointment to the affected areas of the skin once a day. The duration of treatment is determined by the severity of the disease and is individual.

The use of topical corticosteroids in children and on the face should be limited to the minimum amount compared to effective therapeutic regimens, and the duration of treatment should not exceed 5 days.

Moleskin is contraindicated in rosacea, acne vulgaris, skin atrophy, perioral dermatitis, perianal and genital pruritus, diaper rash, bacterial (impetigo, pyoderma), viral (herpes simplex, herpes zoster and chickenpox, simple warts, acute condyloma, molluscum contagiosum), parasitic and fungal (candida or dermatophyte) infections, tuberculosis, syphilis or post-vaccination reactions. Moleskin should not be used on wounds or on ulcerated skin. The drug is contraindicated in patients with signs of hypersensitivity to any of its components or other corticosteroids.

Infections and infestations: folliculitis, infections, boils.

From the nervous system: burning sensation, paresthesia.

Skin and subcutaneous tissue disorders: pruritus, contact dermatitis, skin hypopigmentation, hypertrichosis, atrophic skin streaks, acneiform dermatitis, skin atrophy.

General disorders and administration site conditions: application site pain, application site reactions.

Propylene glycol, which is part of the drug, can cause skin irritation.

Local adverse reactions that have been reported infrequently in association with the use of topical dermatological corticosteroids include skin dryness and irritation, dermatitis, perioral dermatitis, skin maceration, increased lesion area, increased allergic manifestations, erythema, striae, telangiectasia, papular, pustular rashes, and tingling sensation.

Moleskin, cream/ointment for external use 0.1%, is not intended for use in ophthalmology. Do not allow the drug to get into the eyes.

As a result of systemic absorption, when various corticosteroids are used topically, reversible suppression of the hypothalamic-pituitary-adrenal axis may occur, as well as symptoms of glucocorticoid insufficiency after drug withdrawal. Cushing’s syndrome, hyperglycemia, and glycosuria may also develop.

Patients using topical corticosteroids for treatment of large areas of skin or using occlusive dressings should be periodically checked for signs of hypothalamic-pituitary-adrenal (HPA) suppression. This can be done by performing an ACTH stimulation test, measuring morning cortisol levels in plasma and in other media than urine. Occlusion should not be used in children or on the face. Contact of the cream/ointment with mucous membranes should be avoided.

Sometimes signs and symptoms of GCS insufficiency may appear, requiring additional use of systemic GCS. Unless prescribed by a doctor, the drug should not be applied to the face, as well as in the axillary and inguinal folds.

If irritation or sensitization occurs, mometasone furoate cream/ointment should be discontinued and appropriate treatment instituted. Allergic contact dermatitis with the use of the drug is usually diagnosed by the failure of treatment, rather than by clinical symptoms of exacerbation, as is done with topical non-glucocorticosteroid medications. This observation should be confirmed by patch testing.

In case of concomitant skin infection, an appropriate antifungal or antibacterial agent should be used. If positive dynamics are not achieved within a short time, the use of Moleskin cream/ointment should be discontinued until the infection is completely eliminated.

Abrupt discontinuation of long-term treatment may result in a rebound effect in the form of dermatitis with intense redness, irritation and burning. This can be prevented by gradual withdrawal, e.g. intermittent treatment, until complete discontinuation. Glucocorticoids may alter the appearance of some lesions and make the correct diagnosis more difficult, which will also delay recovery.

The product contains propylene glycol, which may cause skin irritation, as well as cetostearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis).

If there is no improvement within 2 weeks after the start of therapy, the diagnosis should be clarified.

Use during pregnancy and breastfeeding. During pregnancy and breastfeeding, treatment with the drug should be carried out only as prescribed by a doctor. However, in this case, it is necessary to avoid using the cream / ointment on large areas of skin or for a long period. There is no convincing evidence of the safety of the drug for women during pregnancy. Like other topical corticosteroids, Moleskin should be prescribed to pregnant women only if the potential benefit of use for the mother outweighs the potential risk to the fetus.

It is not known whether topical corticosteroids can cause significant systemic absorption to produce amounts of the drug that can be detected in breast milk. Moleskin should be used during breastfeeding only after a careful benefit-risk analysis. If treatment is prescribed in high doses or for a long period, breastfeeding should be discontinued.

Children. The drug is not used in children under 2 years of age. In children over 2 years of age, the drug is used only as prescribed by a doctor. The safety of using mometasone in children for more than 6 weeks has not been studied.

Children may experience more frequent signs of hypothalamic-pituitary-adrenal (HPA) suppression and Cushing’s syndrome with any topical corticosteroid than adults, due to greater absorption of the drug due to a larger skin surface area to body weight ratio. Therefore, the use of topical corticosteroids in children should be limited to the minimum effective amount.

The course of treatment should not exceed 5 days.

Prolonged violence prevention therapy can cause growth and development disorders in children.

Moleskin should not be used to treat diaper dermatitis. The cream/ointment should not be used under occlusive dressings unless directed by a doctor, and should not be applied to areas covered by diapers or waterproof pants, as this will cause the cream/ointment to be under the occlusive dressing.

Ability to influence the reaction rate when driving vehicles or working with other mechanisms. There is no data on the adverse effect of the drug on the ability to drive vehicles and work with mechanisms.

Interactions with other drugs have not been described to date. Due to the chemical properties of mometasone furoate, it is incompatible with alkalis.

Symptoms: excessive or prolonged use of topical corticosteroids may lead to suppression of the hypothalamic-pituitary-adrenal axis, which may cause secondary adrenal insufficiency. In case of suppression of the hypothalamic-pituitary-adrenal axis, the interval between applications should be increased or a less potent corticosteroid should be used, or the drug should be discontinued.

The steroid content in each container is so small that in the unlikely event of accidental ingestion of the drug, the toxic effect is almost imperceptible or absent.

Treatment: symptomatic. Acute symptoms of hypercorticism are usually reversible. If necessary, correction of electrolyte imbalance is indicated. In case of prolonged use, gradual withdrawal of corticosteroids is recommended.

At a temperature not exceeding 25 °C.