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Pharmacological properties

Mometasone furoate is a potent glucocorticosteroids that has anti-inflammatory, antipruritic, vasoconstrictive effects. mometasone furoate is a potent inhibitor of the in vitro production of three cytokines involved in the development of the inflammatory process and its maintenance: interleukin (il) -1, il-6 and tumor necrosis factor (fno) -α.

Salicylic acid helps exfoliate the stratum corneum of the skin and improves the penetration of mometasone furoate into the skin.

Pharmacokinetics After a single topical application of Moleskin C ointment for 12 hours without the use of an occlusive dressing, about 1.5% of the applied dose is exposed to systemic absorption. The drug, which entered the systemic circulation, is rapidly excreted in urine and feces.

Indications

Treatment of moderate to severe plaque psoriasis.

Application

For adults and children over the age of 12, the ointment is applied a thin layer on the affected surface of the skin 1 or 2 times a day (morning and / or evening). the maximum daily dose is 15 g, which is applied on no more than 30% of the body surface. the duration of treatment is determined by the doctor depending on the severity of the course of the disease. the duration of treatment for more than 3 weeks was not evaluated in the main studies. as with all powerful corticosteroids, it is recommended to gradually reduce the dose.

Contraindications

Hypersensitivity to any component of the drug. bacterial (including tuberculosis, syphilis, pyoderma), viral (herpes simplex, chickenpox, herpes zoster, warts, genital warts, molluscum contagiosum) or fungal infections of the skin (dermatophytes and yeast), as well as parasitic skin diseases in the absence of concomitant adequate therapy. perioral dermatitis or rosacea, post-vaccination reactions, common acne, skin atrophy.

Side effects

The following are the adverse reactions that have been reported with the use of local glucocorticosteroids: very often (1/10); often (from ≥1 / 100 to 1/10); infrequently (from ≥1 / 1000 to 1/100); rarely (from ≥1 / 10,000 to 1/1000); very rarely (1/10 000, including individual messages).

From the endocrine system: rarely - inhibition of adrenal function.

On the part of the skin and subcutaneous tissue: often - itching, local atrophy of the skin; infrequently - striae, rosacea-like dermatitis, ecchymosis, folliculitis, furunculosis; rarely - hypertrichosis, hypopigmentation of the skin; unknown - skin irritation, maceration of the skin, dry skin, acne dermatitis, dermatitis, contact dermatitis, peeling of the skin, telangiectasia, prickly heat.

General disorders and disorders at the site of use: often - a burning sensation at the site of application, tingling.

Infections and infestations: infrequently - infections.

On the part of the immune system: rarely - hypersensitivity.

In addition, perioral dermatitis has been reported infrequently as an additional side effect when using local GCS.

Long-term continuous use of local corticosteroids can lead to the development of local atrophy of the skin, striae and expansion of the superficial blood vessels, especially on the face.

Prolonged use of preparations containing salicylic acid can cause dermatitis.

special instructions

Moleskin c is indicated for external use only and is not intended for use in ophthalmology.

As with other topical corticosteroids, appropriate precautions should be taken if ointments are applied to large areas of the skin (should not be used for common plaque psoriasis) or in the case of long-term treatment. This is especially important in the treatment of children, since they may be more sensitive to suppression of the hypothalamic-pituitary-adrenal system and the appearance of Cushings syndrome under the influence of local corticosteroids than adults, which is associated with greater absorption of the drug through a larger ratio of skin surface area to body weight children.

Moleskin C ointment is not recommended for use under occlusive dressings. It should not be applied to the skin of the face or axillary and inguinal areas, genitals and diaper rash. Avoid getting ointment on the mucous membrane and open wounds. Moleskin C should not be used for ulcerative skin lesions, wounds and striae.Moleskin C is not recommended for pustular or drip psoriasis.

With the development of skin irritation, including excessive dryness of the skin, you should stop using the ointment and choose the appropriate therapy for the patient.

In case of prolonged use, it is recommended that corticosteroids be gradually withdrawn, since corticosteroid withdrawal syndrome (e.g. dermatitis, burning sensation) may occur.

GCS can mask, stimulate, or worsen a skin infection.

With the development of concomitant skin infection, an appropriate antifungal or antibacterial agent should be used. If the response to treatment is not reached quickly, the use of Moleskin C ointment should be discontinued until the infection is properly eliminated.

Salicylic acid may be a sunscreen. Therefore, with the combined use of the drug Moleskin C and UV therapy, it is recommended that before the start of UV irradiation, the remnants of the ointment be removed and the area of ​​the skin to be treated cleaned. After a UV treatment session, the ointment can be applied again.

Any side effects observed with the use of systemic corticosteroids, including inhibition of the function of the adrenal cortex, are possible with local use of corticosteroids, especially in infants and children.

Moleskin C contains propylene glycol monopalmitostearate, which can cause skin irritation.

Use during pregnancy or lactation. There were no controlled studies on the use of the drug during pregnancy. Moleskin ointment is contraindicated during pregnancy.

It is not known whether topical application of corticosteroids or salicylic acid through systemic absorption can lead to their penetration into breast milk, therefore, it is not recommended to prescribe Moleskin C for women during breast-feeding.

Children. The safety and effectiveness of the use of the drug Moleskin C in children under the age of 12 years have not been established. In children, a minimum amount of GCS should be used to achieve the effect. Long-term therapy with the use of corticosteroids can adversely affect the growth and development of children.

The ability to influence the reaction rate when driving vehicles or other mechanisms.

Typically, the drug does not affect the reaction rate when driving vehicles or working with other mechanisms.

Interactions

After topical use of the drug moleskine c, absorption of a very small but measurable amount of salicylates in the blood plasma was noted. A review of the literature on the interaction of salicylates with other substances after oral administration or application to the skin revealed that changes in the effects of drugs such as tolbutamide, methotrexate, heparin, pyrazinamide, uricosuric agents and coumarin-type drugs are possible. other corticosteroids and ammonium sulfate can affect the content of salicylic acid. the specified interaction should be borne in mind when prescribing the drug moleskin with combined with the above drugs.

Overdose

Excessive or prolonged use of topical corticosteroids can inhibit the function of the pituitary-adrenal system and, as a result, cause the development of secondary insufficiency of the adrenal cortex and the appearance of symptoms of hypercorticism, including cushing syndrome.

Treatment. When signs of inhibition of the hypothalamic-pituitary-adrenal system appear, the frequency of application of the drug should be reduced or its use discontinued. Appropriate symptomatic therapy is also prescribed.

In the clinical program, doses exceeding the recommended maximum daily dose of 15 g had a temporary effect on the function of the hypothalamic-pituitary-adrenal system.

When applied to large areas of the skin, a systemic effect inherent in salicylic acid may occur.

In case of toxicity caused by salicylic acid, the use of Moleskin C should be discontinued. Prescribe fluid for the induction of diuresis. If necessary, apply sodium bicarbonate and potassium (oral or iv).

Storage conditions

At a temperature not exceeding 25 ° C. do not freeze.

Tags: Salicylic Acid, Mometasone