Moleskin

General characteristics. Structure:

Active ingredient: mometasone;

100 g of cream contain a mometazon of furoate in terms of 100% substance – 0,1 g;

excipients: hexyleneglycol, глицерол monostearate, alcohol of tsetosteariloviya, polyethyleneglycol (macrogoal) tsetostearilovy ether, wax white, titanium dioxide (Е 171), the aluminum salt of octenylsuccinate of starch, phosphoric acid divorced paraffin white m'yakiya, the water purified.

Pharmacological properties:

Pharmacodynamics. Mometazona furoate is a synthetic glucocorticosteroid (GKS) having antiinflammatory effect. As well as other GKS of topical administration, a mometazon furoate has antipruritic, anti-exudative and vasoconstrictive effect. In general the mechanism of antiinflammatory action of GKS is not clear for topical administration. Assume that GKS induce release of the proteins inhibiting a phospholipase of A2 and known under the general name of a lipokortina. These proteins control biosynthesis of such strong mediators of an inflammation as prostaglandins and leukotrienes by braking of release of their common precursor – arachidonic acid.

Pharmacokinetics. Extent of penetration of a mometazon of furoate through skin depends on various factors, including composition of drug and integrity of an epidermal barrier. The researches conducted in public showed that about 0,4% of the dose applied on the unimpaired skin (without occlusive bandage) 0,1% of cream of a mometazon of furoate were found in the blood circulatory system in 8 hours. The inflammatory and other processes which are taking place in skin can lead to strengthening of penetration of drug through skin.

Pharmaceutical characteristics

Main physical and chemical properties: cream of white or almost white color.

Indications to use:

The inflammatory phenomena and itch at the dermatosis which is giving in to therapy by corticosteroids including psoriasis (except widespread blyashkovy psoriasis) and atopic dermatitis, at adults and children aged from 2 years.

Route of administration and doses:

Moleskin to apply a thin film of cream on affected areas of skin of 1 times a day. Duration of treatment is defined by weight, the course of a disease and is defined individually.

Children and on a face need to limit use of local corticosteroids to the minimum quantity in comparison with the effective therapeutic modes, at the same time duration of treatment should not exceed 5 days.

Features of use:

Moleskin, cream for external use of 0,1% is not intended for use in ophthalmology. It is impossible to allow hits of drug in eyes.

At topical administration of various corticosteroids reversible suppression of function гипоталамо - pituitary and adrenal system, and also symptoms of glucocorticosteroid insufficiency after drug withdrawal can result from system absorption. Cushing's syndrome, a hyperglycemia and a glucosuria can also develop.

The patients applying glucocorticosteroids to topical administration for treatment of big sites of skin or using occlusive bandages have to undergo periodically testing for existence of signs of suppression of function гипоталамо - pituitary and adrenal system. Such check can be executed by test with AKTG-stimulation, measurements of morning maintenance of cortisol in a blood plasma and in other environments, except urine. At children or on a face occlusion should not be applied. It is necessary to avoid hit of cream on mucous membranes.

There can sometimes be signs and symptoms of glucocorticosteroid insufficiency that demands additional use of glucocorticosteroids of systemic action. If it is not offered the doctor, drug should not be put on a face, and also in the field of axillary and inguinal folds.

At emergence of irritation or a sensitization it is necessary to stop use of cream from a mometazon furoate and to appoint the corresponding treatment. Allergic contact dermatitis at drug use is usually diagnosed on the basis of inefficiency of treatment, but not on clinical symptoms of an aggravation as it is done at topical administration of the medicines which are not containing glucocorticosteroids. Such observation should be supported by conducting application skin test.

In case of development of the accompanying infection of skin it is necessary to apply the appropriate antifungal or antibacterial agent. If throughout short time it is not possible to reach positive dynamics, cream use Moleskin should be stopped until the infection is not completely eliminated.

At the sudden termination of prolonged treatment the effect of return of symptoms in the form of dermatitis with intensive reddening, irritation and burning can develop. Slow drug withdrawal, for example treatment with breaks can prevent it, up to complete cessation. Glucocorticoids can change signs of some defeats and complicate definition of the corresponding diagnosis that recovery will also detain.

Drug contains propylene glycol which can cause irritation of skin, and also cetostearyl alcohol which can cause local to the koyena of reaction (for example, contact dermatitis).

If within 2 weeks after the beginning of therapy improvement does not happen, it is necessary to specify the diagnosis.

Ability of a vliyatn speed of response at control of motor transport or work with other mechanisms

Data on an adverse effect of drug on ability to manage vehicles and mechanisms are absent.

Side effects:

Infections and invasions: folliculitis, infections, furuncles.

Disturbances from a nervous system: burning sensation, paresthesias.

Disturbances from skin and hypodermic cellulose: itch, contact dermatitis, hypoxanthopathy, hypertrichosis, atrophic strips of skin, dermatitis aknepodobny, skin atrophy.

The general disturbances and reactions in a site of application: pain in a site of application, reaction in a site of application.

The propylene glycol which is a part of drug can cause irritation of skin.

Local side reactions about which it was infrequently reported in connection with use of topical dermatological corticosteroids include: dryness and irritation of skin, dermatitis, perioral dermatitis, maceration of skin, increase in the area of defeat, strengthening of displays of an allergy, erythema, striya, heat rash and teleangiectasias, papular, pustular rashes and feeling of a pricking.

Interaction with other medicines:

Interactions with other medicines are not described so far. On chemical properties of a mometazon furoate is not compatible to alkalis.

Contraindications:

Moleskin is contraindicated at a rozatse, an acne вульгарис, a skin atrophy, perioral dermatitis, a perianal and genital itch, podguznikovy rash, bacterial (impetigo, piodermit), virus (a herpes simplex, herpes surrounding and chicken pox, simple warts, acute condylomas, a contagious mollusk), parasitic and fungal (Candida or a dermatophyte) infections, tuberculosis, syphilis or postvaccinal reactions. Moleskin it is not necessary to apply on wounds or on the skin covered with ulcers. Drug is contraindicated to the patients having hypersensitivity signs to any of its components or to other corticosteroids.

Overdose:

Symptoms: excessive or prolonged use of local corticosteroids (KS) can lead to function oppression гипоталамо - pituitary and adrenal system that can become the reason of development of secondary insufficiency of bark of adrenal glands. In case of oppression гипоталамо - pituitary and adrenal system it is necessary to increase an interval between drawings or to apply KS with smaller activity, or to cancel drug.

The maintenance of a steroid in each container so is not enough that at improbable accidental a drug proglatyvaniye the toxic effect will be almost imperceptible or to be absent.

Treatment: symptomatic. Acute symptoms of a hypercorticoidism are usually reversible. Correction of an electrolytic imbalance is in case of need shown. In case of prolonged use gradual cancellation of corticosteroids is recommended.

Use during pregnancy or feeding by a breast

During pregnancy or feeding by a breast treatment by drug should be carried out only on doctor's orders. However and in this case it is necessary to avoid use of cream on big sites of skin or during the long period. There are no convincing proofs of safety of drug for the woman during pregnancy. As well as with other glucocorticosteroids of topical administration, Moleskin pregnant women should appoint only if the potential advantage of use for mother exceeds potential risk for a fruit.

It is unknown whether topical administration of corticosteroids can cause considerable system absorption that the amount of drug which can be revealed in breast milk was formed. Moleskin it is necessary to apply during feeding by a breast only after the careful analysis of a ratio of advantage and risk. If treatment by high doses or use throughout the long period is appointed, feeding by a breast needs to be stopped.

Children

Not to use drug to children up to 2 years. To children 2 years are more senior to use drug only on doctor's orders. Safety of use of a mometazon for children for more than 6 weeks was not studied.

At children perhaps more frequent emergence of signs of oppression гипоталамо - pituitary and adrenal system and Cushing's syndrome at use of any corticosteroids of local action, than at adults that is connected with bigger absorption of drug because of a bigger ratio of surface area of skin to body weight. In this regard children should limit use of local corticosteroids to minimum effective amount of drug.

The course of treatment should not exceed 5 days.

Long corticosteroid therapy can cause a growth disorder and development of children.

Moleskin it is not necessary to apply to treatment of the dermatitis caused by carrying diapers. Cream should not be applied under occlusive bandages if only it is not appointed by the doctor, and also to apply on the sites captured by diapers or waterproof pants as in that case cream will be under an occlusive bandage.

Storage conditions:

Period of validity. 2 years. Not to use drug after the termination of the period of validity specified on packaging. To store at a temperature not above 25 °C. To store in the place, unavailable to children.

Issue conditions:

According to the recipe

Packaging:

On 15 g in a tuba. On 1 tuba in a pack.