Унидерм®

General characteristics. Structure:

Active ingredient: 0,001 g of a mometazon of furoate.

Excipients: hexyleneglycol, glyceryl monostearate 40-55, cetostearyl alcohol, a macrogoal the 20th cetylstearate, wax white, titanium dioxide, starch aluminum octenylsuccinate, the phosphoric acid divorced the water purified vaseline white.

Pharmacological properties:

Pharmacodynamics. Mometazon - a synthetic glucocorticosteroid (GKS) possessing antiinflammatory, antipruritic and anti-exudative action. GKS induces release of the proteins inhibiting A2 phospholipase and known under the general name of a lipokortina which control biosynthesis of such mediators of an inflammation as prostaglandins and leukotrienes, by braking of release of their common precursor, arachidonic acid.

Pharmacokinetics. Absorption ^{of Uniderm® cream} is insignificant. In 8 hours after drawing on the unimpaired skin (without occlusive bandage) in a system blood-groove about 0,4% of drug are found.

Indications to use:

The inflammatory phenomena and itch at the dermatosis which is giving in to glucocorticosteroid therapy.

Route of administration and doses:

Outwardly. A thin film ^{of Uniderm® cream} is applied on affected areas of skin once a day. Duration of a course of treatment is defined by its efficiency, and also portability the patient, existence and expressiveness of side effects.

Features of use:

When drawing on big sites of skin for a long time, especially at use of occlusive bandages, development of systemic action of GKS is possible. Considering it, patients have to be observed concerning function suppression signs гипоталамо - pituitary and adrenal system and development of a syndrome of Cushing.

It is necessary to avoid hit ^{of Uniderm® cream} in eyes.

The propylene glycol which is a part of drug can cause irritation in a site of application. In such cases it is necessary to stop use ^{of Uniderm® cream} and to appoint the corresponding treatment.

It is necessary to consider that GKS are capable to change displays of some diseases of skin that can complicate diagnosis. Besides, use of GKS can be the cause of a delay of healing of wounds.

At long therapy of GKS the sudden termination of therapy can lead to development of a syndrome of the ricochet which is shown in the form of dermatitis with intensive erubescence and a burning sensation. Therefore after a long course of treatment drug withdrawal should be made gradually, for example, passing to the intermittent scheme of treatment before completely to stop it.

Use in pediatrics. Safety and efficiency ^{of Uniderm® cream} at topical administration at children during the period exceeding 6 weeks were not studied.

Because children have a size of a ratio of surface area and body weight it is more, than at adults, children are subject to bigger risk of suppression of function гипоталамо - pituitary and adrenal system and development of a syndrome of Cushing at use of any GKS of local action.

Prolonged treatment of children of GKS can bring to disturbance of their growth and development. Children have to receive the minimum dose of drug sufficient for achievements of effect. At children from 6 months to 2 years the course of treatment should not exceed 5 days.

Use during pregnancy and a lactation. Safety of use ^{of Uniderm® cream} during pregnancy and a lactation is not studied. Glucocorticosteroids get through a placental barrier. It is necessary to avoid prolonged treatment and use of high doses during pregnancy in connection with threat of negative impact on fetation.

Glucocorticosteroids are allocated with breast milk. In case use of GKS in high doses and/or is supposed for a long time, it is necessary to stop breastfeeding.

Side effects:

Seldom - irritation and a xeroderma, a burning sensation, an itch, a folliculitis, a hypertrichosis, acne rash, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of skin, accession of consecutive infection, signs of an atrophy of skin, a striya, a heat rash. Less than in 1% of cases - papulation, pustules.

At Uniderm® cream use for a long time and/or for treatment of big sites of skin, or with use of occlusive bandages, especially children and teenagers, can have side effects characteristic of GKS of systemic action, including adrenal insufficiency and Cushing's syndrome.

Contraindications:

- hypersensitivity to any component of drug or to glucocorticosteroid means;
- pink eels, perioral dermatitis;
- bacterial, virus (Herpes simplex, chicken pox, Herpes zoster) or fungal infection of skin;
- tuberculosis, syphilis;
- postvaccinal reactions;
- children's age up to 6 months;
- pregnancy (treatment of extensive sites of skin, prolonged treatment);
- the lactation period (use in high doses or/and for a long time).

With care. Drawing on face skin and in folds, use of occlusive bandages, and also treatment of big sites of skin and/or prolonged treatment (especially at children).

Overdose:

Symptoms: function oppression гипоталамо - pituitary nadpo-chechnikovoy systems, including secondary adrenal insufficiency.

Treatment: symptomatic, if necessary - correction of an electrolytic imbalance, drug withdrawal (at long therapy - gradual cancellation).

Storage conditions:

List B. At a temperature from 15 to 25 °C. To store in the place, unavailable to children.
Not to use after expiry date. A period of validity - 2 years.

Issue conditions:

According to the recipe

Packaging:

Cream for external use of 0,1%. On 15 and 30 g in a tuba aluminum. Each tuba together with the application instruction is placed in a pack from a cardboard.