Название документа

Pharmacological properties

Mometazon's

furoate — synthetic gks for topical administration. has anti-inflammatory, antipruritic and anti-exudative effect.

Pharmacokinetics. Results of a research showed that system absorption after local drawing a mometazon of furoate of 0.1% is minimum; about 0.4% of a dose are brought out of an organism during 72 h after drawing. It was almost impossible to establish the nature of metabolites because of a small amount in blood plasma and excrement.

Indication

Inflammatory phenomena and an itch at the dermatosis sensitive to corticosteroid therapy, including psoriasis (except widespread blyashechny psoriasis) and atopic dermatitis, at adults and children is aged more senior than 2 years.

Elok lotion is applied by

also to treatment of a dermatosis on the surface of skin of a hairy part of the head.

Use Ointment or cream apply

to

with a thin layer on affected areas of skin of 1 times a day. duration of treatment depends on weight, a course of the disease and is defined individually.

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

Several drops of lotion apply

on affected areas of skin of 1 times a day and accurately and carefully rub before full absorption.

Contraindication

Rozatsea, an acne vulgaris, skin atrophies, perioral dermatitis, a perianal and genital itch, rashes owing to wearing diapers, bacterial (for example impetigo, piodermita), virus (for example idle time, the surrounding herpes and chicken pox, simple warts, peaked condylomas, a contagious mollusk), parasitic and fungal (for example a dermatofitiya or the sorts candida caused by representatives) infections, tuberculosis, syphilis or vaccine-challenged reactions. medicine should not be applied on wounds or the skin covered with ulcers. medicine is contraindicated to patients with hypersensitivity to any of components of medicine or another gks.

Side effects

are given by

Below side reactions about which it was reported in connection with use of medicine, on the systems of bodies and frequency: very often (≥1/10); often (≥1/100, 1/10); infrequently (≥1/1000, 1/100); seldom (≥1/10,000, 1/1,000); very seldom (1/10,000); it is unknown (it is impossible to estimate on the available data).

Infection and invasion: very seldom — a folliculitis; it is unknown — infections, furuncles.

from nervous system: very seldom — burning sensation; it is unknown — paresthesias.

from skin and hypodermic cellulose: very seldom — an itch; it is unknown — contact dermatitis, hypoxanthopathy, a hypertrichosis, atrophic strips on skin, dermatitis aknepodobny, a skin atrophy.

General violations and reactions in the site of application: it is unknown — pain in the site of application, reaction in the site of application.

Propylene glycol which is a part of medicine can cause irritation of skin. Local side reactions about which it was seldom reported in connection with application of topical dermatological corticosteroids include: dryness and irritation of skin, dermatitis, perioral dermatitis, maceration of skin, striya, heat rash and teleangiectasias, papular, pustulous rashes and feeling of pricking.

Special instructions

If during use of medicine note irritation or hypersensitivity, treatment it is necessary to stop and appoint the corresponding therapy.

At development of the accompanying infection of skin needs to apply the appropriate antifungal or antibacterial agent. If throughout short time it is not possible to reach positive effect, it is necessary to stop use of medicine before elimination of symptoms of an infection.

System absorption at topical administration of various GKS can cause reversible oppression of function gipotalamo - a hypophysial and adrenal system with possible GKS-insufficiency after the treatment termination. Some patients can have manifestations of a syndrome of Cushing, a hyperglycemia and a glucosuria.

Patients, applying local steroid on big sites of skin or with use of occlusive bandages, it is necessary to check periodically for function oppression existence gipotalamo - a hypophysial and adrenal system. Such check can be executed by test with AKTG-stimulation, measurements of morning maintenance of cortisol in blood plasma and in other environments, except urine.

Any side effects arising at application of system GKS, including oppression of function of bark of adrenal glands, can be noted by

also at topical administration of GKS, especially at babies and children.

At children and also on area of the person are not applied by occlusive bandages. It is necessary to avoid hit of medicine on a mucous membrane.

Topical steroids can be dangerous at psoriasis for many reasons, including a recurrence after development of tolerance, risk of generalized pustulous psoriasis and development of local or system toxicity because of the weakened barrier function of skin. In case of use of medicine at psoriasis it is very important to carry out careful observation of patients.

At the sudden termination of long-term treatment the effect of return of symptoms in the form of dermatitis with intensive reddening, irritation and burning can develop. It is possible to prevent it, slowly canceling medicine, for example treatment with breaks, up to complete cessation.

signs of some defeats can change

GKS and complicate establishment of the diagnosis that will also delay recovery.

Ointment and lotion Elok contain propylene glycol which can cause irritation of skin.

Drug is not intended to

by Elok for ophthalmologic application, including drawing on eyelids. It is impossible to allow hits of medicine in eyes.

At application of corticosteroids of systemic and local action (including intranasal, inhalation and intraocular ways of introduction) disorders of vision can arise. If there are such symptoms as illegibility of sight or other disorders of vision, the patient should undergo inspection at the ophthalmologist for assessment of possible causes of infringement of sight which can include a cataract, glaucoma or such rare diseases as the central serous horioretinopatiya what it was reported after application of corticosteroids of systemic and local action about.

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

Does not know to

whether topical administration of corticosteroids can cause considerable system absorption that will result in amount of medicine which can be revealed in breast milk. Elok it is necessary to apply during feeding by a breast only after the careful analysis of a ratio of advantage and risk. If to appoint treatment in high doses or to use medicament during the long period, feeding by a breast needs to be stopped.

Children. To children aged from 2 years to use medicament only on doctor's orders.

As 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 gipotalamo - the hypophysial and adrenal system and manifestations of a syndrome of Cushing at application of any GKS of local action which raises when drawing on the area more than 20% of a body surface.

recommends to apply

smallest quantity of GKS necessary for obtaining therapeutic effect, especially at children. The course of treatment should not exceed 5 days. Long-term treatment of GKS can delay growth and development of the child.

Safety of use of medicine by Elok for children during more than 6 weeks was not studied by

.

only limited data on treatment of children under 2 years Exist.

Mometazon should not apply

to treatment at the dermatitis caused by wearing diapers.

ointment/cream/lotion should not be applied under occlusive bandages if only it is not offered the doctor and also to apply on sites under diapers or pants which do not pass moisture.

Ability to influence speed of response at control of vehicles or work with other mechanisms. Not established.

to

Are unknown to

Interaction

.

Overdose

Excessive and prolonged use local gks can cause oppression of function of a hypophysial and adrenal system that can become the reason of development of secondary insufficiency of bark of adrenal glands which is usually reversible.

in case of oppression of this system should increase an interval between drawings or to apply GKS with smaller activity or to cancel medicine.

steroid Content in each container so is not enough

that in case of improbable accidental ingestion of medicine the toxic effect will be almost imperceptible or to be absent.

Storage conditions

to Store

out of children's reach at a temperature not above 25 °C.

Characteristics
Active ingredients Mometazon
Amount of active ingredient 1 mg/g
Applicant MSD
Code of automatic telephone exchange D07AC13 Mometazon
Interaction with food It doesn't matter
Light sensitivity Not sensitive
Market status Original
Origin Chemical
Prescription status According to the prescription
Primary packing tuba
Producer N.V. SHERING-PLAU LABO.
Quantity in packing 15 g
Release form ointment for external use
Route of administration External
Sign Import
Storage temperature from 2 °C to 25 °C
Trade name Elok

Reviews Elok ointment of 0.1% of a tube of 15 g

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Elok ointment of 0.1% of a tube of 15 g

  • Product Code: 179757
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