Elokim 0.1g of 15% cream in the tube

The instruction for medical use

of Elokom® medicine

the Trade name
of Elokom®

the International unlicensed


name Mometazon Lekarstvennaya a form
Cream of 0.1%

Structure
One gram of cream contains
active agent - a mometazon furoate of 1 mg,
excipients: hexyleneglycol, water the purified, phosphoric acid, the phosphatidylsincaline hydrogenated the titan dioxide (E171), octenylsuccinate starch aluminum salt, wax white, vaseline white.

The description
White or almost white uniform cream of soft consistence, without foreign inclusions.

Pharmacotherapeutic group
Glucocorticosteroids for topical treatment of diseases of skin. Glucocorticosteroids. Glucocorticosteroids active (group III). Mometazon.
The ATX D07AC13 code

the Pharmacological

Pharmacokinetics Degree properties of penetration of corticosteroids of topical administration through skin depends on many factors, including composition of drug and integrity of an epidermal barrier and also use of occlusive bandages.
Absorption
In 8 hours after drawing 0.1% of cream or 0.1% of ointment for the uninjured skin (without occlusive bandage) at healthy volunteers system absorption of a 3H-mometazon of furoate is about 0.4% and 0.7%, respectively.
Distribution
because of very insignificant absorption of a mometazon of furoate at topical use, the pharmacokinetics of drug was estimated by means of intravenous administration of a mometazon of furoate. The volume of distribution was 917 liters, indicating that any quantity of the absorbed mometazon of furoate extensively is distributed. In plasma of the person of a mometazon furoate contacts proteins more than for 99%.
Metabolism
the furoate Absorbed a mometazona is exposed to fast and extensive metabolism on multiple metabolites. The formed metabolites are more polar, than a mometazona furoate, and because of polarity are not pharmacological active. After intravenous administration, the general clearance of a mometazon of furoate is 976 ml/min. that confirms his active metabolism.
Removal
Effective plasma elimination half-life makes 5.8 hour. Removal is carried out in the form of metabolites, generally through bile, in limited quantity - through urine.
A pharmacodynamics
Pharmakodinamichesky effect of drug is directly connected with its active component - a mometazona furoate.
As well as other corticosteroids for external use, a mometazon furoate has anti-inflammatory, antipruritic, vasoconstrictive effect. The mechanism of anti-inflammatory effect of topical steroids in general is not installed. However it is supposed that corticosteroids work by activation of the inhibiting proteins of a phospholipase of A2 which are called lipokortina. It is supposed that these proteins control biosynthesis of active mediators of inflammation, such as prostaglandins and leukotrienes, by suppression of release of arachidonic acid. Arachidonic acid is released from a phospholipid membrane by means of A2 phospholipase.
Mometazona furoate in the conditions of in vitro is strong inhibitor of production of three inflammatory cytokines which participate in initiation and maintenance of an inflammatory state: interleukin 1 (IL-1), interleukin 6 (IL-6) and tumor necrosis factor - α (TNF-α).

Indications
˗




and doses
of Elokom® apply symptoms of inflammation and naggers at the dermatosis of skin demanding use of corticosteroid therapy ˗ psoriasis ˗ atopic dermatitis ˗ contact dermatitis of the allergic and not allergic nature the Route of administration on affected areas of skin once a day. The course of treatment the drug Elokom® depends on disease severity and is defined by the attending physician.
Use of local corticosteroids at children or in a face should be limited up to the minimum volume necessary for achievement of the effective mode of therapy. Duration of treatment should not exceed 5 days.

Side effects
Frequency is determined as: very often (≥1/10), it is frequent (≥1/100, & lt, 1/10), infrequently (≥1/1000, & lt, 1/100), is rare (≥1/10000, & lt, 1/1000), is very rare (& lt, 1/10000) and it is unknown (it cannot be established on the available data).
Very seldom
˗ a folliculitis
˗ local reactions in the form of burning and
the nagger Neizvestno
˗ bacterial infections, a furunculosis
˗ paresthesia
˗ contact dermatitis, hypoxanthopathy, a hypertrichosis, skin striya, acneform rashes, a skin atrophy
˗ pain and local reactions on the site of use of drug
Are available data on emergence of local side reactions owing to use of topical dermatological corticosteroids, such as
˗ dryness and irritation of skin
˗ dermatitis, perioral dermatitis
˗ maceration of skin
˗ a heat rash and telangiectasias

of the Contraindication
˗ hypersensitivity to any of drug components
˗ children's age up to 2 years

Medicinal interactions
Medicinal interactions are not described.

Special instructions
If at use of drug the irritation or hypersensitivity is noted, treatment the patient should stop and pick up other therapy. In the presence of a dermatological infection it is necessary to appoint the corresponding antifungal or antibacterial therapy. If throughout short time it is not possible to reach positive effect, it is necessary to stop use of drug before elimination of symptoms of an infection.
System absorption of topical corticosteroids can cause reversible suppression of the gipotalamo-a hypophysial and adrenal system (GHAS) with a possibility of insufficiency of glucocorticosteroids after the treatment termination. Manifestations of a syndrome of Cushing, a hyperglycemia and a glucosuria are also possible at some patients at system absorption of topical corticosteroids during treatment. The patients applying topical steroids on big sites of a surface of skin or sites under a bandage have to be checked for manifestations of suppression of GGNS periodically.
Any of side reactions about which it was reported after use of system corticosteroids including suppression of function of adrenal glands, can also arise at use of topical corticosteroids, especially at newborns and children.
Development of local and general toxic reactions is possible, especially at prolonged continuous use on extensive sites of the injured skin, on flexion surfaces or under polyethylene bandages. It is not recommended to use bandages at children. At applique in a face the course of treatment should not exceed 5 days, it is not recommended to use bandages. Regardless of age of patients it is not necessary to appoint long continuous courses of therapy.
Purpose of topical glucocorticosteroids in psoriasis can lead ment of undesirable effects, including a disease recurrence with the subsequent development of stability to drug, development of pustulous psoriasis, local or system effects owing to disturbance of barrier function of skin. Therefore in psoriasis it is necessary to control a condition of such patients. As well as at therapy other topical steroids do not recommend to interrupt sharply a course of treatment owing to a possibility of development of a withdrawal which can be shown in the form of the dermatitis which is followed by hyperaemia phenomena, burning sensation and pain. It can be avoided by gradual drug withdrawal, gradually interrupting therapy before complete cessation of treatment.
Purpose of glucocorticosteroids can change manifestation of some skin diseases, complicating diagnosis or to delay process of healing.
Elokom® cream contains propylene glycol which can cause irritation of skin.
Элоком® it is shown only for dermatological use and not intended for use in ophthalmology though insignificant risk of developing glaucoma or subkapsulyarny cataract is noted.
Use in pediatrics
the equivalent doses of drug can cause stronger reactions owing to higher ratio of surface area to body weight In children.
In this regard, use of local corticosteroids at children has to be limited to minimum effective amount of drug and the minimum period of use. Owing to lack of data on safety and efficiency the prescribing of Elokom® cream is not recommended to children 2 years are younger.
Because children have a size of a ratio of surface area and body weight it is more, than at adults, at children higher susceptibility to suppression of GGNS and to Cushing's syndrome is revealed at use of topical corticosteroids. Long-term treatment by corticosteroids can influence growth and development of children.
Элоком® it is not necessary to apply on the sites of skin which are under diapers or waterproof shorts and to apply to treatment of the dermatitis caused by wearing diapers.
Pregnancy and a lactation
of Experience of use for pregnant women are not present. It is known that corticosteroids get through a placental barrier and are excreted in breast milk therefore appointment of this group of drugs during pregnancy and a lactation is justified only if the potential advantage for the woman exceeds potential risk for mother, a fruit and the child.
The feature of influence of medicine on ability to run the vehicle and other potentially dangerous
Elokom® mechanisms does not affect speed of reaction at control of motor transport or work with other mechanisms.

Overdose
Symptoms: excessive or prolonged use of local glucocorticosteroids 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.
Treatment: symptomatic. Acute symptoms of a hypercorticoidism are usually reversible. If necessary correction of an electrolytic imbalance is shown. In case of chronic toxic action the gradual cancellation of glucocorticosteroids is recommended.

A form of release and packing
On 15 g of drug in tubas aluminum with internal varnish coating on an epoxy basis, closed a membrane and the screw-on plastic cap.
On 1 tuba together with the instruction for medical use in the state and Russian languages place in a cardboard box.


To Store storage conditions at a temperature not above 25 °C.
To store out of children's reach!

A period of storage
2 years
not to apply after an expiration date

Prescription status
According to the prescription


Shering-Plau Labo Producer H. B., Belgium

the Owner of the registration certificate
Shering-Plau Sentral East AG, Switzerland

the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods)
Representative office of Shering-Plau Sentral East AG in
Kazakhstan, Almaty, Dostyk Ave., 38, business center "Ken Dala", the 5th floor
Ph. +7 (727) 330-42-66, +7 (727) 259-80-84
Fax +7 (727) 259-80-90
e-mail: dpoccis2@merck.com, pharmacovigilance.ukraine&cis@merck.com