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Description
The instruction
for medical use
of Mometoks Torgovoye medicine a name
of Mometoks
the International unlicensed
name Mometazon Lekarstvennaya a form
Cream, 15 g
Structure
of 1 g of cream contains
active agent – a mometazon furoate of 1.10 mg (it is equivalent to a mometazon) 1.00 mg,
excipients: paraffin white soft, paraffin easy liquid, the propylene glycol, wax emulsified sodium citrate, chlorocresol, tsetomakrogol the wax emulsified, the water purified.
Description
White soft uniform cream.
Pharmacotherapeutic group
Glucocorticosteroids for topical treatment of diseases of skin. Glucocorticosteroids active (group III).
The code of automatic telephone exchange D07AC13
Pharmacological properties
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 to the uninjured skin (without occlusive bandage) 0.1% of cream of a mometazon of furoate were found in the blood circulatory system in 8 h. The inflammatory and other processes happening in skin can lead to strengthening of penetration of drug through skin. Children have an absorption of a mometazon of furoate higher, than at adults.
A pharmacodynamics
of Mometoks – a synthetic glucocorticosteroid (GKS) rendering anti-inflammatory, antipruritic, anti-exudative and vasoconstrictive action. Drug induces synthesis of protein inhibiting a phospholipase of A2 and known under the general name of a lipokortina. These proteins control biosynthesis of such strong mediators of inflammation and an allergy as prostaglandins and leukotrienes, by slowing down of release of their common precursor – arachidonic acid. Drug suppresses an accumulation and further migration of cells in the field of damage and also eliminates expansion and hyperpermeability of vessels in the field of damage, reduces a hyperplasia of cells in psoriasis.
Indications
– the inflammatory phenomena and an itching at the dermatosis which is giving in to therapy by glucocorticosteroids
– atopic and seborrheal dermatitis
– psoriasis, eczema
the Route of administration and doses
the Drug Mometoks cream is intended only for skin use in dermatology.
Adults and children are more senior than 2 years
apply a Thin film of cream on affected areas of skin once a day. The doctor, proceeding from the diagnosis, efficiency of treatment, presence of side effects and also tolerance of drug has to determine by patients the scheme and duration of treatment.
Side effects
Seldom
– in decreasing order of emergence frequency: irritation and xeroderma, a folliculitis, a hypertrichosis, acneform rash, hypopigmentation, perioral dermatitis, allergic contact dermatitis, consecutive infection, striya, a heat rash
– adrenal insufficiency, Cushing’s syndrome and other system side reactions characteristic of GKS (at use for a long time and/or for treatment of big sites of skin or with use of occlusive bandages, especially at children and teenagers)
– a hyperglycemia, a glucosuria
Very seldom
– local reactions: burning, an itching, a skin atrophy, appearance of pink eels
of the Contraindication
– hypersensitivity to any of drug components
– pink eels, perioral dermatitis
– a bacterial, viral or fungal infection of skin
– vaccine-challenged reactions
– children’s age up to 2 years
Medicinal interactions
of Interaction with other medicines are not described so far. On chemical properties of Mometoks it is incompatible with alkalis.
Special instructions
It is impossible to allow hits of drug in eyes. At topical administration of drug
the reversible suppression of function gipotalamo – a hypophysial and adrenal system and also symptoms of glucocorticosteroid insufficiency after drug withdrawal can result from system absorption. The patients receiving Mometoks for treatment of big sites of skin or using occlusive bandages have to undergo periodically testing for presence of signs of suppression of function gipotalamo – a hypophysial and adrenal system. Such check can be executed by test with AKTG-stimulation, measurements of morning maintenance of cortisol in plasma and in other environments, except urine. In case oppression of this system is noted, it is necessary to increase an interval between drawings or to use less active GKS, or to cancel drug. Function restoration gipotalamo – a hypophysial and adrenal system usually happens soon after drug withdrawal. Sometimes additional use of GKS of systemic action is required. 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 patients as a result of system absorption of GKS at topical administration Cushing’s syndrome, a hyperglycemia and a glucosuria can also develop.
At emergence of irritation it is necessary to stop use of cream and to appoint the corresponding treatment.
Allergic contact dermatitis at Mometoks’s use is usually diagnosed on the basis of inefficiency of treatment, but not on clinical symptoms of aggravation as it is done at topical administration of the medicines which are not containing GKS. 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 within a short period of time it is not possible to reach positive dynamics, use of Mometoks cream should be suspended until the infection is not completely eliminated.
If within 2 weeks after the beginning of therapy of improvement does not occur, it is necessary to specify the diagnosis.
Use in pediatrics
to Children is aged more senior than 2 years drug is used only on doctor’s orders.
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 oppression of function gipotalamo – a hypophysial and adrenal system and to emergence of a syndrome of Cushing at use of any GKS of local action which raises when drawing GKS on the area more than 20% of a body surface. For the same reason the risk of emergence of insufficiency of adrenal glands at cancellation of treatment of GKS of local action at children is higher. At treatment by local GKS children have atrophic changes of skin up to emergence of atrophic strips easier.
Mometoks it is not necessary to apply to treatment of the dermatitis caused by wearing diapers.
Cream should not be applied under occlusive bandages if only it is not offered the doctor, also to put on the sites covered by diapers or waterproof pants as in this case cream will be under an occlusive bandage.
Pregnancy and the period of a lactation
Mometoks Cream is applied at pregnant women only if the expected advantage for mother exceeds potential threat for a fruit.
The feeding women need to interrupt breastfeeding for drug treatment Mometoks.
Features of influence on ability to run the vehicle or potentially dangerous mechanisms
Data on an adverse effect of drug on ability to run vehicles and mechanisms are absent.
Overdose
Symptoms: system absorption at topical administration of Mometoks of cream can lead to emergence of system effects.
Treatment: symptomatic.
A form of release and packing
On 15 g of cream in an aluminum tuba.
On 1 tuba together with the instruction for medical use in the state and Russian languages put in a pack from cardboard.
To Store storage conditions at a temperature not over 25 ºС.
To store out of children’s reach!
3 years
not to apply a period of storage after an expiration date.
Prescription status
According to the prescription
Oxford Laboratories Pvt Producer.
Ltd Oxford Laboratories Pvt. Ltd.
of Mumbai, India
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods)
Representative office Oxford of Laboratories Pvt. Ltd
Almaty, Auezov St. 3
Ph./fax + 7 727 266 95 50
E-mail:
almatyoxford@hotmail.com
Additional information
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