It is APPROVED
by the Order of the Chairman of the Committee of control of medical and pharmaceutical activity
of the Ministry of health and social development
of the Republic of Kazakhstan
from ____ ______________ 201_ g
the Trade name
Mezhdunarodnoye the unlicensed name
no Dosage form
1 g of ointment contains
active agents – Dipropionas betamethasone, in terms of 100% substance – 0.64 mg, salicylic acid in terms of 100% substance – 30.0 mg,
excipients: mineral oil, paraffin white soft.
Ointment of white color
Glucocorticosteroids for topical treatment of diseases of skin. Corticosteroids in a combination with other drugs. Betamethasone in a combination with other drugs.
ATX D07X C01 code.
Pharmacokinetics Absorption properties Dipropionas betamethasone organism perhaps mainly after long-term treatment on the extensive surface of skin.
It is metabolized in a liver. Metabolites are removed mainly with urine, an insignificant part – with bile.
Anti-inflammatory, antipruritic, vasoconstrictive, antiallergic, keratolytic, antiseptic.
Betamethasone Dipropionas slows down release of interleukins 1 and 2, gamma interferon, inflammation mediators, reduces metabolism of arachidonic acid, induces formation of the lipokortin having antiedematous activity.
Salicylic acid promotes the best penetration of betamethasone of Dipropionas into deep structures of skin, has keratolytic and antiseptic effect.
the Subacute and chronic dermatosis with a hyperkeratosis (including hairy sites of skin):
– acute and chronic eczema
– red flat deprive
– disgidrotichesky dermatitis
– seborrheal dermatitis
– an ichthyosis and other ichthyotic defeats
– seborrhea of hairy sites of skin
the Route of administration and doses
to use Drug only outwardly: to put with a thin layer, slightly rubbing to the site of the affected skin 2 times a day.
For some patients for achievement of satisfactory result can be rather single daily drawing.
Duration of treatment is defined by stopping of inflammatory process, the termination of an itching, clarification of integuments, but should not exceed 10 days.
To use drug to children from 2 years. Not obkhodimo to limit treatment duration for children up to 5 days.
At use of local corticosteroids can be observed such undesirable phenomena:
– burning, an itching, irritation, dryness
– a folliculitis
– a hypertrichosis
– acne rash
– perioral dermatitis, allergic contact dermatitis
the undesirable Below-mentioned effects can arise more often at use of occlusive bandages:
– maceration of skin
– consecutive infection
– a skin atrophy
– striya, a heat rash
of Striya and vasodilatation (generally on a face) can be result of long continuous putting drug.
– individual hypersensitivity to drug components
– the acne, pink eels
– perioral dermatitis
– widespread blyashechny psoriasis
– a perianal and genital itching
– a varicosity
– a diaper dermatitis
– chicken pox
– a tuberculosis cutis
– other bacterial and fungal infections of skin without appropriate antibacterial and anti-fungal therapy
– a herpes simplex
– a contagious mollusk
– skin manifestations of syphilis
– skin reactions after vaccination
– children’s age up to 2 years
does not know Interaction at use of drug in the form of ointment.
If during use of drug the irritation or hypersensitivity take place, treatment should be stopped.
When dandruff or an orogovelost disappears, continue treatment only by corticosteroids.
In case of accession of an infection it is necessary to appoint the corresponding therapy.
The side effects arising at use of system kortikosteriod, including oppression of function of bark of adrenal glands, can be noted also at excessive and prolonged use of corticosteroids, especially in pediatric practice.
System absorption of local corticosteroids and salicylic acid increases at treatment of considerable sites of skin and also at use of occlusive bandages.
At use on face skin or to children it is necessary to limit therapy course duration up to 5 days.
It is necessary to avoid long therapy by drug to all patients irrespective of age.
At development of irritation of skin, including its excessive dryness, it is necessary to stop drug use.
Patients with abnormal liver functions are more sensitive to system influence.
The recurrence at treatment interruption is possible. There can be an exacerbation of an infection, healing can also slow down.
Not to use drug in ophthalmology.
It is necessary to avoid hit of drug in eyes and on mucous membranes, wound surfaces and ulcers.
Putting drug on sites with atrophied skin is contraindicated.
Use in pediatrics
to use Drug to children aged from 2 years. Treatment duration for children has to be reduced by minimum possible time.
Children have signs of oppression gipotalamo more often – a hypophysial and adrenal system and emergence of outer corticosteroid effects under the influence of local corticosteroids, than at adult patients. It is connected with bigger absorption of drug at children because of bigger value of a ratio of surface area of skin to body weight. At the children receiving treatment by topical corticosteroids can be observed oppression gipotalamo – a hypophysial and adrenal system, Cushing’s syndrome, a linear growth inhibition, insufficient gain of body weight, increase in intracranial pressure. Manifestations of adrenal suppression at children: low level of cortisol of blood plasma and lack of the response to AKTG-stimulation. Increase in intracranial pressure is shown by protrusion of a fontanel, a headache, bilateral hypostasis of disks of optic nerves.
Not to use drug under diapers.
Pregnancy and the period of a lactation
Safety of use of local glucocorticosteroids is not proved to pregnant women therefore appointment of this group of medicines during pregnancy is possible only in case the potential advantage for the woman exceeds potential risk for a fruit. During pregnancy drugs of this group should not be used in high doses or a long time.
It is unknown whether can lead topical administration of corticosteroids by system absorption to emergence them in breast milk. The decision on the termination of chest feeding or drug withdrawal should be accepted taking into account need of use of drug for mother.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
it was not studied
Symptoms: excess or prolonged use of local corticosteroids can lead to oppression of function of a hypophysial and adrenal system that there can be the reason of development of secondary insufficiency of adrenal glands and emergence of symptoms of a hypercorticoidism, including Cushing’s disease.
Excess or prolonged use of the topical drugs containing salicylic acid can cause emergence of symptoms of a salitsilizm.
Treatment: the corresponding symptomatic treatment is shown. 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 a corticosteroid is recommended.
Treatment of a salitsilizm symptomatic. It is necessary to take measures for faster removal of salicylates from an organism. To orally apply Natrii hydrocarbonas to alkalization of urine and strengthening of a diuresis.
A form of release and packing
On 15 g in tubas aluminum.
On 1 tuba together with the instruction for medical use in the state and Russian languages place in a pack from cardboard for medicines.
To Store storage conditions in original packing at a temperature not above 25 °C.
To store out of children’s reach!
A period of storage
not to apply after expiry date
According to the prescription
PJSC Kiyevmedpreparat Producer, Ukraine, 01032, Kiev, Saksagansky St., 139
the Owner of the registration certificate
of PJSC Kiyevmedpreparat, Ukraine, 01032, Kiev, Saksagansky St., 139
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products:
Representative office of Arterium corporation in
Republic of Kazakhstan 050060, Almaty, Al-Farabi Avenue 97, 3 entrance, office 54
Ph. / fax: 8 (727) 315-82-09, 8 (727) 315-82-10,
To Develop Almaty@arterium.ua