The instruction for medical use
of Diprosalik® medicine
the Trade name
the International unlicensed name
Is not present
the Dosage form
1 gram of ointment contains
active agents: betamethasone of 0.5 mg (in the form of Dipropionas betamethasone), salicylic acid of 30 mg,
excipients: liquid paraffin, paraffin white soft.
Smooth uniform ointment of almost white color, without visible mechanical inclusions
Glucocorticosteroids for topical treatment of diseases of skin. Glucocorticosteroids in a combination with other drugs. Corticosteroids strong in a combination with other drugs. Betamethasone in a combination with other
drugs ATX D07XC01 Code Pharmacological Pharmacokinetics At Properties putting ointment salicylic acid has only local effect. Extent of absorption of topical corticosteroids depends on a form of medicine, integrity of epidermis and existence of occlusive bandages. Topical corticosteroids can get through the intact healthy integuments. The absorbability of drug increases in the presence of inflammatory processes in skin. Penetration of topical corticosteroids is promoted by use of occlusive bandages.
After dermal absorption, topical corticosteroids pass the same pharmacokinetic way, as system corticosteroids. Corticosteroids in various degree contact proteins of blood plasma, are metabolized mainly in a liver and removed through kidneys. Some topical corticosteroids and their metabolites are removed with bile.
of Diprosalik® – the combined drug which contains Dipropionas betamethasone ether – the glucocorticoid having the main properties of corticosteroids and salicylic acid which has keratolytic properties. Thanks to presence of salicylic acid, softens skin, eliminates horn stratifications and promotes deeper penetration of betamethasone of Dipropionas. Betamethasone Dipropionas has anti-inflammatory, antipruritic and vasoconstrictive effect and is effective at therapy of a number of a dermatosis. In pharmacological doses the corticosteroids possess anti-inflammatory and immunosuppressive action. Physiological, pharmacological and clinical effects of corticosteroids are well-known, mechanisms of their action in various diseases remain not up to the end studied.
– the dry and giperkeratichesky dermatosis demanding use
of corticosteroid therapy
– chronic atopic dermatitis
– deprive chronic idle time
– flat deprive
– eczema (including monetovidny eczema, eczema of hands, eczematic dermatitis), a dyshydrosis (edema)
– seborrheal dermatitis of a hairy part of the head
– an ichthyosis usual and other ichthyotic states.
The route of administration and doses
to Adults and children are more senior than one year apply ointment a thin layer twice a day – in the morning and in the evening, completely covering affected areas of skin. At some patients of satisfactory effect it is possible to reach at less frequent use of drug. Duration of treatment is defined by weight and a course of the disease.
the Course of treatment for children makes no more than 5 days.
– burning, an itching, irritation, dryness, a folliculitis, a hypertrichosis, acneform rashes, hypopigmentation, perioral dermatitis
– allergic contact dermatitis
– maceration of skin, consecutive infection, an atrophy of skin, a striya, a heat rash (at use of occlusive bandages)
– a local hirsutism, teleangiectasias, a purpura (at prolonged use)
– a growth inhibition, an Icenco-Cushing syndrome, benign increase in intracranial pressure after the end of treatment, a hyperglycemia, a glucosuria, a hypopotassemia, increase in the ABP (system manifestations of side effects of betamethasone of Dipropionas when drawing on big surfaces)
– pallor, increased fatigue, drowsiness, a hyperventilation against the background of a tachypnea, nausea, vomiting, a hearing disorder, confusion of consciousness (system manifestations of side effects of salicylates when drawing on big surfaces)
– hypersensitivity to drug components
– children’s age up to one year
– bacterial, viral and fungus skin diseases (a pyoderma, syphilis, a tuberculosis cutis, chicken pox, herpes, actinomycosis, a zymonematosis, a sporotrichosis)
– vaccine-challenged skin reactions
– perioral dermatitis, a rozatsea, trophic ulcers against the background of chronic venous insufficiency
– skin tumors (carcinoma cutaneum, a nevus, an atheroma, an epithelioma, a melanoma, a hemangioma, a xanthoma, sarcoma).
– a liver failure.
Medicinal interactions are not described.
If against the background of use of drug there was an irritation of skin or on –
vyshenny sensitivity, treatment should be stopped. In case of accession of an infection it is necessary to appoint the corresponding therapy.
The side effects characteristic of system corticosteroids, including oppression of function of bark of adrenal glands, can be noted at topical administration of corticosteroids, especially at newborns and at children.
System absorption of local corticosteroids and salicylic acid increases at treatment of considerable sites of skin and also when using occlusive bandages.
It is necessary to avoid putting ointment on open wounds or the injured skin. It is necessary to adhere to these precautionary measures also at prolonged use, especially at treatment of children.
In case of irritation of skin, including excessive xeroderma, it is necessary to stop drug use.
Drug is not used in ophthalmology.
It is necessary to avoid hit of drug in eyes and on mucous membranes.
Use in pediatrics
For children perhaps more frequent emergence of signs of oppression gipotalamo – 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 higher absorption of drug at children owing to the bigger size of a ratio of surface area to body weight. At the children receiving treatment by topical corticosteroids can be observed function oppression gipotalamo – a hypophysial and adrenal system, Cushing’s syndrome, a linear growth inhibition, lag in a weight increase, increase in intracranial pressure. Manifestations of adrenal suppression at children: low level of cortisol in blood plasma and lack of the response to stimulation of AKTG. Increase in intracranial pressure is shown by protrusion of a fontanel, a headache, bilateral hypostasis of disks of optic nerves. 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.
Pregnancy and a lactation
Appointment of this group of drugs during pregnancy is justified only if 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 it is long.
The feeding women should use drug with care.
The decision on the termination of breastfeeding 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
Drug does not affect ability to run vehicles or difficult technical devices.
Symptoms: there are no data on drug overdose. However at its long use on big surfaces perhaps system manifestation of side effects of betamethasone of Dipropionas, namely: Icenco-Cushing syndrome, benign increase in intracranial pressure, development of secondary insufficiency of adrenal glands, or salicylates: pallor, fatigue, drowsiness, other symptoms of a salitsilizm.
Treatment: symptomatic treatment. The specified manifestations of overdose are usually reversible. If necessary correction of an electrolytic imbalance is shown. At manifestation of symptoms of a salitsilizm take measures for faster removal of salicylates from an organism. Orally apply Natrii hydrocarbonas to alkalifying of urine and strengthening of a diuresis.
In case of chronic manifestation of symptoms of overdose the slow drug withdrawal is recommended.
A form of release and packing
On 30 g in tubas aluminum with a membrane, with internal varnish coating, the membranes which are screwing up a plastic cap with a pin for piercing.
On 1 tuba together with the instruction for medical use in the state and Russian languages place in a box.
To Store storage conditions at a temperature not over 25 ºС.
To store out of children’s reach.
not to apply a period of storage after an expiration date.
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 of 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
Fax +7 (727) 321-60-47
To Develop firstname.lastname@example.org