The instruction for medical use
the Trade name
the International unlicensed
name Hydrocortisone Dosage Form Ointment for external use of 1%, 10 g
of 100 g of ointment contains
active agent: Hydrocortisoni acetas – 1.0 g,
excipients: methylparahydroxybenzoate (nipagin), propilparagidroksibenzoat (nipazol), vaseline, stearic acid, lanolin anhydrous, pentaerythrityl dioleate (pental), the water purified.
Ointment white with a yellowish shade or light yellow color.
Glucocorticosteroids for topical treatment of diseases of skin. Hydrocortisone.
The code of automatic telephone exchange D07AA02
Pharmacokinetics Later properties of applique collects in epidermis (generally in a granular layer). It is metabolized directly in epidermis, and further in a liver. Metabolites and an insignificant part of an invariable hydrocortisone are allocated with urine or with bile.
the Hydrocortisone is synthetic glucocorticoid drug for topical administration. Has anti-inflammatory, antiedematous, antipruritic effect. Slows down release of cytokines (interleukins and interferon) from lymphocytes and macrophages, release by eosinophils of mediators of inflammation oppresses, reduces metabolism of arachidonic acid and synthesis of prostaglandins. Stimulating steroid receptors, induces formation of a special class of proteins – the lipokortin having antiedematous activity. Reduces inflammatory cellular infiltrates, reduces migration of leukocytes and lymphocytes to the area of inflammation. Topical administration of drug in the recommended doses does not cause side system effects.
Inflammatory and allergic diseases of skin of not microbic etiology:
– allergic and contact dermatitis
the Route of administration and doses
Locally. Ointment is applied a thin layer on affected areas of skin by 2-3 times a day. Duration of a course of treatment depends on the nature of a disease and efficiency of therapy, being, as a rule, 6-14 days, at the persistent course of the disease it can be prolonged up to 20 days. On the limited centers for strengthening of effect it is possible to use occlusive bandages. At use of ointment for children of 2 years is also more senior it is necessary to limit the general duration of treatment and to exclude the actions leading to strengthening of a resorption of absorption of steroid (warming, fixing and occlusive bandages).
– puffiness and an itching in sites of application of ointment
At prolonged use of ointment or use of an occlusive bandage:
– a hypercorticoidism as manifestation of resorptive action of Hydrocortisoni acetas
– secondary infectious damages of skin, atrophic changes in it, a hypertrichosis.
– hypersensitivity to drug or other its components
– wound and cankers, bacterial, viral and fungus diseases of skin
– a tuberculosis cutis
– syphilitic damages of skin
– a rozatse, vulgar eels
– perioral dermatitis
– the postvaccinal period
– pregnancy, the lactation period
– skin tumors
– children’s age up to 2 years.
With care in diabetes.
For prevention of infectious damages of skin recommend to appoint drug in combination with antibacterial and antifungal agents.
instructions Use in pediatrics
In cases of use of drug for children, duration of a course of treatment it is necessary to reduce by area of the person.
At children’s age the suppression of function of bark of adrenal glands can quicker develop. Besides, decrease in excretion of growth hormone can be observed. At drug use it is necessary to watch the body weight, growth, plasma cortisol level for a long time.
It is necessary to avoid hit of ointment in eyes. To children up to 12 years drug is appointed only under stringent medical control. If after 7 days of use there does not occur improvement or aggravation of symptoms and also in case of resuming of symptoms in several days after drug withdrawal is observed, use of drug it is necessary to stop and consult with the doctor. At long-term treatment and/or drawing it is recommended to appoint a diet with restriction of sodium and the increased maintenance of K+ to big surfaces, to enter enough protein into an organism.
For prevention of infectious damages of skin drug is recommended to appoint in combination with antibacterial and antifungal agents.
It is necessary to control the ABP, glucose content in blood, blood clotting, a diuresis, body weight of the patient, plasma cortisol level.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
Symptoms does not influence: at prolonged use of drug in high doses the emergence of symptoms of a hypercorticoidism is possible.
Treatment: drug withdrawal. Symptomatic therapy.
The form of release and packing
On 10 g of drug place in tubas aluminum with internal coating is delicious from bushona.
Each tuba together with the instruction for medical use in the state and Russian languages is placed in a pack from cardboard.
To Store storage conditions at a temperature not over 15 ºС.
To store out of children’s reach!
not to apply a period of storage after an expiration date.
ProizvoditelOAO’s prescription Biosintez, Russian Federatsiya440033, Penza, Druzhby St., 4, ph. / fax (8412) 57-72-49, e-mail: email@example.com
the Name and the country of the owner of the registration certificate
of JSC Biosintez, the Russian Federation
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods) of JSC Biosintez, Russian Federatsiya440033, Penza, Druzhby St., 4, ph. / fax (8412) 57-72-49, e-mail: firstname.lastname@example.org