The instruction for medical use
the Trade name
the International unlicensed
name Prednisolonum Dosage Form Ointment for external use of 5 mg/g
One tuba contains
active agent – Prednisolonum – 0.05 g,
excipients: glycerin, white soft paraffin, stearic acid, a macrogoal cetostearyl ether (A 6 cremophore, A 25 cremophore), methylparahydroxybenzoate, propilparagidroksibenzoat, water
the Ointment of white color of uniform consistence purified the Description.
Glucocorticosteroids for topical treatment of diseases of skin. Slaboaktivny glucocorticosteroids. Prednisolonum.
The ATX D07AA03 code
Pharmacokinetics At properties topical administration happens Prednisolonum absorption, and active agent gets to a blood stream. In plasma of 90% of Prednisolonum is in the connected look (with transcortinum and albumine). It Biotransformirutsya by oxidation mainly in a liver, the oxidized forms glyukuronizirutsya or sulphated. It is removed with urine and a stake in the form of metabolites, partially – in not changed look. Gets through a placental barrier and in small amounts it is found in breast milk.
the Dehydrogenated hydrocortisone analog. At external use renders anti-inflammatory, antiallergic, antipruritic and anti-exudative action.
Suppresses education, release and activity of mediators of inflammation (a histamine, a kinin, prostaglandins, lizosomalny enzymes). Suppresses migration of cells to the place of inflammation, reduces a vazodilatation and hyperpermeability of vessels in the inflammation center.
Reduces exudation thanks to vasopressor action.
– in complex therapy of inflammatory and allergic diseases of skin of not microbic etiology: urticaria, allergic dermatitis, contact dermatitis, atopic dermatitis, diffusion neurodermatitis, simple chronic deprive (limited neurodermatitis), eczema, psoriasis, a diskoidny lupus erythematosus, a toxidermia, an erythrosis.
Route of administration and doses
Outwardly. 1-3 times a day inflict a thin layer on the centers defeats by a uniform layer. Duration of treatment depends on the nature of a disease and efficiency of therapy and is from 6 to 14 days. According to indications the treatment can be continued. On the limited centers for strengthening of effect occlusive bandages can be used.
At use of ointment for children of 1 year 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 and absorption (warming, fixing and occlusive bandages).
– hyperaemia, puffiness, an itching within the site of putting drug, steroid eels, teleangiectasias, burning, irritation, xeroderma, especially at patients with individual intolerance
are secondary infectious damages of skin, atrophic changes in it, a hypertrichosis (at prolonged use of drug)
– a hypercorticoidism as manifestation of resorptive effect of Prednisolonum (at prolonged use, especially on big sites). In these cases drug is cancelled.
– hypersensitivity to drug components
– tuberculosis, syphilis, skin tumors
– ordinary eels, pink eels (exacerbation of a disease is possible)
– wound, skin cankers
– bacterial, viral and fungus diseases of skin
– pregnancy and the period of a lactation
– children’s age till 1 year.
Emergence of a hirsutism and eels is promoted by simultaneous use with Prednisolonum of other glucocorticosteroids, androgens, estrogen, oral contraceptives and steroid anabolic steroids.
Prednisolonum strengthens anticoagulative effect of anticoagulants. Increases the probability of bleedings against the background of intake of salicylates. Raises a possibility of disturbances of electrolytic exchange at a concomitant use of diuretics. Enhances risk of intoxication cardiac glycosides. Reduces hypoglycemic effect of antidiabetic drugs and reduces antibacterial activity of rifampicin. It is not recommended to combine with antiacid drugs.
For prevention of infectious damages of skin recommend to appoint ointment in combination with antibacterial and antifungal agents.
Duration of use of medicine should not exceed 14 days.
At children’s age the suppression of function of bark of adrenal glands can quicker develop. Besides, decrease in secretion of growth hormone can be observed.
With extra care to apply at children up to 10 years, estimating a ratio of risk of complications and advantage of Prednisolonum use. At Prednisolonum use for a long time (more than 14 days) need to be watched the body weight, growth, plasma cortisol level, results of stimulation AKTG – the test.
To use only on doctor’s orders.
Only for external use.
To avoid hit in eyes.
Not to put on a face, in inguinal and an underarm.
To apply occlusive bandages or compresses with Prednisolonum only on doctor’s orders.
Not to apply to treatment of diaper dermatitis.
The feature of influence of medicine on ability to drive the car or potentially dangerous mechanisms
does not influence ability to drive the car or potentially dangerous mechanisms.
At prolonged use of medicine in large numbers the emergence of symptoms of a hypercorticoidism is possible.
Treatment: cancellation of medicine and symptomatic therapy.
The form of release and packing
On 10 g of drug place in tubas aluminum. Each tuba together with the instruction for medical use in the state and Russian languages is placed in a pack from cardboard.
At a temperature from 5 ºС to 15 ºС.
To protect from children!
not to use a period of storage after expiry date.
According to the prescription
the Borisovsky Plant of Medications Open joint stock company Producer, Republic of Belarus, Minsk Region, Borisov, Chapayev St., 64/27,
ph. / fax 8-(10375177) 744280.
The owner of the registration certificate
Borisovsky Plant of Medications Open joint stock company, Republic of Belarus
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods) Borisovsky Plant of Medications Open joint stock company, Republic of Belarus, Minsk Region, Borisov, Chapayev St., 64/27, ph. / fax 8-(10375177) 744280, the e-mail address of email@example.com