Project Description

Prednisolon

ointment 0,5% Unguentum Prednisoloni 0,5%

international nonproprietary name

Prednisolon.

Ref

BP-0111

Pharmacotherapeutic group

Preparation for treatment of skin pathology — glucocorticosteroid.

Composition of the preparation

1 g of ointment contains prednisolon 5 mg.

Pharmacological action

Pharmacodynamics

The action of the preparation is secured by pharmacology properties of the agent — prednisolon. The preparation has a marked local anti-inflammation, antiallergic and antiexudative action. Anti-inflammation action of prednisolon in the skin and other tissues is achieved mainly with the help of cytosol receptors of glucocorticosteroids. Hormone-receptor complex penetrating into the skin target cell nucleus (keratinocytes, fibroblasts, lymphocytes), increases the expression of genes coding the synthesis of lipocortins that inhibit phospholipase А2 and reduce the synthesis of products of arachidonic acid metabolism — cyclic endoperoxides, prostaglandins and thromboxane. Antiproliferative action of prednisolon is related to the inhibition of nucleic acid synthesis (mainly RNA) in the cells of the epidermis basal layer and corium dermocytes. Antiallergic affect is conditioned by the reduction in number of basocytes, direct inhibition of secretion and synthesis of biologically active substances.

Pharmacokinetics

On local application the absorption of prednisolon takes place and the agents gets into the blood flow. 90% prednisolon in plasma is bound (with transcortin and albumin). It is subject to biotransformation mainly in the liver by oxidation; oxygenized forms are glucuronized or sulphanized. It is excreted in the urine or faeces, partly — unaltered. It penetrates through placenta barrier and small quantities of the preparation are found in breast milk.

Indications 

The preparation is used on allergic and contact dermatitis, eczema, atopic dermatitis, seborrheic dermatitis, psoriasis.

special indication

Not established

special warning

Not established

Dosage and method of administration

The preparation is for external use. It should be uniformly applied onto the lesion focus 1—3 times a day. The duration of treatment depends on the nature of disease and makes from 8 till 14 days. On application of the preparation in children the course of treatment should be shorter (from 3 to 7 days). Heating, fixed and occlusive bandage should be excluded.

overdosage

Not established

safety measures

Treatment should be carried out under the doctor’s control.

Side effects

As a rule, the preparation is tolerated well. In rare cases, esp.on a prolonged treatment, itching, burning and erythema are possible. Folliculitis, hypertrichosis, perioral dermatitis, allergic reactions to several components of the preparation may develop in certain patients. The indicated symptoms do not require additional treatment and pass when the administration of the preparation is stopped.

It should be taken into account that in case of application of the preparation onto the damaged skin or prolonged application (especially, when applied onto major sites of the skin) prednisolon systemic side effects may develop.

Contraindications

Individual intolerance, tuberculosis and syphilitic processes in the area of the preparation application, chicken pox, zoster and other etiologic diseases; skin reaction to the vaccination; bacterial and fungus injuries; skin tumor; pregnancy, lactation (breast-breeding shall be stopped for this period).

Interactions with other medicinal preparations

Prednisolon increases anticoagulative action of anticoagulants. It increases the likelihood of hemorrhage on the basis of salicylates. It increases the possibility of electrolytic metabolism on simultaneous administration of diuretics. It increases the risk of intoxication with cardiac glycosides. The preparation decreases a hypoglycemic effect of antidiabetic preparations and reduces antibacterial activity of rifampicin. Combination with antacid preparations is not recommended.

The form of release

Ointment 0,5% 10 g in glass cans or tubes.