Prednisolone, ointment 0.5% 15 g

Prednisolone has anti-inflammatory, anti-allergic, antipruritic and anti-exudative effects.

Decreases formation, release and activity of inflammatory mediators (histamine, kinin, lysosomal enzymes). Suppresses cell migration to the site of inflammation, decreases vasodilation and increased vascular permeability in the inflammation focus. It reduces exudation due to vasoconstrictor action.

Suppresses the action of macrophages, target cells, cytokines, which are involved in the development of the reaction in the form of allergic contact dermatitis. Prevents access of sensitized T-lymphocytes and macrophages to target cells.

Indications

It is used in the complex therapy of inflammatory and allergic skin diseases of non-microbial etiology: eczema, allergic, seborrheic and contact dermatitis, neurodermatitis, psoriasis, lupus erythematosus.

Active ingredient

Composition

Active substance:

Prednisolone – 0.5 g.

Auxiliary substances:

distilled glycerin,

medical Vaseline,

stearic acid,

Emulsifier №1,

Nipagin,

Nipazole,

Purified water.

How to take, the dosage

Externally.

The ointment is applied in a thin layer on the affected areas of the skin 1-3 times a day. The course of treatment depends on the nature of the disease and the effectiveness of therapy; as a rule, it is 6-14 days. During the recovery period it is possible to use the drug once a day.

On areas of thicker skin (e.g., elbows, palms, feet) and places where the product rubs off easily, the ointment can be applied more frequently.

In limited areas, occlusive dressings may be used to enhance the effect.

Interaction

Barbiturates, phenytoin and rifampicin accelerate metabolism of Prednisolone.
Simultaneous use of Prednisolone and salicylates increases the risk of gastrointestinal erosive ulcers. Prednisolone reduces the effect of vaccines and anatoxins.

Special Instructions

The duration of use should not exceed 14 days.

Do not apply to the skin in the eye area (due to possible development of glaucoma and cataracts).

In case of use on the face or under occlusive dressings, and in children 1 year and older, the duration of treatment should be shortened.

In children, suppression of adrenal cortical function may develop more rapidly. In addition, a decrease of growth hormone excretion may be observed. When using the drug for a long time, body weight, growth, plasma cortisol levels should be monitored.

Pediatric use

In children 1 year and older, the total duration of treatment should be limited and measures leading to increased resorption of steroid absorption (warming, fixation and occlusive dressings) should be excluded.

Please note that in young children, skin folds, diapers and diapers may have an effect similar to that of the occlusive dressing and increase systemic resorption of the active ingredient of the drug. Because children have a greater surface area to body weight ratio than adults, children are at greater risk of hypothalamic-pituitary-adrenal suppression and Icenko-Cushing’s syndrome with any topical glucocorticosteroid. Prolonged treatment with a glucocorticosteroid may impair a child’s growth and development. Therefore, children should receive the minimum dose of the drug to achieve an effect, and the use of the drug should be supervised by a physician.

The effect on the ability to drive:

The drug in this dosage form has no effect on the ability to drive motor vehicles and engage in other potentially hazardous activities requiring increased concentration and rapid psychomotor reactions.

Contraindications

Bacterial, viral, fungal skin diseases, skin tuberculosis, cutaneous syphilis, skin tumors, postvaccination period, skin integrity disorders (ulcers, wounds), childhood (under 2 years, with itching in the anus area – under 12 years), rosacea, acne vulgaris, perioral dermatitis.

Side effects

When using the drug, especially in patients with individual intolerance, hyperemia, swelling, itching within the area of application of the drug, steroid acne, telangiectasia, irritation, dry skin may occur.

In prolonged use of the drug it is also possible to develop secondary infectious skin lesions, atrophic changes in the skin, hypertrichosis.

In order to prevent infectious skin lesions the drug is recommended to be used in combination with antibacterial and antifungal agents.

In prolonged use of the drug, especially in large areas of lesions, development of hypercorticism is possible as a manifestation of resorptive action of prednisolone. In these cases, the drug is withdrawn.

Overdose

Long-term use of the drug in high doses may cause symptoms of hypercorticism.

Pregnancy use

Pregnancy

Prednisolone penetrates the placental barrier. Its use in pregnancy is contraindicated.

Breast-feeding

Prednisolone is excreted with breast milk. If it is necessary to use the drug, breastfeeding should be stopped.

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