PREDNISOLONE

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT PREDNISOLONE

Composition:

Active ingredient: prednisolone;

1 g of ointment contains 0.005 g of prednisolone;

Excipients: glycerol, white soft paraffin, stearic acid, emulsifier No. 1, methylparaben (E 218), propylparaben (E 216), purified water.

Pharmaceutical form. Ointment.

Main physicochemical properties: white-colored ointment.

Pharmacotherapeutic group. Corticosteroids for dermatological use. Prednisolone. ATC code D07AA03.

Pharmacological properties.

Pharmacodynamics.

Prednisolone is a synthetic glucocorticosteroid agent for topical use. It exerts anti-inflammatory, antiallergic, and anti-edematous effects. It inhibits the release of inflammatory mediators (histamine, prostaglandins, leukotrienes, lysosomal enzymes). It suppresses inflammatory skin reactions, reduces vasodilation and increased vascular permeability at the site of inflammation, and decreases itching and pain at the application site.

Pharmacokinetics.

After minimal absorption from the skin surface, prednisolone binds to plasma proteins, is metabolized in the liver, and excreted via the kidneys. Impaired skin integrity or application under occlusive dressing may increase transdermal absorption of prednisolone. Prednisolone crosses the placental barrier and passes into breast milk in small amounts.

Clinical characteristics.

Indications. As part of complex therapy for inflammatory and allergic skin diseases of non-microbial etiology: eczema, seborrheic dermatitis, psoriasis, lupus erythematosus, erythrodermas.

Contraindications. Individual hypersensitivity to any component of the drug, Cushing's syndrome, varicella (chickenpox), vaccination period, herpes simplex, wound or ulcerative lesions, bacterial, viral or fungal skin infections, cutaneous tuberculosis, syphilitic skin manifestations, skin tumors, common acne, rosacea, herpes zoster, perioral dermatitis, atrophic dermatitis, skin reactions following vaccination at the site of drug application.

Interaction with other medicinal products and other forms of interaction. To prevent skin infections, prednisolone is recommended to be prescribed in combination with antibacterial and antifungal agents. Vaccination against smallpox or other types of immunization should not be performed during treatment with this drug due to the immunosuppressive effect of glucocorticosteroids. Application of the ointment to large skin areas or prolonged treatment may cause interactions similar to those observed during systemic therapy. However, to date, no such interactions have been reported. If it is necessary to use any other medicinal products concomitantly, consult a physician.

Special precautions for use.

The drug should be used at the lowest doses and for the shortest duration necessary to achieve the desired therapeutic effect. High doses should be administered under strict medical supervision in patients with a history of psychosis. Sudden discontinuation after prolonged use is potentially dangerous and may lead to disease exacerbation and worsening of the patient's general condition. Therefore, the drug should be discontinued gradually. During treatment, regular ophthalmological monitoring and blood pressure control are required. Treatment must be conducted under physician supervision. To minimize the risk of adverse reactions, corticosteroids (CS) should be alternated with nonsteroidal drugs. The maximum allowable skin surface area treated with CS should not exceed 20% of the total body surface. CS should be used only in short courses and for managing exacerbations, not for prophylaxis. When prescribing prednisolone, the daily secretory rhythm of glucocorticosteroids (GCS) and the rhythm of adrenal cortex hormone secretion should be considered: higher doses should be administered in the morning, medium doses during the day, and lower doses in the evening.

Use with caution in immunodeficient conditions (including HIV infection).

In the presence of bacterial skin infections and/or fungal skin lesions, additional specific treatment with antibacterial and/or antifungal agents is required.

Avoid contact of the drug with the eyes and with deep open wounds or mucous membranes.

When corticosteroids for topical use are applied over large body areas or for prolonged periods, especially under occlusive dressings, the risk of adverse effects significantly increases.

Visual disturbances (e.g., after high-dose use, application over large areas for prolonged periods, use of occlusive dressings, or application to skin around the eyes) may occur during treatment with systemic or topical corticosteroid agents. If a patient experiences symptoms such as blurred vision or other visual disturbances, they should consult an ophthalmologist to determine the cause, which may include cataract, glaucoma, or rare conditions such as central serous chorioretinopathy (CSC), which has been reported following the use of systemic or topical corticosteroid agents.

Prolonged use of topically applied drugs may lead to sensitization. In such cases, therapy should be discontinued and appropriate treatment initiated.

Do not use for more than 14 days.

The medicinal product contains methylparahydroxybenzoate (E 218) and propylparahydroxybenzoate (E 216), which may cause allergic reactions.

Use during pregnancy or breastfeeding. Do not use during pregnancy. Breastfeeding should be discontinued during treatment with this drug.

Ability to influence reaction rate when operating vehicles or machinery. No effect.

Dosage and Administration

Apply the ointment as a thin layer to affected skin areas 1–3 times daily, gently rubbing in. The duration of treatment depends on the nature of the disease and therapeutic response, usually lasting 6–14 days. Do not use the medication for longer than 14 days. For enhanced effect on limited areas, occlusive dressings may be used.

When prescribing the drug to children aged 1 year and older, total treatment duration should be limited to 5–7 days, and measures leading to increased absorption of corticosteroids (warming, fixing, and occlusive dressings) should be avoided.

Children. Use the drug in children aged 1 year and older (only under medical supervision) on limited skin areas for no more than 5–7 days. Use in children aged 1 to 3 years is possible only if the expected therapeutic benefit outweighs the potential risk. Do not apply the drug to facial skin.

In pediatric patients, adrenal suppression may develop more rapidly. Additionally, reduced growth hormone excretion may occur. During prolonged treatment, monitor body weight, growth, and plasma cortisol levels.

Overdose. Overdose may lead to intensification of adverse reactions. Prolonged use of large amounts of Prednisolone may result in symptoms of hypercorticism.

Symptoms of overdose: headache, heart failure, urticaria, rash, severe itching.

Treatment: symptomatic. Discontinue the drug and consult a physician. In severe cases, emergency medical assistance is required.

If cutaneous atrophy occurs due to overdose from topical application, treatment should be discontinued. Symptoms usually regress within 10–14 days.

Side effects.

When using the medication, especially in patients with individual sensitivity to its components, hypersensitivity reactions may occur. These may include hyperemia, swelling, itching, urticaria, rash, steroid acne, purpura, telangiectasias, burning sensation, irritation, dryness of the skin at the application site, pustules, vesicles, pain, papules at the site of application, and skin fissures. As with topical use of other corticosteroids, the following adverse effects (frequency not known) may also be observed: skin thinning (skin atrophy), development of striae, inflammation of hair follicles (folliculitis) at the application site, perioral dermatitis, skin discoloration, bacterial cellulitis, contact dermatitis, and allergic skin reactions to any component of the medicinal product. With prolonged treatment, secondary infectious skin lesions, atrophic changes, and hypertrichosis may also develop. Prolonged use of the ointment, especially over large affected skin areas, may lead to hypercorticism as a manifestation of the systemic absorption effect of prednisolone.

In such cases, the medication should be discontinued.

When topical corticosteroids are used in conditions leading to thinning of the cornea or sclera, cases of perforation may occur. There is information about delayed wound healing, ptosis, mydriasis, and blurred vision (see section “Special precautions for use”).

Shelf life. 2 years.

Do not use after the expiry date stated on the packaging.

Storage conditions. Store at a temperature not exceeding 25 °C. Keep out of reach of children.

Packaging.

10 g in a tube. One tube per cardboard box.

Prescription status. Prescription only.

Manufacturer.

LLC "FZ “STADA”.

Manufacturer's location and address of business activity.

37 Kyivska St., Bila Tserkva, Kyiv region, 09100, Ukraine.