Prednisolone-Ferein (Ointment) Instructions for Use

Marketing Authorization Holder

Bryntsalov-A, JSC (Russia)

ATC Code

D07AA03 (Prednisolone)

Active Substance

Prednisolone (Rec.INN WHO registered)

Dosage Form

Prednisolone-Ferein

Ointment for external use 0.5%: tubes 10 g or 15 g

Dosage Form, Packaging, and Composition

10 g – aluminum tubes (1) – cardboard packs.
15 g – aluminum tubes (1) – cardboard packs.

Clinical-Pharmacological Group

Topical corticosteroids for external use

Pharmacotherapeutic Group

Topical glucocorticosteroid

Pharmacological Action

Glucocorticosteroid. Suppresses the functions of leukocytes and tissue macrophages. Limits the migration of leukocytes to the area of inflammation. Impairs the ability of macrophages to phagocytose and to form interleukin-1. Promotes stabilization of lysosomal membranes, thereby reducing the concentration of proteolytic enzymes in the area of inflammation. Reduces capillary permeability caused by the release of histamine. Suppresses fibroblast activity and collagen formation.

Inhibits the activity of phospholipase A₂, which leads to suppression of the synthesis of prostaglandins and leukotrienes. Suppresses the release of COX (mainly COX-2), which also contributes to the reduction of prostaglandin production.

Reduces the number of circulating lymphocytes (T- and B-cells), monocytes, eosinophils, and basophils due to their movement from the vascular bed into the lymphoid tissue; suppresses antibody formation.

Prednisolone suppresses the release of ACTH and β-lipotropin by the pituitary gland but does not reduce the level of circulating β-endorphin. Inhibits the secretion of TSH and FSH.

When applied directly to blood vessels, it has a vasoconstrictor effect.

Prednisolone has a pronounced dose-dependent effect on the metabolism of carbohydrates, proteins, and fats. Stimulates gluconeogenesis, promotes the uptake of amino acids by the liver and kidneys, and increases the activity of gluconeogenesis enzymes. In the liver, Prednisolone enhances glycogen storage by stimulating the activity of glycogen synthase and the synthesis of glucose from protein metabolism products. The increase in blood glucose levels stimulates insulin release.

Prednisolone suppresses glucose uptake by fat cells, which leads to activation of lipolysis. However, due to increased insulin secretion, lipogenesis is stimulated, which promotes fat accumulation.

It has a catabolic effect in lymphoid and connective tissue, muscles, adipose tissue, skin, and bone tissue. To a lesser extent than hydrocortisone, it affects water-electrolyte metabolism: promotes the excretion of potassium and calcium ions, and the retention of sodium ions and water in the body. Osteoporosis and Cushing’s syndrome are the main factors limiting long-term glucocorticosteroid therapy. Due to the catabolic effect, growth suppression in children is possible.

When used externally and locally, the therapeutic activity of prednisolone is due to its anti-inflammatory, anti-allergic, and anti-exudative (due to the vasoconstrictor effect) action.

Pharmacokinetics

When taken orally, it is well absorbed from the gastrointestinal tract. C_max in plasma is noted after 90 minutes. In plasma, most of the prednisolone is bound to transcortin (cortisol-binding globulin). Metabolized mainly in the liver.

T_1/2 is about 200 minutes. Excreted by the kidneys unchanged – 20%.

Indications

As part of complex therapy for prednisolone-sensitive skin diseases of non-microbial etiology: eczema, allergic, seborrheic and contact dermatitis; atopic dermatitis (diffuse neurodermatitis); lichen simplex chronicus (circumscribed neurodermatitis); psoriasis; discoid lupus erythematosus; erythroderma.

ICD codes

Dosage Regimen

For external use, apply a thin layer to the affected skin surface. The duration of use depends on the nature of the disease and can be 6-14 days; if necessary and as prescribed by a doctor – up to 20 days.

In children over 1 year of age, the area of application of the drug containing Prednisolone should be limited, the minimum effective doses should be used for the shortest possible course, and manipulations that may lead to increased skin resorption of prednisolone (warming, fixing, and occlusive dressings) should be excluded.

Adverse Reactions

Immune system disorders: allergic reactions.

Skin and subcutaneous tissue disorders within the application area – hyperemia, swelling, burning, irritation and dry skin; when applied to a large area, with prolonged use or under an occlusive dressing – skin atrophy, telangiectasia, hyper- and hypopigmentation, petechiae, ecchymoses, striae, delayed wound healing, steroid acne, folliculitis, hypertrichosis, tendency to develop pyoderma and candidiasis.

Contraindications

Bacterial, viral, fungal skin diseases, skin tuberculosis, skin manifestations of syphilis, skin tumors, post-vaccination period, impaired skin integrity (ulcers, wounds), childhood (under 1 year), rosacea, acne vulgaris, perioral dermatitis, pregnancy, breastfeeding period.

With caution

Children over 1 year of age, elderly patients.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and breastfeeding.

Use in Hepatic Impairment

Use with caution in severe chronic liver failure.

Use in Renal Impairment

Use with caution in severe chronic renal failure.

Pediatric Use

Contraindicated in children under 1 year of age. Use with caution in children over 1 year of age and only in dosage forms intended for this category of patients.

Geriatric Use

Use with caution in elderly patients.

Special Precautions

Should not be used externally for more than 14 days. In case of use for acne vulgaris or rosacea, exacerbation of the disease is possible.

Drug Interactions

Do not apply to the skin in the eye area or to wound surfaces.

To prevent relapses when treating chronic diseases, therapy should be continued for some time after the symptoms disappear.

In case of application to the facial area, under occlusive dressings, or in children over 1 year of age, the duration of treatment should be reduced.

It should be taken into account that in young children, skin folds, diapers, and swaddling can act as an occlusive dressing, which increases the absorption of prednisolone and increases the risk of systemic adverse reactions. Due to the fact that the ratio of surface area to body weight is greater in children than in adults, children are at greater risk of suppression of the hypothalamic-pituitary-adrenal system and the development of Cushing’s syndrome when using any glucocorticosteroids for external and local use.

The use of prednisolone in children should be carried out under medical supervision (monitoring of body weight, height, and plasma cortisol concentration).

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.