Prednisolone ointment for external use 0.5% -

pharmachologic effect

Prednisolone has anti-inflammatory, antiallergic, antipruritic and antiexudative effects.

Reduces the formation, release and activity of inflammatory mediators (histamine, kinin, lysosomal enzymes). Suppresses cell migration to the site of inflammation; reduces vasodilation and increased vascular permeability at the site of inflammation.

Reduces exudation due to vasoconstrictor action.

Suppresses the action of macrophages, target cells, cytokines that 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.

Pharmacokinetics

When applied externally, prednisolone is absorbed and the active substance enters the bloodstream. In plasma

90% of prednisolone is in bound form (with transcortin and albumin). Biotransformed by oxidation mainly in the liver; oxidized forms are glucuronidated or sulfated.

It is excreted by the kidneys and bile in the form of metabolites, partially unchanged.

Penetrates the placental barrier and is found in small quantities in breast milk.

Contraindications

Hypersensitivity to prednisolone or any of the components of the drug, wound, ulcerative, bacterial, viral, fungal skin lesions, open wounds, trophic ulcers, skin post-vaccination reactions, tuberculosis, syphilis, skin tumors, acne vulgaris, rosacea (possible exacerbation of the disease ), pregnancy, breastfeeding period, children under 1 year of age.

If you have one of the listed diseases, be sure to consult your doctor before using the drug.

Use during pregnancy and breastfeeding

Glucocorticosteroids cross the placenta. The drug is contraindicated during pregnancy.

Glucocorticosteroids are excreted in breast milk, so breastfeeding must be stopped during treatment during lactation.

Use in pediatrics

When using the drug in children aged 1 year and older, the total duration of treatment should be limited and measures leading to increased resorption of steroid absorption (warming, fixing and occlusive dressings) should be excluded.

It must be taken into account that in young children, skin folds, diapers and diapers can have an effect similar to the effect of an occlusive dressing and increase the systemic resorption of the active substance of the drug.

Due to the fact that in children the ratio of surface area to body weight is greater than in adults, children are at greater risk of suppressing the function of the hypothalamic-pituitary-adrenal axis and developing Cushing's syndrome when using any glucocorticosteroids for external use. Long-term treatment with glucocorticosteroids can lead to impaired growth and development of the child. Therefore, children should receive a minimum dose of the drug to achieve an effect, and the use of the drug should be carried out under the supervision of a physician.

Prednisolone ointment 5mg/g 10g No.1

Name

Prednisolone ointment d/nar. approx. 5 mg/g in tubes 10 g in pack No. 1

Description

The ointment is white.

Main active ingredient

Prednisolone

Release form

Ointment

Dosage

5mg/g

pharmachologic effect

Prednisolone is a synthetic glucocorticosteroid, a drug for topical use. Has anti-inflammatory, anti-allergic, anti-edema effects. Inhibits the release of inflammatory mediators (histamine, prostaglandins, leukotrienes, lysosomal enzymes). Suppresses the skin inflammatory reaction, reduces vasodilation and increased vascular permeability at the site of inflammation, reduces itching and pain at the site of application.

Indications for use

As part of complex therapy for inflammatory and allergic diseases of non-microbial skin. etiologies: urticaria, eczema, allergic and seborrheic dermatitis, psoriasis, lupus erythematosus, erythroderma.

Directions for use and doses

The ointment is applied in a thin layer to the affected areas of the skin, 1-3 times a day, lightly rubbing. The duration of treatment depends on the nature of the disease and the effectiveness of therapy, usually 6-14 days. The drug should not be used for more than 14 days. It is necessary to stop treatment gradually, increasing the intervals between applications or switching to drugs that do not contain corticosteroids. Children. When prescribing the drug to children over 1 year old, the total duration of treatment should be limited to 3-7 days and measures that lead to increased absorption of corticosteroids (warming, fixing and occlusive dressings, diapers) should be excluded.

Use during pregnancy and lactation

The drug is contraindicated in pregnant women. Nursing mothers are advised to stop breastfeeding during the treatment period.

Impact on the ability to drive a car and potentially dangerous mechanisms

No studies have been conducted to assess the effect on the ability to drive or operate machinery. Taking into account the profile of adverse reactions of the drug, no effect on the speed of reaction when driving or operating other mechanisms is expected.

Precautionary measures

The drug should be prescribed in the smallest dosages and in the shortest possible time required. to achieve the desired therapeutic effect. If there is a history of psychosis, high doses are prescribed under the strict supervision of a physician. With long-term use of the drug, sudden withdrawal is dangerous. An exacerbation of the disease and a deterioration in the general condition of the patient is possible. Therefore, the drug should be discontinued gradually. During treatment, monitoring by an ophthalmologist and blood pressure monitoring are necessary. Treatment should be carried out under the supervision of a physician. In order to reduce the development of adverse reactions, corticosteroids and non-steroidal drugs should be alternated. The maximum permissible area of skin treated with corticosteroids should not exceed 20% of the body surface. Corticosteroids should be used in short courses and only for the treatment of exacerbations, but not for prevention. To prescribe prednisolone, one should take into account the daily secretory rhythm of glucocorticosteroids and the rhythm of the release of hormones from the adrenal cortex: large doses are prescribed in the morning, medium doses in the afternoon, small doses in the evening. If used for acne vulgaris or rosacea, an exacerbation of the disease is possible. Do not allow the drug to come into contact with the mucous membrane of the organs of vision. Use with caution in immunodeficient conditions (including AIDS or HIV-infected people). It is recommended to use the drug with caution on the skin of the face, axilla and groin area, since its absorption increases and the risk of developing unwanted reactions increases. The drug should not be applied to areas with atrophied skin. Like other topical corticosteroids, prednisolone should not be applied to the skin around the eyes due to the risk of developing glaucoma or subcapsular cataracts. Corticosteroids may mask the symptoms of an allergic reaction to any of the components of the drug. The drug should be used with caution in elderly patients as they may be more sensitive to its effects due to thinning of the skin. When using glucocorticoids, the risk of secondary skin infections increases. In case of infection, it is necessary to prescribe appropriate therapy using antibacterial and/or antifungal drugs. The drug should be used with caution in patients with psoriasis, since topical use of glucocorticoids can be dangerous due to the possibility of disease relapse, the development of tolerance, the risk of generalization of pustular psoriasis, and the development of local or systemic toxicity due to impaired skin barrier function. Corticosteroids may change the appearance of some skin lesions, making diagnosis difficult. Due to the content of parahydroxybenzoates, allergic reactions (including delayed ones) may develop after using the drug. In children over one year of age, use with caution, under medical supervision. It is necessary to limit the total duration of treatment and exclude measures leading to increased resorption and absorption of the drug. Do not use for the treatment of diaper dermatitis. Due to the fact that children have a larger body area to weight ratio than adults, children are at greater risk of suppressing the function of the pituitary-adrenal axis and developing Cushing's syndrome when using topical corticosteroids. With long-term use of the drug in children, it is necessary to monitor body weight, height, and plasma cortisol levels.

Interaction with other tools

When prednisolone is applied topically in the form of an ointment, drug interactions have not been described. During the treatment period, vaccination against smallpox or other types of immunization should not be carried out, especially with long-term use of the drug over a large surface area of the skin.

Contraindications

Hypersensitivity to the components of the drug, Cushing's syndrome, chicken pox, vaccination period, herpes simplex, wound or ulcerative lesions, bacterial or viral and fungal skin diseases, skin tuberculosis, skin manifestations of syphilis, skin tumors, acne vulgaris, rosacea, perioral dermatitis, children under 1 year of age, pregnancy, breastfeeding period.

Compound

Composition per tube: active ingredient - prednisolone - 50 mg; excipients - glycerin, soft white paraffin, stearic acid, emulsifier No. 1, methyl parahydroxybenzoate, propyl parahydroxybenzoate, purified water.

Overdose

In case of overdose, the manifestations of adverse reactions may increase. With prolonged use of the drug in large doses, symptoms of hypercortisolism may appear. Symptoms: headache, increased blood pressure, heart failure, hyperglycemia, glycosuria. If symptoms of overdose appear, you should consult a doctor. Under the supervision of a doctor, gradual withdrawal of the drug and symptomatic treatment are carried out. In severe cases, emergency medical attention is required.

Side effect

From the immune system: very rarely - allergic skin reactions (itching, rash, urticaria). From the skin and subcutaneous tissue: skin irritation (burning, redness), dry skin at the site of application of the ointment. With long-term use: skin atrophy (sometimes irreversible), telangiectasia, striae, steroid acne, perioral dermatitis, purpura, changes in skin pigmentation, hypertrichosis, impaired wound healing, development of secondary skin infections. From the endocrine system: with prolonged use, use on large areas of the skin, application under occlusive dressings or in the area of skin folds, the development of hypercortisolism (hyperglycemia, glycosuria, reversible inhibition of adrenal function, signs of Cushing's syndrome) is possible, as a manifestation of the resorptive effect of prednisolone. In this case, the drug should be discontinued. In children, due to the relatively larger skin surface area compared to body weight, the risk of decreased adrenal function is higher. Long-term use of topical corticosteroids may affect the growth and development of children. If the above adverse reactions or adverse reactions not listed in this instruction occur, you should consult a doctor.

Storage conditions

Store at temperatures between 8°C and 15°C. Keep out of the reach of children.

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Instructions for use for Prednisolone ointment 5mg/g 10g No. 1

special instructions

The duration of use of the drug should not exceed 14 days.

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

In cases where the drug is used on the face or under occlusive dressings, as well as in children aged 1 year and older, the duration of treatment should be reduced.

In childhood, suppression of adrenal function may develop more quickly. In addition, a decrease in growth hormone excretion may occur. When using the drug for a long time, it is necessary to monitor body weight, height, and plasma cortisol levels.

Impact on the ability to drive vehicles and operate machinery

The drug in this dosage form does not affect the ability to drive vehicles or engage in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Directions for use and doses

Externally. The ointment is applied in a thin layer to the affected areas of the skin 1 - 3 times a day. The duration of treatment depends on the nature of the disease and the effectiveness of therapy, usually ranging from 6 to 14 days. During the follow-up period, it is possible to use the drug once a day.

On areas with thicker skin (for example, elbows, palms, feet), as well as places from which the drug is easily washed off, the ointment can be applied more often.

On limited lesions, occlusive dressings can be used to enhance the effect.

Description of the drug PREDNISOLONE

Use with caution in case of parasitic and infectious diseases of a viral, fungal or bacterial nature (currently or recently suffered, including recent contact with a patient) - herpes simplex, herpes zoster (viremic phase), chickenpox, measles, amoebiasis, strongyloidiasis (established or suspected), systemic mycosis; active and latent tuberculosis. Use for severe infectious diseases is permissible only against the background of specific therapy.

Use with caution within 8 weeks before and 2 weeks after vaccination, with lymphadenitis after BCG vaccination, with immunodeficiency conditions (including AIDS or HIV infection).

Use with caution for gastrointestinal diseases:

peptic ulcer of the stomach and duodenum, esophagitis, gastritis, acute or latent peptic ulcer, recently created intestinal anastomosis, ulcerative colitis with the threat of perforation or abscess formation, diverticulitis.

Use with caution for diseases of the cardiovascular system, incl. after a recent myocardial infarction (in patients with acute and subacute myocardial infarction, the necrotic focus may spread, slowing down the formation of scar tissue and, as a result, rupture of the heart muscle), with decompensated chronic heart failure, arterial hypertension, hyperlipidemia), with endocrine diseases - diabetes mellitus ( including impaired tolerance to carbohydrates), thyrotoxicosis, hypothyroidism, Itsenko-Cushing's disease, with severe chronic renal and/or liver failure, nephrourolithiasis, with hypoalbuminemia and conditions predisposing to its occurrence, with systemic osteoporosis, myasthenia gravis, acute psychosis , obesity (III-IV degree), with poliomyelitis (with the exception of the form of bulbar encephalitis), open- and closed-angle glaucoma.

If intra-articular administration is necessary, use with caution in patients with a general severe condition, ineffectiveness (or short duration) of the action of 2 previous administrations (taking into account the individual properties of the corticosteroids used).

During treatment (especially long-term), it is necessary to observe an ophthalmologist, monitor blood pressure and water-electrolyte balance, as well as pictures of peripheral blood and blood glucose; In order to reduce side effects, you can prescribe anabolic steroids, antibiotics, and also increase the intake of potassium in the body (diet, potassium supplements). It is recommended to clarify the need for ACTH administration after a course of treatment with prednisone (after performing a skin test!).

In Addison's disease, concomitant use with barbiturates should be avoided.

After stopping treatment, withdrawal syndrome, adrenal insufficiency, and exacerbation of the disease for which prednisolone was prescribed may occur.

For intercurrent infections, septic conditions and tuberculosis, simultaneous antibiotic therapy is necessary.

In children during the growth period, GCS should be used only for absolute indications and under the close supervision of a physician.

It should not be used externally for more than 14 days. If used for acne vulgaris or rosacea, an exacerbation of the disease is possible.

Side effect

When using the drug, especially in patients with individual intolerance, hyperemia, swelling, itching within the area where the drug is applied, steroid acne, telangiectasia, irritation, and dry skin may occur. With long-term use of the drug, it is also possible to develop secondary infectious skin lesions, atrophic changes in it, and hypertrichosis. To prevent infectious skin lesions, the drug is recommended to be prescribed in combination with antibacterial and antifungal agents.

With long-term use of the drug, especially in large areas of the lesion, the development of hypercortisolism is possible, as a manifestation of the resorptive effect of prednisolone. In these cases, the drug is discontinued.

If any adverse reaction occurs, consult your doctor as soon as possible. If any of the side effects indicated in the instructions get worse or you notice any other side effects not listed in the instructions, tell your doctor.

Prednisolone ointment for external use 0.5% 10g

Compound

Active substance: prednisolone 0.5 g.
Excipients: glycerol 18.5 g, petroleum jelly 14 g, stearic acid 5 g, emulsifier No. 1 7 g, methyl parahydroxybenzoate 0.08 g, propyl parahydroxybenzoate 0.02 g, purified water 54.9 g.

Pharmacokinetics

After absorption from the skin surface, Prednisolone binds to plasma proteins and undergoes metabolism, which occurs mainly in the liver. Excreted by the kidneys. Penetrates the placental barrier and is found in small quantities in breast milk.

Indications for use

Prednisolone ointment is used in the complex treatment of inflammatory and allergic skin diseases of non-microbial etiology: eczema, allergic, seborrheic and contact dermatitis, atopic dermatitis (diffuse neurodermatitis), psoriasis, discoid lupus erythematosus, erythroderma.

Contraindications

Hypersensitivity to prednisolone and other components of the drug, tuberculous and syphilitic skin lesions, skin tumors, acne vulgaris, rosacea (possible exacerbation of the disease), wound, ulcerative lesions, bacterial, viral and fungal skin diseases, acne, rosacea, perioral dermatitis, skin post-vaccination reactions, children's age (up to 1 year), pregnancy, breastfeeding period.

If you have one of the listed diseases, be sure to consult your doctor before using the drug.

With caution: children over 1 year old, elderly.

Directions for use and doses

Externally. For adults and children from 1 to 18 years of age, apply a thin layer of ointment to the affected areas of the skin 1-3 times a day. The duration of treatment depends on the nature of the disease and the effectiveness of therapy, usually 6-14 days; if the disease persists, it can be extended to 20 days. During the follow-up period, it is possible to use the drug once a day. On areas with thicker skin (for example, elbows, palms and feet), as well as places from which the drug is easily washed off, the ointment can be applied more often.

For limited lesions, occlusive dressings can be used to enhance the effect.

When using the ointment in children, it is necessary to limit the total duration of treatment, the area of application, use the minimum effective doses and exclude measures that lead to increased absorption of prednisolone (warming, fixing and occlusive dressings).

Storage conditions

Store at a temperature not exceeding 15 °C. Keep out of the reach of children.

Best before date

2 years. Do not use after the expiration date.

special instructions

The duration of treatment, if possible, should not exceed 14 days.
Like other glucocorticosteroids for external use, Prednisolone ointment should not be applied to the skin in the eye area (due to the possible development of glaucoma and cataracts), as well as to wound surfaces.

If the course of the disease is complicated by the development of a secondary bacterial or fungal infection, a specific antibacterial or antifungal agent must be added to therapy with Prednisolone.

To prevent relapses in the treatment of chronic diseases, therapy should be continued for some time after all symptoms disappear. When using the drug on the face or under occlusive dressings, as well as in children, the duration of treatment should be reduced.

In elderly patients, glucocorticosteroids are recommended to be used with caution.

It must be taken into account that in young children, skin folds, diapers and diapers can have an effect similar to the effect of an occlusive dressing and increase systemic resorption of the glucocorticosteroid. Due to the fact that in children the ratio of surface area to body weight is greater than in adults, children are at greater risk of suppressing the function of the hypothalamic-pituitary-adrenal system and developing Cushing's syndrome when using any topical glucocorticosteroids. Long-term treatment with glucocorticosteroids can lead to impaired growth and development of the child. Therefore, children should receive the minimum effective dose of the drug to achieve an effect, in the shortest possible course and on a body surface area not exceeding 10%. The use of the drug in children should be carried out under the supervision of a doctor (monitoring body weight, height, cortisol concentration in the blood plasma).

Description

Glucocorticosteroid for local use.

Pharmacodynamics

When used externally, it has anti-inflammatory, antiallergic, antipruritic and antiexudative effects.

Reduces the formation, release and activity of inflammatory mediators (histamine, kinin, Pg, lysosomal enzymes). Suppresses cell migration to the site of inflammation; reduces vasodilation and increased vascular permeability at the site of inflammation.

Reduces exudation due to vasoconstrictor action.

Side effects

Immune system disorders: allergic reactions.

Disorders of the skin and subcutaneous tissue: within the area of application of the drug: hyperemia, swelling, burning, itching, irritation and dryness; use over a large area (more than 10% of the body surface area) or prolonged use, and especially under an occlusive dressing, can lead to skin atrophy; telangiectasia, hyper- or hypopigmentation, petechiae, ecchymoses, skin thinning, stretch marks, delayed healing may also occur. wounds, steroid acne, folliculitis, hypertrichosis, tendency to develop pyoderma and candidiasis.

General disorders: with prolonged use of the drug, especially in large areas of the lesion, the development of hypercortisolism is possible, as a manifestation of the resorptive effect of prednisolone. In these cases, use of the drug should be stopped and consult a doctor.

If you experience side effects listed in the instructions or they get worse, or you notice any other side effects not listed in the instructions, tell your doctor.

Use during pregnancy and breastfeeding

Pregnancy

Prednisolone crosses the placental barrier. Use during pregnancy is contraindicated.

Breast-feeding

Prednisolone is excreted in breast milk. If you need to use the drug, you should stop breastfeeding.

Interaction

No data available.

Overdose

Symptoms: inhibition of the function of the hypothalamic-pituitary-adrenal system, hyperglycemia, glycosuria, Itsenko-Cushing syndrome. Symptoms disappear after stopping use of the drug.

Treatment: gradual withdrawal of the drug, symptomatic treatment, if necessary, correction of electrolyte imbalance.

Impact on the ability to drive vehicles and operate machinery

Not studied.