Hydrocortisone ointment for external use 1%, 10g

Superficial, uninfected, sensitive to local glucocorticosteroids skin diseases:

• dermatitis, including atopic, contact, seborrheic;

• eczema;

• psoriasis.

If necessary, please consult your doctor before using this medication.

Outwardly. The drug is preferably used for acute and subacute skin processes (without getting wet).
The drug is applied to the affected skin with a thin layer 1-3 times a day. To improve penetration, the drug is applied with light massaging movements. If positive dynamics appear, the frequency of application of the drug can be reduced to 2-3 times a week. The course of treatment is 1-3 weeks. In children, the course of treatment should not exceed 7 days.
If after treatment there is no improvement or new symptoms appear, you should consult your doctor. Use the drug only according to the method of administration and in the doses indicated in the instructions. If necessary, please consult your doctor before using this medicinal product.

Active ingredient: hydrocortisone acetate - 1.00 g.
Excipients : petrolatum -45.00 g; lanolin - 10.00 g; pentaerythrityl dioleate - 5.00 g; stearic acid - 3.00 g; methyl parahydroxybenzoate - 0.08 g; propyl parahydroxybenzoate - 0.02 g; water - up to 100.00 g

Hypersensitivity to hydrocortisone and any of the excipients of the drug; wound, ulcerative skin lesions, bacterial, viral and fungal skin infections; tuberculosis, syphilis; rosacea, acne vulgaris, perioral dermatitis; skin tumors, post-vaccination reactions, children under 2 years of age.

Carefully

Diabetes mellitus, tuberculosis (systemic damage), application to the skin of the face and intertriginous skin, application of occlusive dressings, application to large areas of the skin, and / or long-term treatment (especially in children), pregnancy (application to large areas of the skin, long-term treatment), lactation period (use in large doses or / and for a long time).

Trade name of the drug:

Hydrocortisone

International non-proprietary name:

Hydrocortisone

Dosage form:

Ointment for external use

Composition:

Active ingredient: hydrocortisone acetate - 1.00 g.
Excipients : petrolatum -45.00 g; lanolin - 10.00 g; pentaerythrityl dioleate - 5.00 g; stearic acid - 3.00 g; methyl parahydroxybenzoate - 0.08 g; propyl parahydroxybenzoate - 0.02 g; water - up to 100.00 g

Description:

Ointment from white with a yellowish tinge to light yellow, with a characteristic odor.

Pharmacotherapeutic group:

Topical glucocorticosteroid

ATX code:

D07AA02

Pharmacological properties

Pharmacodynamics

Hydrocortisone is a synthetic glucocorticosteroid drug for external use. It has anti-inflammatory, anti-edema, antipruritic effect.
It inhibits the release of cytokines (interleukins and interferon) from lymphocytes and macrophages, inhibits the release of inflammatory mediators by eosinophils, disrupts the metabolism of arachidonic acid and the synthesis of prostaglandins. Reduces inflammatory cell infiltrates, reduces the migration of leukocytes, incl. lymphocytes in the area of ??inflammation.

Pharmacokinetics
Absorption
After application, the active substance accumulates in the epidermis, mainly in the granular layer, systemic absorption is negligible. A small amount of hydrocortisone is absorbed into the systemic circulation unchanged.
Metabolism
Most of the hydrocortisone is metabolized directly in the epidermis, and later in the liver.
Excretion
Metabolites and a small part of unchanged hydrocortisone are excreted by the kidneys and through the intestines.

Indications for use

Superficial, uninfected, sensitive to local glucocorticosteroids skin diseases:

• dermatitis, including atopic, contact, seborrheic;

• eczema;

• psoriasis.

If necessary, please consult your doctor before using this medication.

Contraindications

Hypersensitivity to hydrocortisone and any of the excipients of the drug; wound, ulcerative skin lesions, bacterial, viral and fungal skin infections; tuberculosis, syphilis; rosacea, acne vulgaris, perioral dermatitis; skin tumors, post-vaccination reactions, children under 2 years of age.

Carefully

Diabetes mellitus, tuberculosis (systemic damage), application to the skin of the face and intertriginous skin, application of occlusive dressings, application to large areas of the skin, and / or long-term treatment (especially in children), pregnancy (application to large areas of the skin, long-term treatment), lactation period (use in large doses or / and for a long time).

Application during pregnancy and during breastfeeding

Pregnancy

The safety of using hydrocortisone during pregnancy and during breastfeeding has not been studied. Glucocorticosteroids cross the placental barrier. Long-term treatment and the use of large doses during pregnancy should be avoided due to the threat of negative effects on the development of the fetus.
Breastfeeding period

Glucocorticosteroids are excreted in breast milk. In the case when it is supposed to use a glucocorticosteroid in large doses and / or for a long time, you should stop breastfeeding.

Method of administration and dosage

Outwardly. The drug is preferably used for acute and subacute skin processes (without getting wet).
The drug is applied to the affected skin with a thin layer 1-3 times a day. To improve penetration, the drug is applied with light massaging movements. If positive dynamics appear, the frequency of application of the drug can be reduced to 2-3 times a week. The course of treatment is 1-3 weeks. In children, the course of treatment should not exceed 7 days.
If after treatment there is no improvement or new symptoms appear, you should consult your doctor. Use the drug only according to the method of administration and in the doses indicated in the instructions. If necessary, please consult your doctor before using this medicinal product.

Side effect

Hyperemia, swelling, itching and irritation of the skin at the sites of application of the ointment.
With prolonged use of a glucocorticosteroid, the development of secondary infectious skin lesions, atrophic changes, hypertrichosis is possible.
When applied to large surfaces and / or using occlusion, the development of symptoms of hypercorgicism (hyperglycemia, glucosuria, reversible suppression of the adrenal cortex function, manifestation of Itsenko-Cushing's syndrome) is possible, as a manifestation of the resorptive effect of hydrocortisone.
If any of the side effects indicated in the instructions: ururgublschoted, or any other side effects not listed in the instructions are noted, you should immediately inform your doctor about it.

Overdose

Acute overdose is unlikely, however, when the drug is used on large areas of the affected skin with an increased ability to resorption, for a long time or using an occlusive dressing, a chronic overdose is possible, accompanied by signs of hypercortisolism.
Treatment : symptomatic, if necessary, correction of water and electrolyte balance, drug withdrawal (with prolonged therapy - gradual withdrawal).

Interaction with other medicinal products

Interaction of hydrocortisone with external use with other drugs has not been identified.

special instructions

If there are signs of hypersensitivity or skin irritation associated with the use of the drug, you should stop treatment and consult a doctor.
With prolonged treatment, when the drug is applied to extensive skin surfaces, when using occlusive dressings, as well as in children, systemic absorption of the glucocorticosteroid is possible; suppression of the function of the hypothalamic-pituitary-adrenal system and the development of symptoms of hypercortisolism is possible.
On the skin of the face more often than on other surfaces of the body, after long-term treatment with topical glucoorgicosteroids, atrophic changes may appear; the course of treatment in this case should not exceed 5 days.
Care must be taken when applying the drug to the face, folds, areas of natural folds, on areas with thin skin.
Avoid contact with eyes. Do not apply the drug to mucous membranes.
It should be borne in mind that glucocorticosteroids can change the manifestation of some skin diseases, which can complicate the diagnosis. In addition, the use of glucocorticosteroids may cause delayed wound healing.
With prolonged therapy with glucocorticosteroids, a sudden cessation of therapy can lead to the development of rebound syndrome, which manifests itself in the form of dermatitis with intense redness of the skin and a burning sensation. Therefore, after long-term treatment, the drug should be withdrawn gradually, for example, by switching to an intermittent treatment regimen before completely stopping it.
Propyl parahydroxybenzoate, which is part of the drug, can cause allergic reactions (possibly delayed). In such cases, the drug should be discontinued.

Application in pediatrics

The drug can be used in children from 2 years of age. It should be borne in mind that in young children, skin folds, diapers, diapers can have an effect similar to that of an occlusive dressing, and increase the systemic resorption of the glucocorticosteroid. In addition, in children, a high degree of systemic resorption is possible due to the ratio between the surface of the skin and body weight, as well as due to insufficient skin maturity. Long-term treatment of children with a glucocorticosteroid can lead to impaired growth and development. Therefore, long-term use of the drug should be carried out under the supervision of a physician. Children should receive the minimum dose of the drug sufficient to achieve the effect. In children, the course of treatment should not exceed 7 days.

Influence on the ability to drive vehicles and mechanisms

The drug does not affect the ability to drive vehicles and perform other potentially hazardous activities.

Release form

Ointment for external use 1%.
10, 30 g in aluminum tubes.
One tube, together with instructions for use, is placed in a cardboard package (pack).

Storage conditions

Store at a temperature not exceeding 25 ? C.
Keep out of the reach of children.

Shelf life

3 years. Do not use the drug after the expiration date.

Vacation conditions

Available without a prescription.