pharmachologic effect
Hydrocortisone is a synthetic glucocorticosteroid drug for external use. Has anti-inflammatory, anti-edematous, antipruritic effects. 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. By stimulating glucocorticosteroid receptors, it induces the formation of lipocortin. Reduces inflammatory cell infiltrates, reduces the migration of leukocytes, including lymphocytes, to the area of inflammation. When prescribed in recommended doses, it does not cause systemic side effects.
Hydrocortisone ointment 1% 10g No. 1
Product description
Hydrocortisone.
Release form
Ointment for external use.
Dosage
1% 10 g Quantity per package: 1 pc.
Manufacturer
Nizhpharm OJSC.
INN
Hydrocortisone.
FTG
Glucocorticosteroid for local use.
Compound
1 g of ointment contains: active ingredient - hydrocortisone acetate - 0.01 g; excipients: petrolatum - 0.45 g, lanolin - 0.1 g, pentaerythrityl dioleate (pentol) - 0.05 g, stearic acid 95 - 0.03 g, methyl parahydroxybenzoate - 0.0008 g, propyl parahydroxybenzoate - 0.0002 g , purified water - up to 1 g.
Description
The ointment is white with a yellowish tint or light yellow. Pharmacotherapeutic group: Corticosteroids for local use in dermatology. Corticosteroids are weakly active (group I). ATX code: D07AA02.
Pharmacological properties
Pharmacodynamics Hydrocortisone is a synthetic glucocorticosteroid drug for local use, has anti-inflammatory, anti-edematous, antipruritic effects. Inhibits the release of cytokines (interleukins and interferon) from lymphocytes and macrophages, inhibits the release of inflammatory mediators by eosinophils, reduces the metabolism of arachidonic acid and the synthesis of prostaglandins. By stimulating steroid receptors, it induces the formation of lipocortin. Reduces inflammatory cell infiltrates, reduces the migration of leukocytes and lymphocytes to the area of inflammation. Local use of the drug in recommended doses does not cause systemic side effects. Pharmacokinetics Absorption After application to the skin, 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 hydrocortisone is metabolized directly in the epidermis and subsequently in the liver. Excretion Metabolites and a small part of unchanged hydrocortisone are excreted by the kidneys and intestines.
Indications for use
Inflammatory and allergic skin diseases of non-microbial etiology: eczema, allergic and contact dermatitis, neurodermatitis, psoriasis, insect bites.
Contraindications
Hypersensitivity to hydrocortisone or other components of the drug, post-vaccination period, violation of the integrity of the skin (ulcers, wounds), bacterial, viral and fungal skin diseases, skin tuberculosis, syphilitic skin lesions, skin tumors, children under 2 years of age. Rosacea, acne vulgaris, perioral dermatitis. Pregnancy, breastfeeding (due to the lack of clinical data on the safety of use).
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. As the condition improves, the frequency of applying the ointment can be reduced (once a day or 2-3 times a week). The duration of treatment is determined by the doctor and depends on the nature of the disease and the effectiveness of therapy. As a rule, the duration of treatment is 6-14 days. The drug should not be used for more than 14 days.
Use in children
The drug is contraindicated in children under 2 years of age. For children under 12 years of age, the drug is prescribed under strict medical supervision. If the drug is used in children, the duration of treatment should be reduced to 7 days and measures leading to increased resorption (absorption) of the steroid (warming, fixing and occlusive dressings) should be excluded. Adverse reactions The assessment of undesirable adverse reactions is based on the following data on the frequency of occurrence: very often (≥1/10), often (≥1/100 to
Overdose
With prolonged use of the drug in large doses, symptoms of hypercortisolism may appear.
Precautionary measures
If after 7 days of treatment there is no improvement or worsening of the condition, the use of the drug should be stopped and consult a doctor. If symptoms of the disease recur a few days after stopping the drug, you should also consult a doctor. The drug should be used with caution in case of diabetes mellitus, immunodeficiency states (including HIV infection, AIDS). Systemic adverse reactions with topical corticosteroids in adults are extremely rare but can be serious. This is especially true for adrenocortical suppression with long-term use of the drug. The risk of systemic effects increases in the following cases: application using a dressing (warming, fixing and occlusive dressings or applying ointment to the skin folds); application on large areas of skin; long-term treatment; use in children. Long-term continuous topical therapy with hydrocortisone in children can lead to suppression of adrenal function even without the use of an occlusive dressing. In children, growth hormone production may also be suppressed. If long-term treatment with hydrocortisone drugs is necessary, the child’s height and weight should be regularly monitored, and the level of cortisol in the blood plasma should be determined. It is not recommended to apply the ointment to the skin of the face, scalp and anogenital area. Avoid getting the ointment in your eyes. Do not apply the ointment to the area around the eyes and eyelids due to the possibility of contact with the conjunctiva, which increases the risk of developing glaucoma and/or subcapsular cataracts. For long-term treatment and/or application of the drug to large surfaces of the body, it is recommended to prescribe a diet with limited sodium, high potassium content and sufficient protein. It is necessary to monitor blood pressure, blood glucose, blood clotting, diuresis, the patient’s body weight, and the level of cortisol in the blood plasma. In the event of a bacterial or fungal infection, the drug is recommended to be prescribed in combination with antibacterial and antifungal agents.
Use during pregnancy and lactation
The use of the drug is contraindicated during pregnancy and breastfeeding. If it is necessary to use the drug during lactation, breastfeeding should be discontinued.
Impact on the ability to drive vehicles and operate machinery
types of activities that require increased concentration and speed of psychomotor reactions.
Interaction with other drugs
With long-term use, due to possible resorption into the systemic circulation, hydrocortisone can reduce the effectiveness of insulin, oral hypoglycemic and antihypertensive drugs, anticoagulants, and reduce the concentration of salicylates and praziquantel in the blood plasma. The risk of developing side effects of hydrocortisone increases: androgens, estrogens, oral contraceptives, anabolic steroids (hirsutism, acne); antipsychotic drugs, carbutamide, azathioprine (cataracts); anticholinergics, antihistamines, tricyclic antidepressants, nitrates (glaucoma); diuretics (hypokalemia); nonsteroidal anti-inflammatory drugs (increased risk of ulceration in the gastrointestinal tract); paracetamol (hepatotoxicity). When used with cardiac glycosides, digitalis intoxication may develop. Simultaneous use of lead and silver with preparations leads to mutual inactivation. When used together with amphotereptine B, the development of dilated myocardial damage and heart failure is possible. Barbiturates, antiepileptic and antihistamine drugs reduce the effectiveness of hydrocortisone. During the treatment period, smallpox vaccination or other types of immunization should not be performed due to the immunosuppressive effect of glucocorticosteroids, especially with long-term use over large areas of the skin. If you are currently using/taking other medications, tell your doctor.
Release form
Ointment for external use 1%. 10 g in aluminum tubes. Each tube, along with instructions for medical use of the drug, is placed in a cardboard pack.
Storage conditions
At temperatures from 2 to 20 °C. Keep out of the reach of children.
Best before date
3 years. Do not use the drug after the expiration date indicated on the package.
Conditions for dispensing from pharmacies
On prescription.
Buy Hydrocortisone ointment d/nar.prim. 1% in tubes 10g per pack. No. 1 in pharmacy
Price for Hydrocortisone ointment d/nar.approx. 1% in tubes 10g per pack. No. 1
Instructions for use for Hydrocortisone ointment d/nar.prim. 1% in tubes 10g per pack. No. 1
Contraindications
Hypersensitivity to hydrocortisone or other components of the drug, wound, ulcerative skin lesions, bacterial, viral and fungal skin diseases, skin tuberculosis and syphilitic skin lesions. Rosacea, acne vulgaris, perioral dermatitis, skin tumors, pregnancy, breastfeeding, children under 2 years of age.
Carefully
Diabetes mellitus, tuberculosis (systemic damage).
Use during pregnancy and breastfeeding
The drug is contraindicated during pregnancy and breastfeeding.
special instructions
In cases of use of the drug in children, on the face area under occlusive dressings, the duration of the course of treatment should be reduced to two weeks. In childhood, suppression of adrenal function may develop more quickly. In addition, a decrease in the secretion of growth hormone somatropin may be observed. For children from 2 to 12 years of age, the drug should be used only after consultation with a doctor and then under medical supervision.
Avoid contact of the ointment with the eyes and mucous membranes.
If after 7 days of use there is no improvement or worsening of the condition, the use of the drug should be stopped and consult a doctor. If symptoms recur a few days after stopping the drug, you should consult your doctor.
For long-term treatment and/or application to large surfaces, it is recommended to prescribe a diet with limited sodium and high potassium content; introduce a sufficient amount of protein into the body. It is necessary to monitor blood pressure, blood glucose, blood clotting, diuresis, the patient’s body weight, and plasma cortisol concentration.
To prevent infectious lesions, the drug is recommended to be prescribed in combination with antibacterial and antifungal agents.
Impact on the ability to drive vehicles and operate machinery
During treatment with the drug, caution should be exercised when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.
Advantages of phonophoresis
Based on most clinical pictures, it is noted that physiotherapy has a positive effect on the dynamics of treatment, thus, the patient’s rehabilitation and recovery are many times faster. This happens for a number of reasons:
- ultrasound promotes accelerated and deep penetration of medicinal substances into the skin and tissues, targeting the affected area;
- there is no need to endure painful procedures and expose the body to stress;
- affordable session cost and ease of use.
You need to know that phonophoresis will not give instant results. It will take several sessions to notice the effect of use. The medicine must accumulate in the skin within 5–7 days and reach the required therapeutic value. However, being developed quite a long time ago and being an old-generation drug, hydrocortisone has a number of serious contraindications.
Directions for use and doses
Externally. The ointment is applied in a thin layer to the affected areas of the skin 2 - 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; if the disease persists, it can be extended to 20 days. On limited lesions, occlusive dressings can be used to enhance the effect. When using the ointment in children aged 2 years and older, the total duration of treatment should be limited to no more than two weeks and measures leading to increased absorption of hydrocortisone (warming, fixing and occlusive dressings) should be excluded.
Procedure
The sensor for physiotherapy is similar to that used for ultrasound diagnostics. The only difference will be that the conductor for ultrasound is not a gel, but an ointment based on hydrocortisone. The stages of the session are no different:
- disinfection of the skin area that will be affected;
- applying hydrocortisone ointment and distributing it evenly;
- exposure to ultrasound of a certain power within different frequencies.
This approach ensures rapid penetration of hydrocortisone into tissues. And alternating different frequencies gives good results in the long term, despite the short duration of the session. After completing the phonophoresis procedure with hydrocortisone, you should not remove the ointment from the body for another 2-3 hours. To obtain a positive effect, a course of 10–14 daily procedures is required. Please note that re-treatment is possible no earlier than after 3-5 months.
Mechanism of action
Transport of any drug through the skin is limited by its ability to penetrate the epidermis (top layer of skin) and dermis (deep layer). The easiest and surest route is through the sebaceous glands and hair follicles, so warming the skin before the procedure significantly increases the rate and percentage of drug transfer.
Warming up immediately after phonophoresis significantly increases the time of absorption of hydrocortisone by the body’s vascular system. Sensors and devices used in physical therapy have many modes of operation at different frequencies and intensities. When choosing a device, the doctor focuses on solving the main problem without damaging the skin. And only then, he sets the pace and frequency of the impact, taking into account the patient’s sensations and the characteristics of his body, excluding contraindications and pathologies.
Side effect
Hyperemia, swelling and itching in areas where the ointment is applied. With long-term use, it is also possible to develop secondary infectious skin lesions, atrophic changes in the skin, and hypertrichosis. With prolonged use of the ointment or the use of an occlusive dressing, especially in large areas of the lesion, the development of symptoms of hypercortisolism (hyperglycemia, glucosuria, reversible inhibition of adrenal cortex function, manifestation of Itsenko-Cushing syndrome), as a manifestation of the resorptive effect of hydrocortisone, is possible.
Overdose
Acute overdose is unlikely, however, with excessive or prolonged use of the drug, chronic overdose is possible, accompanied by signs of hypercortisolism: hyperglycemia, glycosuria, reversible inhibition of adrenal function, manifestation of Itsenko-Cushing syndrome.
Treatment. Appropriate symptomatic treatment is indicated. In case of chronic toxic effects, gradual withdrawal of the drug is recommended.
Interaction with other drugs
Barbiturates, antiepileptics and antihistamines reduce effectiveness.
Paracetamol promotes the development of hepatotoxicity.
Reduces the activity of salicylates and hypoglycemic agents, and increases the activity of anticoagulants.
Cardiac glycosides and non-potassium-sparing diuretics increase hypokalemia, anabolic steroids increase tissue hydrophilicity.
When combined with amphotericin B, the development of dilated myocardial damage and heart failure is possible.
