HYDROCORTISONE-RICHTER susp. d/injection 125 mg vial. 5 ml

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.

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.

GLUCOCORTICOID DRUGS

Toolkit

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.

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

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Instructions for use for Hydrocortisone ointment d/nar.prim. 1% in tubes 10g per pack. No. 1

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.

APPLICATION IN DERMATOLOGY

Glucocorticoids are used externally in the form of ointments, creams, gels, and lotions for a number of skin diseases. They have a local anti-inflammatory, anti-allergic effect, eliminate swelling, hyperemia, and itching. When using glucocorticoids externally, it is very important, depending on the location and nature of the lesion, to choose the optimal dosage form, each of which has some features (Table 13).

Table 13.

Features of the action of dosage forms for external use.

Classification

Glucocorticoid preparations for external use are traditionally divided into several groups, depending on the strength of the local anti-inflammatory effect. Moreover, there are some, not of fundamental importance, differences between the classifications considered in different literary sources. According to the above classification (Table 14), drugs are divided into 4 groups.

Table 14.

Classification of glucocorticoids for external use.

The most powerful effect is exerted by fluorinated glucocorticoids (“very strong” and “strong” drugs), which are poorly absorbed from the surface of the skin and have a predominantly local effect. Their disadvantage is the more frequent development of local adverse reactions compared to other drugs (see below).

Drugs belonging to groups III and IV (prednisolone, hydrocortisone acetate and others) are characterized by a greater ability to be absorbed from the area of ​​application, therefore their local effect is weaker, and the likelihood of developing systemic adverse reactions is higher.

The strength of the drug also depends on the type of dosage form (ointment > cream > lotion) and concentration.

One of the modern principles of systematization of glucocorticoid drugs for external use is their division into four generations, differing in their characteristics of action. To the first generation

includes hydrocortisone acetate, which has the mildest effect.
The second
is prednisolone, which has a moderate effect.

Third generation

is represented by a wide range of fluorinated glucocorticoids, which have a “strong” or “very strong” local effect.
The fourth group
includes “strong” glucocorticoids that do not contain a fluorine atom in their structure - hydrocortisone-17-butyrate, mometasone furoate, as well as a drug of moderate activity - prednicarbate.

The fourth generation drugs created in recent years are considered the most preferable, since they successfully combine the positive properties of their predecessors: they have high activity comparable to the potency of fluorinated glucocorticoids, and minimal undesirable local effects characteristic of hydrocortisone acetate.

Mometasone furoate ( elokom

- cream, ointment, lotion) refers to fourth generation glucocorticoids. It is superior to hydrocortisone, dexamethasone and betamethasone in its ability to block the formation of cytokines (interleukin-1 and interleukin-6), which play an important role in skin inflammation, in particular in psoriasis. Controlled clinical studies have shown higher efficacy of mometasone in psoriasis and atopic dermatitis compared to hydrocortisone and betamethasone. The drug is well tolerated and does not cause skin atrophy. Mometasone has a prolonged effect, so it is applied once a day. Thanks to its improved tolerability, it is suitable for use in children and the elderly.

Hydrocortisone 17-butyrate ( laticort, locoid

), unlike hydrocortisone acetate, is poorly absorbed from the area of ​​application, so the likelihood of systemic action is extremely low. At the same time, like fluorinated glucocorticoids, it has a powerful local effect, but, unlike the latter, it rarely causes local adverse reactions and may have wider use.

Prednicarbate ( dermatope

) is a glucocorticoid with a moderate degree of activity and is characterized by a mild, gentle local effect. It practically does not cause systemic adverse reactions. Local effects are very rare. Can be used on large surfaces and applied to areas of the skin with the most increased sensitivity (face, groin area). Controlled clinical studies have shown high efficacy and good tolerability of prednicarbate in children from 2 months to 16 years and the elderly, therefore the drug is recommended primarily for use in these age groups.

Indications

Psoriasis, eczema, neurodermatitis, contact dermatitis, solar dermatitis, seborrheic dermatitis, atonic dermatitis, lichen planus, discoid lupus erythematosus, erythroderma.

Rules of application

1. Before using glucocorticoid drugs, it is necessary to establish an accurate diagnosis.
2. It is recommended to start treatment with the use of a drug with weak activity (Table 14), if there is no effect within 2-3 weeks, switch to a stronger one, and after achieving the effect, use a weak glucocorticoid again.
3. Drugs with very strong activity (clobetasol propionate, chalcinonide) should be used only for lichenoid eczema and discoid lupus erythematosus.
4. The drug is applied to clean skin (after a bath or shower) 2 times a day, in a thin layer, do not rub or massage. It is recommended to carry out the procedure with gloves. Mometasone furoate and fluticasone propionate, which have a prolonged effect, are applied once a day, which is convenient for diseases that require long-term use of glucocorticoids (eczema, psoriasis).
5. After applying the drug to enhance the therapeutic effect (usually for psoriasis), you can use occlusive dressings for a short time, no more than 2 days.
6. The process of releasing the active substance from an ointment is usually slower than from a cream, so for chronic processes it is preferable to use an ointment.
7. When the lesion is localized on the scalp, it is recommended to use a gel or lotion.
8. If an infection is suspected, combined topical glucocorticoids containing antimicrobial components should be used (see below).

Adverse reactions

1. From the skin:

• atrophy (more often on the face - “corticosteroid face”, therefore, if possible, strong ointments should not be used on the face, with the exception of hydrocortisone 17-butyrate); striae; depigmentation; skin irritation; telangiectasia;
• acne;
• Tinea incognito
  is an atypical clinical picture of dermatomycosis when using glucocorticoids (both locally and systemically);
• perioral dermatitis (more often in young women; tetracycline can be used for treatment for 4-6 weeks);
• hirsutism or frontal alopecia in women.

• Accession or dissemination of infection.
• Systemic action
  (with long-term use, application to large areas of the body, more often in children and when using occlusive dressings).
• Withdrawal syndrome
  (usually requires resumption of the use of local glucocorticoids).

Contraindications

• Acne, including acne rosacea
  .
• Perioral dermatitis.
• Scabies.
• Tuberculosis.
• Syphilis.
• Viral and helminthic skin lesions.
• Bacterial and fungal skin infections that have not previously been treated with other drugs.
• Skin reactions after vaccination.
• During pregnancy, it is not recommended to use for a long time and on large areas of the body.

Features of use in children

In children, with local use of glucocorticoids, there is a higher susceptibility to their systemic action

than in adults (including suppression of the function of the hypothalamic-pituitary-adrenal system, the development of Cushing's syndrome, growth and development delay), since the ratio of surface area to body weight in children is greater.

Therefore, glucocorticoid preparations should be used in limited areas, especially in newborns, if possible, for a short course. In children under 1 year of age, only ointments with hydrocortisone (no more than 1%) or the fourth generation glucocorticoid prednicarbate should be used; for children under 5 years of age, ointments of medium strength and hydrocortisone 17-butyrate should be used.

Combination drugs

Combination ointments and creams are produced, which, along with glucocorticoids, include other components (Table 15). They may include antibiotics (neomycin and others), drugs that combine antifungal and antibacterial activity (miconazole, triclosan and others), antifungal and antitrichomoniacal action (natamycin), antiseptics, salicylic acid, local anesthetics, vitamin-like compounds, antihistamines.

Some features of the composition of the drug may be indicated by the presence of an additional letter in its trade name. For example, flucinar N

includes the antibiotic neomycin,
sinalar K
- the antifungal agent clioquinol,
lorinden A
- salicylic acid.
In other cases, combination drugs have special trade names (localen, triderm)
.

Preparations containing antimicrobial components are recommended for use in case of a bacterial or fungal infection, suspicion of it and a high probability of its development (weeping processes, intertriginous lesions, anogenital and senile itching). It should be borne in mind that neomycin, when applied externally, can be absorbed and have oto- and nephrotoxic effects, therefore dosage forms containing it should not be used for a long time and on large surfaces.

Salicylic acid has a kerato- and squamolytic effect, promotes the penetration of glucocorticoids through excessively keratinized epidermis, restores the protective cover of the skin, and has a weak antiseptic effect. Therefore, drugs that contain it are advisable to use for diseases accompanied by increased keratinization of the epidermis, desquamation, hyperkeratosis, callus, for example, with lichenoid eczema, chronic cases of psoriasis, ichthyosis and others.

Table 15.

Combined preparations of glucocorticoids for external use.

APPLICATION IN OPHTHALMOLOGY AND ENTRYNOLARYNGOLOGY

The use of glucocorticoids in ophthalmology is based on their local anti-inflammatory, antiallergic, and antipruritic effects. They prevent the expansion of capillaries, reduce their permeability, inhibit the migration of leukocytes, the release of kinins, reduce the deposition of fibrin, collagen, and the formation of scar tissue. When used, pain, burning, lacrimation and photophobia are reduced.

Indications

are various inflammatory diseases of eye tissue of non-infectious etiology, including after injuries and operations (iritis, iridocyclitis, scleritis, keratitis, uveitis, severe forms of conjunctivitis and others).

The most preferred are special preparations of glucocorticoids for topical use - solutions, suspensions, ointments (Table 16). They have a more pronounced local anti-inflammatory effect than glucocorticoids used orally or parenterally in such situations. The most effective “ophthalmic” drugs are fluorometholone and prednisolone acetate.

In particularly severe cases, glucocorticoids can be administered subconjunctivally. For this, dexamethasone and betamethasone phosphate are used, and injections of the second are less painful. There is evidence of the possibility of subconjunctival administration of betamethasone phosphate/dipropionate (diprospan)

.

Glucocorticoids are contraindicated

for acute infectious eye diseases. If necessary, combination drugs containing antibiotics are used.

Table 16.

Glucocorticoids for local use in ophthalmology. Applied Therapeutics, 1995 [8]

Adverse reactions

Despite the fact that glucocorticoids, when applied topically, in contrast to systemic administration, do not enhance, but rather inhibit the formation of chamber humor, they can also cause an increase in intraocular pressure (dexamethasone to the greatest extent, fluorometholone to the least) and lead to the development of glaucoma . Exophthalmos may be present. Sometimes a serious complication is posterior subcapsular cataract. In diseases accompanied by thinning of the cornea, perforation is possible.

Combination drugs

In ophthalmological and otorhinolaryngological practice, a number of combination drugs are used, which, in addition to glucocorticoids, include antibiotics (Table 17). They combine anti-inflammatory and bactericidal effects, and more preferable are drugs that include the glucocorticoid betamethasone, which has less effect on intraocular pressure (Garazon)

.

In ophthalmology

These drugs are used for inflammatory and allergic eye diseases, if a bacterial infection is present or suspected (staphylococcal blepharoconjunctivitis, fluctenular and microbial-allergic keratoconjunctivitis, keratitis, episcleritis, dacryocystitis, iridocyclitis, eye injuries and others).

In otorhinolaryngology

indications for the use of combined drugs are acute and chronic external otitis; eczema of the external auditory canal; seborrheic dermatitis; contact dermatitis complicated by secondary infection; allergic and vasomotor rhinitis, complicated by secondary infection.

Precautionary measures.

It is not recommended to use the same bottle of the drug to treat otitis, rhinitis and eye diseases to avoid the spread of infection.
It is not advisable to use these drugs for the treatment of otitis media, which requires systemic (oral, parenteral) use of antibiotics. The drug maxitrol
, containing two ototoxic antibiotics (neomycin and polymyxin B), can only be used in short courses.

Table 17.

Combined preparations of glucocorticoids for use in ophthalmology and otorhinolaryngology.

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.