Description of the active substance hydrocortisone acetate. Hydrocortisone suspension in ampoules and vials - instructions for use. Interaction with other drugs

Trade name:

Hydrocortisone acetate

International name:

Hydrocortisone (Hydrocortisone)

Group affiliation:

Glucocorticosteroid

Description active substance(INN):

Hydrocortisone

Dosage form:

lyophilizate for preparation of solution for intravenous administration, solution for intravenous administration, suspension for intramuscular and periarticular administration, suspension for intraarticular and periarticular administration, tablets

Pharmachologic effect:

GCS has anti-inflammatory, anti-shock, desensitizing, anti-toxic, anti-allergic, immunosuppressive and anti-metabolic effects. Unlike cytostatics, immunosuppressive properties are not associated with a mitostatic effect, but are the result of the suppression of various stages of immunogenesis: stem cell migration ( bone marrow), B-cell migration, and T- and B-lymphocyte interactions. It 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 Pg. By stimulating steroid receptors, it induces the formation of lipocortin. Promotes the deposition of glycogen in the liver, increases blood glucose, inhibits the excretion of Na + and water, enhances the excretion of K + from the body, reduces the synthesis of histamine. Reduces inflammatory cell infiltrates, reduces the migration of leukocytes and lymphocytes to the area of inflammation. AT large doses ax inhibits the development of lymphoid and connective tissue, incl. RES; reduces the number of mast cells, which are the site of the formation of hyaluronic acid; inhibits hyaluronidase and helps to reduce capillary permeability. Delays the synthesis and accelerates the breakdown of proteins. Influencing the pituitary gland, inhibits the production of corticotropin. Long-term administration into the body can lead to suppression and atrophy of the adrenal cortex, inhibition of the formation of gonadotropic and thyroid-stimulating hormones of the pituitary gland. Hydrocortisone acetate is characterized by a slowly developing, but longer-lasting effect than that of water-soluble drugs. Used for injection into joints, injury sites and soft tissues, where it has a local anti-inflammatory effect, although the development of systemic hormonal effects. Therapeutic effect with intra-articular administration, it occurs within 6-24 hours and lasts from several days to several weeks. Injections of hydrocortisone phosphate are accompanied by a rapid suppression of inflammation, but on short term(use in acute conditions).

Indications:

Shock (burn, traumatic, surgical, toxic, cardiogenic) with the ineffectiveness of other therapy. Allergic reactions (acute, severe forms), transfusion shock, anaphylactic shock, anaphylactoid reactions. Cerebral edema (including against the background of a brain tumor or associated with surgical intervention, radiation therapy or head trauma). Bronchial asthma (severe form), status asthmaticus. Systemic connective tissue diseases (SLE, rheumatoid arthritis). Acute adrenal insufficiency. thyrotoxic crisis. Acute hepatitis, hepatic coma. Poisoning with caustic fluids (reduction of inflammation and prevention of cicatricial constrictions).

Contraindications:
Side effects:

Frequency of development and severity side effects depend on the duration of use, the size of the dose used and the possibility of observing the circadian rhythm of the appointment. From the side endocrine system: decreased glucose tolerance, "steroidal" diabetes mellitus or manifestation of latent diabetes mellitus, suppression of adrenal function, Itsenko-Cushing's syndrome (moon face, pituitary-type obesity, hirsutism, increased blood pressure, dysmenorrhea, amenorrhea, myasthenia gravis, striae), delayed sexual development in children. From the side digestive system: nausea, vomiting, pancreatitis, "steroid" gastric and duodenal ulcer, erosive esophagitis, bleeding and perforation of the gastrointestinal tract, increased or decreased appetite, flatulence, hiccups. In rare cases, an increase in the activity of "liver" transaminases and alkaline phosphatase. From the CCC: arrhythmias, bradycardia (up to cardiac arrest); development (in predisposed patients) or increased severity of CHF, ECG changes characteristic of hypokalemia, increased blood pressure, hypercoagulation, thrombosis. In patients with acute and subacute myocardial infarction - the spread of necrosis, slowing down the formation of scar tissue, which can lead to rupture of the heart muscle. From the side nervous system: delirium, disorientation, euphoria, hallucinations, manic-depressive psychosis, depression, paranoia, increased intracranial pressure, nervousness or restlessness, insomnia, dizziness, vertigo, cerebellar pseudotumor, headache, convulsions. From the senses: sudden loss of vision (with parenteral administration in the head, neck, turbinates, scalp, crystals of the drug may be deposited in the vessels of the eye), posterior subcapsular cataract, increased intraocular pressure with possible damage optic nerve, tendency to develop secondary bacterial, fungal or viral infections eye, trophic changes in the cornea, exophthalmos. From the side of metabolism: increased excretion of Ca2 +, hypocalcemia, weight gain, negative nitrogen balance (increased protein breakdown), increased sweating. Caused by ISS activity - fluid retention and Na + (peripheral edema), hypernatremia, hypokalemia syndrome (hypokalemia, arrhythmia, myalgia or muscle spasm, unusual weakness and fatigue). From the musculoskeletal system: growth retardation and ossification processes in children (premature closure of epiphyseal growth zones), osteoporosis (very rarely, pathological bone fractures, aseptic necrosis heads of the humerus and femur), rupture of the tendons of the muscles, "steroid" myopathy, decreased muscle mass(atrophy). From the side skin and mucous membranes: delayed wound healing, petechiae, ecchymosis, thinning of the skin, hyper- or hypopigmentation, steroid acne, striae, a tendency to develop pyoderma and candidiasis. Allergic reactions: generalized ( skin rash, skin itching, anaphylactic shock), local allergic reactions. Other: the development or exacerbation of infections (the appearance of this side effect is facilitated by jointly used immunosuppressants and vaccination), leukocyturia, "withdrawal" syndrome. Local with parenteral administration: burning, numbness, pain, paresthesia and infection at the injection site, rarely - necrosis of surrounding tissues, scarring at the injection site; skin atrophy and subcutaneous tissue with i / m administration (especially dangerous is the introduction into the deltoid muscle). With a / in the introduction: arrhythmias, "tides" of blood to the face, convulsions. With intracranial administration - nosebleeds. With intra-articular administration - increased pain in the joint.

Dosage and administration:

In/in jet; in / in drip, in / m, intra- and periarticularly, inside. At emergency care acute conditions is recommended in / in the introduction. The initial dose is 100 mg (introduced 30 s); 500 mg (introduced 10 minutes), then again every 2-6 hours, depending on the patient's condition. Large doses are prescribed only until the patient's condition stabilizes, but usually no more than 48-72 hours (if necessary, longer GCS therapy, it is advisable to replace it with another drug with less ISS activity). Depot forms are administered intra- and periarticularly. In large joints (shoulder, hip, knee) - 25-50 mg (in acute conditions - up to 100 mg); in small joints (elbow, carpal, interphalangeal) - 10-20 mg once. Injections are repeated every 1-3 weeks (sometimes after 3-5 days). A single dose in children with periarticular administration at the age of 3 to 12 months is 25 mg; from 1 year to 6 years - 25-50 mg; from 6 to 14 years - 50-75 mg. V / m (deep into the gluteal muscle) - at a dose of 125-250 mg / day. The pharmacodynamic effect occurs 6-25 hours after administration and lasts several days or weeks. Inside, the initial dose of 20-240 mg / day. The maintenance dose is determined by gradually reducing the initial dose to the lowest one that maintains the desired effect. With an exacerbation multiple sclerosis- 800 mg / day for 7 days, and then - 320 mg / day for a month. Sudden cessation of administration may exacerbate the process. The end of treatment should be carried out by gradually reducing the dose.

Special instructions:

During treatment, a Na+-restricted and K+-enhanced diet is recommended; introduction of a sufficient amount of protein into the body. It is necessary to control blood pressure, blood glucose concentration, blood clotting, diuresis, body weight of the patient. During treatment, you can not carry out any type of vaccination. Induced relative adrenal insufficiency may persist for several months after its withdrawal (and therefore, with stressful situations resume hormone therapy with the simultaneous appointment of salts and ISS). In patients with active tuberculosis, it is used only in combination with appropriate anti-tuberculosis therapy; with a latent form of tuberculosis or during a turn tuberculin samples the patient's condition should be carefully monitored, and if necessary, chemoprophylaxis should be carried out. Some forms of the drug in the composition of the solvent contain benzyl alcohol, which is sometimes associated with the development of dyspnea syndrome with lethal outcome(Gasping syndrome) in premature babies. Children whose mothers received hydrocortisone during pregnancy should be closely monitored for signs of adrenal insufficiency. In children during the period of growth, GCS should be used only according to absolute readings and under the close supervision of the attending physician.

Interaction:

Pharmaceutical hydrocortisone is incompatible with other drugs (may form insoluble compounds). Hydrocortisone increases the toxicity of cardiac glycosides (due to the resulting hypokalemia, the risk of developing arrhythmias increases). Accelerates the excretion of ASA, reduces its level in the blood (when it is canceled, the concentration of salicylates in the blood increases and the risk of side effects increases). At simultaneous application with live antiviral vaccines and against the background of other types of immunizations increases the risk of virus activation and the development of infections. Increases the metabolism of isoniazid, mexiletine (especially in "fast acetylators"), which leads to a decrease in their plasma concentrations. Increases the risk of developing hepatotoxic effects of paracetamol (induction of "liver" enzymes and the formation of a toxic metabolite of paracetamol). Increases (with prolonged therapy) the content of folic acid. Hypokalemia caused by corticosteroids can increase the severity and duration of muscle blockade against the background of muscle relaxants. AT high doses ah reduces the effect of somatropin. Antacids reduce the absorption of corticosteroids. Hydrocortisone reduces the effect of hypoglycemic drugs; enhances the anticoagulant effect of coumarin derivatives. Weakens the effect of vitamin D on the absorption of Ca2 + in the intestinal lumen. Ergocalciferol and parathyroid hormone prevent the development of osteopathy caused by corticosteroids. Reduces the concentration of praziquantel in the blood. Cyclosporine (inhibits metabolism) and ketoconazole (reduces clearance) increase toxicity. Thiazide diuretics, carbonic anhydrase inhibitors, etc. GCS and amphotericin B increase the risk of hypokalemia, Na +-containing drugs - edema and increased blood pressure. NSAIDs and ethanol increase the risk of ulceration of the gastrointestinal mucosa and bleeding, in combination with NSAIDs for the treatment of arthritis, it is possible to reduce the dose of corticosteroids due to the summation of the therapeutic effect. Indomethacin, displacing GCS from its association with albumin, increases the risk of developing its side effects. Amphotericin B and carbonic anhydrase inhibitors increase the risk of osteoporosis. The therapeutic effect of GCS is reduced under the influence of phenytoin, barbiturates, ephedrine, theophylline, rifampicin and other inducers of "liver" microsomal enzymes (increased metabolic rate). Mitotan and other inhibitors of the function of the adrenal cortex may necessitate an increase in the dose of corticosteroids. GCS clearance increases against the background of drugs - thyroid hormones. Immunosuppressants increase the risk of developing infections and lymphoma or other lymphoproliferative disorders associated with the Epstein-Barr virus. Estrogens (including oral estrogen-containing contraceptives) reduce the clearance of corticosteroids, prolong T1 / 2 and their therapeutic and toxic effects. The appearance of hirsutism and acne contributes to the simultaneous use of other steroid hormonal drugs - androgens, estrogens, anabolics, oral contraceptives. Tricyclic antidepressants may increase the severity of depression caused by taking corticosteroids (not indicated for the treatment of these side effects). The risk of developing cataracts increases when used against the background of other corticosteroids, antipsychotic drugs (neuroleptics), carbutamide and azathioprine. Simultaneous administration with m-anticholinergics (including antihistamines, tricyclic antidepressants), with nitrates contributes to an increase in intraocular pressure.

Description of the drug Hydrocortisone acetate is not intended for treatment without the participation of a physician.
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OJSC "Farmak", Kyiv, Ukraine
CJSC "Kharkov enterprise for the production of immunobiological and medicines"Biolik", Kharkov, Ukraine

Active ingredient: Hydrocortisone Acetate

Hydrocortisone.

Release forms of Hydrocortisone Acetate

Suspension for injections 2.5%, 2 ml in ampoules No. 10

Who is Hydrocortisone Acetate indicated for?

Osteoarthritis, monoarthrosis (knee, elbow, hip joints), synovitis in osteoarthritis, rheumatoid arthritis and arthritis of other origin (with the exception of tuberculosis, gonorrheal arthritis), bursitis, epicondylitis, tendovaginitis, inflammatory contractures, systemic diseases connective tissue, acute severe dermatoses.
Acute adrenal insufficiency (Waterhouse-Frideriksen syndrome), congenital adrenal hypoplasia;
Serum sickness, hypersensitivity reaction to drug administration, prevention and treatment of conditions such as hemorrhagic, cardiogenic and traumatic shock;
Spontaneous and orthostatic hypotension, myocardial infarction, hemorrhagic stroke, Morgagni-Adams-Stokes syndrome;
Coma due to cerebrovascular accident or inflammatory diseases brain, hypothyroid and hepatic coma, multiple bleeding, acute liver failure,
Post-transfusion complications, Mendelssohn's syndrome, thyrotoxic crisis, thyroiditis;
bronchial asthma and other life-threatening allergic conditions.

How to use Hydrocortisone Acetate

Method of application and dose.

Before use, the contents of the ampoule are shaken until a homogeneous suspension is formed. The drug is used as follows: 5-25 mg (0.1-1 ml, depending on the size of the joint) is injected into the joint cavity once a week, 3-5 injections per course. The action of the drug begins 6-25 hours after administration and lasts several days or weeks.

Intramuscularly injected deep into the gluteal muscle at a dose of 50 - 300 mg to 1000 - 1500 mg per day. In acute, life-threatening conditions, 100-150 mg is administered every 4 hours for 48 hours; then - every 8 - 12 hours. Children - every 4 hours 1 - 2 mg / kg, optimal daily doses - 6 - 9 mg / kg.

Application features.

During the treatment period, a diet with sodium restriction, a high content of potassium, vitamins and proteins is recommended. With prolonged use, potassium preparations should be prescribed to prevent hypokalemia. It is necessary to control blood pressure, blood sugar levels, control the state of the blood coagulation system, diuresis and body weight of the patient. During treatment with hydrocortisone, vaccination is not recommended. To prevent the development of hypocorticism caused by discontinuation of treatment, the dose should be reduced gradually. Treatment with hydrocortisone may mask symptoms infectious process.

During pregnancy and lactation, the drug is used for health reasons. Causes immunosuppression, which increases the risk of infection in the mother and fetus. May lead to the development of congenital cataracts and a decrease in the function of the adrenal cortex in the newborn. The drug is prescribed only in cases where the benefits of the use outweigh the risk of negative consequences.

For the treatment of children during the period of growth, the drug should be used only according to absolute indications.

Side Effects of Hydrocortisone Acetate

Against the background of the use of hydrocortisone acetate suspension, a decrease in immunological reactivity is possible, which leads to an exacerbation of chronic foci of infection.

Against the background of treatment, there may be: exacerbation of the ulcerative process of the gastrointestinal tract, stomach ulcer and duodenum, erosive esophagitis, nausea, vomiting, increased arterial and intraocular pressure, cataracts, delayed wound healing. Decreased glucose tolerance, steroid diabetes mellitus, adrenal suppression, Itsenko-Cushing's syndrome, delayed sexual development in children. Sodium is retained in the body, at the same time there is an increased excretion of potassium and calcium with the possibility of developing edema, hypokalemia and osteoporosis, slowing growth and ossification processes in children. There may be an increase in blood clotting, menstrual irregularities, as well as a violation of the functions of the nervous system: insomnia, agitation, euphoria, epileptiform convulsions, headache, depression, psychosis. In rare cases, allergic reactions (with prolonged use), arthralgia, arthropathy are possible.

Who should not take Hydrocortisone Acetate?

Hypersensitivity to hydrocortisone acetate or components of the drug, pre-and post-vaccination period.

Diabetes mellitus, arterial hypertension, severe atherosclerosis, thromboembolism, pyelo- and glomerulonephritis with kidney failure, generalized osteoporosis, alcoholism, epilepsy, acute psychosis, Itsenko-Cushing's syndrome and disease, ulcerative lesions of the gastrointestinal tract, trophic ulcers, acute infectious diseases (tuberculosis in the active phase, mycoses, viral diseases, AIDS, syphilis), recent surgery, systemic fungal infections, hypercoagulation of blood.

Interactions of Hydrocortisone Acetate

Do not inject in the same syringe with heparin, as a precipitate forms.

Phenobarbital, difenin and other drugs that stimulate metabolic processes in the liver accelerate the biotransformation and elimination of hydrocortisone.

The simultaneous use of hydrocortisone with diuretics and amphotericin B can lead to increased excretion of potassium from the body, an increased risk of developing heart failure, with sodium-containing drugs - to the development of edema and increased blood pressure;
with cardiac glycosides - may increase the risk of developing ventricular extrasystole;
with ethanol and non-steroidal anti-inflammatory drugs - increase the risk of ulcers digestive tract, enhance the effect of hydrocortisone, with paracetamol - increase the hepatotoxicity of paracetamol;
With acetylsalicylic acid- accelerate its release and reduce the concentration in the blood;
with insulin, oral hypoglycemic drugs, antihypertensive drugs - reduce their effectiveness;
with M-anticholinergics - provoke the development of glaucoma; with estrogens - enhance the effect of hydrocortisone;
with live virus vaccines and against the background of other types of immunization - increase the risk of virus activation and the development of infections.

Overdose of Hydrocortisone Acetate

Exceeding the dose or prolonged administration of the drug can lead to inhibition of its own production of glucocorticoids, increased blood pressure, ulcerative bleeding from the digestive tract, exacerbation chronic infections, arthralgia, the development of Itsenko-Cushing's syndrome.

Treatment of overdose is symptomatic.

Name: Hydrocortisone acetate (Hydrocortisoni acetas)

Pharmacological effect:
Hydrocortisone acetate belongs to the group of naturally occurring glucocorticosteroids. It has anti-shock, antitoxic, immunosuppressive, anti-exudative, antipruritic, anti-inflammatory, desensitizing, anti-allergic effects. It inhibits hypersensitivity reactions, proliferative and exudative processes in the focus of inflammation. The effect of hydrocortisone acetate is mediated through specific intracellular receptors. The anti-inflammatory effect is to suppress all phases of inflammation: stabilization of cellular and subcellular membranes, a decrease in the release of proteolytic enzymes from lysosomes, inhibition of superoxide, hydroxyl and other free oxygen radicals. Hydrocortisone lowers the release of inflammatory mediators, including interleukin-1 (IL-1), histamine, serotonin, bradykinin and others; lowers the release of arachidonic acid from phospholipids and the synthesis of prostaglandins, leukotrienes, thromboxane; inhibits the production of collagenase and activates the synthesis of protease inhibitors. Increases the level of glycogen in the liver, inhibits the release of sodium and water, while increasing the volume of circulating blood and increasing arterial pressure(anti-shock effect). Increases potassium excretion, increases protein catabolism. Like other glucocorticoids, hydrocortisone lowers the number of T-lymphocytes in the blood, thereby lowering the effect of T-helpers on B-lymphocytes, lowers the formation of fixed immune complexes, reducing the manifestations of allergic reactions.

Pharmacokinetics
Relatively slowly absorbed from the injection site. It binds to blood proteins up to 90% of the drug (transcortin - 80% and albumin - 10%), about 10% is in the form of a free fraction. Metabolism is carried out in the liver. A small amount of the drug penetrates the placenta (up to 67% is destroyed in the placenta itself to inactive metabolites), unlike synthetic derivatives. Metabolites of hydrocortisone are excreted mainly through the kidneys.

Hydrocortisone acetate - indications for use:

Non-infectious arthritis, synovitis in osteoarthritis, osteoarthritis of rheumatic and other origin (with the exception of tuberculosis, gonorrhea, purulent and other arthritis associated with infections), bursitis, epicondylitis, tendovaginitis, inflammatory contractures.

Acute adrenal insufficiency (Waterhouse-Friderichsen syndrome), congenital adrenal hypoplasia; serum sickness, hypersensitivity reaction to drug administration, prevention and treatment of anaphylactic, hemorrhagic, cardiogenic and traumatic shock; spontaneous and orthostatic hypotension, myocardial infarction, hemorrhagic stroke, Morgagni-Adams-Stokes syndrome; coma in violation of cerebral circulation and inflammatory diseases of the brain, hypothyroid and hepatic coma, multiple bleeding, acute liver failure, post-transfusion complications, Mendelssohn's syndrome, thyrotoxic crisis, thyroiditis; bronchial asthma and other allergic conditions.

Hydrocortisone acetate - method of application:

Before use, the contents of the ampoules are shaken until a homogeneous suspension is formed. The drug is used: 5-25 mg (0.1-1 ml (depending on the size of the joint) 1 time per week, 3-5 injections per course) are injected into the joint cavity. The effect of the drug begins 6-25 hours after administration and lasts for several days or weeks.

Intramuscularly injected deep into the gluteal muscle at a dose of 50-300 mg to 1000-1500 mg per day. In acute, life-threatening conditions, 100-150 mg is administered every 4 hours for 48 hours; then - every 8-12 hours. Children - every 4 hours 1-2 mg / kg, the optimal daily dosage is 6-9 mg / kg.

Hydrocortisone acetate - side effects:

When using a suspension of hydrocortisone acetate, there may be a decrease in immunological reactivity, leading to an exacerbation of chronic foci of infection. Against the background of treatment, there may be: exacerbation of ulcerative lesions of the gastrointestinal tract, increased arterial and intraocular pressure, cataracts, delayed wound healing, hyperglycemia. There is a delay in the body of sodium and increased excretion of potassium and calcium with the ability to develop edema, hypokalemia and osteoporosis. There may be an increase in blood clotting, menstrual irregularities, as well as dysfunctions of the nervous system: insomnia, agitation, euphoria, epileptiform convulsions, headache, depression, psychosis. In some cases, allergic reactions are possible (with prolonged use).

Hydrocortisone acetate - contraindications:

Pregnancy and lactation period, junior childhood, diabetes, hypertonic disease, severe atherosclerosis, thromboembolism, pyelo- and glomerulonephritis with renal failure, generalized osteoporosis, alcoholism, epilepsy, acute psychosis, Itsenko-Cushing's syndrome and disease, ulcerative lesions of the gastrointestinal tract, trophic ulcers, acute infectious diseases (tuberculosis in the active phase, fungal infections, viral diseases, AIDS, syphilis), recent surgery, systemic fungal infections, blood hypercoagulability.

Hydrocortisone acetate - pregnancy:

Pregnancy and lactation are contraindications to the use of the drug.

Interaction with others medicines:
It is forbidden to inject in the same syringe with heparin due to the formation of sediment. Phenobarbital, difenin and other drugs that stimulate metabolic processes in the liver accelerate the biotransformation and elimination of hydrocortisone.

Hydrocortisone accelerates the elimination of drugs that are metabolized in the liver (barbiturates, digitoxin, antibiotics of the penicillin group, chloramphenicol and others). Increases the reaction to catecholamines, which can provoke a hypertensive crisis. At joint application with paracetamol increases its hepatotoxicity.

When combined with amphotericin B, the development of dilated myocardial damage and heart failure is likely. Exercise caution when co-administering hydrocortisone with antidiabetic drugs, diuretics, salicylates.

Hydrocortisone acetate - overdose:

Exceeding the dosage or prolonged administration of the drug can lead to inhibition of its own production of glucocorticoids, increased blood pressure, ulcerative bleeding of the gastrointestinal tract, exacerbation of chronic infections, and the development of Itsenko-Cushing's syndrome. Treatment of overdose is symptomatic.

Hydrocortisone acetate - release form:

2.5% suspension.
10 ampoules of 2 ml in cardboard packs.

Hydrocortisone acetate - storage conditions:

Store in a place protected from light at a temperature not exceeding +18 °C. Freezing is not allowed. The shelf life is indicated on the packaging.
Leave conditions - according to the recipe.

Hydrocortisone acetate - composition:

International and chemical name
hydrocortisone; pregnen-4-triol-11b, 17a, 21-dione-3,20,21-acetate.

Main physiochemical properties
A white or white with a yellowish tint suspension with a specific odor, which settles when standing. The settled particles with vigorous shaking for 2 minutes again go into suspension.

Compound
One ampoule contains - hydrocortisone acetate 0.05 g (1 ml - 0.025 g);
excipients - propylene glycol, polyvinyl pyrrole and don, sodium chloride, benzyl alcohol, sorbitol, water for injection.

Hydrocortisone acetate - optional:

With prolonged use, potassium preparations should be prescribed to prevent hypokalemia. It is necessary to monitor blood pressure, blood sugar, potassium in the blood, blood clotting, diuresis and body weight of the patient. Vaccination is not recommended during treatment with hydrocortisone. To prevent the development of secondary hypocorticism caused by discontinuation of treatment, the dosage should be reduced gradually. Treatment with hydrocortisone can mask some of the manifestations of the infectious process, the addition of new infections.

Manufacturer
JSC "Farmak"

Important!
Before using the medicine Hydrocortisone acetate you should consult your doctor. This instruction is for informational purposes only.

Hydrocortisone is a drug of a group of steroid hormones belonging to the class of potent drugs used in the treatment of inflammatory, allergic, autoimmune and other pathologies. Doctors often compare them with surgery: with an undeniable therapeutic effect, there is always a risk of complications and adverse reactions. This is also warned by the instructions for the use of the drug. Therefore, the use of Hydrocortisone in ampoules is considered appropriate when exposure nonsteroidal drugs does not give the expected effect or when there is a threat to the life of the patient.

Hydrocortisone is a hormone secreted in the human body by the adrenal cortex, a glucocorticoid. In medical practice for systemic and local application use natural hydrocortisone or its esters (in particular, hydrocortisone acetate).

Hydrocortisone has anti-inflammatory, desensitizing (preventing or inhibiting allergic reactions) and anti-allergic effects, has immunosuppressive (suppressing the body's defenses) activity.

It inhibits connective tissue reactions during the inflammatory process and reduces the intensity of scar tissue formation. Reduces the number of mast cells that produce hyaluronic acid, inhibits the activity of hyaluronidase and helps to reduce capillary permeability. Reduces synthesis and accelerates the processes of protein breakdown in muscle tissue.

By stimulating steroid receptors, it induces the formation of a special class of proteins - lipocortins, which have a decongestant effect. Increases the level of glycogen in the liver, which leads to the development of hyperglycemia.

Detains sodium ions and water in the body, while increasing the volume of circulating blood and increasing blood pressure (anti-shock effect).

Stimulates the excretion of potassium, reduces the absorption of calcium from the digestive tract, reduces the mineralization of bone tissue.

Like other glucocorticoids, hydrocortisone inhibits the formation of immune complexes, reducing the manifestations of allergic reactions.

With intra- and periarticular administration, hydrocortisone penetrates into the systemic circulation. Communication with proteins more than 90%. It is metabolized in the liver, the final metabolites are excreted by the kidneys. Adsorption after injection into the joints and introduction into soft tissues is slow, which ensures a prolonged action.

Release form

Hydrocortisone acetate.
The drug for intramuscular and intraarticular administration is produced in ampoules in the form of a suspension - a liquid with fine solid particles distributed in it, which settle when settling.

After shaking, the contents of the ampoule have the form of a suspension of white or white with a yellowish tint and a specific odor.

The volume of one ampoule is 2 ml.

active substance - hydrocortisone acetate 25 mg,
excipients - propylene glycol, benzyl alcohol, sorbitol, povidone, sodium chloride, water for injection.

The package may contain 5 or 10 ampoules of Hydrocortisone acetate and instructions for use.

Hydrocortisone Richter.
Suspension for intraarticular and periarticular injections is available in colorless glass vials.

hydrocortisone acetate - 125 mg;
lidocaine - 25 mg.

The topical agent is available in the form of an ointment (1%), eye ointment (0.5%), eye drops (0.5-2.5%).

Ointments in pharmacies are dispensed without a prescription. To buy ampoules or vials with a suspension, you will need a prescription from your doctor.

Indications for use

The introduction of the suspension is indicated for the systemic treatment of allergic, shock conditions and inflammatory diseases various etiologies and localization.

The drug is used in cardiology to provide emergency care with cardiogenic and traumatic shock, as well as for complex treatment arterial hypotension.

As part of complex therapy suspension can be used to treat hay fever, lupus erythematosus, anaphylactic shock, hepatic coma, acute adrenal insufficiency, thyrotoxic crisis, bronchial asthma(in patients with asthmatic status). good effect gives the use of hydrocortisone acetate for the relief of edematous syndrome with damage to the brain and respiratory organs.

Intramuscular administration of hydrocortisone is indicated as part of resuscitation measures for plummet blood pressure and acute disorder blood supply is vital important organs caused by Addison's disease.

In traumatology and orthopedics, indications for intra-articular (intra-articular) administration of Hydrocortisone can be:

Periarticular administration (into the periarticular bags, to the places of attachment of the tendons, sometimes to the muscles surrounding the joint) of the suspension is used for persistent inflammatory diseases of the periarticular tissues that are not amenable to treatment with other drugs, accompanied by pain syndrome and dysfunction of the joints:

capsulitis,
tendovaginitis,
plantar fasciitis,
forearm tunnel syndrome.

The ability of glucocorticoids to suppress the immune system (immunosuppressive effect) is used in transplantation (transplantation) of organs and tissues to suppress the rejection reaction, as well as in various autoimmune diseases.

Contraindications

Hydrocortisone has a large number of contraindications.

For contraindications for injection Hydrocortisone include:

hypersensitivity to the active substance or to any of the auxiliary components of the drug;
progressive osteoporosis;
Itsenko-Cushing's syndrome (hypercorticism syndrome);
epilepsy, since hydrocortisone can increase the excitability of brain tissue and help lower the seizure threshold;
tuberculosis (in active form);
immunodeficiency syndrome.

Syndrome of hypercortisolism (Itsenko-Cushing)

In high doses, hydrocortisone stimulates excess production of hydrochloric acid and pepsin in the stomach, which contributes to the development of peptic ulcers.

Intravenous and intramuscular administration of Hydrocortisone acetate is contraindicated in diabetes mellitus, arterial hypertension (with an increase in pressure to 150/100 and above), acute psychoses, systemic fungal infection of the body.

Since the metabolites of the active substance are excreted from the body by the kidneys, the drug should not be prescribed to persons with severe pathologies of the renal system. Absolute contraindication for treatment is nephrosis - a degenerative lesion of the kidney parenchyma, characterized by the degeneration of the tubules and connective structures of the organ.

Contraindications for intra-articular administration of Hydrocortisone and injections directly into the lesion are:

severe periarticular osteoporosis;
osteoarthritis of the joint without signs of inflammation (the so-called dry joint);
joint deformity (sharp narrowing of the joint space or ankylosis);
aseptic necrosis of the epiphyses of the bones forming the joint;
intraarticular fracture;
infectious arthritis;
blood clotting disorder;
previous surgical treatment of the joint.

Do not use Hydrocortisone 8 weeks before and 2 weeks after vaccination, as well as in children under 1 year old and pregnant women.

Side effects

The variety of pharmacological effects of glucocorticoids determines not only their high therapeutic value, but also the possibility of adverse reactions. Long-term use of Hydrocortisone gives a high risk of side effects, which include:

peripheral edema, which develops against the background of retention of sodium ions and fluid in the body;
increased blood pressure;
an increase in blood glucose levels up to the development of steroid diabetes mellitus;
increased calcium excretion and the development of osteoporosis;
development of Itsenko-Cushing's symptom complex (moon-shaped face, obesity, menstrual irregularities);
increased blood clotting with the risk of thrombosis;
diseases of the gastrointestinal tract (pancreatitis, peptic ulcer stomach and duodenum, erosive esophagitis);
violation heart rate up to a complete cardiac arrest against the background of hypokalemia (loss of potassium);
or muscle spasm accompanied by unusual weakness and fatigue;
convulsive syndrome;
mental disorders.

The use of hydrocortisone in children may inhibit physical growth, inhibit activity immune system cause psycho-emotional and behavioral changes.

In the elderly, the side effects of hydrocortisone may be more intense.

Instructions for use of the suspension in ampoules and vials

Long-term use of Hydrocortisone can lead to serious side effects, so you should read the instructions before starting treatment.

Before use, the contents of the ampoule or vial are shaken until a homogeneous suspension is formed.

Hydrocortisone acetate is produced as deep as possible into the gluteal muscle to prevent the development of muscle atrophy.

If the patient is in serious condition, life threatening condition, forced administration of the drug at a dosage of 100-150 mg at intervals of 4 hours between injections during the first 48 hours is shown. Further, the intervals between applications are increased to 8-12 hours. Such a scheme must be followed until the relief of an acute condition.

When prescribing the drug to children, one should take into account not only their age, but also body weight. For emergency care, the suspension is injected into the muscle every 4 hours at a rate of 1-2 mg / kg. Daily dose for children of any age should not exceed 9 mg / kg.

Suspension Hydrocortisone Richter used to treat pathologies of the musculoskeletal system, when intra-articular administration is indicated. The dosage depends on the underlying diagnosis, comorbidities, joint size, severity of the inflammatory process, general condition patient and can be from 5 to 50 mg of hydrocortisone per day.

The largest dose of Hydrocortisone 25-50 mg is injected into large joints (hip, knee), 2 times lower dose 10-25 mg - into the middle (shoulder, elbow, ankle), the smallest 5-10 mg - into small (metacarpophalangeal, interphalangeal and others). The therapeutic effect with intraarticular administration of the drug occurs within 6-24 hours.

Repeated injections, if necessary, are carried out at intervals from several weeks to 3-4 months, depending on the degree and duration of the therapeutic effect.

If after the second injection in the same joint there is no improvement, it is not recommended to continue treatment with Hydrocortisone.

Injections for the joints should be done by a highly qualified orthopedic doctor, only in this case it can be guaranteed that the injection will be safe and relatively painless.

Intra-articular injection should be carried out under conditions of strict asepsis and antisepsis, and only after the exclusion of the infectious process in the joint.

When performing injections for the joints, a syringe with a long needle is used. The needle should hit exactly in the joint space. In order to avoid errors, such injections are most often carried out under ultrasound control.

Before the introduction medicinal substance it is necessary to pump out and examine the fluid from the joint cavity.
Hydrocortisone acetate (ampoules 2.5% 10 pcs.) - from 186 hryvnias;

Hydrocortisone Richter (bottle 5 ml 1 pc.) - from 315 hryvnia.

Analogues

The most popular analogue of Hydrocortisone is Prednisolone. This is a synthetic glucocorticoid hormone, which belongs to the drugs of medium strength. It inhibits the migration of leukocytes and macrophages to the focus of inflammation and reduces the number of basophils.

Replacement with Prednisolone is possible if hydrocortisone therapy has been ineffective, or the patient is in a serious (critical) condition. Prednisolone is considered to be a medium strength drug and its action is more prolonged than hydrocortisone.

Sopolkort N;
Methylprednisolone;
Solu Cortef;
Kenalog;
Triamcinolone.

The listed drugs differ in composition, list of contraindications and side effects, as well as age restrictions, so you should remember that in order to avoid severe complications corticosteroid analogues can be used and used strictly according to the doctor's prescription.

Release form: Liquid dosage forms. Injection.

General characteristics. Compound:

Active ingredient: hydrocortisone;

1 ml of suspension contains hydrocortisone acetate in terms of 100% dry matter 25 mg;

excipients: propylene glycol, sorbitol (E 420), povidone, sodium chloride, benzyl alcohol, water for injection.

Pharmacological properties:

Pharmacodynamics. Hydrocortisone acetate belongs to the group of naturally occurring glucocorticosteroids. It has anti-shock, antitoxic, immunosuppressive, anti-exudative, antipruritic, anti-inflammatory, desensitizing, anti-allergic effects. It inhibits the hypersensitivity reaction, proliferative and exudative processes in the focus of inflammation. The action of hydrocortisone acetate is mediated through specific intracellular receptors. The anti-inflammatory action is based on the inhibition of all phases of inflammation: stabilization of cellular and subcellular membranes, a decrease in the release of proteolytic enzymes from lysosomes, inhibition of the formation of superoxide anion and other free radicals. Hydrocortisone inhibits the release of inflammatory mediators, including interleukin-1 (IL-1), histamine, serotonin, bradykinin, etc., reduces the release of arachidonic acid from phospholipids and the synthesis of prostaglandins, leukotrienes, thromboxane. Reduces inflammatory cell infiltrates, reduces the migration of leukocytes and lymphocytes to the focus of inflammation. It inhibits connective tissue reactions during the inflammatory process and reduces the intensity of scar tissue formation. Reduces the number of mast cells that produce hyaluronic acid, inhibits the activity of hyaluronidase and helps to reduce capillary permeability. It inhibits the production of collagenase and activates the synthesis of protease inhibitors. Reduces synthesis and enhances protein catabolism in muscle tissue. By stimulating steroid receptors, it induces the formation of a special class of proteins - lipocortins, which have an anti-edematous effect. It has a contrainsular effect, increasing the level of glycogen in the liver and causing development. Retains sodium and water in the body, while increasing the volume of circulating blood and increasing blood pressure (anti-shock effect).

Stimulates the excretion of potassium, reduces the absorption of calcium from the digestive tract, reduces the mineralization of bone tissue.

Like other glucocorticoids, hydrocortisone reduces the number of T-lymphocytes in the blood, thereby reducing the effect of T-helpers on B-lymphocytes, inhibits the formation of immune complexes, reducing the manifestations of allergic reactions.

Pharmacokinetics. Hydrocortisone, which is applied topically, can be absorbed and exhibit systemic effects. Relatively slowly absorbed from the injection site. Up to 90% of the drug binds to blood proteins (with transcortin - 80%, with albumin - 10%), about 10% is a free fraction. Metabolism is carried out in the liver. Unlike synthetic derivatives, a small amount of the drug penetrates the placenta (up to 67% is destroyed in the placenta itself to inactive metabolites). Metabolites of hydrocortisone are excreted mainly by the kidneys.

Pharmaceutical specifications

Basic physical and chemical properties: after shaking for 2 minutes, the drug is a suspension of white or white with a yellowish tint, which settles when standing, with a specific odor.

Indications for use:

Osteoarthritis, various monoarthroses (knee, elbow, hip joints), and arthritis of other origin (with the exception of tuberculous and gonorrheal arthritis). Shoulder blade, . Before surgery on ankylosing joints. As a topical adjunct to systemic corticosteroid therapy.

Important! Get to know the treatment

Dosage and administration:

Before use, the contents of the ampoules are shaken until a homogeneous suspension is formed.

Adults and children over 14 years of age: a single dose depends on the size of the joint and the severity of the disease - 5-50 mg of hydrocortisone intra-articularly and periarticularly.

For 24 hours, adults can be injected into no more than three joints. Children: a single dose of hydrocortisone depends on the size of the joint and the severity of the disease -

5-30 mg intraarticularly and periarticularly.

The therapeutic effect with intra-articular administration of the drug occurs within 6-24 hours and lasts from several days to several weeks. Re-introduction of the drug is possible after 3 weeks.

The drug can not be injected directly into the tendon, therefore, with tendinitis, the drug must be injected into the tendon sheath.

The drug should not be used for systemic corticosteroid therapy.

Application Features:

Use during pregnancy or lactation

The appointment of the drug in the first trimester of pregnancy is contraindicated. In the future, the drug is prescribed only in cases where the benefit to the mother outweighs the risk of negative consequences for the fetus.

Corticosteroids are excreted in milk, so breastfeeding should be discontinued during treatment.

For the treatment of children during the period of growth, the drug is used only according to absolute indications. The drug contains benzyl alcohol, therefore it is not recommended for use in children under the age of 2 years.

Intra-articularly administered corticosteroid may increase the possibility of recurrence inflammatory processes. The drug can provoke bacterial infection of the joint, so Hydrocortisone acetate can only be administered under aseptic conditions.

During treatment with hydrocortisone, vaccination should not be carried out due to a high risk of developing neurological complications and inhibition of antibody production.

During therapy with corticosteroids, the body's ability to localize the infection may decrease.

The introduction of conventional and high doses of corticosteroids can cause an increase in blood pressure, increase the retention of sodium and water in the body and stimulate the excretion of potassium from the body. All corticosteroids increase the excretion of calcium from the body.

With latent tuberculosis, it can only be used together with tuberculostatic agents.

In infectious diseases, use with caution and only in conjunction with specific antibacterial therapy.

During therapy with hydrocortisone acetate, it is necessary to adjust the dose of oral antidiabetic agents and anticoagulants.

Should be controlled electrolyte metabolism in the body with the simultaneous use of diuretics.

With prolonged use, potassium preparations should be additionally prescribed for prophylaxis.

in the nursery and adolescence the drug should be used in a shorter course at the minimum effective dosage due to the possibility.

During treatment, it is advisable to regularly measure blood pressure, analyze urine and feces.

Treatment should be completed by gradually reducing the dose of the drug and deciding whether to use ACTH (skin test).

When combined with salicylates, if the dose of corticosteroid is reduced, it is necessary to simultaneously reduce the dose of salicylate.

Care should be taken when prescribing the drug to patients with a history of psychosis, diabetes(including family history), arterial hypertension, glaucoma, steroid myopathy, epilepsy, history of tuberculosis.

The ability to influence the reaction rate when driving vehicles or working with other mechanisms

There are no data that would confirm that the use of the drug affects the reaction rate when driving vehicles or working with other mechanisms. In the case when during treatment with the drug are observed, etc., you should refrain from administering vehicles and performing tasks that require attention.

Side effects:

For intravenous use steroid drug one of the side effects may be swelling or pain at the injection site. This phenomenon usually resolves on its own within a few hours after administration.

Against the background of prolonged and uncontrolled use of hydrocortisone acetate suspension, there may be observed adverse reactions, which are typical for all corticosteroids (systemic action).

Violations of water and electrolyte balance: sodium and fluid retention in the body; hypokalemia, hypokalemia; , .

Violations by musculoskeletal system: aseptic ; steroid; ; growth retardation in children.

Gastrointestinal disorders: with possible perforation and bleeding; stomach bleeding; ; ; increased appetite, .

Dermatological disorders: hirsutism, hypopigmentation, delayed wound healing, skin, acne, irritation, dryness, thinning and hypersensitivity of the skin, dilation of skin capillaries.

Metabolic disorders: negative nitrogen balance.

Neurological disorders: increased intracranial pressure with edema of the nipple of the optic nerve (symptom of congestive nipple); mental disorders; convulsions, dizziness, insomnia, agitation,.

Endocrine disorders: suppression of adrenal function, especially with prolonged use or when using large doses; Itsenko-Cushing's syndrome; decreased carbohydrate tolerance and increased need for insulin or oral hypoglycemic agents; delayed sexual development in children, menstrual irregularities.

Interaction with other drugs:

It is necessary to avoid combination with barbiturates in the treatment of patients who suffer from Addison's disease (a crisis may occur).

Care must be taken when administering at the same time:
with barbiturates, phenylbutazone, phenytoin and rifampicin (the effect of corticosteroids may decrease);
with oral antidiabetic agents (it is necessary to change their dose taking into account the hyperglycemic effect of corticosteroids);
with anticoagulants (strengthening or weakening of the anticoagulant effect);
with salicylates (may reduce plasma levels of salicylates, occult gastrointestinal bleeding or the possibility of ulcers);
with amphotericin, diuretics, theophylline, cardiac glycosides (the risk of developing hypokalemia increases);
with oral contraceptives (the concentration of corticosteroids in the blood increases);
with antihypertensive agents (corticosteroids reduce the effectiveness of antihypertensive agents);
with mefipristone (the effectiveness of corticosteroids decreases).

Contraindications:

Hypersensitivity to the components of the drug. Intra-articular infection. I trimester of pregnancy. Infectious diseases and without antibiotic therapy. Syndrome Itsenko-Cushing. Achilles tendon treatment. period of vaccination. Peptic ulcer of the stomach and duodenum. Osteoporosis. Tendency to thromboembolism. . Arterial hypertension heavy flow. Simple herpes. Chicken pox. active tuberculosis. .

Overdose:

There is no characteristic clinical syndrome with an overdose of hydrocortisone acetate.

In case of an overdose, there may be an increase in both local and systemic adverse reactions.

Treatment: symptomatic. There is no specific antidote. With a significant overdose, dialysis may be used.

Storage conditions:

Best before date. 3 years. Do not use the drug after the expiration date indicated on the package. Store in a place protected from light at a temperature not exceeding 15 ° C. Freezing is not allowed. Keep out of the reach of children.

Leave conditions:

On prescription

Package:

2 ml per ampoule. 10 ampoules in a pack.