Hydrocortisone acetate instructions for use. Hydrocortisone, solution for intramuscular administration (ampoules). The ability to influence the reaction rate when managing motor vehicles or other mechanisms

Hydrocortisone is a drug group steroid hormonesbelonging 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 indisputable medical effect there is always a risk of developing complications and adoption of adverse reactions. This warns the instructions for the use of the drug. Therefore, the use of hydrocortisone in ampoules is considered appropriate when the impact of nonsteroidal means does not give the expected effect or when there is a threat to the life of the patient.

Hydrocortisone - hormone, secreted in the human body of adrenal cortex, is glucocorticoid. In medical practice for system and local application Use natural hydrocortisone or its esters (in particular, hydrocortisone acetate).

Hydrocortisone has anti-inflammatory, desensitizing (warning or braking allergic reactions) and anti-allergic effect, has an immunosuppressive (overwhelming body's protective forces) activity.

Inhibits the connective tissue reactions during the inflammatory process and reduces the intensity of the formation of scar tissue. Reduces the amount of fat cells producing hyaluronic acid suppresses the activity of hyaluronidase and helps to reduce the permeability of capillaries. Reduces synthesis and accelerates protein cleavage processes in muscle tissue.

Stimulating steroid receptors, induces the formation of a special class of proteins - lipocortins that have an anti-ethnic effect. Increases the level of glycogen in the liver, which leads to the development of hyperglycemia.

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

Stimulates the removal of potassium, reduces calcium absorption 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.

When in- and the near-block administration, hydrocortisone penetrates the systemic blood flow. Communication with proteins more than 90%. Metabolized in the liver, the final metabolites are derived by the kidneys. Adsorption after injection inside joints and administration in soft fabrics Slow, which provides a prolonged action.

Form release

Hydrocortisone acetate.
The drug for intramuscular and intra-articular administration is made in ampoules in the form of a suspension - liquid with small solid particles distributed in it, which are settled.

After shaking the contents of the ampoule has the form of a suspension of white or white with a yellowish color tinge and a specific smell.

The volume of one ampoule is 2 ml.

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

The packaging may contain 5 or 10 ampoules of the hydrocortisone acetate and instructions for use.

Hydrocortisone Richter.
The suspension for intra-articular and occasional injections is produced in colorless glass bottles.

hydrocortisone acetate - 125 mg;
lidocaine - 25 mg.

The tool for local use is produced in the form of ointments (1%), eye ointment (0.5%), eye drops (0.5-2.5%).

Ointe in pharmacies are released without a recipe. To buy ampoules or vials with a suspension, you will need a recipe for the attending physician.

Indications for use

The introduction of suspension is shown for the systemic treatment of allergic, shock conditions, as well as inflammatory diseases of various etiology and localization.

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

As part of complex therapy, the suspension can be used to treat hay fever, red lupus, anaphylactic shock, hepatic coma, acute adrenal insufficiency, thyrotoxic crisis, bronchial asthma (in patients with asthmatic status). Good effect It gives the use of acetate hydrocortisone to relieve the enemy syndrome when the brain is damaged and the respiratory organs.

The intramuscular administration of the hydrocortisone is shown in the resuscitation activities at sharp fall Blood pressure I. acute violation The blood supply to vital organs provoked by Addison's disease.

In traumatology and orthopedics indications for intraarticular (intra-art) administration of hydrocortisone can be:

Periarticular administration (in the occasional bags, to places of attachment of tendons, sometimes into the surrounding joint muscles) suspension is used with persistent, non-treatment of other drugs of inflammatory diseases of the inclined tissues accompanied by painful syndrome and violation of the joints of the joints:

capsule
tendovaginit
plantar fasci
pre-tunnel syndrome.

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

Contraindications

Hydrocortisone has a large number of Contraindications.

Contraindications for injection of hydrocortisone include:

increased sensitivity K. active substance or to any of the auxiliary components of the drug;
progressive osteoporosis;
itsenko-Cushing syndrome (hypercorticism syndrome);
epilepsy, since hydrocortisone can increase the excitability of brain tissues and contributes to a decrease in the threshold of convulsive readiness;
tuberculosis (active form);
immunodeficiency syndrome.

Hypercorticism syndrome (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.

It is contraindicated with intravenous and intramuscular administration of acetate hydrocortisone with diabetes mellitus, arterial hypertension (With the increase in pressure to 150/100 and higher), acute psychosis, systemic fungal lesion of the body.

Since the metabolites of the active substance are removed from the body by the kidneys, should not be prescribed to persons with severe pathologies of the renal system. The absolute contraindication for treatment is nephrisosis - dystrophic damage to the kidney parenchyma, characterized by the reincarnation of the tubules and the connecting structures of the organ.

Contraindications for intra-articular administration of hydrocortisone and injections directly to the lesions are:

pronounced inclusive osteoporosis;
osteoarthrosis of the joint without signs of inflammation (the so-called dry joint);
sustav deformation (sharp narrowing of the articular gap or ankylosis);
aseptic necrosis forming the joint epiphysis bones;
intra-art fracture;
infectious arthritis;
blood coagulation disorders;
previous surgery Sustav.

The use of hydrocortisone for 8 weeks before and 2 weeks after vaccination, as well as in children under 1 year and pregnant women is not allowed.

Side effects

The variety of pharmacological effects of glucocorticoids causes not only their high therapeutic value, but also the possibility of unwanted reactions. Long-term use of hydrocortisone gives high risk of development side EffectsTo which include:

peripheral edema, developing against the background of the delay of sodium ions and fluids in the body;
raising arterial pressure;
growth of blood glucose levels up to the development of steroid diabetes;
enhancing calcium extraction and osteoporosis development;
the development of symptom complex Izeno-Cushing (moon-like face, obesity, menstrual disorder);
raising blood clotting with risk of thrombosis;
diseases of the gastrointestinal tract (pancreatitis, ulcer of the stomach and duodenal gut, erosive esophagitis);
violation heart Rhythm up to the full stop of the heart against the background of hypokalemia (potassium loss);
or muscle spasm accompanied by unusual weakness and fatigue;
convulsive syndrome;
mental disorders.

The use of hydrocortisone in children can suppress physical growth, inhibition of the activity of the immune system, to cause psycho-emotional and behavioral changes.

In the elderly, the side effects of the hydrocortisone can manifest themselves more intensively.

Instructions for the use of suspension in ampoules and bottles

Long-term use of hydrocortisone can lead to serious side effects, so before starting treatment, you should familiarize yourself with the instructions.

Before use, the contents of the ampoule or the vial shake up to the formation of a homogeneous suspension.

The acetate hydrocortisone is made as deeper into the buttock muscle to prevent the development of muscle atrophy.

If the patient is in severe, threatening Life condition, the forced administration of the drug in the dosage of 100-150 mg was shown at intervals of 4 hours between injections during the first 48 hours. Next intervals between applications increase to 8-12 hours. Such a scheme must be adhere to the decolation of an acute state.

When prescribing the drug, children should consider not only their age, but also body weight. To provide emergency care, the suspension is introduced into the muscle every 4 hours at the rate of 1-2 mg / kg. The daily dose for children of any age should not exceed 9 mg / kg.

Suspension Hydrocortisone Richter It is used to treat pathologies of the musculoskeletal system when the intra-articular administration is shown. Dosage depends on the main diagnosis, accompanying pathologies, size of the joint, gravity of the inflammatory process, the general state of the patient and can range from 5 to 50 mg of hydrocortisone per day.

The greatest dose of hydrocortisone 25-50 mg is introduced into large joints (hip, knee), 2 times a smaller dose of 10-25 mg - in the middle (shoulder, elbow, ankle), the smallest 5-10 mg - in small (psyche-phalangeal, Interfalane and others). Therapeutic effect at intra-articular administration of the drug occurs within 6-24 hours.

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

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

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

Casting administration should be carried out under strict arsetics and antiseptics and only after the exclusion of the infectious process in the joint.

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

Before administration medicinal substance It is necessary to pump out and explore the liquid from the joint cavity.
Hydrocortisone acetate (ampoules 2.5% 10 pcs.) - from 186 hryvnia;

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

Analogs

The most popular analogue of the hydrocortisone is considered prednisolone. This is a synthetic glucocorticoid hormone, which refers to medium-power drugs. It suppresses the migration of leukocytes and macrophages into the focus of inflammation and reduces the number of basophils.

The replacement prednisolone is possible if the therapy with hydrocortisone was ineffective, or the patient is in a serious (critical) state. Prednisolone is considered to be a drug of medium strength, and its action is more prolonged compared to hydrocortisone.

Copolkort n;
Methylprednisolone;
Salu Cortef;
Kenalog;
Triamcinolone.

These drugs are distinguished by the composition, list of contraindications and side effects, as well as age limitations, so it should be remembered that in order to avoid severe complications, it is necessary to use and use analogs-corticosteroids with an appointment of a doctor.

packages polyethylene two-layer (1) - tin barrels.
packages polyethylene two-layer (1) - packing cardboard.

A description of the active components of the drug " Hydrotisut»

pharmachologic effect

GKS. Suppresses the functions of leukocytes and tissue macrophages. Limits the migration of leukocytes to the inflammation area. Violates the ability of macrophages to phagocytosis, as well as to the formation of interleukin-1. It contributes to the stabilization of lysosomal membranes, thereby reducing the concentration of proteolytic enzymes in the field of inflammation. Reduces the permeability of capillaries due to the release of histamine. Suppresses the activity of fibroblasts and the formation of collagen.

Inhibits the activity of phospholipase A 2, which leads to the suppression of the synthesis of prostaglandins and leukotrienes. Suppresses the release of the COF (mainly COF-2), which also helps to reduce the production of prostaglandins.

Reduces the number of circulating lymphocytes (T- and B cells), monocytes, eosinophils and basophils due to their displacement from the vascular bed to lymphoid fabric; Suppresses the formation of antibodies.

The hydrocortisone suppresses the release of the ACTH and β-lipotropine hypophysia, but does not reduce the level of circulating β-endorphine. Inhibits the secretion of TSH and FSH.

With direct appliqués on the vessels has a vasoconstrictor effect.

Hydrocortisone has a pronounced dose-dependent effect on the metabolism of carbohydrates, proteins and fats. Stimulates glukegenesis, promotes the seizure of amino acids with liver and kidneys and increases the activity of glukegenesis enzymes. In the liver, hydrocortisis enhances the deposit of glycogen, stimulating the activity of glycogenacentase and glucose synthesis from protein exchange products. Increased blood glucose content activates insulin allocation.

The hydrocortisone suppresses the grip seizure with fat cells, which leads to the activation of lipolysis. However, due to an increase in the secretion of insulin, lipogenesis is stimulated, which leads to the accumulation of fat.

Has a catabolic effect in lymphoid and connective tissue, muscles, adipose tissue, leather, bone tissue. To a lesser extent than mineralocorticoids, affects the processes of water and electrolyte metabolism: contributes to the removal of potassium and calcium ions, delay in sodium and water ions. Osteoporosis and Itsenco Cushing syndrome are the main factors limiting the long-lasting GKS therapy. As a result of catabolic action, it is possible to suppress growth in children.

In high doses, hydrocortisone can increase the excitability of brain tissues and contributes to a decrease in the threshold of convulsive readiness. Stimulates excess production of hydrochloric acid and pepsin in the stomach, which contributes to the development of peptic ulcers.

With systemic use, the therapeutic activity of the hydrocortisone is due to anti-inflammatory, anti-allergic, immunosuppressive and antiproliferative effect.

In the external and local application, the therapeutic activity of the hydrocortisone is due to anti-inflammatory, anti-allergic and anti-acudative (thanks to the vasoconstrictor effect) action.

According to anti-inflammatory activity, 4 times weaker prednisolone, in mineralocuticoid activity, exceeds the other GKS.

Indications

For parenteral applications: acute adrenal insufficiency, allergic reactions of immediate type, asthmatic status, prevention and treatment of shock, myocardial infarction, complicated with cardiogenic shock, thyrotoxic crisis, thyroiditis, congenital adrenal hyperplasia, hypercalcemia due to tumor disease, short or additional therapy in the acute period of rheumatic diseases, collagen diseases, bubble, bullous herpetyiform dermatitis (Durring disease), polymorphic bullous erythema, exfoliative dermatitis, mushroom micaosis, heavy forms of psoriasis and seborrheic dermatitis, heavy sharp and chronic allergic and inflammatory processes with eye damage, symptomatic sarcoidosis, lefball syndrome, not amenable to other types of therapy, beryllium, focal or Disseminated form of tuberculosis with simultaneous anti-tuberculosis chemotherapy, aspiration pneumonitis, idiopathic thrombocytopenic purple of adults (only in / B!), Secondary thrombocytopenia of adults, acquired (autoimmune) hemolytic anemia, erythroblasting, congenital (erythroid) hypoplastic anemia, palliative therapy for leukemia and lymphomes of adults , P. acute leukemia in children, to enhance the diurea or to reduce proteinuria in nephrotic syndrome without uremia, with an nephrotic syndrome of idiopathic type or with a red lolly, in the critical stage of ulcerative colitis and regional regional enteritis (as systemic treatment), tuberculosis Meningitis With the development of the subarachnoid block or with its threat (in combination with anti-tuberculosis chemotherapy), trichinosis with defeat nervous system or myocardial bronchial asthma, diseases of the joints.

For local applications: Inflammation of the Front Department eyeball With the naked corneal epithelium and after injury and surgical interventions on the eyeball.

For outdoor use: allergic dermatitisSeborrhea, various forms of eczema, neurodermatitis, psoriasis, scratch, red flat warthy deprived.

Dosing mode

For parenteral use. Dosing mode individual. Apply in / in the stroke, in / in drip, rarely - in / m. For urgent therapy, it is recommended to / in the introduction. The initial dose is 100 mg (introduced in 30 seconds) - 500 mg (introduced in 10 minutes), then repeated every 2-6 hours, depending on the clinical situation. High doses should be applied only before stabilizing the state of the patient, but usually not more than 48-72 hours, since It is possible to develop hypernatremia. Children - at least 25 mg / kg / day. In the form of a depot-shape, administered intra- or periarticular at a dose of 5-50 mg once with an interval of 1-3 weeks. In / m - 125-250 mg / day.

In ophthalmology, use 2-3 times / day.

Externally - 1-3 times / day.

Side effect

From the endocrine system: Reducing glucose tolerance, steroid diabetes or manifestation of latent diabetes mellitus, inhibition of adrenal functions, Izsenko-Cushing syndrome (including moon-shaped face, hypophized obesity, hirsutism, increase blood pressure, dysmenorrhea, amenorrhea, miastic, strry), delay sexual development in children.

From the metabolism: increased elimination of calcium ions, hypocalcemia, body weight increase, negative nitrate balance (increased disintegration of proteins), increased sweating, fluid delay and sodium ions (peripheral swelling), hypernatraemia, hypokalemic syndrome (including hypokalemia, arrhythmia, myalgia or muscle spasm, unusual weakness and fatigue).

From the CNS: Delium, disorientation, euphoria, hallucinations, manico-depressive psychosis, depression, paranoia, increase intracranial pressure, nervousness or anxiety, insomnia, dizziness, vertigo, pseudo-turn cerebellum, headache, cramps.

From side of cardio-vascular system: arrhythmias, bradycardia (up to a heart stop); Development (in predisposed patients) or enhancing the severity of chronic heart failure, changes in ECG, characteristic of hypokalemia, increased blood pressure, hypercoagulation, thrombosis. In patients with sharp and subacted myocardial infarction - the spread of the focus of necrosis, slowing down the formation of scar tissue, which can lead to a rupture of the heart muscle; In case of intracranial administration - nasal bleeding.

From side digestive system: nausea, vomiting, pancreatitis, steroid ulcer of the stomach and duodenal intestine, erosive esophagitis, bleeding and perforation of the gastrointestinal tract, increase or decreased appetite, meteorism, okota; Rarely - increasing the activity of hepatic transaminases and SFF.

From the senses: Sudden loss of vision (with parenteral administration in the head, neck, nose shells, head of the head is possible deposition of drug crystals in eye vessels), rear subcapsular cataracts, increasing intraocular pressure with possible damage to the optic nerve, tendency to the development of secondary bacterial, fungal or viral infections Eye, trophic changes of the cornea, Exophthalm.

On the side of the musculoskeletal system: slowdown in the growth and processes of infiltration in children (premature closure of epiphyseal growth zones), osteoporosis (very rarely - pathological fractures of bones, aseptic necrosis of the head of the shoulder and femoral bone), rupture of muscle tendons, steroid myopathy, decline muscular mass (Atrophy; at intra-articular administration - enhancing pain in the joint .

Dermatological reactions: Slowed healing of wounds, petechia, ekkimosis, skin thinning, hyper- or hypopigmentation, steroid eels, strry, tendency to the development of pyodermia and candidiasis.

Allergic reactions: generalized (including skin rash, itching of the skin, anaphylactic shock), local allergic reactions.

Effects caused by immunosuppressive action: Development or aggravation of infections (jointly used immunosuppressants and vaccination) are promoted by the appearance of this side effect).

Local reactions: in parenteral administration - burning, numbness, pain, paresthesia and infections at the injection site, rarely - necrosis of the surrounding tissues, the formation of scars at the injection site; With a / m administration (especially in the deltoid muscle) - skin atrophy and subcutaneous fiber.

Others: Leukocyturia, cancellation syndrome.

When in / in the introduction of arrhythmias, the "tides" of the blood to the face, convulsions.

With outdoor use: rarely - itching, hyperemia, burning, dry, folliculitis, acne, Hypopigmentation, perioreral dermatitis, allergic dermatitis, skin maceration, secondary infection, skin atrophy, Strya, Pader. With prolonged use or application to extensive areas, the development of system side effects characteristic of GCS is possible.

Contraindications

For short-term use on life indications - increased sensitivity to hydrocortisone.

For intra-articular administration and administration directly into the lesion center: preceding arthroplasty, pathological bleeding (endogenous or caused by the use of anticoagulants), intra-art bone fracture, infectious (septic) inflammatory process in the joint and periarticular infections (including in history), as well as the general infection, lack of signs of inflammation in the joint ("dry" joint, for example, with osteoarthritis without synovitis), pronounced bone destruction and joint deformation (sharp narrowing of the articular gap, ankylosis), joint instability as an outcome of arthritis, aseptic necrosis forming bone epiphysis .

For outdoor use: Bacterial, viral, fungal skin disease, skin tuberculosis, skin manifestations of syphilis, skin tumors, post-specific period, integrity disorder skin Pokrov (ulcers, wounds), childhood (up to 2 years, with itching in the field of anus - up to 12 years old), Rosacea, vulgar acne, perioreral dermatitis.

For use in ophthalmology: Bacterial, viral, fungal eye diseases, tuberculous eye damage, trachom, violation of the integrity of the eye epithelium.

Pregnancy and lactation

Application during pregnancy is possible only when the estimated benefit for the mother exceeds the potential risk to the fetus; It is recommended to use minimum doses and short-term therapy. Children whose mother in pregnancy received hydrocortisone is subject to careful observation to identify signs of lack of adrenal cortex.

If you need to use during the lactation period, it is necessary to resolve the issue of cessation of breastfeeding.

IN experimental studies It is shown that the GCS can cause disruption of the development of the fetus. Currently, there is no clear confirmation of this data in humans.

Application with violations of liver function

With caution to apply with severe liver failure.

Application with violations of the kidney function

With caution to apply with severe chronic renal failure.

Application for children

Contraindications for outdoor use: Children's age up to 2 years, with itching in the area of \u200b\u200bthe anus - up to 12 years.

special instructions

With caution, apply for 8 weeks before and 2 weeks after vaccination, with lymphadenitis after the BCG vaccination, during immunodeficiency states (including AIDS or HIV infection).

With caution to apply with gastrointestinal diseases: peptic disease Stomach and duodenum, esophagitis, gastritis, acute or latent peptic ulcers, recently created intestinal anastomose, nonspecific ulcerative colitis With the threat of perforation or abscess, diverticulite.

With caution to apply in diseases of the cardiovascular system, incl. After the myocardial infarction recently suffered (in patients with acute and subacted myocardial infarction, it is possible to spread the focus of necrosis, slowing the formation of scar tissue and as a result of this, the gap of the heart muscle), with decompensited chronic heart failure, arterial hypertension, hyperlipidemia), endocrine diseases - diabetes mellitus (including violations of tolerance to carbohydrates), thyrotoxicosis, hypothyroidism, diseases of itezo-cushin, with severe chronic renal and / or hepatic insufficiency, nephrowolithiasis, with hypoalbuminemia and states predisposing to its occurrence, with systemic osteoporosis, Miasthenia, acute psychosis, obesity (III-IV degree), with polio (with the exception of the shape of bulbar encephalitis), open and clotted glaucoma, pregnancy, lactation.

If it is necessary to use intra-articular administration to be used in patients with a general difficult condition, inefficiency (or short-term) actions of 2 previous administrations (taking into account the individual properties of the GKS).

With insufficient efficacy of the hydrocortisone for 48-72 hours and the need for longer therapy is advisable to replace the hydrocortisone to another glucocorticoid preparation, not causing sodium delays in the body. During treatment with hydrocortisone, it is recommended to assign a diet with sodium limit and increased potassium content.

A relative adrenal insufficiency caused by hydrocortisone can persist within a few months after its cancellation. Considering this, with stressful situations arising within the specified period, hormonal therapy resumes simultaneously appointing salts and / or mineralocorticoids.

In patients with an active form of tuberculosis, hydrocortisone should be used in combination with the corresponding anti-tuberculosis therapy. With the latent form of tuberculosis or in a period of viysray of tuberculin samples, the patient's condition should be carefully monitored, and if necessary, carry out chemoprophylaxis.

Medicinal interaction

With simultaneous use, hydrocortisone increases the toxicity of cardiac glycosides (due to emerging hypokalemia, the risk of developing arrhythmias increases); with acetylsalicylic acid - accelerates its removal and reduces its concentration in the blood plasma (with the abolition of hydrocortisone, the concentration of salicylates in the blood increases and the risk of developing side effects) is increasing); with paracetamol - an increase in the risk of developing the hepatotoxic effect of paracetamol (induction of hepatic enzymes and the formation of toxic paracetamol metabolite); with cyclosporin - the strengthening of the side effects of the hydrocortisone due to the oppression of its metabolism; With ketoconazole - enhance the side effects of the hydrocortisone due to the decline in its clearance.

Hydrocortisone reduces the effectiveness of hypoglycemic agents; Enhances the effect of indirect anticoagulants of Cumarine derivatives.

Hydrocortisone reduces the effect of vitamin D to the absorption of calcium ions in the intestinal lumen. Ergocalciferol and pararathgamon prevent the development of osteopathy caused by GKS.

Hydrocortisis enhances the metabolism of isoniazide, Mexyleletine (especially in "fast acetyluoris"), which leads to a decrease in their plasma concentrations; increases (with long therapy) content folic acid; Reduces the concentration of the prazicvantel in the blood.

Hydrocortisone in high doses reduces the effect of somatropin.

Hypokalemia caused by GKS may increase the severity and duration of muscle blockade against the background of the muscle relaxants.

Antacids reduce GCS absorption.

With simultaneous use with GKS thiazide diuretics, carbonic henchridez inhibitors, other GKS, amphotericin in raising the risk of hypokalemia, preparations containing sodium ions - swelling and increase blood pressure.

NSAIDs and ethanol increase the risk of developing the ulceration of the mucous membrane of the tract and bleeding mucous membrane, in combination with NSAIDs for the treatment of arthritis it is possible to reduce the dose of GCS due to the sum of the therapeutic effect. Indomethacin, displacing the GKS from communication with albumin, increases the risk of developing its side effects.

Amphotericin in and carboanhydrase inhibitors increase the risk of osteoporosis.

The therapeutic effect of GKS is decreasing under the influence of inductors of microsomal liver enzymes (including phenyotine, barbiturates, ephedrine, theophylline, rifampicin) due to the increase in the metabolic rate of these substances.

Inhibitors of the function of the adrenal cortex (including mitanka) can determine the need to increase the dose of GKS.

GKS clearance increases against the background of thyroid hormone preparations.

Immunosuppressants increase the risk of developing infections and lymphoma or other lymphoproliferative violations related to Epstein-Barra virus.

Estrogens (including oral estrogen-containing contraceptives) reduce GCS clearance, lengthen T 1/2 and their therapeutic and toxic effects. The appearance of hirsutism and eels contributes to the simultaneous use of other steroid hormonal products - androgen, estrogen, anabolics, oral contraceptives.

Tricyclic antidepressants can enhance the severity of depression caused by the GCS reception (not shown for therapy of the side effects).

The risk of cataract development increases when applied against the background of other GCS, antipsychotic means (neuroleptics), carbututamide and azatiotric. Simultaneous purpose with m-cholinoblocators, as well as with means with M-choline-blocking effects (including antihistamines, tricyclic antidepressants), with nitrates contributes to an increase in intraocular pressure.

With the simultaneous use of GKS with alive antiviral vaccines and against the background of other types of immunization, the risk of virus activation and the development of infections increases.

Dosage form"Type \u003d" Checkbox "\u003e

Dosage form

Suspension for injection 2.5% 2 ml

Structure

1 ml of suspension contains

active substance - hydrocortisone acetate in recalculation by 100% dry substance 25 mg

auxiliary substances: propylene glycol, sorbitol (E 420), Pisidone, sodium chloride, alcohol benzyl, water for injection.

Description

The drug after stamping for 2 minutes is a white or white suspension with a yellowish colors, which is settled, with a specific odor

Pharmacotherapeutic group

Corticosteroids for system use. Glucocorticosteroids. Hydrocortisone.

ATH code H02AB09

Pharmacological properties

Pharmacokinetics

Hydrocortisone, which is applied locally, can be absorbed and manifesting a systematic action. Comparatively slowly absorbed from the place of administration. Up to 90% of the drug binds to blood proteins (with translastin - 80%, with albumin - 10%), about 10% is a free fraction. Metabolism is carried out in the liver. Unlike synthetic derivatives, a slight amount of the drug penetrates through the placenta (up to 67% collapsed in the placenta itself to inactive metabolites). The metabolites of the hydrocortisone are removed mainly by the kidneys.

Pharmacodynamics

Hydrocortisone acetate refers to a group of glucocorticosteroids of natural origin. It has anti-shock, antitoxic, immunosuppressive, anti-acudative, anti-dishortonic, anti-inflammatory, desensitizing effect. Throws the reaction of hypersensitivity, proliferative and exudative processes in the focus of inflammation. The action of acetate hydrocortisone is indiscriminated through specific intracellular receptors. Anti-inflammatory effect is based on the braking of all phases of inflammation: stabilization of cellular and subcellular membranes, reducing the release of proteolytic enzymes from lysosomes, braking the formation of superoxide anion and other free radicals. Hydrocortisone slows down the release of inflammation mediators, including interleukin-1 (IL-1), histamine, serotonin, bradykinin, etc., reduces the release of arachidonic acid from phospholipids and synthesis of prostaglandins, leukotrienes, thromboxane. Reduces inflammatory cell infiltrates, reduces the migration of leukocytes and lymphocytes to the focus of inflammation. Inhibits the connective tissue reactions during the inflammatory process and reduces the intensity of the formation of scar tissue. Reduces the amount of fat cells that produce hyaluronic acid, inhibits the activity of hyaluronidase and helps to reduce the permeability of capillaries. Inhibits the products of collagenase and activates the synthesis of protease inhibitors. Reduces the synthesis and enhances the catabolism of proteins in muscle tissue. Stimulating steroid receptors, induces the formation of a special class of proteins - lipocortins, which are inherent in the opposite effect. It has a conjunctional effect, increasing the level of glycogen in the liver and causing the development of hyperglycemia. It delays sodium and water in the body, while increasing the volume of circulating blood and increasing blood pressure (anti-shock action).

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

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

Indications for use

Osteoarthritis

Different monorarrosis (knee, elbow, hip joints)

Rheumatoid arthritis and arthritis of another origin (with the exception of tuberculosis and gonorrheal arthritis)

ShoulderPath Periatritis, Bursitis, Epocondyl, Tendovaginitis

Before surgery on the ankylothic joints

As a local addition to systemic corticosteroid therapy

Method of application and dose

Before use, the contents of the ampoules shake up to the formation of a homogeneous suspension.

Adults and children over 14 years old: motherwise dose It depends on the size of the joint and on the severity of the disease - 5-50 mg of hydrocortisone intracertically and periarticularly.

For 24 hours, adults can be injected at no more than three joints.

Children from 3 years: one-time dose of hydrocortisone depends on the size of the joint and on the severity of the disease - 5-30 mg intrautricly and periarticular.

The healing effect at intra-articular administration of the drug occurs for 6-24 hours and is saved from several days to several weeks. Repeated administration of the drug is possible after 3 weeks.

The drug cannot be administered directly to the tendon, so when trendy the drug must be administered to a tendon vagina.

The drug cannot be used for systemic corticosteroid therapy.

Side effects

Fabric swelling and pain in the injection site

Slowing Wound Healing, Skin Atrophy, Stria, Aknee-like rash, itching, folliculitis, girsutism, hypopigmentation

Dry, thinning and increased skin sensitivity, teleangectasy

With prolonged use of the drug may occur side effectsassociated with the system action of corticosteroid:

Reduction of glucose tolerance and an increase in the need for an antidiabetic preparation, latent diabetes manifestation, steroid diabetes mellitus, oppression of adrenal functions, Izsenko-Cushing syndrome, growth delay and sexual development in children and adolescents, impaired menstrual cycle

Nausea, vomiting, pancreatitis, peptic ulcer, esophagitis, bleeding and perforation of the gastrointestinal tract, rise of appetite, meteorism, IKOT

In rare cases

Improving the activity of hepatic transaminases and alkaline phosphatase

For large doses of hydrocortisone: increased blood pressure, hypokalemia and inherent ECG changes, thromboembolism, heart failure

Insomnia, irritability, excitement, euphoria, epileptiform convulsions, mental disorders, delirium, disorientation, hallucinations, manico-depressive psychosis, depression, paranoia, increase in intracranial pressure with electoral pane

Increased elimination of potassium, hypokalemia, body weight increase, negative nitrogenous balance, reinforced sweating

The ulceration of the cornea, the rear capsular cataract (more likely in children), an increase in intraocular pressure with possible damage to the optic nerve, secondary bacterial fungal and viral eye infections, trophic changes of the cornea, Exophthalm, glaucoma

Slowdown in the growth and processes of ossification in children (premature closure of epiphyseal growth zones), osteoporosis

Liquid and sodium delay with peripheral edema, hypernatremia, hypokalemic syndrome (hypokalemia, arrhythmia, Malgy, muscle spasm, increased weakness, fatigue), hypokalemic alkalosis

Opportunistic infections, aggravation of latent tuberculosis, increased sensitivity reactions; Local and generalized: skin rash, anaphylaitical shock, tendency to the development of pyodermia and candidiasis, exacerbation of infections, especially during vaccination and simultaneous treatment with immunosuppressive means

Necrosis of the surrounding tissues, the formation of scars at the injection site

Rarely

Pathological fractures of bones, aseptic necrosis heads of the shoulder and femoral bone, breaking tendons and muscles, steroid myopathy, reduced muscle mass, arthralgia

In the elderly, the side effects of corticosteroids can manifest more intensively.

Contraindications

Increased sensitivity to active substances or any of the aids of the drug

Infected joint

Gastric ulcer and duodenal ulcer

Thrombophlebitis and thromboembolic phenomena

Epilepsy, mental illness

Heavy Forms of Arterial Hypertension, Cardiac Decompensation, Acute Endocarditis

Osteoporosis

Pregnancy and lactation period

Sugar diabetes, Itsenko-Cushing syndrome

Active forms of tuberculosis, AIDS

Systemic fungal diseases

Acute infectious diseases

Treatment of Achilles Tendonia

Renal failure

Vaccination period

Children's age up to 3 years

Medicinal interactions

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

It must be careful while simultaneously intended:

With barbiturates, phenylbutazone, phenytio 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 (amplification or weakening of the anticoagulant effect);

With salicylate (can reduce the level of salicylates in plasma, there are hidden gastrointestinal bleeding or the possibility of the appearance of an ulcer);

With amphotericin, diuretics, theophylline, cardiac glycosides (increases the risk of hypokalemia);

With oral contraceptives (the concentration of corticosteroids in the blood increases);

With antihypertensive means (corticosteroids reduce the effectiveness of antihypertensive agents);

With Mefipriston (the effectiveness of corticosteroids is reduced).

special instructions"Type \u003d" Checkbox "\u003e

special instructions

Intrautically entered corticosteroid can increase the ability to resume inflammatory processes. The drug can provoke a bacterial joint infection, so hydrocortisone acetate can only be administered under aseptic conditions.

During treatment with hydrocortisone, it is impossible to vaccinate due to the high risk of development of neurological complications and oppression of antibody formation.

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

The introduction of generally accepted and high doses of corticosteroids can cause an increase in blood pressure, enhance the sodium delay and water in the body and stimulate the release of potassium from the body. All corticosteroids enhance the elimination of calcium from the body.

With hidden tuberculosis, it can be used only with tuberculostatic means.

In case of infectious diseases, apply with caution and only together with specific antibacterial therapy.

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

Electrolyte exchange in the body with the simultaneous use of diuretic means should be monitored.

With long-term use, potassium preparations should be additionally prescribed for hypokalemia prevention.

In children's and adolescence, it should be used the drug by a shorter course in the lowest efficient dosage due to the possibility of growth delay.

1 ml - ampoules (10) - packs cardboard.
1 ml - ampoules (5) - Packaging cell contour (2) - packs cardboard.
1 ml - ampoules (5) - Packaging cell contour (5) - Cardboard packs.

pharmachologic effect

The hydrocortisone suppresses the release of the ACTH and β-lipotropine hypophysia, but does not reduce the level of circulating β-endorphine. Inhibits the secretion of TSH and FSH.

With direct appliqués on the vessels has a vasoconstrictor effect.

Hydrocortisone has a pronounced dose-dependent effect on the metabolism of carbohydrates, proteins and fats. Stimulates glukegenesis, promotes the seizure of amino acids with liver and kidneys and increases the activity of glukegenesis enzymes. In the liver, hydrocortisone enhances the deposit of glycogen, stimulating the activity of glycogenacenthasis and the synthesis of protein exchange products. Increased blood glucose content activates insulin allocation.

It has a catabolic effect in lymphoid and connective tissue, muscles, adipose tissue, leather, bone tissue. To a lesser extent than mineralocorticoids, affects the processes of water and electrolyte metabolism: contributes to the removal of potassium and calcium ions, delay in sodium and water ions. Osteoporosis and Itsenco Cushing syndrome are the main factors limiting the long-lasting GKS therapy. As a result of catabolic action, it is possible to suppress growth in children.

With systemic use, the therapeutic activity of the hydrocortisone is due to anti-inflammatory, immunosuppressive and antiproliferative effect.

In the external and local application, the therapeutic activity of the hydrocortisone is due to anti-inflammatory, anti-allergic and anti-acudative (thanks to the vasoconstrictor effect) action.

According to anti-inflammatory activity, 4 times weaker than mineralocorticoid activity exceeds the other GKS.

Pharmacokinetics

Binding with plasma proteins is 40-90%. Metabolized mainly in the liver. T 1/2 - 80-120 min. Examined by the kidneys mainly in the form of metabolites.

Indications

For parenteral applications: acute adrenal insufficiency, allergic reactions of immediate type, asthmatic status, prevention and treatment of shock, myocardial infarction, complicated with cardiogenic shock, thyrotoxic crisis, thyroiditis, congenital adrenal hyperplasia, hypercalcemia due to tumor disease, short or additional therapy in the acute period of rheumatic diseases, collagen diseases, bubble, bullous herpetyiform dermatitis (Durring disease), polymorphic bullous erythema, exfoliative dermatitis, mushroom micaosis, heavy forms of psoriasis and seborrheic dermatitis, severe acute and chronic allergic and inflammatory processes with eye damage, symptomatic sarcoidosis, Lefeler syndrome, non-other treatment, beryllium, focal or disseminated form of tuberculosis with simultaneous anti-tuberculous chemotherapy, aspiration pneumonitis, idiopathic thrombocytopenic purple adults (only in / in!), secondary thrombocytopenia of adults, acquired (autoimmune) hemolytic anemia, erythrobustopian, congenital (erythroid) hypoplastic anemia, palliative therapy for leukemia and lymphomes of adults, with acute leukemia in children, to enhance diuresis or to reduce proteinuria with nephrotic syndrome without Uremia , with an nephrotic syndrome of idiopathic type or with a red lolly, in the critical stage of ulcerative colitis and regional regional enteritis (as systemic treatment), tuberculous meningitis with the development of the subarachnoid block or with its threat (in combination with anti-tuberculosis chemotherapy), trichinosis with the damage to the nervous system or Myocardial, bronchial asthma, diseases of the joints.

For local applications: Inflammation of the front department of the eyeball with the undistuted corneal epithelium and after injuries and surgical interventions on the eyeball.

For outdoor use: Allergic dermatitis, seborrhea, various forms of eczema, neurodermatitis, psoriasis, scratch, red flat warthy deprived.

Contraindications

For short-term use on life indications - increased sensitivity to hydrocortisone.

For intra-articular administration and administration directly into the lesion center: preceding arthroplasty, pathological bleeding (endogenous or caused by the use of anticoagulants), intra-articular bone fracture, infectious (septic) inflammatory process in the joint and periarticular infections (including in history), as well as a general infectious disease, pronounced osteoporosis, lack of signs Inflammation in the joint ("dry" joint, for example, with osteoarthritis without synovitis), pronounced bone destruction and deformation of the joint (sharp narrowing of the joint gap, ankylosis), the unstability of the joint as the outcome of arthritis, the aseptic necrosis forming the joint epiphysis bones.

For outdoor use: Bacterial, viral, fungal skin diseases, skin tuberculosis, skin manifestations of syphilis, leather tumors, post-calibration, impaired integrity of the skin (ulcers, wounds), children's age (up to 2 years old, with an anus area - up to 12 years old), Rosacea , vulgar acne, perioreral dermatitis.

For use in ophthalmology: Bacterial, viral, fungal eye diseases, tuberculous eye damage, trachom, violation of the integrity of the eye epithelium.

Dosage

In ophthalmology, use 2-3 times / day.

Externally - 1-3 times / day.

Side effects

From the metabolism: Increased elimination of calcium ions, hypocalcemia, body weight increase, negative nitrogen balance (increased protein decay), increased sweating, fluid delay and sodium ions (peripheral swelling), hypernatremia, hypokalemic syndrome (including hypokalemia, arrhythmia, myalgia or spasm muscles, unusual weakness and fatigue).

From the CNS: Delium, disorientation, euphoria, hallucinations, manic-depressive psychosis, depression, paranoia, increasing intracranial pressure, nervousness or anxiety, insomnia, dizziness, vertigo, pseudogo cerebellum, headache, convulsions.

From the side of the cardiovascular system: arrhythmias, bradycardia (up to a heart stop); Development (in predisposed patients) or enhancing the severity of chronic heart failure, changes in ECG, characteristic of hypokalemia, increased blood pressure, hypercoagulation, thrombosis. In patients with sharp and subacted myocardial infarction - the spread of the focus of necrosis, slowing down the formation of scar tissue, which can lead to a rupture of the heart muscle; In case of intracranial administration - nasal bleeding.

From the digestive system: nausea, vomiting, pancreatitis, steroid ulcer of the stomach and duodenal intestine, erosive esophagitis, bleeding and perforation of the gastrointestinal tract, increase or decreased appetite, meteorism, okota; Rarely - increasing the activity of hepatic transaminases and SFF.

From the senses: Sudden loss of vision (with parenteral administration in the head, neck, nasal shells, scalp skin is possible deposition of drug crystals in eye vessels), rear subcapsular cataract, increase intraocular pressure with possible damage to the optic nerve, tendency to the development of secondary bacterial, fungal or viral infections Eye, trophic changes of the cornea, Exophthalm.

On the side of the musculoskeletal system: The slowdown in the growth and processes of infiltration in children (premature closure of epiphyseal growth zones), osteoporosis (very rarely pathological fractures of bones, aseptic necrosis of the head of the shoulder and femur), the gap of the tendons of muscles, steroid myopathy, a decrease in muscle mass (atrophy; at intravantic administration - Strengthening pain in the joint .

Dermatological reactions: Slowed healing of wounds, petechia, ekkimosis, skin thinning, hyper- or hypopigmentation, steroid eels, strry, tendency to the development of pyodermia and candidiasis.

Allergic reactions: generalized (including skin rash, itching of the skin, anaphylactic shock), local allergic reactions.

Effects caused by immunosuppressive action: Development or aggravation of infections (jointly used immunosuppressants and vaccination) are promoted by the appearance of this side effect).

Others: Leukocyturia, cancellation syndrome.

When in / in the introduction of arrhythmias, the "tides" of the blood to the face, convulsions.

With outdoor use: Rarely - itching, hyperemia, burning, dryness, folliculitis, acne rash, hypopigmentation, perioreral dermatitis, allergic dermatitis, skin maceration, secondary infection, skin atrophy, Strya, Pader. With prolonged use or application to extensive areas, the development of system side effects characteristic of GCS is possible.

Medicinal interaction

With simultaneous use, hydrocortisone increases the toxicity of cardiac glycosides (due to emerging hypokalemia, the risk of developing arrhythmias increases); C - accelerates its removal and reduces its concentration in the blood plasma (with the abolition of hydrocortisone, the concentration of salicylates in the blood increases and the risk of developing side effects is increasing); with paracetamol - an increase in the risk of developing the hepatotoxic effect of paracetamol (induction of hepatic enzymes and the formation of toxic paracetamol metabolite); with cyclosporin - the strengthening of the side effects of the hydrocortisone due to the oppression of its metabolism; With ketoconazole - enhance the side effects of the hydrocortisone due to the decline in its clearance.

Hydrocortisone reduces the effectiveness of hypoglycemic agents; Enhances the effect of indirect anticoagulants of Cumarine derivatives.

Hydrocortisone reduces the effect of vitamin D to the absorption of calcium ions in the intestinal lumen. Ergocalciferol and pararathgamon prevent the development of osteopathy caused by GKS.

Hydrocortisis enhances the metabolism of isoniazide, Mexyleletine (especially in "fast acetyluoris"), which leads to a decrease in their plasma concentrations; increases (with long therapy) content; Reduces the concentration of the prazicvantel in the blood.

Hydrocortisone in high doses reduces the effect of somatropin.

Hypokalemia caused by GKS may increase the severity and duration of muscle blockade against the background of the muscle relaxants.

Antacids reduce GCS absorption.

With the simultaneous use with GCS thiazide diuretics, carbonic henhydrate inhibitors, other GKS, increase the risk of hypokalemia, preparations containing sodium ions - swelling and increase blood pressure.

Amphotericin in and carboanhydrase inhibitors increase the risk of osteoporosis.

Inhibitors of the function of the adrenal cortex (including mitanka) can determine the need to increase the dose of GKS.

GKS clearance increases against the background of thyroid hormone preparations.

Immunosuppressants increase the risk of developing infections and lymphoma or other lymphoproliferative violations associated with Epstein-Barr virus.

Tricyclic antidepressants can enhance the severity of depression caused by the GCS reception (not shown for therapy of the side effects).

The risk of cataract development increases when applied against the background of other GCS, antipsychotic means (neuroleptics), carbututamide and azatiotric. Simultaneous administration with M-cholinoblockers, as well as with means with a M-choline-blocking effect (including antihistamine preparations, tricyclic antidepressants), with nitrates contributes to an increase in intraocular pressure.

With the simultaneous use of GKS with alive antiviral vaccines and against the background of other types of immunization, the risk of virus activation and the development of infections increases.

special instructions

With caution, apply for 8 weeks before and 2 weeks after vaccination, with lymphadenitis after the BCG vaccination, during immunodeficiency states (including AIDS or HIV infection).

With caution to apply in diseases of the gastrointestinal tract: ulcerative diseases of the stomach and duodenum, esophagite, gastritis, acute or latent peptic peptic ulcers, recently created intestinal anastomose, nonspecific ulcerative colitis with a threat of perforation or abscess, diverticulite.

With caution to apply in diseases of the cardiovascular system, incl. After a recently suffered myocardial infarction (in patients with acute and subacted myocardial infarction, it is possible to spread the focus of necrosis, a slowdown in the formation of scar tissue and, as a result of this, the gap of the heart muscle), with decompensited chronic heart failure, arterial hypertension, hyperlipidemia), with endocrine diseases - diabetes mellitus ( In addition, violations of carbohydrate tolerance), thyrotoxicosis, hypothyroidism, itezo-kushing disease, with severe chronic renal and / or hepatic insufficiency, nephrowolithiasis, with hypoalbuminemia and states predisposing to its occurrence, with systemic osteoporosis, myasthenia, acute psychosis , obesity (III-IV degree), with polio (except for the shape of bulbar encephalitis), open and closed-coronal glaucoma, pregnancy, lactation.

Pregnancy and lactation

If you need to use during the lactation period, it is necessary to resolve the issue of cessation of breastfeeding.

Hydrocortisone acetaterefers to a group of GCS of natural origin, which has anti-shock, antitoxic, immuncurative, anti-essamentative, antiallergic, anti-inflammatory, desensitizing effect.
Throws the reaction of hypersensitivity, proliferative and exudative processes in the focus of inflammation. The action of acetate hydrocortisone is indiscriminated through specific intracellular receptors. The anti-inflammatory effect consists in braking of all phases of inflammation: stabilization of cellular and subcellular membranes, reducing the release of proteolytic enzymes with lysosomes, braking the formation of superoxide anion and other free radicals. Hydrocortisone slows down the release of inflammation mediators, including interleukin-1 (IL-1), histamine, serotonin, bradykinin, reduces the release of arachidonic acid from phospholipids and synthesis of prostaglandins, leukotrienes, thrombooxane. Reduces inflammatory cell infiltrates, reduces the migration of leukocytes and lymphocytes to the focus of inflammation. Inhibits the connective tissue reactions during the inflammatory process and reduces the intensity of the formation of scar tissue. Reduces the amount of fat cells producing hyaluronic acid suppresses the activity of hyaluronidase and helps to reduce the permeability of capillaries. It slows down the production of collagenase and activates the synthesis of protease inhibitors. Reduces the synthesis and enhances the catabolism of proteins in muscle tissue. Stimulating steroid receptors, induces the formation of a special class of proteins - lipocortins, which have an anti-ethnic effect. It has conjunral action, increasing the level of glycogen in the liver and leads to the development of hyperglycemia. It delays sodium and water in the body, while increasing the volume of circulating blood and increasing blood pressure (anti-turn action). Stimulates the removal of potassium, reduces calcium absorption from the digestive tract, reduces the mineralization of bone tissue.
Like other glucocorticoids, hydrocortisone reduces the amount 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 locally, can be absorbed and manifesting a systematic action. Comparatively slowly absorbed from the place of administration. Up to 90% of the drug is associated with blood proteins (translastin - 80%, with albumin - 10%), about 10% is a free fraction. Metabolism is carried out in the liver. Unlike synthetic derivatives, a slight amount of the drug penetrates through the placenta (up to 67% collapsed in the placenta itself to inactive metabolites). The metabolites of the hydrocortisone are removed mainly by the kidneys.

Indications for use

Indications for the use of the drug Hydrocortisone acetateare:
- osteoarthritis, various monorarrosis (knee, elbow, hip joints), rheumatoid arthritis and arthritis of other origin (with the exception of tuberculous and hymealic arthritis). Shoulder-painting periatritis, bursitis, epicondylitis, tendovaginitis.
- Before surgery on the ankylotic joints.
- as a local addition to systemic GKS therapy.

Mode of application

Before use Hydrocortisone acetatethe contents of the ampoule shake before the formation of a homogeneous suspension.
Adults and children over 14 years old one-time dose, depending on the size of the joint and gravity of the disease - 5-50 mg of hydrocortisone intracertically and periarticular.
For 24 hours, adults can be injected at no more than three joints.
Children: a single dose of hydrocortisone, depending on the size of the joint and the severity of the disease - 5-30 mg intrautricly and periarticular.
The healing effect at the intra-articular administration of the drug occurs within 6-24 hours and is saved from several days to several weeks. Repeated administration of the drug is possible after 3 weeks.
The drug cannot be administered directly into the tendon, so the preparation should be administered to the tendon vagina.
The drug cannot be used for systemic GKS therapy.
Children. For the treatment of children, the drug is applied only in absolute indications.

Side effects

The adverse reactions below are typical of all system corticosteroids. Their inclusion in this list does not necessarily mean that a particular phenomenon was observed when this particular dosage form was applied.
Violation of laboratory and instrumental indicators: after treatment with corticosteroids, an increase in the level of Alat (ALT, SGPT), aspartattransaminase (AST, SGOT) and alkaline phosphatase, was observed.

Usually these changes are small, they are not associated with any clinical syndrome and are reversible after discontinuation of treatment. Increase intraocular pressure. Reducing carbohydrate tolerance, increasing the need for insulin or oral anti-diabetic means for diabetes mellitus. Negative nitrous balance due to catabolism proteins. Raising or reduced mobility and quantity of spermatozoa.
From metabolism and nutrition: sodium delay, fluid delay, loss of potassium, hypokalemic alkalosis, an increase in calcium excretion, an increase in appetite, abnormal fat deposits, an increase in body weight.
Hearts: Bradycardia, Heart Stop, Heart Rhythm Disorders, Expanding Heart Borders, Hypertrophic Cardiomyopathy, Light, Synch Elevators, Tachycardia. Stagnant heart failure in susceptible patients.
Vascular disorders: petechia and ekchimosis, bruises, arterial hypertension, vascular collapse, fat embolism, a myocardial break after a recently suffered myocardial infarction, thromboembolism, thrombophlebitis, vasculitis.
From the side of the skin and subcutaneous tissue: urticaria, acne, allergic dermatitis, skin and subcutaneous atrophy, thin weak skin, dryness and peeling of the skin, swelling, erythema, hyperpigmentation, hypopigmentation, hypertrichosis, increased sweating, rash, Stria, thinning of the hair on the head, in patients receiving GKS reported on the development of the sarcoma of the caps.
General impairment and disorders in the place of administration: reactions at the place of administration, including burning or tingling, infection at the injection site, sterile abscess, depression of the reaction to skin samples, deceptive skin reactions, delayed wound healing, manifestation of latent diabetes, disguise infections, latent activation infections, including re-activation of tuberculosis, opportunistic infections caused by any microorganisms, any localization from the lungs to death, reducing resistance to infections, malaise.
From the nervous system: benign intracranial hypertension, convulsive seizures, dizziness, headache, neuritis, neuropathy, paresthesia. Arachnoiditis, meningitis, parapreapes / paraplegia, sensory disorders appeared after intrathecal use.
From the side of the bodies: rear subcapsular cataracts, Exophthalm, glaucoma, rare cases of blindness associated with injections in the peroxy zone.
From side respiratory system, organs chest and mediastinum: In case, for preparation for use, the benzyl alcohol should be taken into account, which can cause the development of death syndrome in premature children.
From the gastrointestinal tract: IKOT, the development of ulcerative disease with possible perforation and bleeding, gastric bleeding, pancreatitis, esophagitis, intestinal perforation, bloating, intestinal dysfunction, nausea.
From the kidneys and urinary system: glucosuria, urinary bubble dysfunction.
From the digestive system: hepateriagaly.
From the side of the musculoskeletal system and connective tissue: corticosteroid myopathy, arthropathy, muscle loss, muscle weakness, osteoporosis, pathological fractures, spinal compression fractures, aseptic necrosis, tendon gap, in particular Achilles tendon, growth delay in children.
Endocrine disorders: irregular menstrual cycle, the development of the Kushingoid state, girsutism, the oppression of the hypophysic-adrenal systems.
From the immune system: hypersensitivity reactions, including anaphylaxis and anaphylactoid reactions (for example, bronchospasm, angioedema edema).
Mental disorders: Euphoria, insomnia, mood changes, personality changes, depression, psyche disorders; The aggravation of the existing emotional instability or trends towards the development of psychosis.

Contraindications

Contraindications for the use of the drug Hydrocortisone acetateare:
- Increased sensitivity to the active substance or to any of the auxiliary substances.
- systemic fungal diseases.
- patients receiving corticosteroids in immunosuppressive doses, is contraindicated by the use of living or visual vaccines (see the section "Features of application").
- intramuscularly corticosteroid preparations are contraindicated with idiopathic thrombocytopenic purple.
- contraindicated for intrathecal administration.

Pregnancy

Animal research has shown that corticosteroids, in case of their use of pregnant in high doses, can cause malformations of the fetus. Additional research of influence on the human body was not conducted.
Therefore, application Hydrocortisone acetateduring pregnancy or women, those who wish to become pregnant, requires careful weighing of benefit from its application compared to potential risks for pregnant and fetus. Since the proof of the safety of the use of a person during pregnancy is indirect, hydrocortisone can be applied during pregnancy, only if the benefit of therapy prevails with the risks associated with it for the fetus.
Corticosteroids easily pass through a placental barrier. Children born to women who received large doses of corticosteroids during pregnancy, should be carefully examined relative to the signs of lack of adrenal cortex.
Application during breastfeeding
Corticosteroids penetrate breast milk. Hydrocortisone can be used during breastfeeding period only when the benefits of therapy prevailing risks associated with it for a child.
Carcinogenicity, mutagenicity, influence on fertility. Adex-wage research on animals over the presence in corticosteroids of carcinogenic or mutagenic action has not been carried out.
Steroids can increase or decrease the mobility and the amount of spermatozoa in some patients.

Interaction with other medicines

Drugs that induce liver enzymes, such as phenobarbital, phenytoin and rifampicin, can increase corticosteroid clearance, and when applied, it may be necessary to increase the dose of corticosteroids to obtain the desired response to treatment.
Drugs such as treolaandomycin and ketoconazole, can inhibit corticosteroid metabolism and thus reduce their clearance. Therefore, the dose of corticosteroids should be titled, in order to avoid the development of the GKS toxicity.
Corticosteroids can increase aspirin clearance, which is used for a long time and in large doses. This can lead to a decrease in serum sylicylate levels or to increase the risk of developing toxicity salictomacy when canceling corticosteroids. Aspirin should be used to apply with corticosteroid patients with hypotompombinemia.
The effect of corticosteroids on oral anticoagulants varies largely; They can both weaken and strengthen their action. Therefore, regular monitoring of the coagulogram indicators should be carried out to maintain the desired anticoagulant effect.
With caution should be used with drugs affecting potassium level (for example diuretics). Do not apply with amphotericin V.
Corticosteroids can cause hyperglycemia, so it is necessary to apply with hypoglycemic agents with caution.
Antibiotics. It was reported that macrolide antibiotics caused a significant reduction in corticosteroid clearance.
Cyclosporins. With the simultaneous use of these drugs, an increase in activity and cyclosporine, and GKS, is observed. It also reported on cases of convulsion.
Anticholinesterase preparations. Simultaneous use can lead to the development of severe weakness in patients with gravel miastenia. Therefore, the use of these drugs must be stopped at least 24 hours before the start of corticosteroid therapy.
Antidiabetic means. Since corticosteroids can increase blood glucose concentrations, there may be a need for correction of the dose of antidiabetic agents.
Anti-tuberculosis means. It is possible to reduce the concentration of isoniazide in the blood plasma.
Cholestyramine can increase corticosteroid clearance.
Aminoglutemid may result in the loss of adrenal suppression by corticosteroids.
Heart glycosides. Patients using heart glycosides have an increased risk of arrhythmia through hypokalemia.
Estrogens, including oral contraceptives. Estrogens can cause a decrease in the metabolism of certain corticosteroids in the liver, which leads to an increase in their effect.
Skin samples. Corticosteroids can suppress reactions to skin samples.
Vaccines. Patients in long-term corticosteroid therapy may show a weakly pronounced response to toxoid and alive or inactivated vaccines Due to suppression of antibody responses. GCS can also strengthen the response of certain organisms contained in living attenuated vaccines.
When applying vaccines or toxoids, according to the vaccination plan, it should be given to postpone vaccination until the treatment with corticosteroids is completed.

Overdose

Clinical overdose syndrome by the drug Hydrocortisone acetatedoes not exist.
Hydrocortisone is output by dialysis.

Storage conditions

Store in the original packaging at a temperature not higher than 25 ° C. Freezing is not allowed. Keep out of the reach of children.

Form release

Hydrocortisone acetate -suspension for injection.
2 ml in ampoule; 10 ampoules in a pack.
2 ml in ampoule; 5 ampoules in a blister, 2 blisters in a pack.

Structure

1 ml of hydrocortisone suspension acetatecontains acetate hydrocortisone in terms of 100% dry substance 25 mg.
Auxiliary substances: propylene glycol, sorbitol (E 420), Pisidone, sodium chloride, alcohol benzyl, water for injection.

Additionally

Patients receiving GCS and transfer unusual stress, before, during and after such a stressful situation, the use of corticosteroids in high doses or speed-acting corticosteroids is shown.
GCS can mask some signs of infection, and when applying new infections may occur. When applying corticosteroids, the body resistance to infections and the body's ability to localize the infection can be reduced.
The development of infections of any localization caused by any microorganisms (including viral, bacterial, fungal, protozoal or gliscate infections) can be associated with the use of corticosteroids as a monotherapy or in combination with other immunosuppressive means that affect the cellular immunity cellular links, cellular immunity Or the function of neutrophils. Such infections may be easy, but may be severe and sometimes have a fatal outcome. With increasing doses of corticosteroids, the rate of development of infectious complications increases.
With an active, disseminated or fulminant tuberculosis, hydrocortisone can be used only for the treatment of the disease together with the corresponding anti-tuberculosis treatment regimen. If the use of corticosteroids is shown to patients with latent tuberculosis or tuberculin reactivity, careful observation is necessary, since the disease can be activated again. During long-term corticosteroid therapy, such patients should receive chemoprophylaxis.
Patients receiving corticosteroids in immunosuppressive doses are contraindicated by the use of living or visual vaccines; Such patients can use killed or inactivated vaccines. However, the response to such vaccines can be reduced. Patients receiving corticosteroids in non-immunosuisulated doses are shown to conduct immunization procedures.
Hydrocortisone can cause an increase in blood pressure, salt and water delay in the body and an increase in the excretion of potassium. Therefore, it may be necessary to comply with the diet with the limitation of the amount of salt and the use of potassium-based nutritional supplements. All corticosteroids increase calcium excretion.
Since in rare cases in patients receiving treatment with corticosteroids parenterally, anaphyactoid reactions developed (for example, bronchospasm), appropriate measures should be taken before their use, especially when the patient's history is allergic to any medicine.
Although recent studies have not been carried out using hydrocortisone or other steroids, the results of studies of the use of methylprednisolone sodium succinate under septic shock indicate that in some subgroups of high-risk patients (i.e. patients with an increase in creatinine levels of more than 2 mg / dl or With secondary infections) it is possible to raise the level of mortality.
The effect of hydrocortisone can be enhanced in patients with liver disease, since they have significantly reduced metabolism and hydrocortisone output.
In children who receive long-term treatment of GCS in separated daily doses, growth can be observed. The use of such a treatment regimen should be limited to the most serious indications.
Corticosteroids should be used with caution to patients with eye-simple herpes, which is accompanied by the risk of cornea perforation.
When applying corticosteroids, mental disorders may occur, which vary from euphoria, insomnia, changes in mood, personality changes to obvious manifestations of psychosis. Also, corticosteroids can cause aggregation of existing emotional instability or trends towards the development of psychosis.
Corticosteroids should be used with caution in non-specific ulcerative colitis if there is a possibility of perforation of perforation in the presence of abscesses or other posogenic infections, as well as with diverticulas, fresh intestinal anastomozah, active or latent peptic ulcers, renal failure, arterial hypertension, osteoporosis and miastic gravis.
When using high doses of corticosteroids, cases of developing acute myopathy are described, which most often occurs in patients with neuro-muscular transmission disorders (in particular, the Miastic gravis), or in patients receiving therapy with neuromuscular blockers (such as pankronia). Such an acute myopathy is generalized, can attract eye and respiratory muscles and can lead to the development of quadripapes. There may be an increase in the level of KFK. Prior to the onset of clinical improvement or recovery after the cancellation of corticosteroids can take place from several weeks to several years.
There were reports of the development of the sarcoma of the caps in patients receiving therapy with corticosteroids, but the cessation of therapy may lead to its clinical remission.
In order to reduce the possibility of the development of skin atrophy at the point of administration, the recommended dose should not be exceeded. Injecting in the deltoid muscle for the high risk of developing subcutaneous atrophy.
High doses of corticosteroids should not be used for treatment during crank-brain injury.
Published data indicate a likely connection between the GCS and the gap of myocardium after the recently suffered myocardial infarction; Therefore, these patients therapy with the use of corticosteroids should be used with caution.
May cause the oppression of the hypothalamic-pituitary-adrenal system, the development of Cushing and hyperglycemia syndrome.
The secondary cortex of adrenal glands caused by the use of the drug can be reduced by a gradual reduction in the dose. Insufficiency of this kind can be maintained within a few months after the termination of therapy. Therefore, in any situation of manifestation of stress during this period hormonal therapy must be restored.
With simultaneous use with amphotericin, there were cases expanding the boundaries of the heart and the development of heart failure (see section "Interaction with other drugs and other types of interactions").
It may cause an exacerbation of intercurrent infections caused by Amoeba, Candida, Cryptococus, Mycobacterium, Nocardia, Pneumocystis, and toxoplasma. Before the start of therapy, corticosteroids are recommended to exclude latent or active Amebiaz in patients who visited tropical countries, or in patients with diarrhea of \u200b\u200bunclear genesis.
Do not apply under cerebral malaria, since there is currently no evidence of benefit from the use of corticosteroids at this state.
Wind shempar and cortex: may be serious or even death complications in adults and children. Patients did not suffer these diseases in the past, it should be carefully protected from the risk of distributing these diseases on them.
The use of corticosteroids can lead to the rear subcapsular cataract, glaucoma, damage to the visual nerves, can contribute to the development of secondary eye infections caused by bacteria, mushrooms or viruses.
Use with caution to patients with a well-known or suspected lesion on strondyloides. In such patients, immunosuppression may lead to hyperinfection and the spread of migration of larvae can lead to severe enterocolitis and lethal gram-negative septicemia.
Caution should be used to patients with stagnant heart failure, hypertension.
Patients with hypothyroidism dose of corticosteroids must be adjusted.
In patients with cirrhosis, there is a strengthened effect by reducing corticosteroid metabolism.
For therapy with corticosteroids it is possible to increase intraocular pressure, which requires its control, especially in the case of long-term therapy.
This drug contains sorbitol. If the patient is installed ?? The intolerance of some sugars should be consulted with the doctor before taking this drug.
This drug contains a benzyl alcohol, so it can be used to premature children and newborn. May cause toxic and allergic reactions in babies and children under 3 years old.
This drug contains less than 1 mmol (23 mg) / sodium dose, that is, practically free from sodium.

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Name:	Hydrocortisone acetate
ATH code:	H02AB09. -