Hydrocortisone-Richter: instructions for use. Pregnancy and lactation. corneal ulceration, increased intraocular pressure, glaucoma, exophthalmos, increased risk of cataracts in pediatric patients

Self-medication can be harmful to your health.
It is necessary to consult a doctor, and also read the instructions before use.

Hydrocortisone-richter: instructions for use

Compound

Propyl parahydroxybenzoate, methyl parahydroxybenzoate, sodium chloride, disodium phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate, povidone, polysorbate 80, N.N-dimethylacetamide, water for injection.

Description

pharmachologic effect

Hydrocortisone is a moderately active anti-inflammatory glucocorticoid. Lidocaine is a membrane stabilizing, topical pain reliever. Per a short time soothes the pain.

Pharmacokinetics

Pharmacokinetic studies have not been conducted with suspension for injection. Topically applied hydrocortisone can be absorbed and exhibit systemic effects. More than 90% of hydrocortisone binds to plasma proteins. It passes through the placental barrier. Hydrocortisone is metabolized in the liver into the forms tetrahydrocortisone and tetrahydrocortisol. These metabolites are excreted in the urine in conjugated form.

In reproductive tests on animals, the fetotoxic effect of hydrocortisone was revealed, and malformations (cleft palate), as well as a significant delay in growth and development of offspring, were identified.

Despite the fact that no such phenomena have been found in humane practice, with prolonged use of hydrocortisone, the risk of delay may increase. prenatal development fetus.

Lidocaine is rapidly absorbed from the mucous membranes and from the affected skin surface. He is in to a large extent binds to plasma proteins. The half-life is 1-2 hours. Lidocaine is metabolized mainly in the liver. It crosses the placenta, crosses the blood-brain barrier, is excreted in mother's milk.

Indications for use

Osteoarthritis affecting few joints, monoarthrosis of some joints (knee, elbow, hip), arthritis of rheumatic or other etiology (with the exception of tuberculosis and gonorrheal arthritis), periarthritis (in particular of the shoulder joint), bursitis, epicondylitis, tendovaginitis. The drug is indicated for administration before surgical intervention on ankyloid (ossified) joints, then for local supplementation of general corticosteroid therapy.

Contraindications

Hypersensitivity to any ingredient of the drug; infected joint; first trimester of pregnancy; the presence of Cushing's syndrome; tendency to thromboembolic diseases, systemic infectious disease without targeted therapy; Achilles tendon treatment.

Pregnancy and lactation

The use of topical corticosteroids in pregnant animals has been proven to cause fetal damage (eg, cleft palate, intrauterine development).

There is no data on the safety of the use of these drugs during pregnancy, therefore, it should not be used in the first trimester of pregnancy, after which the drug can be used after carefully weighing the benefits / risks of taking it. Available small opportunity the appearance of a cleft palate or malformation.

Lactation

Both the corticosteroid and lidocaine are excreted in the mother's milk, so the corticosteroid can interfere with the baby's adrenal glands and cause growth retardation.

Dosage and administration

Adults: depending on the size of the joint and the severity of the disease, 5-50 mg intra- or periarticularly.

Children: 5-30 mg per day, divided into several times.

Elderly: In old age side effects corticosteroid therapy may be more intense.

No more than three joints can be injected within 24 hours. The course of therapy can be carried out at three-week intervals. When the drug is administered intra-articularly, hydrocortisone can adversely affect hyaline cartilage, therefore, within one year, one joint can be treated no more than three times. The drug should not be injected directly into the tendon, therefore, with tendonitis, the drug must be injected into the tendon sheath. The drug should not be used to treat the Achilles tendon. The drug must not be used for systemic treatment(for the treatment of the whole organism).

Side effect

Like other locally applied intra-articular steroid drugs, side effects occur in the form of swelling and pain primarily at the injection site. Usually, these phenomena spontaneously disappear within a few hours after the administration of the drug. Others may appear skin signs: delayed wound healing, skin atrophy, streaks, acne, pruritus, folliculitis, hirsutism, hypopigmentation, irritation, drying, thinning and sensitivity of the skin, as well as the expansion of skin capillaries.

Especially when the drug is administered in a large dose, long time systemic effects of corticosteroid and lidocaine must be considered:

Endocrine system and metabolism

Adrenal suppression may occur, especially with prolonged use or high doses. Due to protein catabolism, a negative nitrogen balance can be observed. Carbohydrate tolerance worsens, and the need for an antidiabetic drug increases.

Water and electrolyte exchange

Sodium and water retention, potassium loss, hypokalemic alkalosis, hypertension, and heart failure may occur.

Musculoskeletal system

Corticosteroids can cause osteoporosis and may stunt a child's growth. May develop steroid myopathy aseptic necrosis.

Gastrointestinal tract

There may be a peptic ulcer of the stomach or duodenum with bleeding and perforation, stomach bleeding, pancreatitis, esophagitis.

central nervous system

There may be an increase intracranial pressure, with swelling of the nipple optic nerve(congested nipple symptom), convulsions, dizziness, headache, insomnia, mental disorders.

Corneal ulcer, increased intraocular pressure, glaucoma, exophthalmos may occur. In childhood, the possibility of cataracts is greater.

The cardiovascular system

If locally administered lidocaine is absorbed, it can cause conduction disturbances or peripheral vasodilation.

Opportunistic infections, exacerbation of latent tuberculosis, leukocytosis, hypersensitivity, thromboembolism, increased appetite, nausea, bad feeling.

Possible signs at the end of corticosteroid therapy Fever, myalgia, arthralgia, adrenal insufficiency.

Overdose

Overdose may manifest itself in local and systemic signs, depending on the amount of corticosteroid and lidocaine ingested.

There is no specific antidote, symptomatic therapy is suggested.

Interaction with other drugs

Patients with Addison's disease should not be prescribed the drug together with barbiturates due to the possibility of a crisis.

Corticosteroids can be taken with caution:

With barbiturates, with phenylbutazone, with phenytoin and rifampicin (the effectiveness of corticosteroids is reduced);

With oral antidiabetic agents (due to a decrease in effectiveness, it may be necessary to increase the dose of antidiabetic agents);

With anticoagulants (the anticoagulant effect may change: it may increase or decrease);

With salicylates (after completion of corticosteroid therapy, the level of salicylates in the blood may increase, causing intoxication; both drugs are ulcerogenic, therefore, when they joint application may increase the risk of gastrointestinal bleeding or ulceration);

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

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

With antihypertensive agents (corticosteroids act against antihypertensive agents);

With mifepristone (the effectiveness of corticosteroids decreases).

Application features

An intra-articularly administered corticosteroid may increase the chance of recovery inflammatory processes. With the introduction of the drug can cause bacterial infection joint, so the drug can only be administered under aseptic conditions.

Active immunization should not be performed during corticosteroid therapy (especially when high doses of corticosteroids are administered), due to the increased possibility of neurological complications due to the lack of antibody production. During therapy with corticosteroids, the body's resistance may decrease, and the body's ability to localize infected areas of the body may decrease. The introduction of generally accepted and large doses of corticosteroids can cause an increase in blood pressure, can increase the retention of sodium and water in the body with a forced release of potassium from the body. All corticosteroids increase the excretion of calcium from the body. In the presence of latent tuberculosis, the drug can be administered using anti-tuberculosis drugs. In the presence of a systemic infection, the drug can be administered only with specific therapy (for example: antibiotic, antiviral agents). During the course of corticosteroid therapy, it is advisable to re-determine the therapeutic dose of oral antidiabetic agents and anticoagulants. With the simultaneous use of corticosteroids with diuretics, it is necessary to strictly monitor the exchange of electrolytes (potassium replacement). With prolonged use of hydrocortisone, potassium replacement may be necessary to prevent hypokalemia. Corticosteroids retard the growth of children in childhood and transitional age. It is suggested to enter the minimum effective dose, and apply the drug in the shortest possible time. The course of therapy should be completed with a gradual decrease in the dose of the drug. During the course of therapy, it is advisable to regularly measure arterial pressure and conduct urine and fecal examinations. In old age, the likelihood of side effects above.

The course of hydrocortisone therapy should be continued with caution: in case of diabetes mellitus or in the presence of a patient with diabetes mellitus in the family, in osteoporosis (among postmenopausal women the risk is higher), in hypertension, in the presence of chronic psychotic reactions, in the presence of tuberculosis in the anamnesis of diseases, in glaucoma, with steroid myopathy, with gastric or duodenal ulcers, with epilepsy, with herpes, with herpes on the eye (due to the risk of corneal perforation) and with chickenpox.

Precautionary measures

Release form

5 ml suspension in a colorless glass vial for injection with a rim (hydrolytic class I.), with a bromobutyl rubber stopper and a FLIPP-OFF combination cap.

One vial (5 ml) per cardboard box with attached instructions for use.

A drug: HYDROCORTISONE-RICHTER (HYDROCORTISONE-RICHTER)

Active ingredient: hydrocortisone, lidocaine
ATX code: H02AB09
KFG: GCS for injection - depot form
ICD-10 codes (indications): M05, M15, M65, M67, M71, M75.0
Reg. number: P N011969/01
Date of registration: 21.06.10
The owner of the reg. acc.: GEDEON RICHTER (Hungary)

PHARMACEUTICAL FORM, COMPOSITION AND PACKAGING

Suspension for injection white or almost white color, with a characteristic odour.

Excipients: propyl parahydroxybenzoate, methyl parahydroxybenzoate, sodium chloride, sodium phosphate, sodium dihydrogen phosphate, povidone, polysorbate 80, N,N-dimethylacetamide, water for injection.

5 ml - colorless glass bottles (1) - packs of cardboard.

INSTRUCTIONS FOR USE FOR THE SPECIALIST.
The description of the drug was approved by the manufacturer in 2010.

PHARMACHOLOGIC EFFECT

Hydrocortisone is a glucocorticosteroid agent that has an anti-inflammatory effect. It inhibits the release of cytokines (interleukins and interferon) from lymphocytes and macrophages, inhibits the release of inflammatory mediators by eosinophils, reduces the intensity of arachidonic acid metabolism and prostaglandin synthesis. Activates steroid receptors, induces the formation of lipocortins, which have anti-edematous activity. Reduces inflammatory cell infiltration, prevents the migration of leukocytes and lymphocytes to the site of inflammation. AT large doses inhibits the development of lymphoid and connective tissue. By reducing the number mast cells, reduces education hyaluronic acid; inhibits hyaluronidase, helps to reduce capillary permeability.

It is intended for i / m, intra- and periarticular administration, in order to provide systemic or local anti-inflammatory, as well as anti-allergic effects. When administered intraarticularly healing effect occurs within 6-24 hours and lasts for several days or weeks.

Lidocaine is a local anesthetic with a membrane stabilizing effect. short term has an analgesic effect.

PHARMACOKINETICS

With intra-articular and peri-articular administration, hydrocortisone penetrates into the systemic circulation. Communication with protein> 90%. It is metabolized in the liver to tetrahydrocortisone and tetrahydrocortisol, which are excreted by the kidneys in conjugated form. Penetrates through the placental barrier.

Absorption of corticosteroids after intra-articular injection or injection into soft tissues slow.

After the / m administration, the suspension is absorbed slowly, which provides a prolonged action.

Lidocaine is well absorbed from the mucous membranes and damaged skin surface, has a high affinity for plasma proteins. Metabolized mainly in the liver. T 1/2 1-2 hours Penetrates into breast milk and across the placental and blood-brain barriers.

INDICATIONS

Rheumatic diseases accompanied by arthritis, incl. osteoarthritis in the presence of synovitis (with the exception of tuberculous, gonorrheal, purulent and other infectious arthritis);

Rheumatoid arthritis;

Shoulder-shoulder periarthritis;

epicondylitis;

Tendovaginitis.

DOSING MODE

Intra- and periarticular. In one day, you can enter no more than 3 joints. Re-introduction injections are possible subject to a 3-week interval. Injection directly into the joint may adversely affect the hyaline cartilage, so the same joint can be treated no more than 3 times a year.

For tendonitis, the injection should be given into the sheath of the tendon - not directly into the tendon. Not suitable for systemic treatment and for the treatment of the Achilles tendon.

Adults: depending on the size of the joint and the severity of the disease, 5-50 mg intra- and periarticularly. In / m adults, the drug is injected deep into the gluteal muscle at a dose of 125-250 mg / day.

Children: 5-30 mg/day divided into several doses. single dose with periarticular injection children aged 3 months to 1 year: 25 mg from 1 year to 6 years: 25-50 mg, 6 to 14 years old: 50-75 mg.

In the elderly patients at risk of developing adverse reactions above.

SIDE EFFECT

Adverse reactions primarily occur at the injection site, most often in the form of tissue edema and pain, spontaneously disappear after a few hours. In addition, delayed wound healing, skin atrophy, striae, acne-like rash, itching, folliculitis, hirsutism, hypopigmentation, skin irritation, dry, thinned and sensitive skin telangiectasia.

At long-term treatment and the use of large doses of glucocorticoids and lidocaine may develop systemic side effects.

From the side endocrine system: decreased glucose tolerance and increased need for hypoglycemic drug, manifestation latent diabetes, steroid diabetes. With long-term treatment - suppression of adrenal function, Itsenko-Cushing's syndrome, growth retardation in children and adolescents.

From the side digestive system: nausea, vomiting, pancreatitis, peptic ulcer, esophagitis, bleeding and perforation of the gastrointestinal tract, increased appetite, flatulence, hiccups, rare cases- increased activity of hepatic transaminases and alkaline phosphatase.

From the side of cardio-vascular system: with significant absorption, lidocaine can cause impaired conduction in the heart and peripheral vasodilation; at high doses of hydrocortisone: increased blood pressure, hypokalemia and its characteristic ECG changes thromboembolism, heart failure.

From the side nervous system: insomnia, irritability, anxiety, agitation, euphoria, epileptiform convulsions, mental disorders, delirium, disorientation, hallucinations, manic-depressive psychosis, depression, paranoia, increased intracranial pressure with papilledema, dizziness, cerebellar pseudotumor, headache.

From the side of metabolism: increased excretion of potassium, hypokalemia, weight gain, negative nitrogen balance, increased sweating.

From the side of the organ of vision: corneal ulceration, posterior capsular cataract (more likely in children), increased intraocular pressure With possible damage optic nerve, secondary bacterial fungal and viral infections eye, trophic changes in the cornea, exophthalmos, glaucoma.

From the side musculoskeletal system: growth retardation and ossification processes in children (premature closure of the epiphyseal growth zones), osteoporosis, very rarely - pathological fractures bones, aseptic necrosis of the head of the humerus and femur, tendon and muscle rupture, steroid myopathy, decreased muscle mass, arthralgia.

Effects due to the mineralocorticoid activity of the drug: fluid and sodium retention with the formation of peripheral edema, hypernatremia, hypokalemia syndrome (hypokalemia, arrhythmia, myalgia, muscle spasm, increased weakness, fatigue), hypokalemic alkalosis.

From the side immune system: opportunistic infections, exacerbation of latent tuberculosis, reactions hypersensitivity; local and generalized: skin rash, itching, anaphylactic shock, delayed wound healing, a tendency to develop pyoderma and candidiasis, exacerbation of infections, especially with vaccination and simultaneous treatment immunosuppressive agents.

Dermatological reactions: petechiae, ecchymosis, hyper- and hypopigmentation, steroid acne, striae, skin atrophy and subcutaneous tissue at the injection site (especially dangerous is the introduction into the deltoid muscle), folliculitis, hirsutism, hypopigmentation, irritation, telangiectasia.

Others: malaise, withdrawal syndrome heat body, myalgia, arthralgia, adrenal insufficiency), leukocyturia, leukocytosis.

Local reactions: increased pain in the joint when injected into the joint, tissue swelling, burning, numbness, paresthesia at the injection site, rarely - necrosis of surrounding tissues, scarring at the injection site.

CONTRAINDICATIONS

Infected joint;

Syndrome Itsenko-Cushing;

Tendency to thrombosis;

I trimester of pregnancy;

Systemic infection without specific treatment;

Diseases of the Achilles tendon;

Hypersensitivity to the components of the drug.

Intra-articular administration is contraindicated in:

Transferred arthroplasty;

Pathological bleeding (endogenous or caused by anticoagulants);

Intra-articular fracture of bones;

Infectious (septic) arthritis and periarticular infection (including history);

General infectious disease;

Severe periarticular osteoporosis;

Osteoarthritis without synovitis (the so-called "dry" joint);

unstable joint;

Aseptic necrosis of the joint-forming epiphyses of the bones;

Severe bone destruction and joint deformity (significant narrowing of the joint space, ankylosis).

Carefully: peptic ulcer stomach and duodenum, herpes simplex, herpes simplex eye (possibility of perforation of the cornea of ​​the eye), arterial hypertension, diabetes mellitus incl. family history, osteoporosis (risk of osteoporosis increases in postmenopausal women), chronic psychotic reactions, history of tuberculosis, glaucoma, steroid myopathy, epilepsy, measles, chronic heart failure, elderly age(> 65 years), pregnancy (I-III tr.), lactation.

PREGNANCY AND LACTATION

Pregnant women in the first trimester, the appointment of the drug is contraindicated due to the lack of sufficient data on the safety of the drug in this group, more late dates- possible only after careful weighing of the intended benefits for the mother and potential risk for the fetus (the likelihood of the formation of a split palate and intrauterine disorders is small). In II-III trimesters pregnancy is prescribed with caution. Children whose mothers received hydrocortisone during pregnancy should be closely monitored for signs of adrenal insufficiency.

Use with caution during lactation.

The use of the drug during lactation can lead to impaired adrenal function and the development infants, because glucocorticosteroids and lidocaine pass into breast milk.

SPECIAL INSTRUCTIONS

The injection is administered subject to the rules of asepsis in order to avoid the development of bacterial infection.

During treatment, any vaccination is contraindicated, because. during treatment with corticosteroids, especially in high doses, can lead to insufficient synthesis of antibodies.

It is necessary to control blood pressure, measure the level of glycemia, blood clotting, control urine and feces.

Relative adrenal insufficiency, which occurs after the end of the action of GCS, may persist for several months after discontinuation of the drug, therefore, in a state of increased stress, it should be resumed hormone therapy with the simultaneous appointment of mineralocorticosteroids and salts.

Children whose mothers received hydrocortisone during pregnancy should be closely monitored for signs of adrenal insufficiency.

At latent form tuberculosis and during the turn tuberculin samples careful monitoring of the patient's condition and, if necessary, chemoprophylaxis is necessary.

GCS slow down the growth and development of children and adolescents. It is recommended to prescribe the drug in the smallest therapeutic doses and, if possible, within the shortest possible time.

OVERDOSE

Depending on the dose of corticosteroids and lidocaine, both local and systemic symptoms may appear.

There is no specific antidote. Spend symptomatic treatment.

DRUG INTERACTIONS

In Addison's disease, simultaneous administration with barbiturates can provoke a crisis. Increases the toxicity of cardiac glycosides (proarrhythmogenic effect of hypokalemia).

Reduces the hypotensive effect of antihypertensive drugs. Accelerates excretion acetylsalicylic acid reducing its concentration in the blood.

With the abolition of hydrocortisone, the concentration of salicylates in the blood may increase and lead to the development of adverse reactions. Both drugs have an ulcerogenic effect, their simultaneous use may increase the risk of ulceration and bleeding.

Vaccination with live antiviral vaccines and other types of immunization during treatment with hydrocortisone contributes to the activation of viruses and the development of infections.

Increases the metabolism of isoniazid, mexiletin, especially in patients with fast acetylators, reducing plasma concentrations these medicines.

Enhances the hepatotoxic effect of paracetamol, because. induces liver enzymes and the formation of a toxic metabolite of paracetamol.

With long-term treatment increases the content of folic acid.

Hypokalemia caused by corticosteroids increases the severity and duration of muscle blockade of muscle relaxants.

High doses of hydrocortisone reduce the effect of growth hormone.

Reduces the effectiveness of oral hypoglycemic agents, dose adjustment may be required.

Reduces or enhances the effect of anticoagulant drugs.

Ergocalciferol and parathyroid hormone prevent the development of glucocorticosteroid osteopathy.

Reduces the concentration of praziquantel in the blood.

Cyclosporine inhibits the metabolism of hydrocortisone.

Ketoconazole reduces clearance and increases the toxicity of hydrocortisone.

Thiazide diuretics, carbonic anhydrase inhibitors, amphotericin B, theophylline and other corticosteroids increase the risk of hypokalemia.

NSAIDs and ethanol contribute to ulceration of the gastrointestinal mucosa and the development of bleeding. When treating arthritis with hydrocortisone in combination with NSAIDs, the dose of hydrocortisone should be reduced to avoid an additive therapeutic effect.

Indomethacin, displacing hydrocortisone from its association with proteins, contributes to the development of adverse reactions of the latter.

Amphotericin B and carbonic anhydrase inhibitors increase the risk of osteoporosis.

Phenytoin, barbiturates, ephedrine, theophylline, phenylbutazone, rifampicin and other inducers of microsomal liver enzymes reduce the effect of hydrocortisone, increasing its metabolism.

With the simultaneous use of mitotane and other inhibitors of the adrenal cortex, an increase in the dose of hydrocortisone may be required.

Medications - Hormones thyroid gland increase the clearance of hydrocortisone.

Immunosuppressive agents increase the risk of developing infections, lymphoma, and lymphoproliferative processes caused by the Epstein-Barr virus.

Estrogens, including oral estrogen-containing contraceptives, reduce the clearance of hydrocortisone, lengthening the half-life and enhancing the therapeutic and toxic effects of the latter.

Simultaneous use with other steroid hormonal means(androgens, estrogens, anabolics, oral contraceptives) contributes to the development of acne and hirsutism.

Simultaneous reception with M-anticholinergics, incl. antihistamines, tricyclic antidepressants and nitrates, increases intraocular pressure.

The action of GCS weakens with simultaneous reception with mifepristone.

TERMS AND CONDITIONS OF STORAGE

Storage conditions:

store in the original packaging at a temperature of 15-30 ° C, protected from light and out of the reach of children.

Best before date:

Do not use after the expiry date stated on the package.

Hydrocortisone-Richter belongs to the group of glucocorticosteroids, it is intended for injection. It is necessary to read in more detail the instructions for the use of this medication.

What is the composition and form of the drug Hydrocortisone Richter (suspension)?

The product is available in a white suspension, which is used for injection, it has a characteristic odor. The active substances are hydrocortisone acetate and lidocaine hydrochloride. Auxiliary compounds Hydrocortisone-Richter: povidone, propyl parahydroxybenzoate, methyl parahydroxybenzoate added, sodium chloride, polysorbate 80, sodium phosphate, water for injection, sodium dihydrogen phosphate, and N, N-dimethylacetamide.

The drug Hydrocortisone Richter is placed in five-ml bottles of colorless glass, which are packed in cardboard packs. Store the medication in its original packaging in a dark place, the temperature should not exceed 30 degrees. The suspension is sold for two years from the date of its manufacture, after which it cannot be used.

What is the effect of Hydrocortisone Richter (suspension)?

Means Hydrocortisone-Richter has an anti-inflammatory effect on the human body. The drug inhibits the release of so-called cytokines directly from macrophages and from lymphocytes, in addition, it inhibits the release of inflammatory mediators, lowers the metabolism of arachidonic acid, and inhibits the synthesis of prostaglandins.

The drug activates steroid receptors, affects the formation of lipocortins, which have a decongestant effect. Reduces cellular infiltration inflammatory nature, inhibits the migration of leukocytes to the immediate site of inflammation. In high doses, it reduces the development of connective and lymphoid tissue.

The active substances of the drug reduce the number of mast cells, reduce the synthesis of hyaluronic acid, in addition, help to reduce the so-called capillary permeability.

The tool is intended for intramuscular injection, as well as for periarticular and intraarticular, in order to provide a local and systemic anti-inflammatory effect, as well as anti-allergic action. One of active substances This medication is represented by lidocaine - it is a local anesthetic that has an analgesic effect on the body in a fairly short time.

What are the indications for use of Hydrocortisone Richter (suspension)?

The drug Hydrocortisone-Richter instructions for use allow for use in the presence of rheumatic diseases, which are often accompanied by arthritis, including the suspension is used for osteoarthritis and synovitis, excluding tuberculosis, purulent and gonorrheal etiology.

The drug is indicated for patients with rheumatoid arthritis, in addition, with bursitis and tendovaginitis. It is prescribed for the so-called humeroscapular periarthritis and epicondylitis.

What are Hydrocortisone Richter (suspension) contraindications for use?

Among the contraindications, there are quite a few conditions when Hydrocortisone-Richter cannot be used, it is worth listing them:

With an infected joint, the medication is not used;
Suspension is contraindicated in Itsenko-Cushing's syndrome;
In the first trimester of pregnancy;
With the patient's tendency to thrombosis;
With the pathology of the Achilles tendon;
With increased sensitivity to the components of the drug.

Intra-articular administration of this agent is contraindicated in the following cases:

Do not prescribe a suspension for transferred arthroplasty;
In the presence of pathological bleeding;
Do not use the drug for intra-articular fracture bones;
With periarticular osteoporosis of a pronounced nature;
With infectious arthritis, as well as in the presence of the so-called periarticular infection;
With an infectious disease general;
With an unstable joint;
With osteoarthritis without synovitis, as well as with aseptic necrosis of the epiphyses of bones;
With severe bone destruction and joint deformity, in particular with ankylosis.

With caution, Hydrocortisone-Richter is prescribed for peptic ulcer, with herpes simplex, with arterial hypertension, with epilepsy and diabetes mellitus, with psychotic reactions chronic nature, with tuberculosis, in addition, with glaucoma and measles, as well as during pregnancy, lactation and in the elderly.

What is Hydrocortisone Richter (suspension) use and dosage?

The suspension is administered intraarticularly and periarticularly. In one day, it is recommended to inject no more than three joints. Re-treatment carried out after a three-week interval. Depending on the joint and severity clinical picture the amount of the drug can vary from 5 to 50 milligrams.

Overdose Hydrocortisone Richter (suspension)

In case of an overdose of the suspension, systemic, as well as local manifestations. There is no antidote. The patient is treated symptomatically.

What are the side effects of Hydrocortisone Richter (suspension)?

Adverse reactions will appear the following symptoms: decreased glucose tolerance, the so-called steroid diabetes mellitus, suppression of the adrenal glands, flatulence, Itsenko-Cushing syndrome develops, children experience growth retardation, nausea, vomiting, and also pancreatitis, ulcers, esophagitis, and hiccups.

In addition, insomnia, irritability, anxiety, agitation are possible, euphoria, convulsions join, in addition, mental disorders, disorientation, hallucinations, as well as psychosis and depression, headache, paranoia, cerebellar pseudotumor, hypokalemia, and hyperhidrosis.

What are Hydrocortisone Richter (suspension) analogues?

The drug Hydrocortisone + Lidocaine is an analogue.

Conclusion

Hydrocortisone Richter - a hormonal medication systemic action. It is produced in many forms and is used to treat diseases of the joints, mucous membranes, eyes and skin. It has a good anti-inflammatory effect.

Hydrocortisone Richter for hemorrhoids - the composition and action of the drug

For use in the form of an ointment. Operates locally. Main active substance is a hormone produced by the adrenal glands - the glucocorticosteroid hydrocortisone. Its highest concentration in the blood is observed in the morning, and in the evening it decreases.

Hormone regulates lipid metabolism in the body, increases metabolism, affects the balance of all necessary trace elements, eliminates stress reactions and is aimed at preserving vital resources.

Hydrocortisone ointment for external use is made from a synthetic glucocorticosteroid, which acts in a similar way natural hormone. 1 g of ointment contains 10 mg of hydrocortisone acetate. Auxiliary components are:

  • medical vaseline - softens and protects the skin and mucous membranes;
  • lanolin - a wax of animal origin, thanks to which the medicine enters the affected area faster;
  • stearic acid - thickener.

The ointment additionally contains preservatives and binders: pentol and methyl parahydroxybenzoate.

For a greater effect, you first need to make an enema with chamomile, and then smear the irritated intestine with ointment.

Release form

Manufactured and sold in different forms for both indoor and outdoor use:

  • In tubes of 5 g and 30 g.
  • Hydrocortisone eye ointment.
  • Hydrocortisone in ampoules in the form of a suspension for intramuscular and periarticular injections.
  • In the form of lyophysilate, which is diluted with dry powder.
  • Tablets containing 5, 10 or 20 mg active compound. They come to pharmacies under the name Cortef. You can learn more about them.

Suitable shape release and dose is determined individually depending on the disease and its severity.


pharmachologic effect

The drug belongs to the group of corticosteroids for systemic use.

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Hydrocortisone is an inhibitor of the release of mediators by eosinophils, reduces metabolic functions arachidonic acid. Activates steroid receptors, which, in turn, form lipocortins. Due to this, the drug has a decongestant effect. Reduces inflammation and prevents lymphocytes and leukocytes from entering its focus.

In high doses, Hydrocortisone is able to stop the development of connective and lymphoid tissues.

The number of mast cells is reduced, which causes a decrease in the formation of hyaluronic acid and significantly reduces capillary permeability. For injections, Hydrocortisone is used with Lidocaine. it local anesthetic, which well and quickly eliminates pain.

Pharmacodynamics and pharmacokinetics

The medication is intended in injections for intramuscular, intra- or periarticular administration, and in the form of an ointment - for external use. At intra-articular application therapeutic effect occurs in about 6-24 hours and may last for several days or weeks depending on the severity of the condition.


Pharmacokinetic studies with suspension have not been conducted. For local use the medicine is well absorbed. More than 90% of the substance binds to plasma proteins. The active compound is able to penetrate the blood-brain barrier. It is metabolized by the liver to form tetrahydrocortisone and terahydrocortisol, which are excreted in the urine.

Lidocaine is rapidly absorbed from mucous membranes or skin binding primarily to blood proteins. The half-life of the drug is quite short - 1-2 hours. Metabolism is carried out in the liver.

Indications for the use of Hydrocortisone Richter

There are several direct indications for the use of the drug in the form of injections:

  • osteoarthritis;
  • osteoporosis;
  • joint monoarthrosis;
  • arthritis;
  • rheumatoid arthritis;
  • humeroscapular periarthritis;
  • bursitis;
  • epicondylitis.

In addition, the medication is used before operations on ankylotic joints as a local addition to complex glucocorticosteroid therapy.

In the form of ointments, it is used for such diseases:

  • eczema;
  • allergic dermatitis;
  • neurodermatitis;
  • autoimmune skin diseases;
  • acute conjunctivitis;
  • allergy to insect bites;
  • prevention of postoperative complications.

Additionally, Hydrocortisone is also used for inhalation into the nose or ear for otitis media.


With hemorrhoids

Hydrocortisone 1% ointment is used in proctology for the treatment of hemorrhoids, in the case when it is accompanied by the following phenomena:

  • proctitis;
  • inflammation of the rectal mucosa;
  • education .

The medication well and quickly eliminates inflammation, increases the resistance of tissues to the penetration of pathogenic microorganisms.

Contraindications

There are a number of contraindications for use.


The most common among them are:

  • hypersensitivity reactions to the components of the drug;
  • intraarticular infection;
  • various kinds of infections;
  • diseases of the Achilles tendon;
  • stomach or duodenal ulcer;
  • osteoporosis;
  • the possibility of developing thromboembolism;
  • kidney failure;
  • arterial hypertension;
  • herpes, syphilis;
  • first trimester of pregnancy.

Before prescribing Hydrocortisone, the physician should review the patient's history. Self-medication is not allowed.


Side effects of Hydrocortisone Richter

With the intra-articular use of a hormonal medication, a reaction may occur in the form of the formation of peripheral edema or pain at the injection site. They pass on their own.

Hydrocortisone inhibits the function of the adrenal glands, retains sodium and water in the body. The risk of developing hypokalemia is greatly increased. Perhaps the development of hypertension and insufficiency of the heart muscle. Rarely, internal bleeding occurs.

On the part of the skin, inflammation may occur at the site of injection or application of ointment, expansion of subcutaneous capillaries, local skin rashes accompanied by itching.

On the part of the eyes, the development of glaucoma, cataracts, conjunctivitis, and corneal perforation is possible. Often there is an increase in intraocular pressure.


Overdose

One-time overdose or if too long-term use can cause unpleasant symptoms:

  • inhibition of the production of own glucocorticoids;
  • jumps in blood pressure;
  • ulcerative bleeding of the gastrointestinal tract;
  • exacerbation of chronic infections;
  • development of the Yatsenko-Cushing syndrome.

The degree of manifestation of signs will depend on the amount of Hydrocortisone and Lidocaine that have been ingested. There is no specific treatment, therapy will be only symptomatic.

Application and dosage of Hydrocortisone Richter

The drug is administered both intra- and periarticularly. At the same time, it is possible to introduce no more than 3 large joints. Repeated injections are carried out only after a three-week break. Hydrocortisone is injected directly into the joint bag. This has a bad effect on hyaline cartilage, so therapy is carried out only once a year. In chronic tendonitis (inflammation of the tendons or degeneration of their tissues), the drug is injected only into the sheath of the tendon, and not into the tendon itself.


When and how to breed

For adults, the solution for administration is prepared on the basis of water for injection. It is diluted so that from 5 to 50 mg of fluid can be injected into the joint into each joint.

For children, the dose of 5-30 mg is divided into several times. For children under 1 year - 25 mg, from 1 year to 6-50 mg, from 6 to 14 years - 75 mg.

Interaction

In patients with Addison's disease, co-administration of hydrocortisone with barbiturates should be avoided.

Caution should be taken when using in parallel the following drugs and groups of drugs:

  • antidiabetic agents;
  • anticoagulants;
  • salicylates;
  • diuretics and cardiac medications due to the risk of hypokalemia;
  • oral contraceptives, which increase the amount of corticosteroids in the blood;
  • antihypertensive agents, the effect of which is reduced by taking corticosteroids.

special instructions

Vaccination is contraindicated as antibodies may not be sufficient. A diet high in potassium and low in sodium is recommended.

Be sure to monitor blood glucose and blood pressure.

With latent tuberculosis, mandatory chemoprophylaxis is carried out.

Application in childhood

In children, premature closure of the growth zones is often observed, which affects the ossification of the skeleton. It is recommended to take the medicine at the lowest effective dose.

During pregnancy and lactation

You can not use the medication during childbearing and during breastfeeding, since its effect on children's body not yet fully explored. Only in the later stages, when the fetus is already fully formed, it is possible to use Hydrocortisone, but only if the benefit to the woman will significantly outweigh the risks to the fetus.

It is advisable to refuse breastfeeding at the time of treatment, as this can lead to developmental delay and impaired adrenal function.


Analogues

There are a number of analogues. The most common among them are the following:

  • Prednisolone;
  • Dexamethasone;
  • Metipred;
  • Solu Cortef;
  • Betaspan;
  • Diprospan.

We should not forget that only a doctor can prescribe an analogue based on the patient's condition and other indications. It is forbidden to change the drug on your own.

Terms of sale

Released only on special prescription from a doctor.

Price

The cost in pharmacies varies from 190 to 220 rubles. for 1 pack.

Storage conditions and shelf life

Keep medical preparation should only be in the original packaging when room temperature. Protect as much as possible from direct sunlight. Hide from small children.

Dexamethasone | instructions for use (tablets)

Prednisolone | instructions for use (tablets)

Shelf life is 2 years from the date of manufacture indicated on the package.

Instructions for use

Description

Hydrocortisone has an anti-inflammatory, desensitizing (preventive or inhibitory) allergic reactions) and anti-allergic effect, has an immunosuppressive (overwhelming defensive forces organism) activity.

Active ingredients
Release form

Suspension

Compound

In 1 vial: Lidocaine (lidocaine) 25 mg; hydrocortisone (hydrocortisone) 125. Excipients: propyl parahydroxybenzoate - 0.5 mg, methyl parahydroxybenzoate - 4.5 mg, sodium chloride - 20.5 mg, sodium phosphate - 31.5 mg, sodium dihydrogen phosphate - 47.8 mg, povidone - 50 mg, polysorbate 80 - 25 mg, N, N-dimethylacetamide - 390 mg, water for injection - up to 5 ml.

Pharmacological effect

Hydrocortisone acetate is a glucocorticosteroid agent. It has an anti-inflammatory effect. Hydrocortisone inhibits the release of cytokines (interleukins and interferon) from lymphocytes and macrophages, inhibits the release of inflammatory mediators by eosinophils, reduces the intensity of arachidonic acid metabolism and prostaglandin synthesis. Activates steroid receptors, induces the formation of lipocortins, which have anti-edematous activity. Reduces inflammatory cell infiltration, prevents the migration of leukocytes and lymphocytes to the site of inflammation. In large doses, it inhibits the development of lymphoid and connective tissue. By reducing the number of mast cells, it reduces the formation of hyaluronic acid, inhibits hyaluronidase, and helps to reduce capillary permeability. It is intended for intramuscular, intra- and periarticular administration, in order to provide a systemic or local anti-inflammatory effect. With intra-articular administration, the therapeutic effect occurs within 6-24 hours and lasts for several days or weeks. Lidocaine is a local anesthetic with a membrane stabilizing effect that has an analgesic effect in a short time.

Pharmacokinetics

With intra-articular and peri-articular administration, hydrocortisone penetrates into the systemic circulation. Communication with proteins - more than 90%. It is metabolized in the liver to tetrahydrocortisone and tetrahydrocortisol, which are excreted by the kidneys in conjugated form. Penetrates through the placental barrier. Lidocaine is well absorbed and has a high affinity for plasma proteins. Metabolized mainly in the liver. The half-life is 1-2 hours. Lidocaine passes into breast milk, through the placental and blood-brain barriers.

Indications

Rheumatic diseases accompanied by arthritis, including osteoarthritis in the presence of synovitis (with the exception of tuberculous, gonorrheal, purulent and other infectious arthritis), rheumatoid arthritis, humeroscapular periarthritis, bursitis, epicondylitis, tendovaginitis.

Contraindications

Infected joint; Itsenko-Cushing's syndrome; tendency to thrombosis; I trimester of pregnancy; systemic infection without specific treatment; - diseases of the Achilles tendon; hypersensitivity to the components of the drug. Intra-articular administration is contraindicated in: Postponed arthroplasty; pathological bleeding (endogenous or caused by anticoagulants); intra-articular fracture of bones; infectious (septic) arthritis and periarticular infection (including history); common infectious disease; severe periarticular osteoporosis; osteoarthritis without synovitis (the so-called dry joint); unstable joint; aseptic necrosis of the epiphyses of the bones forming the joint; severe bone destruction and joint deformity (significant narrowing of the joint space, ankylosis).

Precautionary measures

With caution: peptic ulcer of the stomach and duodenum, herpes simplex, herpes simplex of the eye (the possibility of perforation of the cornea of ​​the eye), arterial hypertension, diabetes mellitus, incl. family history, osteoporosis (risk of osteoporosis increases in postmenopausal women), chronic psychotic reactions, history of tuberculosis, glaucoma, steroid myopathy, epilepsy, measles, chronic heart failure, advanced age (> 65 years), pregnancy (I-III tr.) , lactation period.

Use during pregnancy and lactation

Pregnant women in the first trimester, the administration of the drug is contraindicated due to the lack of sufficient data on the safety of the drug in this group; In the II-III trimesters of pregnancy, it is prescribed with caution. Children whose mothers received hydrocortisone during pregnancy should be carefully monitored to detect signs of adrenal insufficiency. Use with caution during lactation. glucocorticosteroids and lidocaine pass into breast milk.

Dosage and administration

Intra- and periarticular. In one day, Hydrocortisone-Richter can be injected into no more than 3 joints. Repeated injection is possible subject to a 3-week interval. The introduction of Hydrocortisone-Richter directly into the joint can have an adverse effect on hyaline cartilage, so the same joint can be treated no more than 3 times a year. For tendonitis, the injection should be given into the sheath of the tendon - it cannot be injected directly into the tendon. Adults: depending on the size of the joint and the severity of the disease, 5-50 mg intra- and periarticularly. Children: 5-30 mg/day divided into several doses. A single dose for periarticular administration to children aged 3 months. up to 1 year: 25 mg, from 1 year to 6 years: 25-50 mg, from 6 to 14 years: 50-75 mg.

Side effects

From the endocrine system: a decrease in glucose tolerance and an increase in the need for a hypoglycemic drug, the manifestation of latent diabetes, steroid diabetes mellitus. With long-term treatment - suppression of adrenal function, Itsenko-Cushing's syndrome, growth retardation in children and adolescents. On the part of the digestive system: nausea, vomiting, pancreatitis, peptic ulcer, esophagitis, bleeding and perforation of the gastrointestinal tract, increased appetite, flatulence, hiccups, in rare cases cases - an increase in the activity of hepatic transaminases and alkaline phosphatase. From the side of the cardiovascular system: with significant absorption, lidocaine can cause impaired conduction in the heart and peripheral vasodilation; at high doses of hydrocortisone: increased blood pressure, hypokalemia and its characteristic ECG changes, thromboembolism, heart failure. depressive psychosis, depression, paranoia, increased intracranial pressure with edema of the optic nerve papilla, dizziness, pseudotumor of the cerebellum, headache. From the side of metabolism: increased excretion of potassium, hypokalemia, weight gain, negative nitrogen balance, increased sweating. From the side of the organ of vision : corneal ulceration, posterior capsular cataract (more likely in children), increased intraocular pressure with possible damage to the optic nerve, secondary bacterial fungal and viral eye infections, trophic changes in the cornea, exophthalmos, glaucoma. 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 of the head of the humerus and femur, rupture of tendons and muscles, steroid myopathy, decreased muscle mass, arthralgia. Effects due to the mineralocorticoid activity of the drug: fluid and sodium retention with the formation of peripheral edema, hypernatremia, hypokalemic syndrome (hypokalemia, arrhythmia, myalgia, muscle spasm, increased weakness, fatigue), hypokalemic alkalosis. From the immune system: opportunistic infections, exacerbation of latent tuberculosis, hypersensitivity reactions; local and generalized: skin rash, itching, anaphylactic shock, delayed wound healing, a tendency to develop pyoderma and candidiasis, exacerbation of infections, especially with vaccination and simultaneous treatment with immunosuppressive agents. Dermatological reactions: petechiae, ecchymosis, hyper- and hypopigmentation, steroid acne, striae, atrophy of the skin and subcutaneous tissue at the injection site (injection into the deltoid muscle is especially dangerous), folliculitis, hirsutism, hypopigmentation, irritation, telangiectasia. Others: feeling unwell, withdrawal syndrome (high body temperature, myalgia, arthralgia, adrenal insufficiency), leukocyturia, leukocytosis. Local reactions: increased pain in the joint when injected into the joint, tissue swelling, burning, numbness, paresthesia at the injection site, rarely - necrosis of surrounding tissues, formation scarring at the injection site.

Overdose

Depending on the dose of corticosteroids and lidocaine, both local and systemic symptoms may appear. There is no specific antidote. Carry out symptomatic treatment.

Interaction with other drugs

In Addison's disease, simultaneous administration with barbiturates can provoke a crisis. Increases the toxicity of cardiac glycosides (proarrhythmogenic effect of hypokalemia). Reduces the hypotensive effect of antihypertensive drugs. Accelerates the excretion of acetylsalicylic acid, reducing its concentration in the blood. With the abolition of hydrocortisone, the concentration of salicylates in the blood may increase and lead to the development of adverse reactions. Both drugs have an ulcerogenic effect, their simultaneous use can increase the risk of ulceration and bleeding. Vaccination with live antiviral vaccines and other types of immunization during treatment with hydrocortisone contributes to the activation of viruses and the development of infections. Increases the metabolism of isoniazid, mexiletine, especially in patients with fast acetylators, reducing plasma concentrations of these drugs. It enhances the hepatotoxic effect of paracetamol, because induces liver enzymes and the formation of a toxic metabolite of paracetamol. With prolonged treatment, it increases the content of folic acid. Hypokalemia caused by corticosteroids increases the severity and duration of muscle blockade of muscle relaxants. High doses of hydrocortisone reduce the effect of somatotropin. Reduces the effectiveness of oral hypoglycemic agents, dose adjustment may be required. Reduces either enhances the effect of anticoagulant drugs. Ergocalciferol and parathyroid hormone prevent the development of glucocorticosteroid osteopathy. Reduces the concentration of praziquantel in the blood. Cyclosporine inhibits the metabolism of hydrocortisone. Ketoconazole reduces clearance and increases hydrocortisone toxicity. Thiazide diuretics, carbonic anhydrase inhibitors, amphotericin B, theophylline and other corticosteroids increase the risk of hypokalemia. Sodium-containing medicines contribute to the formation of edema and increase blood pressure. NSAIDs and ethanol contribute to ulceration of the gastrointestinal mucosa and the development of bleeding. When treating arthritis with hydrocortisone in combination with NSAIDs, the dose of hydrocortisone should be reduced to avoid an additive therapeutic effect. Indomethacin, displacing hydrocortisone from its association with proteins, contributes to the development of adverse reactions of the latter. Amphotericin B and carbonic anhydrase inhibitors increase the risk of osteoporosis. Phenytoin, barbiturates, ephedrine, theophylline , phenylbutazone, rifampicin and other inducers of microsomal liver enzymes reduce the effect of hydrocortisone, increasing its metabolism. With the simultaneous use of mitotane and other inhibitors of the adrenal cortex, an increase in the dose of hydrocortisone may be required. Drugs - thyroid hormones increase the clearance of hydrocortisone. Immunosuppressive agents increase the risk of developing infections, lymphoma and lymphoproliferative processes caused by the Epstein-Barr virus. Estrogens, including oral estrogen-containing contraceptives, reduce the clearance of hydrocortisone, prolonging the half-life and increasing aya therapeutic and toxic effects of the latter. Simultaneous use with other steroid hormonal agents (androgens, estrogens, anabolics, oral contraceptives) contributes to the development of acne and hirsutism. they can aggravate the course of depression. Simultaneous administration with M-anticholinergics, incl. antihistamines, tricyclic antidepressants and nitrates, contributes to an increase in intraocular pressure. The action of GCS weakens when taken with mifepristone.

special instructions

The injection is administered subject to the rules of asepsis in order to avoid the development of bacterial infection. During treatment, any vaccination is contraindicated, because. during treatment with corticosteroids, especially in high doses, can lead to insufficient synthesis of antibodies. During treatment, a sodium-restricted diet is recommended, high content potassium and provision enough protein in food. It is necessary to control blood pressure, measure the level of glycemia, blood coagulation, control urine and feces. Relative adrenal insufficiency that occurs after the end of the action of GCS can persist for several months after drug withdrawal, therefore, in a state of increased stress, hormone therapy should be resumed with concomitant administration of mineralocorticosteroids and salts. Children whose mothers received hydrocortisone during pregnancy should be carefully monitored to detect signs of adrenal insufficiency. In the latent form of tuberculosis and during the turn of tuberculin tests, careful monitoring of the patient's condition and, if necessary, chemoprophylaxis is necessary. GCS slow down the growth and development of children and adolescents. It is recommended to prescribe the drug in the smallest therapeutic doses and, if possible, for the shortest possible time.

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