Hydrocortisone suspension 25mg/ml vial 5 ml №1

Indications

- rheumatic diseases associated with arthritis, incl. osteoarthritis in the presence of synovitis (with the exception of tuberculous, gonorrheal, purulent and other infectious arthritis);

- rheumatoid arthritis;

- humeroscapular periarthritis;

- bursitis;

- epicondylitis;

- tendovaginitis.

Dosage and administration

Intra- and periarticular. In one day, you can enter no more than 3 joints. Repeated injection is possible with a 3-week interval. Introduction directly into the joint may have an adverse effect on hyaline cartilage, therefore, the same joint can be treated no more than 3 times a year.

In case of tendinitis, the injection should be inserted into the vagina of the tendon - it cannot be inserted directly into the tendon. Not acceptable for systemic treatment and for the treatment of Achilles tendon.

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

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

In the elderly patients the risk of adverse reactions is higher.

Adverse effects

Adverse reactions primarily occur at the injection site, most often in the form of tissue swelling 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, thin and sensitive skin, telangiectasia are possible.

With long-term treatment and the use of large doses of glucocorticoids and Lidocaine, systemic side effects may develop.

On the part of the endocrine system: decrease in glucose tolerance and an increase in the need for a sugar-lowering drug, manifestation of latent diabetes, steroid diabetes mellitus. With long-term treatment - inhibition of adrenal function, Itsenko-Cushing syndrome, growth retardation in children and adolescents.

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

Cardiovascular: with significant absorption, lidocaine can cause impaired conduction in the heart and peripheral vasodilation; with large doses of Hydrocortisone : increased blood pressure, hypokalemia and its characteristic ECG changes, thromboembolism, heart failure.

Nervous system: insomnia, irritability, anxiety, agitation, euphoria, epileptiform convulsions, mental disorders, delirium, disorientation, hallucinations, manic-depressive psychosis, depression, paranoia, increased intracranial pressure with swelling of the nipple of the optic nerve, dizziness, cerebellar pseudo-tumor, headache, cerebral palsy

Metabolism: increased excretion of potassium, hypokalemia, weight gain, negative nitrogen balance, increased sweating.

Special senses: corneal ulceration, posterior capsular cataract (more likely in children), increased intraocular pressure with possible damage to the optic nerve, secondary bacterial fungal and viral infections of the eye, trophic changes of the cornea, exophthalmos, glaucoma.

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

Effects caused by 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.

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

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

Other: 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 edema, burning, numbness, paresthesia at the injection site, rarely necrosis of the surrounding tissues, scarring at the injection site.

Contraindications

- an infected joint;

- Itsenko-Cushing syndrome;

- tendency to thrombosis;

- I trimester of pregnancy;

- systemic infection without specific treatment;

- Achilles tendon disease;

- hypersensitivity to the drug.

Intra-articular administration is contraindicated in:

- transferred arthroplasty;

- pathological bleeding (endogenous or caused by anticoagulants);

- intraarticular bone fracture;

- Infectious (septic) arthritis and periarthricular infection (including a history of);

- general infectious disease;

- pronounced periarticular osteoporosis;

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

- unstable joint;

- Aseptic necrosis of the bone-forming epiphyses;

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

Carefully: peptic ulcer and duodenal ulcer, herpes simplex, herpes simplex of the eye (possibility of perforation of the cornea), arterial hypertension, diabetes mellitus including family history, osteoporosis (postmenopausal risk of osteoporosis increases), chronic psychotic reactions, history of tuberculosis, glaucoma, steroid myopathy, epilepsy, measles, chronic heart failure, old age (> 65 years), pregnancy (I-III). lactation period.

Use during pregnancy and lactation

For pregnant women in the first trimester, the drug is contraindicated due to the lack of sufficient data on the safety of the drug in this group, at a later date - possible only after careful weighing of the intended benefits to the mother and the potential risk to the fetus (the probability of formation of a split palate and intrauterine disorders is small). In the II-III trimesters of pregnancy 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.

The use of the drug during lactation can lead to dysfunction of the adrenal glands and the development of infants, because glucocorticosteroids and lidocaine enter breast milk.

Application for violations of the liver

Data on the use of the drug in patients with impaired liver function is not provided.

Application for violations of kidney function

Data on the use of the drug in patients with impaired renal function is not provided.

Use in children

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

Possible growth retardation and ossification processes in children and adolescents (premature closure of the epiphyseal growth zones). It is recommended to prescribe the drug in the smallest therapeutic doses and, if possible, for the least short term.

Use in elderly patients

In elderly patients, the risk of side effects is higher.

special instructions

The injection is administered while observing the asepsis rules in order to avoid the development of bacterial contamination.

During treatment, any vaccination is contraindicated, because during treatment with corticosteroids, especially in large doses, may lead to insufficient antibody synthesis.

During treatment, a diet with sodium restriction, a high content of potassium and the provision of a sufficient amount of protein in food is recommended.

It is necessary to control blood pressure, measure blood glucose, blood clotting, monitor urine and feces.

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

Children whose mothers received hydrocortisone during pregnancy should be carefully monitored to detect signs of adrenal insufficiency.

In the case of latent tuberculosis and during the turn of tuberculin samples, careful monitoring of the patient’s condition and, if necessary, chemoprophylaxis are 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 least short term.

Overdose

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

There is no specific antidote. Symptomatic treatment is performed.

Drug interaction

With Addison's disease, simultaneous administration with barbiturates can trigger a crisis. Increases the toxicity of cardiac glycosides (pro-arrhythmic effect of hypokalemia).

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

With the withdrawal 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 promote the activation of viruses and the development of infections.

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

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

With prolonged treatment increases the content of folic acid.

Hypokalemia caused by GCS 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, you may need a dose adjustment.

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 hydrocortisone metabolism.

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.

Sodium-containing drugs 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. In the treatment of arthritis with hydrocortisone in combination with NSAIDs, the dose of hydrocortisone should be reduced in order to avoid an additive therapeutic effect.

Indomethacin, displacing hydrocortisone from its association with proteins, contributes to the development of side 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 simultaneous use of mitotane and other inhibitors of the adrenal cortex, it may be necessary to increase the dose of hydrocortisone.

Drugs - thyroid hormones increase the clearance of hydrocortisone.

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

Estrogens, including oral estrogen-containing contraceptives, reduce the clearance of hydrocortisone, extending the half-life and enhancing the 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.

It is not recommended to use tricyclic antidepressants for the treatment of hydrocortisone-induced depression, since they can aggravate the course of depression.

Simultaneous reception with M-holinoblokatorami, incl. antihistamines, tricyclic antidepressants and nitrates, promotes an increase in intraocular pressure.

The action of corticosteroids weakens when taken with mifepristone.

Terms and conditions of storage

Storage conditions:

Store in original packaging at a temperature of 15-30 ° C in a dark place and out of reach of children.