Hydrocortisone-Richter suspension for injection 125mg 5ml
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Description
Hydrocortisone has anti-inflammatory, desensitizing (preventing or inhibiting allergic reactions) and antiallergic effect, has immunosuppressive (suppressive body defenses) activity.
Active ingredients
Hydrocortisone
Release form
Suspension
Composition
In 1 vial: Lidocaine (lidocaine) 25 mg; hydrocortisone (hydrocortisone) 125. Auxiliary substances: propyl parahydroxybenzoate - 0.5 mg, methyl parahydroxybenzoate - 4.5 mg, sodium chloride - 20.5 mg, sodium phosphate - 31.5 mg, sodium dihydrophosphate - 47.8 mg, povidone - 50 mg, polysorbate 80 - 25 mg, N, N-dimethylacetamide - 390 mg, water d / and - up to 5 ml.
Pharmacological effect
Hydrocortisone Acetate is a glucocorticosteroid agent. It has 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 the synthesis of prostaglandins. Activates steroid receptors, induces the formation of lipocortins, which have anti-edema activity. Reduces inflammatory cellular infiltration, prevents the migration of leukocytes and lymphocytes to the sites of inflammation. In large doses inhibits the development of lymphoid and connective tissue. Reducing the number of mast cells, reduces the formation of hyaluronic acid, inhibits hyaluronidase, helps to reduce capillary permeability. Designed for intramuscular, intra-and periarticular injection, with the aim of providing systemic or local anti-inflammatory action. With intra-articular administration, the therapeutic effect occurs within 6-24 hours and lasts for several days or weeks. Lidocaine - a local anesthetic with membrane stabilizing effect, in a short time has an anesthetic effect.
Pharmacokinetics
With intraarticular and periarticular injection, hydrocortisone penetrates 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. It penetrates the placental barrier. Lidocaine is well absorbed, has a high affinity with plasma proteins.Metabolized mainly in the liver. The half-life is 1-2 hours. Lidocaine penetrates into breast milk through the placental and blood-brain barriers.
Indications
Rheumatic diseases associated with arthritis, including osteoarthritis in the presence of synovitis (with the exception of tuberculosis, gonorrheal, purulent, and other infectious arthritis), rheumatoid arthritis, scleuroleutomatous periarthritis, bursitis, epicondylitis, tendovaginitis.
Contraindications
Infected joint; Itsenko-Cushing syndrome; tendency to thrombosis; I trimester of pregnancy; systemic infection without specific treatment; - Achilles tendon disease; Hypersensitivity to the components of the drug. Intra-articular administration is contraindicated in: Transferred arthroplasty; abnormal 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).
Precautionary measures
With caution: gastric ulcer and duodenal ulcer, herpes simplex, herpes simplex of the eye (the 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 identify signs of adrenal insufficiency. Use with caution during lactation. 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.
Dosage and administration
Intra- and periarticular. In one day, Hydrocortisone-Richter can be administered in no more than 3 joints. Repeated injection is possible with 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. With tendinitis, an injection should be made into the vagina of the tendon — you cannot directly enter the tendon. Adults: depending on the size of the joint and the severity of the disease, 5-50 mg intra- and periarticular. Children: 5-30 mg / day, divided into several doses. Single dose with periarticular administration in 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
On the part of the endocrine system: a decrease in glucose tolerance and an increase in the need for a glucose-lowering drug, manifestation of latent diabetes, steroid diabetes. With long-term treatment - suppression of adrenal function, Itsenko-Cushing syndrome, growth retardation in children and adolescents. On the digestive system: 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. From the cardiovascular system: with significant absorption, lidocaine can cause impaired cardiac conduction and peripheral vasodilation; at high doses of hydrocortisone: increased blood pressure, hypokalemia and ECG changes, thromboembolism, heart failure characteristic of it. On the nervous system: insomnia, irritability, anxiety, agitation, euphoria, epileptiform seizures, mental disorders, delirium, disorientation, hallucinations, maniacal depression psychosis, depression, paranoia,increased intracranial pressure with swelling of the nipple of the optic nerve, dizziness, cerebellar pseudotumor, headache. Metabolism: increased excretion of potassium, hypokalemia, weight gain, negative nitrogen balance, increased sweating. On the part of the organ of vision: corneal ulceration, posterior capsular cataract (more likely in children), an increase in intraocular pressure with possible damage to the optic nerve, secondary bacterial fungal and viral infections of the eye, trophic changes ova, exophthalmos, glaucoma. From the 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, the tendon and muscle rupture, steroid myopathy, decrease in muscle mass, arthralgia. Effects caused by the mineralocorticoid activity of the drug: fluid and sodium retention with the formation of peripheral edema, hypernatremia, hypokalemic syndrome lyemia, arrhythmia, myalgia, muscle spasm, increased weakness, fatigue), hypokalemic alkalosis. On the immune system: opportunistic infections, exacerbation of latent tuberculosis, hypersensitivity reactions; local and generalized: skin rash, pruritus, anaphylactic shock, delayed wound healing, a tendency to the development of pyoderma and candidiasis, exacerbation of infections, especially during vaccination and simultaneous treatment of immunosuppressive drugs. 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. Others: poor self-feeling no, withdrawal syndrome (high body temperature, myalgia, arthralgia, adrenal insufficiency), leukocyturia, leukocytosis. Local reactions: increased pain in the joint when injected into the joint, swelling of tissues, burning, numbness, paresthesia at the injection site, rarely - necrosis of surrounding tissues , scarring at the injection site.
Overdose
Depending on the dose of GCS and lidocaine, the appearance of both local and systemic symptoms is possible. There is no specific antidote. Symptomatic treatment is performed.
Interaction with other drugs
With Addison's disease, simultaneous administration with barbiturates can trigger 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 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 can increase the risk of ulceration and bleeding. Vaccination with live antiviral vaccines and other types of immunization during treatment with hydrocortisone promotes the activation of viruses and the development of infections. 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 folic acid levels. Hypokalemia caused by GCS increases the severity and duration of muscle blockade of muscle relaxants. High doses of hydrocortisone reduce the effect of somatotropin. enhances the effect of anticoagulant drugs. Ergocalciferol and parathyroid hormone prevent the development of glucocorticosteroid therapy. teopathy. lowers the concentration of praziquantel in the blood 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 to avoid an additive therapeutic effect. Indomethacin, displacing hydrocortisone from its association with proteins, contributes to the development of adverse reactions of the latter. , phenylbutazone, rifampicin, and other inducers of microsomal liver enzymes reduce the effect of hydrocortisone, increasing its metabolism. When applied simultaneously Otan and other inhibitors of the adrenal cortex may require an increase in the dose of hydrocortisone. Medications - thyroid hormones increase the clearance of hydrocortisone. Immunosuppressants increase the risk of developing infections, lymphoma, and lymphoproliferative processes caused by the Epstein-Barr virus. hydrocortisone, lengthening the half-life and enhancing the therapeutic and toxic effects of the latter. Simultaneously Used with other steroid hormonal agents (androgens, estrogens, anabolic steroids, oral contraceptives) contributes to the development of acne and hirsutism. It is not recommended to use tricyclic antidepressants for the treatment of hydrocortisone depression, because they can aggravate the course of depression. Simultaneous intake with M-holinoblokatorami, incl. antihistamines, tricyclic antidepressants and nitrates, promotes an increase in intraocular pressure. The effect of GCS is weakened while taking it with mifepristone.
special instructions
The injection is administered while observing the asepsis rules in order to avoid the development of bacterial contamination. During the treatment, any vaccination is contraindicated, since during treatment, corticosteroids, especially in large doses, can lead to insufficient antibody synthesis. During treatment, a diet with sodium restriction, increased potassium content and ensuring sufficient protein in food is recommended. Blood pressure control, measurement of blood glucose, blood clotting, urine control are needed. and kala. Relative adrenal insufficiency that occurs at the end of the GCS,may persist for several months after discontinuation of the drug, therefore, in a state of increased 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. and during the turn of tuberculin samples, careful monitoring of the patient’s condition is necessary, and, if necessary, carrying out x iprophylaxis. GKS 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.