Hydrocortisone Nizhpharm ointment 1% 10g
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Active ingredients
Hydrocortisone
Release form
Ointment
Composition
1 g contains: hydrocortisone acetate 10 mg.
Pharmacological effect
GKS. Suppresses the function of leukocytes and tissue macrophages. Limits the migration of leukocytes to the area of inflammation. Violates the ability of macrophages to phagocytosis, as well as the formation of interleukin-1. It contributes to the stabilization of lysosomal membranes, thereby reducing the concentration of proteolytic enzymes in the area of inflammation. Reduces capillary permeability due to histamine release. Suppresses the activity of fibroblasts and the formation of collagen. Inhibits the activity of phospholipase A2, which leads to the suppression of the synthesis of prostaglandins and leukotrienes. Suppresses the release of COX (mainly COX-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 movement from the vascular bed to the lymphoid tissue; inhibits the formation of antibodies. Hydrocortisone suppresses the release of ACTH and β-lipotropin by the pituitary gland, but does not reduce the level of circulating β-endorphin. Inhibits the secretion of TSH and FSH. When directly applied to the vessels, it has a vasoconstrictor effect. Hydrocortisone has a pronounced dose-dependent effect on the metabolism of carbohydrates, proteins and fats. Stimulates gluconeogenesis, promotes the uptake of amino acids by the liver and kidneys and increases the activity of gluconeogenesis enzymes. In the liver, hydrocortisone enhances the deposition of glycogen, stimulating the activity of glycogen synthetase and the synthesis of glucose from the products of protein metabolism. An increase in blood glucose activates the release of insulin. Hydrocortisone inhibits glucose uptake by fat cells, which leads to the activation of lipolysis. However, due to an increase in insulin secretion, lipogenesis is stimulated, which leads to fat accumulation. It has a catabolic effect in lymphoid and connective tissue, muscles, adipose tissue, skin, bone tissue. To a lesser extent than mineralocorticoids, it affects the processes of water and electrolyte metabolism: it promotes the excretion of potassium and calcium ions, and the delay in the body of sodium and water ions.Osteoporosis and Itsenko-Cushing syndrome are the main factors limiting long-term therapy of corticosteroids. As a result of the catabolic effect, growth inhibition in children is possible. At high doses, hydrocortisone can increase the excitability of the brain tissue and help lower the threshold of convulsive readiness. Stimulates excess production of hydrochloric acid and pepsin in the stomach, which contributes to the development of peptic ulcer. ) action. By anti-inflammatory activity 4 times weaker than prednisolone, in mineralocorticoid activity exceeds other GCS.
Pharmacokinetics
Binding to plasma proteins - 40-90%. Metabolized mainly in the liver. T1 / 2 - 80-120 min. Excreted by the kidneys mainly in the form of metabolites.
Indications
For parenteral application: acute adrenal insufficiency, allergic immediate type asthmatic status, prevention and treatment of shock, myocardial infarction complicated with cardiogenic shock, thyrotoxic crisis, thyroiditis, congenital adrenal hyperplasia, hypercalcemia due to a tumorous disease, short or adjunctive therapy in acute rheumatic diseases, collagen diseases, pemphigus, dermatitis herpetiform dermatitis (Duhring's disease), polymorphic bullous erythema , Exfoliative dermatitis, mycosis fungoides, severe psoriasis and seborrheic dermatitis, severe acute and chronic allergic and inflammatory processes in eye disease, symptomatic sarcoidosis, Loeffler's syndrome, is not amenable to other therapies, berylliosis, localized or disseminated tuberculosis with simultaneous antituberculosis chemotherapy aspiration pneumonitis, idiopathic thrombocytopenic purpura of adults (only in / in!), secondary thrombocytopenia of adults, acquired (autoimmune) hemolytic anemia, erythroblastopenia, congenital (erythroid) hypoplastic anemia,palliative therapy in adults with leukemia and lymphomas, in acute leukemia in children, to enhance diuresis or to reduce proteinuria in nephrotic syndrome without uremia, in nephrotic syndrome of idiopathic type or in lupus erythematosus, in a critical stage of ulcerative colitis and regional regional enteritis (as a systemic treatment ), tuberculous meningitis with the development of the subarachnoid block or with its threat (in combination with anti-tuberculosis chemotherapy), trichinosis with lesions of the nervous system or myocardium, bronchia flax asthma, diseases of the joints. For local use: inflammation of the anterior part of the eyeball with undisturbed corneal epithelium and after injuries and surgical interventions on the eyeball. For external use: allergic dermatitis, seborrhea, various forms of eczema, neurodermatitis, psoriasis, scruffy red flat wart deprive.
Contraindications
For short-term use for vital reasons, hypersensitivity to hydrocortisone. For intra-articular administration and administration directly into the lesion: anterior arthroplasty, abnormal bleeding (endogenous or caused by anticoagulants), intra-articular fracture of the bone, infectious (septic) inflammation in the joint and periartikulykulyarku (including history), as well as a common infectious disease, marked periarticular osteoporosis, the absence of signs during burning in the joint (dry joint, for example, osteoarthritis without synovitis), severe bone destruction and joint deformity (sharp joint space narrowing, ankylosis), joint instability as an outcome of arthritis, aseptic necrosis of the bone-forming epiphysis. For external use: bacterial, viral, fungal skin diseases, skin tuberculosis, skin manifestations of syphilis, skin tumors, post-vaccination period, violation of the integrity of the skin (ulcers, wounds), children (up to 2 years, with itching in the anus - up to 12 years), p zatsea, acne vulgaris, perioral dermatit.Dlya use in ophthalmology: bacterial, viral, fungal diseases of the eye, eye disease tuberculosis, trachoma, impaired ocular epithelial integrity.
Precautionary measures
Application for violations of liver functionWith caution in severe hepatic insufficiency.Application for violations of renal functionWith caution in severe chronic renal failure.Application in childrenContraindications for external use: children up to 2 years, with itching in the anus - up to 12 years.
Use during pregnancy and lactation
Use during pregnancy is possible only when the intended benefit to the mother outweighs the potential risk to the fetus; It is recommended to use the minimum dose and short-term therapy. Children whose mothers received hydrocortisone during pregnancy should be carefully monitored to detect signs of adrenal insufficiency. If necessary, use should be made to discontinue breastfeeding during lactation. Experimental studies have shown that GCS can cause fetal developmental disorders. Currently, there is no clear evidence of this data in humans.
Dosage and administration
For parenteral use. Dosage regimen is individual. Used in / in jet, in / in drip, rarely - in / m. For emergency treatment is recommended in / in the introduction. The initial dose is 100 mg (administered over 30 seconds) - 500 mg (administered over 10 minutes), then again every 2-6 hours, depending on the clinical situation. High doses should be used only to stabilize the patient's condition, but usually no more than 48-72 hours, because possible development of hypernatremia. Children - at least 25 mg / kg / day. In the form of a depot form is administered intra - or periarticular at a dose of 5-50 mg once with an interval of 1-3 weeks. V / m - 125-250 mg / day. In ophthalmology, apply 2-3 times / day. Outside - 1-3 times / day.
Side effects
From endocrine system: reduction of glucose tolerance, steroid diabetes or a manifestation of latent diabetes mellitus, adrenal suppression, Cushing's syndrome (including moon face, obesity, pituitary type, hirsutism, increased blood pressure, dysmenorrhea, amenorrhea, myasthenia gravis , striae), delayed sexual development in children. On the side of metabolism: increased excretion of calcium ions, hypocalcemia, increased body weight, negative nitrogen balance (increased protein breakdown), increased sweating, ass rzhka fluids and sodium ions (peripheral edema), hypernatremia, hypokalemic syndrome (includinghypokalemia, arrhythmia, myalgia or muscle spasm, unusual weakness and fatigue) For part of the central nervous system: delirium, disorientation, euphoria, hallucinations, manic-depressive psychosis, depression, paranoia, increased intracranial pressure, nervousness or anxiety, insomnia, dizziness, vertigo, cerebellar pseudotumor, headache, convulsions. From the cardiovascular system: arrhythmias, bradycardia (up to cardiac arrest); development (in susceptible patients) or increased severity of chronic heart failure, ECG changes characteristic of hypokalemia, increased blood pressure, hypercoagulation, thrombosis. In patients with acute and subacute myocardial infarction - the spread of necrosis, slowing the formation of scar tissue, which can lead to rupture of the heart muscle; for intracranial administration - nasal bleeding. From the digestive system: nausea, vomiting, pancreatitis, steroid gastric and duodenal ulcer, erosive esophagitis, bleeding and perforation of the gastrointestinal tract, increased or decreased appetite, flatulence, hiccups; rarely, increased activity of hepatic transaminases and alkaline phosphatars. From the sensory organs: sudden loss of vision (when parenterally administered to the head, neck, nasal conchaea, scalp, the crystals of the drug in the eye vessels may be deposited), posterior subcapsular cataract, increased intraocular pressure with possible damage to the optic nerve, a tendency to develop secondary bacterial, fungal or viral infections of the eye, trophic changes of the cornea, exophthalmos. From the musculoskeletal system: growth retardation ossification processes in children (premature closure of epiphyseal growth zones), osteoporosis (very rare - pathological fractures, aseptic necrosis of the humeral head and femur), rupture of tendons of muscles, steroid myopathy, loss of muscle mass (atrophy); with intra-articular injection - increased pain in the joint. Dermatological reactions: delayed wound healing, petechiae, ecchymosis, thinning of the skin, hyper or hypopigmentation, steroid acne, stria, a tendency to develop pyoderma and candidiasis. Allergic reactions: generalized (includingskin rash, itchy skin, anaphylactic shock), local allergic reactions. Effects caused by immunosuppressive effects: the development or exacerbation of infections (jointly used immunosuppressants and vaccination contribute to the occurrence of this side effect). paresthesias and infections at the site of administration; rarely, necrosis of surrounding tissues, scar formation at the injection site; with intramuscular injection (especially in the deltoid muscle) - atrophy of the skin and subcutaneous tissue. Others: leukocyturia, withdrawal syndrome. When administered intravenously, arrhythmias, flushing of the face, convulsions. burning, dryness, folliculitis, acne, hypopigmentation, perioral dermatitis, allergic dermatitis, skin maceration, secondary infection, skin atrophy, stretch marks, prickly heat. With prolonged use or application to large areas of skin may develop systemic side effects characteristic of GCS.
Interaction with other drugs
With simultaneous use of hydrocortisone increases the toxicity of cardiac glycosides (due to the resulting hypokalemia increases the risk of arrhythmias); with acetylsalicylic acid - accelerates its excretion and reduces its concentration in the blood plasma (with the withdrawal of hydrocortisone, the concentration of salicylates in the blood increases and the risk of side effects increases); with paracetamol - an increased risk of the development of the hepatotoxic effect of paracetamol (induction of hepatic enzymes and the formation of a toxic metabolite of paracetamol); with cyclosporine - increased side effects of hydrocortisone due to inhibition of its metabolism; with ketoconazole - increased side effects of hydrocortisone due to a decrease in its clearance. Hydrocortisone reduces the effectiveness of hypoglycemic agents; enhances the effect of indirect anticoagulants of coumarin derivatives. Hydrocortisone reduces the effect of vitamin D on the absorption of calcium ions in the intestinal lumen. Ergocalciferol and parathyroid hormone prevent the development of osteopathy caused by GCS. Hydrocortisone enhances the metabolism of isoniazid, meksiletin (especially in fast acetylators), which leads to a decrease in their plasma concentrations; increases (with long-term therapy) the content of folic acid; reduces the concentration of praziquantel in the blood. Hydrocortisone in high doses reduces the effect of somatropin. Hypokalemia caused by GCS,can increase the severity and duration of muscle blockade on the background of muscle relaxants. Antacids reduce GCS absorption. When used simultaneously with GCS, thiazide diuretics, carbonic anhydrase inhibitors, other GCS, amphotericin B increase the risk of hypokalemia, drugs containing sodium edema and edema and elevated ADS. ethanol increases the risk of ulceration of the mucous membrane of the gastrointestinal tract and bleeding, in combination with NSAIDs for the treatment of arthritis may reduce the dose of GCS due to the summation of the therapeutic effect. Indomethacin, displacing corticosteroids from association with albumin, increases the risk of side effects. Amphotericin B and carbonic anhydrase inhibitors increase the risk of osteoporosis. The therapeutic effect of corticosteroids is reduced under the influence of inducers of microsomal liver enzymes (including phenytoin, barbiturates, ephedrine, theophylline, rifampicin) due to an increase in the metabolic rate of these substances. Inhibitors of the function of the adrenal cortex (including mitotane) may necessitate an increase in the dose of GCS. The clearance of GCS rises against the background of prep Ratov zhelezy.Immunodepressanty thyroid hormones increase the risk of infections and lymphoma or other lymphoproliferative disorders associated with Epstein-Barr.Estrogeny (including oral contraceptives estrogensoderzhaschie) reduce clearance GCS extend T1 / 2 and their therapeutic and toxic effects. The emergence of hirsutism and acne contributes to the simultaneous use of other steroid hormonal agents - androgens, estrogens, anabolic steroids, oral contraceptives. Tricyclic antidepressants may increase the severity of depression caused by the use of GCS (not shown for the treatment of these side effects). The risk of developing cataracts increases when used against others GCS, antipsychotics (neuroleptics), carbutamide and azathioprine. Simultaneous administration with m-holinoblokatorami, as well as with agents that have m-holinoblokiruyuschim action (including antihistamines, tricyclic antidepressants), with nitrates increases intraocular pressure. With the simultaneous use of corticosteroids with live antiviral vaccines and other types of immunization increases the risk of activation viruses and the development of infections.
special instructions
Use with caution in parasitic and infectious diseases of viral, fungal or bacterial nature (currently or recently transferred, including recent contact with a patient) - herpes simplex, herpes zoster (viraemic phase), chicken pox, measles, amebiasis, strongyloidosis (established or suspect), systemic mycosis; active and latent tuberculosis. Use in severe infectious diseases is permissible only against the background of specific therapy. Use with caution for 8 weeks before and 2 weeks after vaccination, for lymphadenitis after BCG vaccination, for immunodeficiency states (including AIDS or HIV infection). With caution to be used for gastrointestinal diseases: gastric ulcer and duodenal ulcer, esophagitis, gastritis, acute or latent peptic ulcer, newly created intestinal anastomosis, nonspecific ulcerative colitis with the threat of perforation or abscess iting, diverticulitis. Use with caution in diseases of the cardiovascular system, including after a recent myocardial infarction (patients with acute and subacute myocardial infarction may spread necrosis, slow the formation of scar tissue and, as a result, rupture of the heart muscle), with decompensated chronic heart failure, hypertension, hyperlipidemia), with endocrine diseases - diabetes mellitus ( including violation of tolerance to carbohydrates), thyrotoxicosis, hypothyroidism, Itsenko-Cushing's disease, with severe chronic renal and / or liver failure, nephrourolithiasis, with hypoalbuminemia and conditions predisposing to its occurrence, with systemic osteoporosis, myasthenia, acute psychosis, obesity (III-IV degree), with poliomyelitis (with the exception of the form of bulbar encephalitis), open-and-closed-angle glaucoma, pregnancy, and a sample, pregnancy, anesthesia, anesthesia the need for intra-articular administration should be used with caution in patients with a general serious condition, ineffectiveness (or short duration) of the effect of the 2 previous injections (taking into account the individual properties of the used GCS). oh efficiency hydrocortisone for 48-72 hours and the need for long-term therapy it is advisable to replace the glucocorticoid hydrocortisone another drug that does not cause sodium retention.During treatment with hydrocortisone, it is recommended to prescribe a diet with sodium restriction and increased potassium content. The relative adrenal insufficiency caused by hydrocortisone may persist for several months after its withdrawal. Given this, in stressful situations that occur during the specified period, hormonal therapy is resumed with simultaneous administration of salts and / or mineralocorticoids. In patients with active tuberculosis, hydrocortisone should be used in combination with appropriate anti-tuberculosis therapy. In the case of latent tuberculosis or during tuberculin turn tests, the patient’s condition should be carefully monitored, and chemoprophylaxis should be carried out if necessary.