Cortef pills 10 mg 100 pcs
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Active ingredients
Hydrocortisone
Release form
Pills
Composition
Active ingredient: Hydrocortisone (Hydrocortisone); Concentration of the active substance (mg): 10
Pharmacological effect
Synthetic analogue of natural GCS. It has primarily anti-inflammatory effect, has moderate mineralocorticoid properties, can be used for replacement therapy in case of deficiency of adrenal hormones. Like other corticosteroids, hydrocortisone has significant and diverse metabolic effects. In addition, hydrocortisone alters the body’s immune response.
Pharmacokinetics
No data provided.
Indications
Apply strictly on doctor's prescription to avoid complications. ; 1. Endocrine diseases; Primary or secondary adrenal insufficiency (drugs of choice - hydrocortisone or cortisone; if necessary, their synthetic analogues can be used in combination with mineralocorticoid, especially in pediatric practice); Congenital adrenal hyperplasia; Subacute thyroiditis; Hypercalcemia against a background of cancer; 2. Rheumatic diseases and arthropathies (as an adjunctive therapy, briefly for removal from an acute condition or during exacerbation); Psoriatic arthritis; Rheumatoid arthritis, including those with juvenile rheumatoid arthritis; cross-up? Systemic diseases of the connective tissue (in the period of exacerbation or, in some cases, as maintenance therapy); Systemic lupus erythematosus (and lupus nephritis); Systemic dermatomyositis (polymyositis); Acute rheumatic heart disease; 4. Skin diseases; Pemphigus; Herpes-shaped bullous dermatitis; Severe erythema multiforme (Stevens-Johnson syndrome); Exfoliative dermatitis; Severe psoriasis; Severe seborrheic dermatitis; 5. Allergic conditions (in the case of severe or disabling conditions in which conventional therapy is ineffective); Seasonal or perennial allergic rhinitis; Serum sickness; Bronchial asthma; Contact dermatitis; Atopic dermatitis; Hypersensitivity reactions to drugs; 6.Eye diseases (severe acute and chronic allergic and inflammatory processes with eye damage); Allergic conjunctivitis; Keratitis; Allergic corneal ulcers; Ocular form Herpes zoster; Iritis and iridocyclitis; Chorioretinitis; Inflammation of the anterior chamber of the eye; Diffuse posterior uveitis and choroiditis; Neuritis of the optic nerve; Sympathetic ophthalmia; 7. Respiratory diseases; Symptomatic sarcoidosis; Leffler syndrome, which is not amenable to treatment with other drugs; Berylliosis; Lightning and disseminated pulmonary tuberculosis in combination with appropriate tuberculosis chemotherapy; Aspiration pneumonitis; 8. Hematologic diseases; Idiopathic thrombocytopenic purpura in adults; Secondary thrombocytopenia in adults; Acquired (autoimmune) hemolytic anemia; Erythroblastopenia (erythrocyte anemia); Congenital (erythroid) hypoplastic anemia; 9. Oncological diseases (as palliative therapy); Leukemia and lymphomas in adults; Acute leukemia in children; Mushroom mycosis (Alibert's disease); 10. Edema syndrome; To stimulate diuresis and achieve remission of proteinuria in patients with nephrotic syndrome without uremia, idiopathic type or due to systemic lupus erythematosus; 11. Diseases of the gastrointestinal tract (for the treatment of acute conditions); Ulcerative colitis; Regional enteritis; 12. Nervous system; Exacerbations of multiple sclerosis; 13. Other indications for use; Tuberculous meningitis with subarachnoid block or with a threat of block (in combination with appropriate anti-tuberculosis chemotherapy)
Contraindications
Systemic fungal infections. ; Hypersensitivity to any component of the drug in history.
Use during pregnancy and lactation
Since research on the effect of GCS on human reproductive function has not yet been conducted, the use of the drug during pregnancy, lactation (breastfeeding) or in women of childbearing age requires an assessment of the likely positive effect and potential risk of therapy for the mother, embryo or fetus .; Children whose mothers received significant doses of GCS during pregnancy should be carefully examined to identify possible symptoms of adrenal insufficiency.
Dosage and administration
Inside The initial dose can vary from 20 mg to 240 mg per day, depending on the indication and the severity of the disease. With a lower degree of severity of the disease, the dose is less, however, in individual patients, a high initial dose may be required. The initial dose can be maintained at the same level or adjusted until the desired effect is achieved. If the clinical effect is not achieved after a sufficiently long use of the drug, the use of Cortef should be stopped and another acceptable therapy should be prescribed. The dose should be selected individually on the basis of the picture of the disease and the reaction of the patient. After a positive result is achieved, the required maintenance dose is determined by gradually reducing the initial dose at appropriate time intervals until the lowest dose is reached that supports the desired effect. At change of a dose careful observation of the patient is necessary. ; Dose adjustment should be carried out in the following cases: when changes in the clinical picture due to remission or exacerbation of the disease, with individual sensitivity and reactivity of the patient, in the event that the patient is under stressful situations not related to the disease about which the treatment is prescribed. In the latter case, it may be necessary to increase the dose of the drug for this period of time. ; If you need to cancel the drug after prolonged use, it is recommended to gradually reduce the dose. ; Multiple sclerosis; In the treatment of multiple sclerosis exacerbations, a daily dose of 200 mg of prednisolone is shown for a week, followed by a dose of 80 mg orally every day for a month (20 mg of hydrocortisone is equivalent to 5 mg of prednisolone). ;
Side effects
The frequency of development and severity of side effects depend on the duration of use, the magnitude of the dose used and the possibility of taking in accordance with the circadian rhythm. ; On the part of the endocrine system: inhibition of adrenal function, secondary adrenal and pituitary disorders of various origins, the development of Itsenko-Cushing syndrome, menstrual disorders, decreased glucose tolerance, latent diabetes, increased need for insulin or oral hypoglycemic agents in people with diabetes, people with diabetes, increased need for insulin or oral hypoglycemic agents ; On the part of the digestive system: peptic ulcer with possible perforation and bleeding, pancreatitis (nausea, vomiting), abdominal distension, erosive / ulcerative esophagitis.; After treatment with GCS, an increase in the activity of alanine transaminase (ALT), aspartate transaminase (AST) and alkaline phosphatase in serum was observed. Usually these changes are minor, are not associated with any clinical syndromes and are reversible after cessation of treatment. ; Since the cardiovascular system: chronic heart failure in patients with appropriate predisposition, increased blood pressure, 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. ; On the part of the nervous system: increased intracranial pressure with swelling of the optic nerve head (pseudotumor of the brain), especially after treatment, convulsions, dizziness, headache, delirium, disorientation, euphoria, hallucinations, manic-depressive psychosis, depression, paranoia. ; On the part of the senses: posterior subcapsular cataract, increased intraocular pressure, glaucoma with possible damage to the optic nerve, exophthalmos, a tendency to develop secondary bacterial, fungal or viral infections of the eye. ; Metabolism: negative nitrogen balance due to protein catabolism. ; Conditioned by MKS activity: sodium retention and body fluids, hypokalemic alkalosis, muscle weakness, potassium loss. ; On the part of the musculoskeletal system: "steroid" myopathy, decrease in muscle mass, osteoporosis, tendon ruptures, especially the Achilles tendon, vertebral compression fractures, aseptic necrosis of the femoral and humeral epiphyses, growth pathology in children. ; On the part of the skin: slow healing of wounds, thinning and reducing the strength of the skin, petechiae, ecchymosis, facial erythema, possible suppression of the reaction during skin tests, hirsutism, increased sweating. ; Allergic reactions: generalized (skin rash / urticaria). ; When using other corticosteroids, there are reports of the following side effects: increased appetite, hiccups, arrhythmias, hypercoagulation, thrombosis, trophic changes of the cornea, increased calcium excretion, hypocalcemia, the development or exacerbation of infections (jointly used immunosuppressants and vaccination contribute to the occurrence of this side effect). When using the drug Cortef, reports of the above side effects are currently absent.
Overdose
Cases of acute toxicity in overdose of corticosteroids are extremely rare .; Treatment: if necessary, conduct symptomatic therapy. There is no specific antidote. Hydrocortisone is eliminated during dialysis.
Interaction with other drugs
Preparations - inducers of microsomal liver enzymes (phenobarbital, phenytoin and rifampin) may increase the clearance of GCS (which may require an increase in the dose of GCS) .; Oleandomycin and ketoconazole can inhibit GCS metabolism and reduce their clearance (in this case, reduce the dose of GCS) .; GCS can increase the clearance of acetylsalicylic acid, used in high doses for a long period, which can lead to a decrease in the level of salicylates in serum or increase the risk of toxic reactions of salicylates if GCS is canceled .; When hypoprothrombinemia prescribe acetylsalicylic acid in combination with GCS with caution. GCS affect the effectiveness of oral anticoagulants (reported to enhance or reduce their effects, therefore, it is necessary to continuously determine clotting indicators).
special instructions
In stressful situations, patients using the drug Cortef need increased doses of fast-acting GCS (before, during and after a stressful situation) .; Secondary insufficiency of the adrenal cortex, caused by the appointment of the drug, can be minimized by gradually reducing the dose. This type of relative deficiency can continue for several months after the end of treatment, therefore, in any stressful situations during this period, the GCS should be reappointed. Since the secretion of mineralocorticoid can be disturbed, the concomitant administration of electrolytes and / or mineralocorticoid is necessary .; It should be borne in mind that against the background of the use of corticosteroids, some infectious diseases can occur in erased form. The development of various infections (caused by viruses, bacteria, fungi, protozoa, or helminths) can be associated with the use of GCS, both as monotherapy and in combination with other immunosuppressants. The severity of the infectious disease may be different. The likelihood of infectious complications increases with increasing doses of GCS.When using GCS, resistance to infections is reduced, as well as the body’s ability to localize the infection process .; Prolonged use of corticosteroids can cause posterior subcapsular cataracts, glaucoma with possible damage to the optic nerve, and also provoke the addition of a secondary fungal or viral infection of the eye .; Patients with a simple herpetic eye infection should be given GCS with caution, since corneal perforation is possible. To control the condition after treatment, the lowest possible doses of GCS should be prescribed, and the dose should be reduced gradually. The use of hydrocortisone in medium or high doses can cause an increase in blood pressure, fluid retention and increased excretion of potassium. It is necessary to limit the consumption of table salt with food and the prescription of potassium preparations. All GCS increase the excretion of calcium .; When using GCS in doses that have an immunosuppressive effect, the introduction of live or live attenuated vaccines is contraindicated, but killed or inactivated vaccines can be administered, but the response to the introduction of such vaccines can be reduced. When using GCS in doses that do not have immunosuppressive effects, according to appropriate indications, immunization can be carried out .; The use of Cortef with active tuberculosis should be limited to cases of fulminant and disseminated tuberculosis, when GCS is used in combination with appropriate anti-tuberculosis chemotherapy .; When prescribing the corticosteroids to patients with latent tuberculosis or with positive tuberculin tests, careful observation is necessary, since the disease can be activated. With prolonged treatment of GCS, this category of patients needs chemoprophylaxis of tuberculosis .; Persons receiving GCS in immunosuppressive doses should avoid contact with patients with chicken pox or measles. Patients should be informed of the need to immediately consult a doctor in case of such contacts. Chickenpox and measles can be more severe or even fatal in unimmunized children or in adults receiving GCS. When chickenpox is infected, prophylactic administration of immunoglobulin for chicken pox serotherapy may be indicated.Upon contact with the causative agent of measles, immunoglobulin (IgG) may be given IM. With the development of varicella, antiviral treatment is indicated; GCS with extreme caution prescribed to patients with confirmed or suspected strongyloidiasis. Immunosuppression caused by GCS in such patients leads to strongyloid hyperinfection and dissemination of the process with widespread migration of larvae (often with the development of severe forms of enterocolitis and gram-negative septicemia with possible death) .; In hypothyroidism and cirrhosis of the liver, the GCS effect is enhanced. When using GCS, it is possible to develop mental disorders (from euphoria, insomnia, instability of mood, personality changes and severe depression to pronounced psychotic manifestations). In addition, when giving GCS, existing emotional instability or psychotic tendencies may increase. In case of non-specific ulcerative colitis, GCS should be prescribed with caution, as there is a possibility of perforation, abscess or other purulent infections .; Caution should be observed when diverticulitis, fresh intestinal anastomoses, active or latent peptic ulcer, renal failure, hypertension, osteoporosis, myasthenia gravis .; It is reported that Kaposi's sarcoma was observed in patients receiving GCS therapy. However, if GCS is canceled, clinical remission may occur .; Despite the fact that controlled clinical studies have shown the effectiveness of corticosteroids for the rapid resolution of multiple sclerosis exacerbation, no effect of CGS therapy on the course of the disease or the outcome of the disease has been identified. Studies have shown that in these cases, to achieve a pronounced therapeutic effect, it is necessary to prescribe GCS at relatively high doses .; Since the complications of GCS therapy depend on the dose and duration of treatment, in each particular case the decision on the need for such treatment, the dosage regimen and the duration of therapy is taken after assessing the potential risk and the intended benefits of using the drug .; Use in pediatrics; With long-term treatment of corticosteroids should carefully monitor the growth and development of children (including newborns).