Directions for use and doses
Inside. The initial dose (depending on the indications and severity of the disease) is 20–240 mg/day. For less severe disease, the dose will be lower, but in some patients a higher initial dose may be required. The initial dose can be maintained at the same level or adjusted until the desired effect is achieved. If, after a sufficiently long-term use of the drug, a clinical effect is not achieved, the use of the drug Cortef should be discontinued and the patient should be prescribed another acceptable therapy. The dose should be selected individually based on the disease picture and the patient's response. Once the desired response is achieved, the required maintenance dose is determined by gradually reducing the initial dose at appropriate time intervals until the lowest dose that maintains the desired effect is reached. It should be borne in mind that when changing the dosage, careful monitoring of the patient is necessary. The dose should be adjusted in the following cases: in case of changes in the clinical picture due to remission or exacerbation of the disease, in case of manifestations of individual sensitivity and reactivity of the patient, in case of influence on the patient by stressful situations not related to the disease for which treatment is prescribed. In the latter case, the dose of the drug should be increased for this period of time. If it is necessary to discontinue the drug during long-term treatment, it is recommended to reduce the dose gradually.
Multiple sclerosis: for the treatment of exacerbations of multiple sclerosis - 200 mg/day prednisolone for 1 week, followed by a dose of 80 mg every day for 1 month (20 mg hydrocortisone is equivalent to 5 mg prednisolone).
Cortef®
Drugs that activate liver enzymes, such as phenobarbital, phenytoin, and rifampicin, may increase the clearance of hydrocortisone, which may require increasing the drug dose to obtain the desired effect.
Drugs such as troleandomycin and ketoconazole can inhibit the metabolism of GCS and reduce its clearance. In this case, the dose of GCS should be reduced to avoid overdose phenomena.
GCS may increase the clearance of acetylsalicylic acid taken in high doses over a long period, which may lead to a decrease in serum salicylate concentrations or increase the risk of salicylate toxicity when GCS is discontinued. In patients with hypoprothrombinemia, acetylsalicylic acid should be prescribed in combination with GCS with caution.
Both increased and decreased effects of oral anticoagulants taken concomitantly with corticosteroids have been reported. To maintain the required effect of the anticoagulant, constant determination of coagulation parameters is necessary. When used simultaneously with live antiviral vaccines and against the background of other types of immunization, GCS increases the risk of viral activation and the development of infections.
GCS accelerate the metabolism of isoniazid and mexiletine, which leads to a decrease in their plasma concentrations.
Increases the risk of developing the hepatotoxic effect of paracetamol due to the induction of “liver” enzymes and the formation of a toxic metabolite of paracetamol. With long-term GCS therapy, higher doses of folic acid may be required.
Hypokalemia caused by GCS can increase the severity and duration of muscle blockade while taking muscle relaxants.
In high doses, GCS reduce the effect of somatropin.
Hydrocortisone reduces the effect of hypoglycemic drugs.
Sodium-containing medications increase the risk of edema and increased blood pressure.
Nonsteroidal anti-inflammatory drugs (NSAIDs) and ethanol increase the risk of developing ulceration of the gastrointestinal mucosa and bleeding, however, when using GCS in combination with NSAIDs for the treatment of arthritis, the therapeutic effect increases, so it is possible to reduce the dose of GCS.
When used together with mitotane and other inhibitors of adrenal cortex function, it may be necessary to increase the dose of GCS.
While taking corticosteroids, immunosuppressants increase the risk of developing infections and lymphoma or other lymphoproliferative disorders caused by the Epstein-Barr virus.
Concomitant use of androgens or anabolic steroids may increase the risk of edema and lead to acne.
Combined use with m-anticholinergics increases intraocular pressure.
GCS increase the toxicity of cardiac glycosides (due to the resulting hypokalemia, the risk of developing arrhythmias increases), weaken the effect of vitamin D on the absorption of calcium in the intestinal lumen.
Thiazide diuretics, carbonic anhydrase inhibitors, other corticosteroids and amphotericin B increase the risk of hypokalemia.
Indomethacin, displacing GCS from its connection with albumin, increases the risk of developing their side effects.
Amphotericin B and carbonic anhydrase inhibitors increase the risk of osteoporosis. The clearance of GCS increases with the use of drugs - thyroid hormones.
Estrogens (including oral estrogen-containing contraceptives) reduce the clearance of corticosteroids, prolong their half-life and therapeutic and toxic effects. Tricyclic antidepressants may increase the severity of depression caused by taking corticosteroids (not indicated for the treatment of these side effects).
The risk of developing cataracts increases when used in conjunction with other corticosteroids, antipsychotic drugs (neuroleptics), carbutamide and azathioprine.
Cortef
The incidence and severity of side effects depend on the duration of use, the size of the dose used and the ability to comply with the circadian rhythm of the prescription.
From the endocrine system: decreased glucose tolerance, “steroid” diabetes mellitus or manifestation of latent diabetes mellitus, suppression of adrenal function, Itsenko-Cushing syndrome (moon-shaped face, pituitary-type obesity, hirsutism, increased blood pressure, dysmenorrhea, amenorrhea, myasthenia, stretch marks) , delayed sexual development in children.
From the digestive system: nausea, vomiting, pancreatitis, “steroid” gastric and duodenal ulcers, erosive esophagitis, bleeding and perforation of the gastrointestinal tract, increased or decreased appetite, flatulence, hiccups. In rare cases, there is an increase in the activity of liver transaminases and alkaline phosphatase.
From the cardiovascular system: arrhythmias, bradycardia (up to cardiac arrest); development (in predisposed patients) or increased severity of CHF, ECG changes characteristic of hypokalemia, increased blood pressure, hypercoagulation, thrombosis. In patients with acute and subacute myocardial infarction - the spread of necrosis, slowing down the formation of scar tissue, which can lead to rupture of the heart muscle.
From the nervous system: delirium, disorientation, euphoria, hallucinations, manic-depressive psychosis, depression, paranoia, increased intracranial pressure, nervousness or anxiety, insomnia, dizziness, vertigo, pseudotumor of the cerebellum, headache, convulsions.
From the senses: sudden loss of vision (with parenteral administration in the head, neck, nasal turbinates, scalp, deposition of drug crystals in the vessels of the eye is possible), posterior subcapsular cataract, increased intraocular pressure with possible damage to the optic nerve, tendency to develop secondary bacterial , fungal or viral eye infections, trophic changes in the cornea, exophthalmos.
From the metabolic side: increased excretion of Ca2+, hypocalcemia, increased body weight, negative nitrogen balance (increased protein breakdown), increased sweating.
Caused by MCS activity - fluid and Na+ retention (peripheral edema), hypernatremia, hypokalemic syndrome (hypokalemia, arrhythmia, myalgia or muscle spasm, unusual weakness and fatigue).
From the musculoskeletal system: slowing of growth 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), rupture of muscle tendons, “steroid” myopathy, decreased muscle mass (atrophy).
From the skin and mucous membranes: delayed wound healing, petechiae, ecchymosis, thinning of the skin, hyper- or hypopigmentation, steroid acne, stretch marks, tendency to develop pyoderma and candidiasis.
Allergic reactions: generalized (skin rash, skin itching, anaphylactic shock), local allergic reactions.
Other: development or exacerbation of infections (the appearance of this side effect is facilitated by jointly used immunosuppressants and vaccination), leukocyturia, flushing syndrome, convulsions.
With intracranial administration - nosebleeds.
When administered intra-articularly - increased pain in the joint.
Cortef 10 mg 100 pcs. pills
pharmachologic effect
A synthetic analogue of natural GCS. It has primarily an anti-inflammatory effect, has moderate mineralocorticoid properties, and can be used for replacement therapy for adrenal hormone deficiency. Like other corticosteroids, hydrocortisone has significant and varied metabolic effects. In addition, hydrocortisone changes the body's immune response.
Composition and release form Cortef 10 mg 100 pcs. pills
Tablets - 1 tablet:
- Active ingredients: hydrocortisone 10 mg.
- Excipients: calcium stearate, corn starch, lactose, mineral oil, sorbic acid, sucrose.
100 pieces. - dark glass bottles (1) - cardboard packs.
Description of the dosage form
The tablets are white, round, with a notch and pressed inscription “CORTEF10”.
Directions for use and doses
The initial dose of the drug can be varied from 20 mg to 240 mg per day, depending on the indications and severity of the disease. In the future, the dose can be maintained at the same level or adjusted (individually, based on the clinical picture) until the desired effect is achieved. Once the desired response is achieved, the required maintenance dose is established, gradually reducing the dose at appropriate intervals until the lowest dose that maintains the desired effect is reached. It should be borne in mind that when changing doses, careful monitoring of the patient is required.
Dose adjustment is carried out in the following cases: when the clinical picture changes (due to remission or exacerbation of the disease), with the individual sensitivity of the patient. In stressful situations (not related to the disease for which therapy is prescribed), the dose of the drug should be increased for this period of time.
If it is necessary to discontinue the drug after long-term therapy, it is recommended to reduce the dose gradually.
If, after a sufficiently long-term use of the drug, a clinical effect is not achieved, Cortef should be discontinued and alternative therapy should be prescribed. When prescribing the drug for exacerbation of multiple sclerosis, it is necessary to take into account that during the first week of therapy the daily dose of GCS is 200 mg of prednisolone. Then, for a month, GCS is prescribed daily at the rate of 80 mg of prednisolone per day. When determining the dose of Cortef, it is necessary to take into account that 20 mg of hydrocortisone is equivalent to 5 mg of prednisolone.
Indications for use Cortef 10 mg 100 pcs. pills
In endocrinology
- adrenal insufficiency (hydrocortisone is the drug of choice for replacement therapy): primary (Addison's disease), usually in combination with mineralocorticoids; secondary (usually without the addition of mineralocorticoids);
- congenital adrenal hyperplasia;
- subacute thyroiditis;
- hypercalcemia in malignant neoplasms.
In rheumatology
As an additional short-term therapy (during an acute attack or exacerbation) for:
- psoriatic arthritis;
- rheumatoid arthritis, including juvenile rheumatoid arthritis (in some cases, low-dose maintenance therapy may be required);
- ankylosing spondylitis;
- acute and subacute bursitis;
- acute nonspecific tenosynovitis;
- acute gouty arthritis;
- post-traumatic osteoarthritis;
- synovitis in osteoarthritis;
- epicondylitis.
During exacerbations or as maintenance therapy in selected cases with:
- systemic lupus erythematosus;
- systemic dermatomyositis (polymyositis);
- acute rheumatic carditis.
In dermatology
- pemphigus;
- bullous dermatitis herpetiformis;
- severe erythema multiforme (Stevens-Johnson syndrome);
- exfoliative dermatitis;
- mycosis fungoides (Aliber's disease);
- severe psoriasis;
- severe seborrheic dermatitis.
In allergology
Control of severe or disabling allergic conditions that cannot be adequately treated with appropriate medications:
- seasonal or year-round allergic rhinitis;
- serum sickness;
- bronchial asthma;
- contact dermatitis;
- atopic dermatitis;
- hypersensitivity reactions to drugs.
In ophthalmology
Severe acute and chronic allergic and inflammatory diseases involving the eyeball and its appendages, such as:
- allergic conjunctivitis;
- keratitis;
- allergic corneal ulcers;
- eye lesions due to herpes zoster;
- iritis and iridocyclitis;
- chorioretinitis;
- inflammatory diseases of the anterior segment of the eye;
- diffuse posterior uveitis and choroiditis;
- optic nerve neuritis;
- sympathetic ophthalmia.
In pulmonology
- symptomatic sarcoidosis;
- Loeffler's syndrome, not treatable by other means;
- berylliosis;
- fulminant or disseminated pulmonary tuberculosis in combination with appropriate anti-tuberculosis chemotherapy;
- aspiration pneumonia.
In hematology
- idiopathic thrombocytopenic purpura in adults;
- secondary thrombocytopenia in adults;
- acquired (autoimmune) hemolytic anemia;
- erythroblastopenia (erythrocyte anemia);
- congenital (erythroid) hypoplastic anemia.
In oncology
For palliative care:
- leukemia and lymphoma in adults;
- acute leukemia in children.
In nephrology
- to stimulate diuresis or remission of proteinuria in nephrotic syndrome without uremia, idiopathic type or due to systemic lupus erythematosus.
In neurology
- exacerbation of multiple sclerosis.
Other indications for use
- tuberculous meningitis with subarachnoid block or threatened block: the drug is used simultaneously with appropriate anti-tuberculosis chemotherapy.
Contraindications
- Systemic fungal infections;
- history of hypersensitivity to the components of the drug.
Application of Cortef 10 mg 100 pcs. pills during pregnancy and breastfeeding
Since studies of the effect of GCS on human reproductive function have 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 the therapy for the mother, embryo or fetus.
Children whose mothers received significant doses of corticosteroids during pregnancy should be carefully examined to identify possible symptoms of adrenal insufficiency.
Use in children
During long-term therapy with GCS, the growth and development of children (including newborns) should be carefully monitored.
special instructions
In stressful situations, patients using the drug Cortef need increased doses of fast-acting corticosteroids (before, during and after a stressful situation).
Secondary adrenal insufficiency caused by the drug can be minimized by gradually reducing the dose. This type of relative deficiency may continue for several months after the end of treatment, so in any stressful situations during this period, corticosteroids should be re-prescribed. Since mineralocorticoid secretion may be impaired, concomitant administration of electrolytes and/or mineralocorticoids is necessary.
It should be taken into account that during the use of GCS, some infectious diseases may occur in an erased form. The development of various infections (caused by viruses, bacteria, fungi, protozoa or helminths) may be associated with the use of GCS either as monotherapy or in combination with other immunosuppressants. The severity of the infectious disease may vary. The likelihood of infectious complications increases with increasing doses of GCS. When using GCS, resistance to infections decreases, as well as the body's ability to localize the infectious process.
Long-term use of GCS can lead to the occurrence of 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 simple herpetic eye infection should be prescribed GCS with caution, since corneal perforation is possible. To control the condition after treatment, the minimum possible doses of GCS should be prescribed, and the dose reduction should be carried out gradually.
The use of hydrocortisone in medium or high doses can cause increased blood pressure, fluid retention and increased potassium excretion. It is necessary to limit the consumption of table salt with food and prescribe potassium supplements. All corticosteroids increase calcium excretion.
When using GCS in doses that have an immunosuppressive effect, the administration of live or live attenuated vaccines is contraindicated, but killed or inactivated vaccines can be administered, however, the response to the introduction of such vaccines may be reduced. When GCS is used in doses that do not have an immunosuppressive effect, immunization can be performed according to appropriate indications.
The use of Cortef in active tuberculosis should be limited to cases of fulminant and disseminated tuberculosis, when corticosteroids are used in combination with appropriate anti-tuberculosis chemotherapy.
When prescribing GCS to patients with latent tuberculosis or with positive tuberculin tests, careful monitoring is necessary, since activation of the disease is possible. With long-term therapy with GCS, this category of patients requires chemoprophylaxis of tuberculosis.
Persons receiving corticosteroids in immunosuppressive doses should avoid contact with patients with chickenpox or measles. Patients should be informed of the need to immediately seek medical attention in the event of such contacts. Chickenpox and measles can be more severe and even fatal in unimmunized children or in adults receiving corticosteroids. When infected with chickenpox, prophylactic administration of immunoglobulin for serotherapy of chickenpox may be indicated. In case of contact with the causative agent of measles, intramuscular administration of immunoglobulin (IgG) may be prescribed. When chickenpox develops, treatment with antiviral drugs is indicated.
GCS is prescribed with extreme caution to patients with confirmed or suspected strongyloidiasis. GCS-induced immunosuppression 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).
With hypothyroidism and liver cirrhosis, the effect of GCS is enhanced.
When using GCS, the development of mental disorders is possible (from euphoria, insomnia, mood instability, personality changes and severe depression to severe psychotic manifestations). In addition, when prescribing GCS, existing emotional instability or psychotic tendencies may increase.
In case of nonspecific ulcerative colitis, GCS should be prescribed with caution, since there is a possibility of developing perforation, abscess or other purulent infections.
Caution should be exercised in case of diverticulitis, fresh intestinal anastomoses, active or latent peptic ulcer, renal failure, hypertension, osteoporosis, myasthenia gravis.
Kaposi's sarcoma has been reported in patients receiving GCS therapy. However, when GCS is discontinued, clinical remission may occur.
Although controlled clinical trials have shown the effectiveness of GCS for rapid resolution of exacerbations of multiple sclerosis, the effect of GCS therapy on the course of the disease or disease outcome has not been identified. Studies have shown that in these cases, in order to achieve a pronounced therapeutic effect, it is necessary to prescribe GCS in relatively high doses.
Since complications of GCS therapy depend on the dose and duration of treatment, in each specific case the decision on the need for such treatment, dosage regimen and duration of therapy is made after assessing the potential risk and expected benefits of using the drug.
Use in pediatrics
During long-term therapy with GCS, the growth and development of children (including newborns) should be carefully monitored.
Overdose
Reports of cases of acute toxicity following an overdose of GCS are extremely rare.
Treatment: if necessary, carry out symptomatic therapy. There is no specific antidote. Hydrocortisone is eliminated by dialysis.
Side effects Cortef 10 mg 100 pcs. pills
From the side of water and electrolyte balance: sodium retention, fluid retention in the body, potassium loss, hypokalemic alkalosis.
From the cardiovascular system: in some cases – manifestations of congestive heart failure, arterial hypertension.
From the musculoskeletal system: muscle weakness, steroid myopathy, loss of muscle mass, osteoporosis, tendon rupture (especially the Achilles tendon), vertebral compression fractures, aseptic necrosis of the heads of the femur and humerus, pathological fractures of tubular bones.
From the digestive system: peptic ulcer with possible perforation and bleeding, pancreatitis, flatulence, ulcerative esophagitis; possible increase in the activity of ALT, AST, alkaline phosphatase (usually insignificant, not associated with any clinical syndromes and reversible after discontinuation of the drug).
Dermatological reactions: slow wound healing, thinning and decreased skin strength, petechiae, ecchymosis, facial erythema, increased sweating. Possible suppression of skin test response.
From the side of the central nervous system: increased intracranial pressure with the development of papilledema (pseudotumor cerebri, often develops after discontinuation of therapy), convulsions, dizziness, headache.
From the endocrine system: development of Cushing's syndrome; growth retardation in children, secondary areactivity of the adrenal glands and pituitary gland of various origins; menstrual irregularities, decreased tolerance to carbohydrates, manifestation of latent diabetes mellitus, increased need for insulin or oral hypoglycemic agents.
From the organ of vision: posterior subcapsular cataract, increased intraocular pressure, glaucoma, exophthalmos.
Metabolism: negative nitrogen balance due to protein catabolism.
Drug interactions
Drugs that are inducers of microsomal liver enzymes (phenobarbital, phenytoin and rifampin) can increase the clearance of GCS (which may require an increase in the dose of GCS).
Oleandomycin and ketoconazole can suppress the metabolism of GCS and reduce their clearance (in this case, the dose of GCS should be reduced).
GCS may increase the clearance of acetylsalicylic acid used in high doses over a long period, which may lead to a decrease in serum salicylate levels or increase the risk of salicylate toxic reactions when GCS is discontinued.
In case of hypoprothrombinemia, acetylsalicylic acid should be prescribed in combination with GCS with caution. GCS affect the effectiveness of oral anticoagulants (their effects are reported to increase or decrease, so constant determination of coagulation parameters is necessary).
