active ingredient: hydrocortisone;
1 bottle contains hydrocortisone in the form of sodium hydrocortisone succinate 100 mg
excipients: sodium dihydrogen phosphate monohydrate sodium phosphate anhydrous.
Powder for preparation of solution for injection.
Basic physico-chemical properties: from white to almost white lyophilizate.
Simple preparations of corticosteroids for systemic use. Glucocorticoid. Hydrocortisone. Code ATC H02A B09.
Solu-cortef has the same quality and therapeutic effects as hydrocortisone.
mechanism of action
After penetration through the cell membrane glucocorticoids form complexes with specific receptors in the cytoplasm. These complexes enter the nuclei, bind with DNA (chromatin) and stimulate transcription of mRNA, and then - further protein synthesis by various enzymes; it is believed that this mechanism is responsible for the systemic effects of glucocorticoids. The maximum pharmacological effects of the drug can be observed before reaching its maximum concentration in plasma, indicating that its effectiveness is more due to the modification of enzymes, rather than its direct effect.
The maximum concentration in the blood plasma is achieved 30-60 minutes after administration.
To maintain the concentration in blood serum at a constant high level to every
4-6 hours to do intravenous or intramuscular injections.
40-90% hydrocortisone is associated with plasma proteins. Most of it is associated with globulin (transcortin), while the smaller - with albumin. Biological activity is determined by the free, unrelated fraction of the hormone, whereas its bound fraction reserve serves as a reserve.
Mainly hydrocortisone is metabolized in the liver.
The dose is almost completely excreted within 12: 00. From 22 to 30% intravenously or intramuscularly administered dose of the drug is excreted in the urine within 24 hours.
States in which it is desirable to obtain a rapid and intense effect of corticosteroids.
Primary or secondary adrenal cortex insufficiency;
acute adrenal cortex insufficiency;
application in the preoperative period, in case of severe injury or disease, patients with adrenal cortex insufficiency or in case of doubts about the backup functions of the adrenal cortex;
shock, insensitive to traditional therapy, or when there is a suspected adrenal insufficiency;
congenital adrenal hyperplasia;
hypercalcemia associated with malignant neoplasm.
Disorders of non-endocrine origin
Rheumatic disease, as secondary therapy for short-term use (to help the patient survive the acute episode or exacerbation) in such diseases:
acute and subacute bursitis,
acute gouty arthritis
acute nonspecific tendosynovit;
rheumatoid arthritis, including juvenile rheumatoid arthritis (some cases may require the appointment of maintenance therapy with low doses of the drug)
synovitis in osteoarthritis.
The collagen diseases, during an exacerbation or as maintenance therapy in some cases of such diseases:
acute rheumatic carditis;
systemic dermatomyositis (polymyositis)
systemic lupus erythematosus.
bullous dermatitis herpetiformis
severe erythema multiforme (Stevens-Johnson syndrome)
severe form of psoriasis;
severe form of seborrheic dermatitis.
Allergic conditions: control of severe allergic conditions or allergic conditions that lead to disability and are not amenable to traditional treatment in the following diseases:
acute non-infectious laryngeal edema
hypersensitivity reactions to drugs;
seasonal or permanent allergic rhinitis
transfusion reactions the type of urticaria.
Ophthalmic diseases : severe acute and chronic allergic and inflammatory processes with involvement of the eyes, such as:
allergic marginal corneal ulcers
inflammation of the anterior segment of the eye;
diffuse posterior uveitis and choroidal;
full-time form of shingles;
iritis and iridocyclitis;
Gastrointestinal diseases to help the patient survive a critical period in the following diseases:
ulcerative colitis (systemic therapy);
regional enteritis (systemic therapy).
fulminant or disseminated tuberculosis of the lungs, while the use of appropriate anti-TB chemotherapy;
Leffler syndrome, not treatable by other means;
acquired (autoimmune) hemolytic anemia
congenital (erythroid) hypoplastic anemia
erythroblastopenia (erythrocytic anemia);
idiopathic thrombocytopenic purpura in adults (intravenous only; intramuscular use is contraindicated)
secondary thrombocytopenia adults.
Neoplastic diseases: for palliative treatment of such diseases:
acute leukaemia of children;
adult leukemia and lymphomas.
Conditions accompanied by edema: for induction of diuresis or remission of proteinuria in nephrotic syndrome without uremia, idiopathic or due to lupus erythematosus.
shock, which developed as a result of insufficiency of the adrenal cortex, shock, or insensitive to traditional therapy, in case of a possible failure of the adrenal cortex;
acute allergic conditions (asthmatic status, anaphylactic reactions, insect bites, etc.) do not pass after the use of epinephrine.
trichinosis with involvement of the nerves or myocardial
tuberculous meningitis with subarachnoid block or the threat of blockade, which is used in conjunction with an appropriate anti-TB chemotherapy.
Hypersensitivity to the active substance or to any of the auxiliary substances.
Systemic fungal infections.
Patients receiving corticosteroids at immunosuppressive doses, do not use live or Atanasova vaccines (see Section "Peculiarities of use").
Intramuscularly corticosteroid drugs are contraindicated in idiomatic thrombocytopenic purpura.
Contraindicated for intrathecal administration.
Interaction with other medicinal products and other forms of interaction
Drugs that induce hepatic enzymes such as phenobarbital, phenytoin and rifampin may increase the clearance of corticosteroids and their use may require higher doses of steroids to get the desired response to treatment.
Drugs such as troleandomycin and ketoconazole may inhibit the metabolism of corticosteroids and thus decrease their clearance. Therefore it is necessary to adjust the dose of corticosteroids to avoid corticosteroids toxicity.
Corticosteroids can increase the clearance of aspirin, which is used for a long time and in large doses. This may lead to a decrease in serum salicylate levels or to an increased risk of salicylate toxicity in corticosteroid withdrawal. Aspirin should be used with caution to be applied together with corticosteroids patients with hypothrombinemia.
The effect of corticosteroids on oral anticoagulants varies greatly; they can both to weaken, and to strengthen their action. Therefore, there should be regular monitoring of coagulation indices to maintain desired anticoagulant effect.
Caution should be used with drugs that affect potassium levels (such as diuretics). Do not use with amphotericin B.
Corticosteroids can cause hyperglycemia, so use with hypoglycemic agents should be careful.
Antibiotics. It was reported that macrolide antibiotics caused a significant decrease in clearance of corticosteroids.
Cyclosporine. With the simultaneous use of these drugs, there is an increase in activity and cyclosporine and GCS. It was also reported the occurrence of seizures.
Anticholinesterase drugs. The simultaneous use can lead to the development of severe weakness in patients with myasthenia gravis. Therefore, the use of these drugs should be stopped at least 24 hours before the start of therapy with corticosteroids.
Antidiabetic agents. Since corticosteroids can increase blood glucose concentrations, it may be necessary to correct the dose of antidiabetic agents.
TB drugs. It is possible to reduce the concentration of isoniazide in blood plasma.
Cholestyramine may increase the clearance of corticosteroids.
Aminoglutaric may cause loss induced by corticosteroids adrenaline suppression.
Cardiac glycoside. Patients who use cardiac glycosides have an increased risk of arrhythmia through hypokalemia.
Estrogens, including oral contraceptives. Estrogens can cause a decrease in the metabolism of certain corticosteroids in the liver, which leads to an increase in their effect.
Skin test. Corticosteroids may suppress reactions to skin tests.
Vaccines. Patients on long-term corticosteroid therapy may have a mild response to toxoids and live or inactivated vaccines due to suppression of antibody responses. Corticosteroids may also potentiate the response of some organisms contained in live vaccines Atanasova.
When using vaccines or toxoids according to the vaccination plan, consideration should be given to postponing vaccination before completion of therapy with corticosteroids.
Patients receiving corticosteroids and suffer unusual stress before, during and after a stressful situation illustrates the use of corticosteroids in high doses of corticosteroids or of quick action.
Despite the lack of well-controlled (double-blind, with the use of a placebo) clinical trials, the results obtained in experimental models in animals indicate that corticosteroids may be useful in hemorrhagic, traumatic and surgical shock, when standard therapy (such as repairing the volume of fluid lost) is ineffective.
GCS can mask some signs of infection, and new infections may occur when used. When using corticosteroids, the body's resistance to infections and the body's ability to localize the infection may be reduced.
The development of infections of any location caused by any microorganisms (including viral, bacterial, fungal, protozoal or worm infections) may be associated with the use of corticosteroids as monotherapy or in combination with other immunosuppressive agents that affect the cellular immunity link, the cellular immunity link or the function of neutrophils. Such infections may be mild but can be severe and sometimes be fatal. With increasing doses of corticosteroids increases the frequency of infectious complications.
In active, disseminated or fulminant tuberculosis hydrocortisone can be used only for the treatment of the disease together with the appropriate anti-tuberculosis treatment regimen. If and when the use of corticosteroids is indicated in patients with latent tuberculosis or tuberculin reactivity, close observation is necessary because the disease may again be activated. During prolonged corticosteroids, such patients should receive chemoprophylaxis.
Patients receiving corticosteroids at immunosuppressive doses, do not use live or Atanasova vaccines; such patients it is possible to use killed or inactivated vaccines. However, the response to such vaccines may be reduced. Patients receiving corticosteroids at doses reimmunoprecipitation showing holding of immunization.
Hydrocortisone may cause an increase in blood pressure, retention of salt and water in the body and increased excretion of potassium. Therefore, it may be necessary to follow a diet with a limited amount of salt and the use of dietary supplements based on potassium. All corticosteroids increase calcium excretion.
In rare cases in patients treated with parenteral corticosteroids, developed anaphylactoid reactions (e.g. bronchospasm), before applying them you should take appropriate measures, particularly when the patient has a history of Allergy to any drug.
Despite the fact that recent studies have not been conducted with the use of hydrocortisone or other steroids, the results of studies of the use of methylprednisolone sodium succinate in septic shock suggest that some subgroups of high-risk patients (i.e. patients with increased creatinine more than 2.0 mg / DL or secondary infections) may increase the mortality rate.
The effect of hydrocortisone can be enhanced in patients with liver disease, as they significantly reduced metabolism and withdrawal of hydrocortisone.
In children who receive long-term treatment of corticosteroids in divided daily doses, you may experience delayed growth. The use of such a treatment regimen should be limited to the most serious indications.
Corticosteroids should be used with caution in patients with ocular herpes simplex, which is accompanied by a risk of corneal perforation.
The use of corticosteroids has been associated with the development of Central serous homeopatie that can lead to retinal detachment.
With the use of corticosteroids may experience mental disorders that range from euphoria, insomnia, mood changes, personality changes with overt manifestations of psychosis. Also corticosteroids can cause aggravate existing emotional instability or trends to the development of psychosis.
It was reported that the development of epidural lipomatosis in patients, mainly with prolonged use of corticosteroids in high doses.
Corticosteroids should be used with caution in non-specific ulcerative colitis, if there is a likelihood of perforation in the presence of abscess or other pyogenic infections, as well as diverticula, fresh intestinal anastomoses, active or latent peptic ulcer, renal failure, arterial hypertension, osteoporosis and myasthenia gravis.
When applying high doses of corticosteroids, cases of acute myopathy are described, which most often occurs in patients with disorders of neuromuscular transmission (in particular, myasthenia gravis), or in patients receiving therapy with neuromuscular blockers (such as pancuronium ). This acute myopathy is generalized, may involve ocular and respiratory muscles and can lead to the development of quadriparesis. There may be an increase in CFC levels. Before the onset of clinical improvement or recovery after corticosteroid withdrawal can take place from a few weeks to several years.
There have been reports of the development of Kaposi's sarcoma in patients receiving corticosteroid therapy, but the cessation of therapy can lead to its clinical remission.
Reported occurrence pheochromocytoma crisis can be fatal, after systemic application of corticosteroids. Patients with suspected or identified pheochromocytoma should be prescribed corticosteroids only after appropriate risk and benefit assessment.
In order to reduce the possibility of skin atrophy at the injection site should not exceed the recommended dose. You should avoid injection in the deltoid muscle because of the higher risk of the development of subcutaneous atrophy.
High doses of systemic corticosteroids should not be used for treatment of traumatic brain injury.
Published data suggest a possible link between GCS and rupture of the myocardium after recent myocardial infarction; therefore, these patients therapy with corticosteroids should be used with caution.
Can cause depression hypothalamic-pituitary-adrenal system, the development of Cushing's syndrome and hyperglycemia.
Secondary adrenal cortex, caused by the use of the drug, can be reduced by gradually reducing the dose. Insufficiency of this kind may persist for several months after the termination of therapy. Therefore, in any situation of stress during that period, hormone therapy should be restored.
With simultaneous use of amphotericin b have been cases of expansion of borders of heart and development of heart failure (see Section " Interaction with other medicinal products and other forms of interaction ").
May cause an exacerbation of intercurrent infections caused by Amoeba, Candida, Cryptoccocus, Mycobacterium, Nocardia, Pneumocystis, and Toxoplasma. Before starting treatment with corticosteroids, it is recommended to exclude latent or active amebiasis in patients who visited tropical countries, or in patients with diarrhea of unknown Genesis.
Do not use in cerebral malaria, as there is currently no evidence of the benefits of the use of corticosteroids in this condition.
Chickenpox and measles: there may be serious or even fatal complications in adults and children. Patients who have not suffered these diseases in the past should be carefully protected from the risk of spreading these diseases to them.
The use of corticosteroids can lead to posterior subcapsular cataract, glaucoma, damage to the optic nerves, can promote the development of secondary eye infections caused by bacteria, fungi or viruses.
Use with caution in patients with known or suspected lesions on Strongyloides. In such patients, immunosuppression can lead to hyperinfection and the spread of larval migration can lead to severe enterocolitis and lethal gram-negative septicemia.
Caution should be used in patients with congestive heart failure, hypertension.
Patients with hypothyroidism should adjust the dose of corticosteroids.
In patients with cirrhosis, there is an enhanced effect by reducing the metabolism of corticosteroids.
In the treatment of corticosteroids may increase intraocular pressure, which requires its control, especially in the case of long-term therapy.
This drug contains less than 1 mmol of sodium (23 mg vial for injection, that is, it practically does not contain sodium). This drug contains 0.4 mmol (9.37 mg) of sodium per vial for injection. This should be taken into account when using doses exceeding 200 mg, patients on a diet with a restriction on the use of sodium.
Application during pregnancy and lactation
Use during pregnancy
Studies on animals have shown that corticosteroids, when applied to a pregnant high doses, may cause fetal malformations. Adequate studies of the impact on the human body was not carried out. Therefore, the use of this drug during pregnancy or women wishing to become pregnant, requires careful weighing of the benefits of its use compared with the potential risks to the pregnant woman and fetus. Since evidence of human safety during pregnancy is indirect, hydrocortisone should be used during pregnancy only if the benefits of therapy exceed the associated risks to the fetus.
Corticosteroids can pass through the placental barrier. Children born to women who received high doses of corticosteroids during pregnancy should be carefully examined for lack of evidence of adrenal cortex deficiency.
Application while breastfeeding
Corticosteroids are excreted in breast milk. Hydrocortisone should be used during nursing only if the benefits of therapy exceed its risks for the child.
In animal studies, a negative effect of corticosteroids on reproductive function was revealed.
The ability to influence the reaction rate when driving motor transport or operating other mechanisms
The effect of corticosteroids on the ability to drive vehicles or use other mechanisms has not been assessed. After treatment with corticosteroids, it is possible to develop undesirable effects such as syncope, vertigo and convulsions. In the presence of the above effects, patients should not drive vehicles or work with other mechanisms.
Method of application and doses
Route of administration: intravenous (bolus, infusion) or intramuscular use.
Preparations for parenteral administration should be checked visually to change the color of the solution or the appearance of particles in the prepared solution in all cases where the solution and packaging allow it to do so.
For intravenous or intramuscular injection, prepare a solution by adding 2 ml of bacteriostatic water for injection or 0.9% NaCl solution for injection to the vial (observing the rules of antisepsis). In the case of intravenous or intramuscular injection, further dilution is not required.
For infusion, the solution prepared as described above can, if necessary, dilute 5% aqueous glucose solution (or physiological sodium chloride solution, or 5% glucose solution in isotonic sodium chloride solution, if the patient does not have sodium retention in the body). A solution containing 100 mg of hydrocortisone sodium succinate, you can dilute in 100-1000 ml. From the microbiological point of view, the prepared solution for infusion should be used immediately.
If it is desirable to introduce a small amount of liquid hydrocortisone sodium succinate, equivalent to 100-3000 mg hydrocortisone, can be diluted in 50 ml with the above solvents. The resulting solution is stable for at least 4:00.
For primary emergency care, intravenous injection is preferred. After the initial emergency it is recommended to use the injection of funds more than long-acting or oral treatment. Treatment should begin with the administration of funds during the period from 30 seconds to 10 minutes (for example, the initial introduction of hydrocortisone sodium succinate at a dose equivalent to 100 mg hydrocortisone, or up to 500 mg). High-dose GCS should be carried out to stabilize the patient - usually no more than 48-72 hours. Although the side effects are highly associated with the use of high doses, in rare cases, ulcers may occur with short-term therapy with corticosteroids. Therefore, it is possible to recommend the use of preventive therapy with antacids.
In necessary during therapy with high doses of hydrocortisone for a period of more than 48-72 hours may develop hypernatremia. Under such conditions it is desirable to replace hydrocortisone sodium succinate corticosteroid product containing methylprednisolone sodium succinate which causes little or no causes a delay of sodium in the body.
The initial dose of sodium succinate hydrocortisone, equivalent to hydrocortisone, ranges from 100 mg to 500 mg (or more) depending on the severity of the condition.
The use of such a dose can be repeated at intervals of 2, 4 or 6:00, which is determined by the patient's response to treatment and its clinical condition.
Patients who have suffered severe stress after corticosteroids should be subject to careful monitoring for signs and symptoms of adrenal cortex insufficiency.
Corticosteroids are used as auxiliary and do not replace traditional therapy.
In patients with liver disease, the effect can be enhanced (see section "Features of the application") and for such patients may reduce the dose.
Children, including infants, can reduce the dose of the drug, but in determining the dose should be guided by a greater degree of severity of the condition and the patient's response to treatment, rather than his age or body weight. The daily dose should be at least 25 mg.
Clinical syndrome overdose hydrocortisone sodium succinate does not exist.
Hydrocortisone is excreted by dialysis.
The following adverse reactions are typical for all systemic corticosteroids. Their inclusion in this list does not necessarily mean that a particular phenomenon has been observed in the application of this particular dosage form.
There is no information about the frequency of adverse reactions.
Study: after treatment with corticosteroids was an increase in the level of Alat (ALT, SGPT), aspartate transaminase (AST, SGOT) and alkaline phosphatase.
Usually these changes are small, they are not associated with any clinical syndrome and are reversible after the termination of treatment.
From the side of cardiovascular system: congestive heart failure in susceptible patients, hypertension, bradycardia, cardiac arrest, heart rhythm disturbances, expansion of borders of heart, circulatory collapse, fat embolism, hypertrophic cardiomyopathy, myocardial rupture after recent myocardial infarction, pulmonary edema , syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis.
Dermatological disorders: acne, allergic dermatitis, reactions at the injection site, including burning or tingling, infections at the injection site, skin and subcutaneous atrophy, dryness and flaking of the skin, bruises, swelling, erythema, hyperpigmentation, hypopigmentation, increased sweating, rash, sterile abscess, striae, suppression of reaction to skin samples, thinning of hair on the head.
Neurological disorders: increased intracranial pressure, benign intracranial hypertension, seizures, epidural lipomatosis, dizziness.
From the side of organs of vision: the rear subcapsular cataracts, increased intraocular pressure, Central serous homeopatie, exophthalmos, glaucoma, posterior subcapsular cataracts, rare instances of blindness associated with injections in periocular area.
From the respiratory system, chest and mediastinal organs: if benzyl alcohol is used to prepare for use, it should be taken into account that it can lead to the development of a lethal dyspnea syndrome in premature infants.
Gastrointestinal disorders: development of peptic ulcer disease with possible perforation and bleeding, gastric bleeding, pancreatitis, esophagitis, intestinal perforation, bloating, intestinal / bladder dysfunction, hepatomegaly, increased appetite, nausea.
From the urinary system: sodium retention, fluid retention, loss of potassium, hypokalemic alkalosis, increased calcium excretion.
The skin and subcutaneous tissue: delayed wound healing, petechiae and ekhimozy, thin weak skin; in patients receiving corticosteroids, reported on the development of Kaposi's sarcoma.
From the blood and lymphatic systems: leukocytosis.
From the side of musculoskeletal system and connective tissue: corticosteroid myopathy, arthropathy, loss of muscle mass, muscle weakness, osteoporosis, pathological fractures, spinal compression fractures, aseptic necrosis, tendon rupture, particularly Achilles tendon.
Endocrine disorders: irregular menstrual cycle, development cushingoid state, glucosuria, hirsutism, hypertrichosis, inhibition of the pituitary - adrenal axis, reduced tolerance to carbohydrates, manifestation of latent diabetes mellitus, increased requirements of insulin or oral antidiabetic remedies for diabetes, growth retardation in children .
From the metabolic and nutrition: a negative nitrogen balance due to protein catabolism.
The immune system: masking of infections, activation of latent infections, including reactivation of tuberculosis, opportunistic infections caused by any microorganism, any location from mild to fatal, hypersensitivity reactions, including anaphylaxis and anaphylactoid reactions (e.g. bronchospasm, angioedema, urticaria, deceptive skin reactions).
Mental disorders: euphoria, insomnia, mood changes, personality changes, depression, headache, neuritis, neuropathy, paresthesia, mental disorders; exacerbation of existing emotional instability or tendencies to the development of psychosis. Arachnoiditis, meningitis, paraparesis / paraplegia, sensory disorders appeared after intratecal application.
Other disorders: abnormal fat deposits, reduced resistance to infection, hiccups, increased or decreased motility and number of spermatozoa, malaise, weight gain.
Report on suspected adverse reactions
Report suspected adverse reactions after registration of the medicinal product is important. This allows continuous monitoring of the relationship between the benefits and risks associated with the use of the drug. Health workers are requested to report any suspected adverse reactions in accordance with regional requirements .
Store at a temperature not exceeding 25 ° C. Keep out of reach of children.
This medicinal product must not be mixed with other medicinal products except those listed in the section "Method of administration and doses".
Powder in vial. 1 bottle in a carton or 25 bottles without secondary packaging in a pallet for transportation.
Category home away from home
Pfizer of Manufacturing Belgium NV.
The location of the manufacturer and its address of the place of business
Rijksweg 12 Puurs, B-2870, Belgium.
L-THYROXINE TABLETS 50MCG
L-Thyroxine is a synthetic medication with the primary the active ingredient levothyroxine sodium 50 mcg weight. The main effect is aimed at activating the growth and development of tissues, metabolism.
The drug has an anabolic effect, promotes fat metabolism. After two weeks of therapy one can observe the expected treatment outcome. Within six months of regular use of medication is gradually disappearing diffuse goiter.
When the facility is displayed
L-Thyroxine is prescribed after diagnosis:
Cancer of the thyroid body.
Diffuse toxic goiter.
The medicine can be used in the form of substitution therapy. Among the contraindications-acute heart disease.
Method of application
The average daily rate is determined by the doctor individually. The drug is used on an empty stomach, washed down with liquid in small quantities. Dosage for adult patients is calculated at 1.8 µg / kg body weight. For men, the initial rate is set at 150 µg (3 tablets).
To dose the medicine correctly, taking into account the therapeutic scheme, tablets should be selected with a suitable portion. The drug can be prescribed to children up to three years of age inclusive.