SOLU-MEDROL® NovaMedika (Solu-Medrol® NovaMedika)

Pharmacological properties of the drug Solu-medrol

An injectable form of synthetic corticosteroids - methylprednisolone, intended for intramuscular and intravenous administration. When dissolved, it forms an aqueous solution of high concentration, intended primarily for use in pathological conditions in which a quick and pronounced effect is required. Methylprednisolone has a pronounced anti-inflammatory, immunosuppressive and antiallergic effect. GCS diffuse through the cell membrane and form complexes with specific cytoplasmic receptors. Then these complexes penetrate into the cell nucleus, bind to DNA (chromatin) and stimulate the transcription of mRNA and the further synthesis of various protein enzymes, which determines the multifaceted effect of GCS when used systemically. GCS influence inflammatory and immune processes, the metabolism of carbohydrates, proteins and fats. Their use in therapeutic practice is based on the anti-inflammatory, immunosuppressive and antiallergic activity of GCS. Thanks to these properties, the following effects are achieved: reducing the number of immunoactive cells around the site of inflammation; decreased vasodilation; stabilization of lysosomal membranes; inhibition of phagocytosis; decreased production of prostaglandins and related compounds. Methylprednisolone at a dose of 4 mg has the same anti-inflammatory effect as hydrocortisone at a dose of 20 mg. Methylprednisolone has negligible mineralocorticoid activity (200 mg methylprednisolone is equivalent to 1 mg deoxycorticosterone). Methylprednisolone has a pronounced effect on protein and carbohydrate metabolism. The maximum pharmacological activity of GCS appears after their concentration in the blood serum becomes below the maximum; this fact suggests that most of the drug's effects are the result of changes in enzyme activity rather than a consequence of direct action. Methylprednisolone sodium succinate in vivo by cholinesterases to form free methylprednisolone. After an intravenous infusion at a dose of 30 mg/kg over 20 minutes or at a dose of 1 g over 30–60 minutes, the maximum concentration of methylprednisolone in the blood plasma (about 20 mcg/ml) is achieved after approximately 15 minutes. After an intravenous bolus administration of methylprednisolone at a dose of 40 mg, its maximum plasma concentration (42–47 mcg/100 ml) is reached after approximately 25 minutes. With intramuscular administration of methylprednisolone at a dose of 40 mg, its maximum concentration in the blood plasma (34 mcg/100 ml) is achieved after 120 minutes. With intramuscular administration, the maximum concentration in the blood is lower than with intravenous administration. With intramuscular administration, methylprednisolone is determined in the blood plasma over a longer period than with intravenous administration in an equivalent dose. The clinical significance of these minor differences is minimal when considering the mechanism of action of GCS. The clinical effect usually develops 4–6 hours after administration. In the case of administration for asthma, the first positive manifestations are observed after 1–2 hours. The half-life of methylprednisolone sodium succinate from blood plasma is 2.3–4 hours and practically does not depend on the route of administration. The biological half-life is 12–36 hours. Such a pronounced difference between the half-life and the period of pharmacological activity of the drug is associated with the intracellular activity of GCS. Pharmacological activity is maintained even when the drug is no longer detectable in the blood plasma. The duration of the anti-inflammatory activity of GCS approximately corresponds to the duration of inhibition of the hypothalamic-pituitary-adrenal axis. The metabolism of methylprednisolone occurs in the liver and is identical to the metabolism of cortisol. The main metabolites are 20-α-hydroxymethyl-prednisolone and 20-β-hydroxy-6-α-methylprednisolone. Metabolites are excreted primarily in the urine in the form of glucuronides, sulfates and unbound compounds. After intramuscular administration of methylprednisolone labeled with C14 carbon, 75% of the total radioactivity is excreted in the urine within 96 hours, 9% is excreted in the feces within 5 days, and 20% is determined in bile.

Description of the drug SOLU-MEDROL

GKS. When used systemically, it has anti-inflammatory, antiallergic, desensitizing, antishock, antitoxic and immunosuppressive effects.

When applied externally and locally, the therapeutic activity of methylprednisolone is due to its anti-inflammatory, antiallergic and antiexudative (due to the vasoconstrictor effect) effect.

Its anti-inflammatory activity is 5 times higher than that of hydrocortisone; it has virtually no mineralocorticoid activity.

Suppresses the functions of leukocytes and tissue macrophages. Inhibits the release of interleukin-1, interleukin-2, interferon gamma from lymphocytes and macrophages.

Methylprednisolone suppresses the pituitary release of ACTH (and secondarily the synthesis of endogenous corticosteroids) and β-lipotropin, but does not reduce the level of circulating β-endorphin. Inhibits the secretion of TSH and FSH.

Interacts with specific cytoplasmic receptors and forms a complex that penetrates the cell nucleus and stimulates the synthesis of mRNA; the latter induces the formation of proteins (including lipocortin) that mediate cellular effects. Lipocortin inhibits the activity of phospholipase A2, which leads to suppression of the release of arachidonic acid, inhibition of the synthesis of prostaglandins, endoperoxides, leukotrienes, which are factors of inflammation and allergic reactions. Suppresses the release of COX (mainly COX-2), which also helps to reduce the production of prostaglandins.

Helps stabilize lysosomal membranes, thereby reducing the concentration of proteolytic enzymes in the area of ​​inflammation. Reduces capillary permeability due to the release of histamine.

Methylprednisolone has a pronounced dose-dependent effect on the metabolism of proteins, fats and carbohydrates.

Reduces the protein content in plasma (due to globulins) with an increase in the albumin/globulin ratio, increases the synthesis of albumins in the liver and kidneys.

It has a catabolic effect in lymphoid and connective tissue, muscles, adipose tissue, skin, bone tissue. Osteoporosis and Itsenko-Cushing syndrome are the main factors limiting long-term GCS therapy. As a result of the catabolic effect, growth suppression in children is possible.

Stimulates the synthesis of higher fatty acids and TG, redistributes adipose tissue (fat accumulates mainly in the shoulder girdle, face, abdomen), leads to the development of hypercholesterolemia.

Increases the absorption of carbohydrates from the gastrointestinal tract; increases the activity of glucose-6-phosphatase, which leads to increased flow of glucose from the liver into the blood; stimulates gluconeogenesis.

Retains sodium ions and water in the body, stimulates the excretion of potassium, reduces the absorption of calcium from the gastrointestinal tract, promotes the leaching of calcium from bones, increases the excretion of calcium by the kidneys.

In high doses, methylprednisolone can increase the excitability of brain tissue and help lower the seizure threshold.

The anti-inflammatory effect is associated with inhibition of the release of inflammatory mediators by eosinophils; inducing the formation of lipocortins and reducing the number of mast cells that produce hyaluronic acid; with a decrease in capillary permeability; stabilization of cell membranes and organelle membranes (especially lysosomal ones).

The antiallergic effect develops as a result of suppression of the synthesis and secretion of allergy mediators, inhibition of the release of histamine and other biologically active substances from sensitized mast cells and basophils, a decrease in the number of circulating basophils, suppression of the development of lymphoid and connective tissue, a decrease in circulating lymphocytes (T- and B-cells) , mast cells, decreased sensitivity of effector cells to allergy mediators, inhibition of antibody production, changes in the body’s immune response.

In COPD, the action is based mainly on inhibition of inflammatory processes, inhibition of development or prevention of swelling of the mucous membranes, inhibition of eosinophilic infiltration of the submucosal layer of the bronchial epithelium, deposition of circulating immune complexes in the bronchial mucosa, as well as inhibition of erosion and desquamation of the mucous membrane. Increases the sensitivity of β-adrenergic receptors of small and medium caliber bronchi to endogenous catecholamines and exogenous sympathomimetics, reduces the viscosity of mucus by inhibiting or reducing its production.

Antishock and antitoxic effects are associated with an increase in blood pressure (due to an increase in the concentration of circulating catecholamines and restoration of the sensitivity of adrenergic receptors to them, as well as vasoconstriction), a decrease in the permeability of the vascular wall, membrane protective properties, and activation of liver enzymes involved in the metabolism of endo- and xenobiotics.

The immunosuppressive effect is due to inhibition of the release of cytokines (interleukin-1, interleukin-2), interferon gamma from lymphocytes and macrophages.

Suppresses fibroblast activity and collagen formation, reduces the possibility of scar tissue formation.

Stimulates excess production of hydrochloric acid and pepsin in the stomach, which increases the risk of developing peptic ulcers.

Indications for use of the drug Solu-Medrol

Endocrine diseases

• primary and secondary adrenal insufficiency;
• acute adrenal insufficiency;
• patients with diagnosed or suspected adrenal insufficiency in the preoperative period, in case of severe injury or serious illness;
• shock that does not respond to other types of therapy, with established or suspected adrenal insufficiency;
• congenital adrenal hyperplasia;
• non-purulent thyroiditis;
• hypercalcemia due to cancer.

Rheumatic diseases As an additional therapy for short-term use (during exacerbation of the process) for the following diseases:

• post-traumatic osteoarthritis;
• synovitis in osteoarthritis;
• rheumatoid arthritis, including juvenile rheumatoid arthritis;
• acute and subacute bursitis;
• epicondylitis;
• acute nonspecific tenosynovitis;
• acute gouty arthritis;
• psoriatic arthritis;
• ankylosing spondylitis.

Collagenoses (immune complex diseases) During exacerbation or as maintenance therapy in some cases for the following diseases:

• systemic lupus erythematosus (including lupus nephritis);
• acute rheumatic carditis;
• systemic dermatomyositis (polymyositis);
• nodular periarthritis;
• Goodpasture's syndrome.

Skin diseases

• pemphigus;
• severe erythema multiforme (Stevens-Johnson syndrome);
• exfoliative dermatitis;
• bullous dermatitis herpetiformis;
• severe seborrheic dermatitis;
• severe psoriasis;
• mycosis fungoides.

Allergic diseases For the treatment of severe or disabling allergic diseases when conventional therapy is ineffective:

• BA;
• contact dermatitis;
• atopic dermatitis;
• serum sickness;
• seasonal or year-round allergic rhinitis;
• hypersensitivity reactions to drugs;
• transfusion reactions such as urticaria;
• acute non-infectious laryngeal edema.

Eye diseases Severe acute and chronic allergic and inflammatory processes with eye damage:

• eye lesions caused by Herpes zoster;
• iritis, iridocyclitis;
• chorioretinitis;
• diffuse posterior uveitis and choroiditis;
• optic neuritis;
• sympathetic ophthalmitis;
• inflammation of the anterior segment of the eyeball;
• allergic conjunctivitis;
• allergic marginal corneal ulcer;
• keratitis.

Gastrointestinal diseases Emergency treatment for the following diseases:

• ulcerative colitis;
• regional enteritis.

Respiratory diseases

• symptomatic sarcoidosis;
• berylliosis;
• fulminant or disseminated pulmonary tuberculosis (used together with appropriate anti-tuberculosis chemotherapy);
• Loeffler's syndrome (if other types of therapy are ineffective);
• aspiration pneumonitis;
• COPD in the acute phase;
• pneumonia caused by Pneumocystis carinii in patients with AIDS.

Blood diseases

• acquired (autoimmune) hemolytic anemia;
• idiopathic thrombocytopenic purpura in adults;
• secondary thrombocytopenia in adults;
• erythroblastopenia (erythrocyte anemia);
• congenital (erythroid) hypoplastic anemia.

Oncological diseases As palliative therapy for the following diseases:

• leukemia and lymphoma in adults;
• acute leukemia in children;
• oncological diseases in the terminal stage.

Conditions that are accompanied by edema To stimulate diuresis and achieve remission of proteinuria in patients with nephrotic syndrome without uremia. Nervous system diseases

• swelling of the brain due to a tumor (primary or metastatic) caused by surgery, radiation therapy or traumatic brain injury;
• multiple sclerosis in the acute phase;
• acute traumatic injuries of the spinal cord (treatment should begin in the first 8 hours after injury).

Diseases of other organs and systems

• tuberculous meningitis with subarachnoid block or threatened block (the drug is used simultaneously with appropriate anti-tuberculosis chemotherapy);
• trichinosis with damage to the nervous system or myocardium;
• organ transplantation;
• prevention of nausea and vomiting caused by antitumor chemotherapy.

Use of the drug Solu-medrol

The drug can be administered intravenously as a bolus, intravenously as a drip, or intramuscularly. If the drug is prescribed as emergency treatment for acute conditions, it is recommended to prescribe it intravenously. Doses of the drug for children may be reduced. The prescribed dose primarily depends on the severity of the disease and the clinical effect obtained; in addition, it is necessary to take into account the age and body weight of the child. The dose for children should not be lower than 0.5 mg/kg per day. Additional therapy for life-threatening conditions Solu-Medrol is recommended to be administered intravenously at a dose of 30 mg/kg for at least 30 minutes. Administration at this dose can be repeated every 4–6 hours for 48 hours. Pulse therapy is prescribed to adults for diseases amenable to corticosteroid therapy, during exacerbations of the disease and/or when standard therapy is ineffective. The following treatment regimens are recommended:

*The duration of administration of the drug at the indicated dose must be at least 30 minutes; administration can be repeated if no improvement is achieved within a week after administration or if the patient’s condition requires it.

Terminal-stage cancer Solu-Medrol at a dose of 125 mg/day with daily intravenous administration for 8 weeks significantly improved the quality of life of patients with terminal-stage cancer. Prevention of nausea and vomiting caused by antitumor chemotherapy During chemotherapy with a slight or moderate emetogenic effect, it is recommended to administer Solu-Medrol intravenously at a dose of 250 mg (at least 5 minutes) 1 hour before the administration of the chemotherapy agent, as well as at the beginning of administration and after its ending. To enhance the effect, chlorphenothiazine preparations can be administered with the first dose of Solu-Medrol. During chemotherapy characterized by a pronounced emetogenic effect, it is recommended to administer Solu-Medrol IV at a dose of 250 mg (at least 5 minutes) in combination with appropriate doses of metoclopramide or butyrophenone 1 hour before the administration of the chemotherapy drug, and then 250 mg IV at the beginning of chemotherapy and after its completion. Acute traumatic injuries of the spinal cord For acute traumatic injuries of the spinal cord, it is recommended to administer an intravenous bolus of methylprednisolone at a dose of 30 mg/kg over 15 minutes, after a 45-minute break - continuous infusion at a rate of 5.4 mg/kg/h for 23 h. The drug should be administered using an infusion pump into an isolated vein. Administration should begin within the first 8 hours after injury. Pneumonia caused by Pneumocystis carinii in patients with AIDS Various treatment regimens are used. One regimen recommends administering Solu-Medrol at a dose of 40 mg every 6–12 hours with a gradual dose reduction over a maximum period of 21 days or until the end of antimicrobial therapy. Treatment should begin within the first 72 hours from the start of specific therapy for infection caused by Pneumocystis carinii. COPD in the acute phase Solu-Medrol is used according to one of two regimens: 0.5 mg/kg IV every 6 hours for 72 hours or 125 mg IV every 6 hours for 72 hours with further use of oral corticosteroids dosage forms with a gradual dose reduction. The total duration of treatment should be at least 2 weeks. Other indications Depending on the nature of the disease, the initial dose for adults can range from 10 to 500 mg. For a short course in severe acute conditions, it may be necessary to prescribe the drug in higher doses. The initial dose, not exceeding 250 mg, should be administered intravenously over at least 5 minutes, and if the dose exceeds 250 mg, then the duration of administration should be at least 30 minutes. Subsequent doses can be administered intravenously or intramuscularly, with the duration of the intervals between administrations depending on the patient's response to therapy and his clinical condition. Corticosteroid therapy is only an additional method and does not replace standard therapy. When treating children, the drug is administered in lower doses, but when choosing a dose, the severity of the condition and the patient’s response to therapy, rather than age and body weight, are primarily taken into account. The dose should not be lower than 0.5 mg/kg per day. Solu-Medrol can be administered intravenously or intramuscularly, but in emergency conditions it is better to start treatment with an intravenous injection. The solution for intravenous (or intramuscular) administration is prepared as indicated below. Preparations for parenteral administration should be checked visually to detect changes in the color of the solution or the appearance of particles in it. a) Two-capacity bottle

1. Press the plastic activator so that the solvent flows into the lower container.
2. Gently rock the bottle until the powder dissolves.
3. Remove the plastic disc covering the center of the plug.
4. Treat the surface of the cork with an antiseptic.
5. Puncture the center of the cork with a needle so that the tip of the needle is visible. Turn the bottle over and draw out the required amount of solution with a syringe.

b) Bottle In compliance with the rules of asepsis, introduce the solvent into the bottle with sterile powder. Use only special solvent. c) Preparation of solution for intravenous infusion First, you should prepare Solu-Medrol solution as indicated above. Therapy can begin with intravenous administration of Solu-Medrol for at least 5 minutes (when administered in doses up to 250 mg inclusive) or at least 30 minutes (when administered in doses exceeding 250 mg). Subsequent doses are administered in the same way. The drug can also be administered in the form of the original solution of the drug mixed with 5% aqueous solution of dextrose, with isotonic solution of sodium chloride, with 5% solution of dextrose in 0.45% or 0.9% solution re sodium chloride. The resulting solutions retain physical and chemical stability for 48 hours.

Solu-medrol®

Since complications of therapy with Solu-Medrol® depend on the dose and duration of treatment, in each specific case, based on an analysis of the risk/benefit ratio, a decision is made on the need for such treatment, and the duration of treatment and frequency of administration are determined.

In order to better control the patient's condition, the lowest dose of Solu-Medrol® should be used. When an effect is achieved, if possible, the dose should be gradually reduced to a maintenance dose or treatment should be discontinued.

Due to the danger of developing arrhythmia, the use of the drug Solu-medrol® in high doses should be carried out in a hospital environment equipped with the necessary equipment (electrocardiograph, defibrillator).

If prolonged spontaneous remission occurs, treatment should be discontinued.

During long-term treatment, the patient should undergo regular examination (chest x-ray, plasma glucose concentration 2 hours after meals, urinalysis, blood pressure, body weight control, preferably an x-ray or endoscopic examination if there is a history of gastrointestinal ulcers). intestinal tract).

The growth and development of children on long-term therapy with Solu-Medrol® should be carefully monitored. Growth retardation may occur in children receiving long-term, daily, multi-dose therapy. This therapy should only be used in the most urgent cases. Taking the drug every other day may reduce the risk of developing this side effect or avoid it altogether.

Children receiving long-term therapy with Solu-Medrol® are at increased risk of developing intracranial hypertension.

The drug Solu-medrol® should also be prescribed with great caution to patients with confirmed or suspected parasitic infections, such as stroigyloidosis. Immunosuppression caused by methylprednisolone 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.

Patients receiving drugs that suppress the immune system are more susceptible to infections than healthy individuals. For example, chickenpox and measles may be more severe and even fatal in unimmunized children or in adults receiving Solu-Medrol®. The effectiveness of Solu-Medrol® in septic shock is questionable. The results of a systematic review of the use of the drug in short courses at high doses do not support its use in this regimen. However, it is assumed that the use of Solu-Medrol® in long courses (5-11 days) in low doses may reduce mortality.

Patients who may be exposed to stress during therapy with Solu-Medrol® are advised to increase the dose of the drug before, during and after a stressful situation.

Due to the fact that an increase in mortality was found at 2 weeks or 6 months after head injury in patients treated with methylprednisolone sodium succinate compared with placebo, Solu-Medrol® should not be used for cerebral edema due to head injury. The causal relationship of deaths with the use of methylprednisolone sodium succinate has not been established.

During therapy with Solu-Medrol®, susceptibility to infections may increase, some infections may occur in an erased form, and new infections may develop. In addition, the body’s ability to localize the infectious process is reduced. The development of infections caused by various pathogenic organisms, such as viruses, bacteria, fungi, protozoa or helminths, which are localized in various systems of the human body, may be associated with the use of Solu-Medrol® both as monotherapy and in combination with other immunosuppressants , affecting cellular immunity, humoral immunity or neutrophil function. These infections may not be severe, but in some cases they can be severe and even fatal. Moreover, the higher doses of the drug are used, the higher the likelihood of developing infectious complications.

In patients receiving treatment with Solu-Medrol® 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 administration of such vaccines may be reduced or even absent. Patients receiving treatment with Solu-Medrol® in doses that do not have an immunosuppressive effect may be immunized according to appropriate indications.

The use of Solu-Medrol® in active tuberculosis should be limited to cases of fulminant and disseminated tuberculosis, when Solu-Medrol® is used to treat the disease in combination with appropriate anti-tuberculosis chemotherapy.

If the drug Solu-Medrol® is prescribed to patients with latent tuberculosis or with positive tuberculin tests, then treatment should be carried out under strict medical supervision, since reactivation of the disease is possible. During long-term drug therapy, such patients should receive appropriate preventive treatment.

Kaposi's sarcoma has been reported in patients treated with Solu-Medrol®. When the drug is discontinued, clinical remission may occur.

Since patients receiving parenteral therapy with Solu-Medrol® may, in rare cases, develop skin reactions and anaphylactic/anaphylactoid reactions, appropriate preventive measures should be taken before administering the drug, especially if the patient has a history of allergic reactions to any medications.

When using the drug Solu-medrol® in therapeutic doses for a long period, suppression of the HPA system (secondary adrenocortical insufficiency) may develop. The degree and duration of adrenocortical insufficiency are individual for each patient and depend on the dose, frequency of use, time of administration and duration of therapy. The severity of this effect can be reduced by using the drug every other day or by gradually reducing the dose. This type of relative deficiency may continue for several months after the end of treatment, so in case of any stressful situations during this period, Solu-Medrol® should be re-prescribed. Since the secretion of myeralocorticosteroids may be impaired, concomitant administration of electrolytes and/or myeralocorticosteroids is necessary.

In addition, the development of acute adrenal insufficiency, leading to death, is possible with abrupt discontinuation of the drug Solu-medrol®.

Withdrawal syndrome, which does not appear to be related to adrenal insufficiency, can also occur due to abrupt discontinuation of Solu-Medrol®. This syndrome includes symptoms such as anorexia, nausea, vomiting, lethargy, headache, fever, joint pain, skin peeling, myalgia, weight loss and/or low blood pressure. It is assumed that these effects occur due to sharp fluctuations in the concentration of methylprednisolone in the blood plasma, and not due to a decrease in the concentration of methylprednisolone in the blood plasma.

In patients with hypothyroidism or cirrhosis, an increased effect of Solu-Medrol® is observed.

The use of Solu-Medrol® may lead to an increase in the concentration of glucose in the blood plasma and a worsening of existing diabetes mellitus. Patients receiving long-term therapy with Solu-Medrol® may be predisposed to the development of diabetes mellitus.

During therapy with Solu-Medrol®, the development of various mental disorders is possible: from euphoria, insomnia, mood instability, personality changes and severe depression to acute psychotic manifestations. In addition, existing emotional instability or psychotic tendencies may be exacerbated.

Potentially severe mental disorders may occur when using Solu-Medrol®. Symptoms usually appear within a few days to weeks after starting therapy. Most reactions disappear either after reducing the dose or after discontinuation of the drug. Despite this, specific treatment may be required.

Patients and/or their relatives should be warned that if changes occur in the patient's psychological status (especially with the development of depression and suicidal attempts), they should seek medical help. Patients or their relatives should also be warned about the possibility of developing mental disorders during or immediately after reducing the dose of the drug or completely stopping it.

Long-term use of the drug Solu-medrol® can lead to the occurrence of posterior subcapsular cataracts and nuclear cataracts (especially in children), exophthalmos or glaucoma with possible damage to the optic nerve and provoke the addition of a secondary ocular fungal or viral infection.

When using the drug Solu-medrol®, there is an increase in blood pressure, fluid and salt retention in the body, loss of potassium, and hypokalemic alkalosis. These effects are less pronounced when using synthetic derivatives, except when used in large doses. You may need to limit your intake of salt and foods containing potassium.

Therapy with Solu-Medrol® may mask the symptoms of a peptic ulcer, in which case perforation or bleeding may develop without significant pain.

Adverse reactions of the drug Solu-medrol® from the cardiovascular system, such as dyslipidemia, increased blood pressure, can provoke new reactions in predisposed patients when using high doses of the drug Solu-medrol® and long-term treatment. In this regard, the drug Solu-Medrol® should be used with caution in patients with risk factors for cardiovascular diseases. Regular monitoring of cardiac function is necessary. Using low doses of Solu-Medrol® every other day may reduce the severity of these side effects.

Impact on the ability to drive vehicles and machinery

Due to the possibility of developing dizziness, blurred vision and weakness, when using the drug Solu-medrol®, persons driving vehicles and engaging in activities that require increased concentration and rapid motor reaction should be careful.

Side effects of the drug Solu-Medrol

The side effects listed below are typical for all corticosteroids when used systemically. Disturbances of water and electrolyte balance - sodium retention, congestive heart failure in predisposed patients, hypertension (arterial hypertension), fluid retention in the body, hypokalemia and hypokalemic alkalosis. From the cardiovascular system - myocardial rupture due to myocardial infarction, hypotension, arrhythmia. From the musculoskeletal system - steroid myopathy, muscle weakness, osteoporosis, pathological bone fractures, vertebral compression fractures, aseptic necrosis and tendon ruptures (especially the Achilles tendon). From the gastrointestinal tract - ulcers with possible perforation and bleeding, gastric bleeding, pancreatitis, esophagitis, intestinal perforation, increased activity of ALT, AST and alkaline phosphatase in the blood serum. On the skin side - delayed wound healing, petechiae and ecchymosis, thinning and increased sensitivity of the skin. On the metabolic side, there is a negative nitrogen balance caused by protein catabolism. From the nervous system - increased intracranial pressure with swelling of the optic disc (pseudotumor cerebri), mental disorders and convulsions. On the part of the endocrine system - menstrual irregularities, development of Itsenko-Cushing syndrome, inhibition of the function of the hypothalamic-adrenal axis, decreased glucose tolerance, clinical manifestation of latent diabetes mellitus, increased need for insulin or oral hypoglycemic drugs in patients with diabetes mellitus, growth retardation in children. From the side of the eyes - posterior subcapsular cataract, increased intraocular pressure and exophthalmos. On the part of the immune system - masking the clinical picture of infections, activation of latent infections, possible occurrence of diseases caused by opportunistic pathogens, possible hypersensitivity reactions, including anaphylaxis, as well as suppression of reactions during skin tests. In addition, during parenteral therapy with GCS, allergic reactions of the anaphylactoid type (with or without circulatory collapse), cardiac arrest, bronchospasm, and prolonged hiccups may occur when using GCS in high doses.

Special instructions for the use of the drug Solu-medrol

The drugs of choice for GCS therapy are hydrocortisone or cortisone; if necessary, synthetic analogues can be used in combination with mineralocorticoids; The addition of mineralocorticoids in pediatrics is especially important; the need to add mineralocorticoids may also arise when using synthetic analogues. Studies have not confirmed the effectiveness of Solu-Medrol in septic shock; Moreover, it has been found that in patients at high risk (for example, with an increase in serum creatinine levels above 2.0 mg% or with secondary infections), the mortality rate may increase. In cases of shock due to adrenal insufficiency, or shock that does not respond to conventional treatment for possible adrenal insufficiency, hydrocortisone is usually the drug of choice. In cases where mineralocorticoid action is undesirable, preference should be given to methylprednisolone. Although controlled, double-blind, placebo-controlled clinical studies have not been conducted, results from animal experiments indicate that Solu-Medrol may be effective in the treatment of hemorrhagic, traumatic and surgical shock when standard therapy (eg, fluid replacement, etc.) is ineffective. In patients who may experience stress during corticosteroid therapy, increased doses of rapid-acting corticosteroids are indicated before, during, and after the stressful situation. During corticosteroid therapy, some infections may have a mild course; in addition, new infections may join them. When using corticosteroids, it is possible to reduce resistance to infections, as well as impair the body's ability to localize the infectious process. The development of infections caused by various pathogenic microorganisms (viruses, bacteria, fungi, protozoa or helminths) and localized in various body systems may be associated with the use of corticosteroids either as monotherapy or in combination with other drugs that have an immunosuppressive effect, affecting on the cellular or humoral component of immunity, the function of neutrophil granulocytes. These infections can have a mild or moderate course, but in some cases the disease can be severe and even fatal. Moreover, the higher the dose of corticosteroids, the more likely the development of infectious complications. Patients receiving immunosuppressive doses of corticosteroids should not receive live or live attenuated vaccines. However, inactivated vaccines may be administered to patients receiving immunosuppressive doses of corticosteroids; however, the immune response to such vaccines may be reduced. Patients receiving immunosuppressive doses of corticosteroids may be immunized according to appropriate indications. The use of Solu-Medrol in active tuberculosis is limited only to cases of fulminant and disseminated tuberculosis when corticosteroids are used in combination with appropriate anti-tuberculosis chemotherapy. If corticosteroids are used in patients with latent tuberculosis or during the period of tuberculin testing, monitoring of the patient's condition is necessary due to the possibility of reactivation of the disease. During long-term corticosteroid therapy, such patients should receive chemoprophylaxis. Due to the increased incidence of tuberculosis reactivation in patients with AIDS, the advisability of specific anti-tuberculosis therapy should be considered if these high-risk patients are treated with corticosteroids. This category of patients should also be under medical supervision due to the fact that they have an increased risk of exacerbation of other latent infections. Because anaphylactoid reactions (eg, bronchospasm) occasionally occur in patients receiving parenteral corticosteroids, appropriate prophylactic measures should be taken before administering corticosteroids, especially if the patient has a history of allergic reactions to any drugs. There are reports of cardiac arrhythmias and/or the development of circulatory collapse and/or cardiac arrest after rapid intravenous administration of methylprednisolone sodium succinate in high doses (more than 0.5 g in less than 10 minutes). During and after rapid intravenous administration of methylprednisolone sodium succinate in high doses, cases of bradycardia were also observed, but they were not always dependent on the speed or duration of infusion. This medicine contains benzyl alcohol, which can cause choking syndrome, which can be fatal in premature newborns. Corticosteroids should be used with caution in the treatment of patients with ocular damage caused by the herpes simplex virus, as this may lead to corneal perforation. During corticosteroid therapy, various mental disorders may develop, ranging from euphoria, insomnia, mood swings, personality changes and severe depression to acute psychotic manifestations. In addition, existing emotional lability or a tendency to psychotic reactions may be exacerbated by corticosteroid therapy. Corticosteroids should be used with caution in ulcerative colitis, if there is a threat of perforation, abscess or other purulent infection, as well as in diverticulitis, in the presence of fresh intestinal anastomoses, in active or latent peptic ulcers, renal failure, hypertension (arterial hypertension), osteoporosis or severe pseudoparalytic myasthenia. Since complications of corticosteroid therapy depend on the dose and duration of treatment, in each specific case the ratio of possible risk and expected therapeutic effect should be assessed regarding both the dose and duration of treatment, and the mode of administration (daily or intermittent course). Acute myopathy has been described with the use of corticosteroids in high doses. Most often occurs in patients with impaired neuromuscular transmission (for example, myasthenia gravis) or in patients who are simultaneously treated with drugs that block neuromuscular transmission (for example, pancuronium). This acute myopathy is generalized and can affect the muscles of the eyes and respiratory system, leading to the development of tetraparesis. It is possible to increase the level of CPK in the blood serum. However, improvement or recovery after stopping corticosteroids may take many weeks or even several years. There are no indications that corticosteroids are carcinogenic or mutagenic or may impair fertility. Cases of Kaposi's sarcoma have been reported in patients receiving corticosteroid therapy. However, when corticosteroids are discontinued, clinical remission may occur. Animal studies indicate that high-dose corticosteroids may cause fetal developmental problems. Before prescribing the drug to pregnant and breastfeeding women, the expected therapeutic effect and potential risk to the fetus should be assessed. Prescription of corticosteroids during pregnancy is possible only when absolutely necessary. Corticosteroids penetrate the placental barrier. Newborns whose mothers received sufficiently high doses of corticosteroids during pregnancy should be under medical supervision to promptly identify signs of adrenal insufficiency. No significant effect of corticosteroids on the birth process has been identified. Corticosteroids pass into breast milk.

SOLU-MEDROL® NovaMedika (Solu-Medrol® NovaMedika)

Since complications of therapy with SOLU-MEDROL® NovaMedica depend on the dose and duration of treatment, in each specific case, based on an analysis of the risk/benefit ratio, a decision is made on the need for methylprednisolone therapy, and its duration and frequency of administration of the drug (daily or intermittent) are determined. .

— In order to better control the patient’s condition, the lowest dose of SOLU-MEDROL® NovaMedica should be used. When the effect is achieved, if possible, the dose should be gradually reduced to a maintenance dose or treatment should be stopped.

— Due to the danger of developing arrhythmia, the use of the drug COLU-MEDROL® NovaMedica in high doses should be carried out in a hospital environment equipped with the necessary equipment (electrocardiograph, defibrillator).

- If prolonged spontaneous remission occurs, treatment should be discontinued.

- During long-term treatment, the patient should undergo regular examination (chest x-ray, determining the concentration of glucose in the blood plasma 2 hours after meals, general urine analysis, blood pressure, body weight control, it is advisable to conduct an x-ray or endoscopic examination if there is a history of peptic ulcers gastrointestinal tract).

— The growth and development of children on long-term therapy with SOLU-MEDROL® NovaMedica should be carefully monitored. Growth retardation may occur in children receiving long-term, daily, multi-dose therapy. Long-term daily use of the drug in children is possible only for absolute indications. Administration of the drug every other day may reduce the risk of developing this adverse reaction or avoid it altogether.

— Children receiving long-term therapy with SOLU-MEDROL® NovaMedica are at increased risk of developing intracranial hypertension.

- The use of high doses of methylprednisolone can lead to the development of pancreatitis in children.

- Rare cases of hepatotoxicity have been reported. Liver damage, including acute hepatitis or increased liver enzyme activity, can be caused by repeated pulse therapy with intravenous methylprednisolone (usually at an initial dose of 1 g or more per day). The first signs of acute hepatitis may take several weeks or later to develop. In most cases, these adverse reactions resolved after discontinuation of therapy. In this connection, appropriate control is required.

— Patients receiving drugs that suppress the immune system are more susceptible to infections than healthy individuals. For example, chickenpox and measles may be more severe, even fatal, in unimmunized children or in adults receiving SOLU-MEDROL® NovaMedica.

— Although controlled clinical studies have shown that methylprednisolone is effective in accelerating the recovery process during exacerbation of multiple sclerosis, it has not been established that methylprednisolone affects the outcome and pathogenesis of this disease. Studies have also shown that sufficiently high doses of methylprednisolone must be administered to achieve a significant effect.

- Cases of severe complications have been reported when methylprednisolone was administered intrathecally or epidurally.

— There are reports of the development of epidural lipomatosis in patients receiving methylprednisolone. Usually with long-term therapy at high doses.

— Due to the fact that an increase in mortality was detected 2 weeks or 6 months after traumatic brain injury in patients who received methylprednisolone therapy compared with placebo, systemic corticosteroids, including the drug SOLU-MEDROL® NovaMedica, are not indicated and are not should be used to treat brain damage caused by trauma. The causal relationship of deaths with the use of methylprednisolone sodium succinate has not been established.

— During therapy with SOLU-MEDROL® NovaMedica, susceptibility to infections may increase, some infections may occur in an erased form, and new infections may develop. In addition, the body’s ability to localize the infectious process is reduced. The development of infections caused by various pathogenic organisms, such as viruses, bacteria, fungi, protozoa or helminths, which are localized in various systems of the human body, may be associated with the use of the drug SOLU-MEDROL® NovaMedica, both as monotherapy and in combination with other immunosuppressants , affecting cellular immunity, humoral immunity or neutrophil function. These infections may not be severe, but in some cases they can be severe and even fatal. Moreover, the higher doses of the drug are used, the higher the likelihood of developing infectious complications.

- In patients receiving immunosuppressive doses of methylprednisolone, the administration of live or live attenuated vaccines is contraindicated, but killed or inactivated vaccines can be administered, however, the response to such vaccines may be reduced or even absent. Patients receiving treatment with SOLU-MEDROL® NovaMedica in doses that do not have an immunosuppressive effect can be immunized according to appropriate indications.

— The use of SOLU-MEDROL® NovaMedica for active tuberculosis should be limited to cases of fulminant and disseminated tuberculosis, when SOLU-MEDROL® NovaMedica is used to treat the disease in combination with appropriate anti-tuberculosis chemotherapy.

— If the drug SOLU-MEDROL® NovaMedica is prescribed to patients with latent tuberculosis or with positive tuberculin tests, then treatment should be carried out under strict medical supervision, since reactivation of the disease is possible. During long-term drug therapy, such patients should receive appropriate preventive treatment.

— It is reported that Kaposi's sarcoma was observed in patients receiving therapy with SOLU-MEDROL® NovaMedica. When the drug is discontinued, clinical remission may occur.

- Recent studies have shown that GCS should not be used for septic shock due to the lack of evidence of effectiveness and a possible increase in the risk of mortality in some groups of patients (with an increase in plasma creatinine concentrations or in the case of the development of a secondary infection during methylprednisolone therapy.

— Injections of the drug SOLU-MEDROL® NovaMedica can lead to atrophy of the skin and subcutaneous fat at the injection site. In order to reduce the likelihood of this complication, maximum precautions should be taken and only the recommended dose of the drug should be administered.

Injection of the drug into the deltoid muscle should be avoided due to the high incidence of subcutaneous fat atrophy.

— Since patients receiving parenteral therapy with SOLU-MEDROL® NovaMedica may, in rare cases, develop skin reactions and anaphylactic/anaphylactoid reactions, appropriate preventive measures should be taken before administering the drug, especially if the patient has a history of allergic reactions to which -or medications.

— When using the drug SOLU-MEDROL® NovaMedica in therapeutic doses for a long period, suppression of the HPA system (secondary adrenal insufficiency) may develop. The degree and duration of adrenal insufficiency is individual for each patient and depends on the dose, frequency, time of administration and duration of methylprednisolone therapy. The degree of suppression of the HPA system can be reduced by reducing the dose of the drug or administering the drug every other day. This type of relative deficiency can continue for several months after the end of treatment, therefore, in case of any stressful situations during this period, SOLU-MEDROL® NovaMedica should be re-prescribed.

· In addition, the development of acute adrenal insufficiency, leading to death, is possible with abrupt discontinuation of the drug SOLU-MEDROL® NovaMedica.

· “Asphyxiation syndrome” and death in children. Despite the fact that the usual therapeutic doses of the drug SOLU-MEDROL® NovaMedica contain benzyl alcohol in smaller doses than those reported for the development of “choking syndrome”, the minimum concentration of benzyl alcohol at which toxic effects may develop is unknown. The risk of developing this complication depends on the amount of drug administered, as well as the ability of the liver and kidneys to detoxify this chemical compound. Premature and low birth weight babies are at greater risk of developing this syndrome than other children. In this regard, the drug is not recommended for use in newborns. The amount of benzyl alcohol is 9 mg per 1 ml of solvent.

Drug interactions Solu-Medrol

Methylprednisolone interacts with oleandomycin, erythromycin, and ketoconazole. This interaction may enhance the therapeutic effects of methylprednisolone and at the same time increase the severity of its side effects. When interacting with rifampicin, a decrease in the therapeutic effectiveness of the latter may be observed, which requires adjustment of the dose of rifampicin. When used simultaneously with cholinesterase inhibitors (neostigmine, pyridostigmine), an increase in the severity of myasthenia gravis may be observed. Interaction with oral anticoagulants and heparin can lead to both acceleration and deceleration of blood clotting, which requires monitoring of coagulation parameters and appropriate adjustment of the dose of anticoagulants. Anticonvulsants (phenobarbital, phenytoin and rifampicin) reduce the effectiveness of methylprednisolone, which may require dose adjustment. Concomitant use with antidiabetic agents (insulin, glibenclamide) may lead to worsening glycemic control. Blood glucose levels should be monitored regularly and the dose of antidiabetic medications adjusted accordingly. The effectiveness of antihypertensive drugs when used simultaneously with methylprednisolone is reduced. Methylprednisolone potentiates the effect of digoxin and other cardiac glycosides and increases the toxicity of diuretics that cause potassium loss; it is necessary to monitor the level of potassium in the blood serum and adjust it accordingly if necessary. Methylprednisolone increases the toxicity of live vaccines (poliomyelitis, BCG, mumps, measles, rubella, chickenpox). During therapy with methylprednisolone, disseminated viral infection may develop in response to the use of live vaccines. Methylprednisolone weakens the immune response to inactivated vaccines. Concomitant use with methotrexate allows you to reduce the dose of corticosteroids. Methylprednisolone slows down the metabolism of cyclosporine, causes a partial reversal of the neuromuscular blockade caused by pancuronium, reduces the effectiveness of anxiolytics and antipsychotics, which usually requires an increase in the dose of these drugs. Methylprednisolone enhances the effects of sympathomimetic drugs, in particular salbutamol, and increases their toxicity. Cases of seizures have been reported with simultaneous use of methylprednisolone and cyclosporine. Because coadministration of these drugs causes mutual inhibition of metabolism, it is likely that seizures and other side effects associated with the use of each drug as monotherapy may occur more frequently when they are used together. CYP3A4 inhibitors (macrolides, triazole antifungals, some calcium channel blockers) may slow the metabolism of methylprednisolone; To avoid steroid toxicity, the dose of methylprednisolone should be titrated. With prolonged use of acetylsalicylic acid in high doses, corticosteroids can increase its excretion. This may result in decreased serum salicylate levels or an increased risk of salicylate toxicity when corticosteroids are discontinued. Acetylsalicylic acid should be administered with caution in combination with corticosteroids to patients with hypoprothrombinemia. The effect of corticosteroids on the pharmacokinetics of oral anticoagulants varies. Both increased and decreased effectiveness of anticoagulants has been reported when administered concomitantly with corticosteroids. Thus, it is necessary to monitor coagulation parameters to maintain the required anticoagulation effect. The compatibility and stability of solutions of methylprednisolone sodium succinate when administered intravenously with other drugs included in solutions for intravenous administration depend on pH, concentration, time, temperature, as well as the solubility of methylprednisolone. Therefore, to avoid problems related to compatibility and stability, it is recommended that Solu-Medrol be administered separately from other medicinal products whenever possible.