Solu medrol side effects. Efficacy and adverse reactions from the use of the drug solu-medrol in multiple sclerosis. Use in children

Solu-Medrol is a glucocorticosteroid. Its active ingredient, methylprednisolone, is also contained in the drug Metypred. This drug has diverse properties - suppression of inflammatory and allergic reactions, relieves the state of sensitization (increased sensitivity of tissues to the effects of any factors, usually irritating, causing allergies). Also, it has antishock and antitoxic activity. Systemic treatment with Solu-Medrol suppresses human immunity. The anti-inflammatory effect of this medicine is approximately five times higher than that of hydrocortisone. It is due to various mechanisms of action of the drug:

• Suppression of the activity of macrophages - that is, cellular immunity;
• Suppression of the production of substances that potentiate inflammation;
• Suppressing the action of histamine, which increases capillary permeability;

The antiallergic activity of Solu-medrol is also associated with several mechanisms of its action:

• Suppression of the activity of cells “responsible” for the development of an allergic reaction;
• Slowing down the release of histamine, a substance that triggers the allergic process;

Antishock effect is due to:

• Increased pressure;

But treatment with Solu-Medrol, like any other drugs of the GCS group, is fraught with complications. Firstly, the patient's health will suffer from increased cholesterol levels in the blood. The drug increases the digestibility of carbohydrates, the formation of glucose in the liver, fat actively begins to accumulate, distributed in the upper part of the body - shoulders, face, neck. Water and sodium are retained in the body, and potassium and sodium are washed out. This can lead to swelling and increased bone fragility. Solu-medrol enhances tissue breakdown processes, which can worsen the condition of osteoporosis and slow growth in young patients. Increased acidity under the influence of the drug can cause stomach ulceration. Therapy with high doses of Solu-Medrol can lower the seizure threshold.

Solu-Medrol is used for:

• Diseases of the adrenal glands (failure of function, congenital hyperplasia);
• Inflammation of the thyroid gland (non-purulent);
• Tumor pathologies that cause increased concentrations of calcium in the blood;
• Rheumatic diseases and connective tissue pathologies;
• Various forms of (severe) diseases of an allergic nature;
• Beryllium;
• Tuberculosis;
• Blood diseases (anemia, thrombocytopenia, leukemia);
• Malignant tumors;
• Multiple sclerosis;
• Brain edema caused by various reasons;
• Lesions of the nervous system, including those of central infectious origin;
• Transplantation;
• And for many other diseases and conditions;

Solu-Medrol is produced in the form of a powder, from which a solution for injection is prepared. Injections can be either intravenous or intramuscular. The instructions for the drug Solu-Medrol, which describe so many indications and contraindications for its use, briefly note that the treatment regimen is selected individually.

Solu-Medrol is contraindicated for:

• Intolerance to the main component of the drug;

During pregnancy, this drug is used only in extreme cases. In this case, severe pathologies in the fetus are possible, which will require special therapy.

In general, Solu-Medrol can be used only for absolute health reasons, when the benefits of such treatment outweigh the risks.

Side effects of Solu-Medrol

The endocrine system is affected by this drug. This can lead to cycle disorders, adrenal dysfunction, steroid diabetes, slow growth and sexual development. The patient's digestion may be affected, leading to ulcerative lesions, dyspepsia, and liver dysfunction. The effect on the cardiovascular system is expressed in increased blood pressure, thrombosis, and decreased coagulation. The leaching of potassium from the body can cause cardiac arrhythmias, even cardiac arrest. The human musculoskeletal system under the influence of Solu-Medrol may suffer from a decrease in bone mineralization, which will lead to fractures. Also, disorders of the muscle and connective tissue are possible - decreased muscle mass, tendon ruptures, and so on. On the part of the nervous system, it is possible to develop a wide variety of disorders - from mental disorders to seizures. And this is just a brief listing of possible pathologies that can develop during the use of Solu-Medrol.

Reviews of Solu-medrol

Although this drug causes horror and sacred awe when introduced to it in absentia, reviews of Solu-Medrol show how effective it is. Here are a few stories of patients with multiple sclerosis who receive droppers of this GCS during periods of exacerbation:

- I completed two courses of such treatment. There were side effects. Be sure to check your stomach to see if there are any ulcers. But any problems with digestion or weight are nothing compared to “problems” in the brain when the body does not listen...

- They gave me some Solu-Medrol and my skin became covered and my neck became very thick. But from a lying position he returned to a standing and walking position.

- I lost my fortune. There was very severe inflammation. And only Solu-Medrol droppers brought me back to life. It took me a long time to recover, but because I was very bad.

- Don’t waste time - get treatment. There is nothing more powerful than these hormones. If you manage to stop the exacerbation and relieve inflammation, you will be able to continue treatment with more gentle means and strengthen the body and immunity.

There is no doubt that Solu-Medrol was created precisely for such critical situations. No one would think of prescribing such medications on their own. As one patient wrote:

- Only a doctor will tell you exactly how dire the situation is. And only he can choose the most effective therapy. And let him take responsibility for your condition after a course of Solu-Medrol.

You can subscribe to each of these theses with peace of mind!

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It often happens that a person is in a critical condition for life. And doctors can provide emergency assistance in this situation. There are many good drugs that do an excellent job. One such medicine is Solu-Medrol.

Solu-Medrol looks like a powdery mass with the smell of benzene alcohol.

Means perfectly fights inflammation, copes with allergic reactions, reduces pain.

Description

Solu-Medrol belongs to the pharmaceutical category. The drug is effective in the treatment of diseases of the spinal cord and brain. The product also helps with inflammation and allergic reactions. Solu-Medrol normalizes the body's metabolic process and improves blood circulation. Copes well with diseases that require quick and positive results. The drug is a white powder for preparing a solution for intramuscular and intravenous injections.

Ask your question to a neurologist for free

Irina Martynova. Graduated from Voronezh State Medical University named after. N.N. Burdenko. Clinical resident and neurologist of the BUZ VO \"Moscow Polyclinic\".

Manufacturer: Pfizer MFG. Country of origin: Belgium.

Is the drug a hormone?

Yes, medicinal product belongs to. But at the same time, Solu-Medrol is a prototype of the hormones that our body produces. That is, we have glucocorticosteroid elements even without this substance.

Release forms

Preparation of solution for intramuscular and intravenous administration:

• 40 mg. Available in paper packaging, inside there is a vessel with two compartments. Ingredients: methylprednisolone, lactose, sodium phosphate monohydrate, disodium phosphate. Cost - from 150 rubles;
• 125-250 mg. A bottle with two compartments in a cardboard package. Ingredients: methylprednisolone, monobasic sodium phosphate monohydrate, secondary sodium phosphate. Cost 250 mg from 300 rubles, 125 mg from 200 rubles;
• 500-1000 mg. Bottles in paper packaging: suspension for infusion, water 1 ml, solvent (benzyl alcohol) 9 mg. Ingredients: methylprednisolone, sodium phosphate monohydrate, disodium phosphate. The cost of 1 g is from 900 rubles, 500 mg from 500 rubles.

Dosages, application regimen

The substance Solu-Medrol is administered intravenously or intramuscularly. Intravenous injections are best done when the patient is feeling unwell.

In critical situations, the dose is no more than 30 mg/kg intravenously, the duration of the procedure is no more than half an hour.

Intravenous injections

Intravenous injections are recommended in case of shock (anaphylactic, burn and shock due to injury) and in case of intolerance by the body to foreign bodies (implants). The recommended dose for children and adults is from 4 to 60 mg per kilogram of weight. To obtain a positive effect, the dosage must be increased. Patients with autoimmune reactions of the body must dilute the drug with 0.9% sodium chlorine NaCl solution or dissolved 0.5% dextrose. Remember that the doctor will prescribe the required dosage of the medicine for you. Age and weight do not affect the amount of dose. The injection should have a positive result for your disease and its form.

For rheumatic diseases, the portion is no more than 1 g per day for treatment from one to four days, and 1 g every 30 days for six months.

Lupus erythematosus: up to 1 gram per day for three days.

For multiple sclerosis: 1 g per day for up to 5 days.

For edema: dose not higher than 30 mg per 1 kg of person’s weight, course of therapy for 4 days, injections every other day.

For cancer, 125 mg per day, every day for 8 weeks.

For severe types of injury to the spinal vertebrae, it is important to start administering the drug in the first 8 hours. Dosage: 30 mg/kg over 15 minutes. Allow 45 minutes between procedures. Then carry out an infusion: 5 mg/kg over 23 hours.

Solution for preparing IV and IM injections

If the bottle is two-capacity, then you need to press a special button. The liquid from the top of the bubble will flow into the bottom. Next, you need to gently shake the bottle so that the powder dissolves completely without any residue. Then remove the rubber stopper, pierce the foil base with a needle and draw the resulting solution into the syringe to the dose you need.

If you have a simple bottle, then you need to add a special solvent into it (usually included).

Solu-Medrol allowed to be diluted with 5% dextrose solution, 0.9% sodium chloride solution, normal saline solution.

You just need to remember that such a medicine can be stored for no more than two days. Otherwise, the drug will lose its properties.

Indications for use

Endocrine system diseases:

• Adrenal insufficiency: primary, secondary and acute forms;
• Shock caused by allergies due to illness, injury;
• Before surgery, treatment of adrenal insufficiency;
• Adrenal hyperplasia acquired from birth;
• Hypercalcemia due to oncology.

Rheumatic diseases:

• Acute psoriatic, rheumatoid and gouty arthritis;
• Osteoarthritis after injuries, sanitis;
• Aggravated bursitis;
• Nonspecific severe tenosynovitis;
• Epicondelitis;
• Ankylosing spondylitis.

Diseases of the connective tissues of the body

• Lupus erythematosus;
• Goodpasture's syndrome;
• Dermatomyositis;
• Rheumacorditis;

Skin diseases

• Pemphigus;
• Severe psoriasis;
• Bullous and seborrheic dermatitis;

Allergic reactions due to illness

• Bronchial asthma;
• Diffuse and contact neurodermatitis;
• Allergic disease to parenteral administration;
• Allergic inflammation of the nasal cavity;
• Itching and blistering of the skin;
• Swelling of the laryngeal part.

Diseases of the eyeball

• Optic neuritis (inflammation of the optic nerve);
• Conjunctivitis;
• Keratitis;

Solu-Medrol should be used for diseases of the stomach and intestines, respiratory tract, hematological and oncological diseases, multiple sclerosis.

Pulse therapy

This method of therapy is prescribed during exacerbation of diseases. When conventional and corticosteroid therapy are not effective.

This treatment used in serious cases. When can the formation of respiratory and bulbar disorders begin? In such a situation, the maximum dose is set to 1 g. It is possible to quickly increase the dosage during a course of therapy of 500 mg-1000 mg-1000 mg. During long-term treatment, it is necessary to constantly monitor your doctor, take tests and undergo examinations.

You cannot stop taking the drug abruptly; this leads to the development of adrenal insufficiency.

Contraindications

Solumedrol should not be consumed if the body is highly sensitive to methylprednisolone. The drug is contraindicated in systemic fungal infections. It is worth remembering that during treatment with Solu-Medrol it is necessary to exclude the use of injections against smallpox and other procedures to strengthen the immune system. Since we accept the risk of complications.

Use with caution when:

• Ulcerative colitis;
• Purulent infections;
• Hidden stomach ulcer;
• Arterial hypertension;
• Muscle weaknesses;
• Use with caution in old age;
• Kidney failure;
• For children, use only when absolutely necessary and under the supervision of a specialist.

Use of the drug during lactation and pregnancy

A doctor can prescribe a drug during pregnancy solely out of necessity. Because there is a risk of adverse reactions for the mother and her unborn child.

During breastfeeding, solumedrol should not be used unless necessary. This way the product passes into mother's milk and can harm the baby.

Overdose and side effects

Side effects are observed in patients who have used the drug for a very long time and in excess dosage.

Let's consider acceptable side reactions for different body systems.

Endocrine system

Possible dysfunction of the adrenal glands, high blood pressure, delayed sexual development in children, progression of latent diabetes mellitus.

Digestive system

Side effects include nausea, deterioration or, conversely, increased appetite, flatulence.

The cardiovascular system

Arrhythmia, bradycardia, and thrombosis may occur. For patients with myocardial syndrome, use only after consultation with a specialist!

Nervous system

Hallucinations, euphoria, headache, depression, nervousness, convulsive reactions.

Sense organs

Sudden loss of vision occurs when the substance is injected into the upper body (head, neck). Increased pressure inside the eyeball, changes in the cornea.

Metabolism

Weight gain, sweating during sleep, rapid absorption of calcium by the body, low excretion of water from the body.

Musculoskeletal system

Children may experience growth dysfunction, osteoporosis, atrophy, and rupture of muscle tendons.

Skin and mucous membranes

Acne, slow skin regeneration process, candidiasis.

Allergic reactions

The appearance of a rash and itching on the skin.

Interaction with other drugs

Solumedrol is incompatible with other medicinal products. Since as a result of the connecting reaction, insoluble substances can be formed. If cardiac drugs are used simultaneously with Solu-Medrol, the risk of arrhythmia increases. Should not be used with antiviral drugs to strengthen the immune system. It is possible that the body will not cope with infections and viruses. To enhance the effect of the drug, the doctor may prescribe chlorphenothosian in parallel.

It is not prescribed with paracetamol. Hormones produced by the adrenal glands will be suppressed by paracetamol.

The use of indomethacin increases the possibility of side effects.

You can use Solu-Medrol with drugs from the same pharmaceutical group, but separately. Acceptable are Solcumedrol and Mitoxantrone, Solumedrol and Metypred.

Storage and release from pharmacies

Solu-Medrol is valid for five years. But the solution should only be stored for 48 hours!!! Not more.

Keep in a cool place, out of reach of children, at a temperature of 20 to 25.

You can purchase the product at the pharmacy only with a doctor's prescription.

Interaction with alcohol

Drinking alcohol during treatment with the drug is unacceptable.

Analogs

• Medrol. In tablets. 32 mg. Cost from 700 rubles;
• . To prepare the solution. Cost from 400 rubles for 250 mg;

Solu-Medrol: instructions for use and reviews

Latin name: Solu-Medrol

ATX code: H02AB04

Active substance: methylprednisolone

Manufacturer: Pfizer MFG. Belgium N.V. (Pfizer MFG. Belgium N.V.) (Belgium)

Updating the description and photo: 27.11.2018

Drug: SOLU-MEDROL®
Active substance of the drug: methylprednisolone
ATX code: H02AB04
KFG: GCS for injection
Registration number: P No. 014983/01-2003
Registration date: 05/20/03
Owner reg. credential: PHARMACIA NV/SA (Belgium)

Solu-medrol release form, drug packaging and composition.

1 fl.

40 mg

Two-capacity bottles (1) with 1 ml solvent - cardboard packs.

Lyophilisate for the preparation of solution for injection in the form of a powder or porous mass of white or almost white color.

1 fl.
methylprednisolone (as methylprednisolone sodium succinate)
125 mg

Solvent: benzyl alcohol (9 mg), water (up to 1 ml).

Two-capacity bottles (1) with 2 ml solvent - cardboard packs.

Lyophilisate for the preparation of solution for injection in the form of a powder or porous mass of white or almost white color.

1 fl.
methylprednisolone (as methylprednisolone sodium succinate)
250 mg

Solvent: benzyl alcohol (9 mg), water (up to 1 ml).

Two-capacity bottles (1) with 4 ml solvent - cardboard packs.

Lyophilisate for the preparation of solution for injection in the form of a powder or porous mass of white or almost white color.

1 fl.
methylprednisolone (as methylprednisolone sodium succinate)
500 mg

Solvent: benzyl alcohol (9 mg), water (up to 1 ml).

Bottles (1) complete with 7.8 ml solvent - cardboard packs.

Lyophilisate for the preparation of solution for injection in the form of a powder or porous mass of white or almost white color.

1 fl.
methylprednisolone (as methylprednisolone sodium succinate)
1 g

Solvent: benzyl alcohol (9 mg), water (up to 1 ml).

Bottles (1) complete with 15.6 ml solvent - cardboard packs.

DESCRIPTION OF THE ACTIVE SUBSTANCE.
All information provided is provided for information only about the drug; you should consult your doctor about the possibility of use.

Pharmacological action Solu-medrol

GCS. 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 release of ACTH by the pituitary gland (and secondarily the synthesis of endogenous corticosteroids) and -lipotropin, but does not reduce the level of circulating -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.

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-sized 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.

Pharmacokinetics of the drug.

After oral administration, it is well absorbed from the gastrointestinal tract. Metabolized in the liver. T1/2 is about 2 hours. It is excreted in the form of metabolites, mainly in the urine.

Indications for use:

For oral administration, intravenous administration (forms of normal duration of action) and intramuscular administration (depot forms): primary or secondary adrenal insufficiency, congenital adrenal hyperplasia, non-purulent thyroiditis, hypercalcemia due to tumor disease, rheumatic diseases, collagen diseases, pemphigus, bullous dermatitis herpetiformis, severe erythema multiforme, exfoliative dermatitis, severe psoriasis, severe seborrheic dermatitis, severe allergic diseases, severe acute and chronic allergic and inflammatory processes with eye damage, symptomatic sarcoidosis, Loeffler's syndrome (not amenable to other therapy), berylliosis, focal or disseminated pulmonary tuberculosis (simultaneously with appropriate anti-tuberculous chemotherapy), idiopathic thrombocytopenic purpura in adults, secondary thrombocytopenia in adults, acquired (autoimmune) hemolytic anemia, erythroblastopenia (erythrocyte anemia), congenital (erythroid) hypoplastic anemia, acute leukemia in children, palliative therapy for malignant tumors; to achieve remission in nephrotic syndrome, in the critical period in ulcerative colitis and regional enteritis, multiple sclerosis in the acute phase; cerebral edema due to a tumor or associated with surgery, radiation therapy, traumatic brain injury; shock due to adrenal insufficiency or resistant to standard therapy, tuberculous meningitis with subarachnoid block or its threat (together with anti-tuberculosis chemotherapy), trichinosis with damage to the nervous system or myocardium, organ transplantation; short-term therapy for diseases of the musculoskeletal system of rheumatic and nonspecific origin.

For administration into synovial fluid or soft tissue (depot form): auxiliary therapy in the acute period of synovitis, rheumatoid arthritis, gouty arthritis, epicondylitis, nonspecific tenosynovitis, post-traumatic osteoarthritis.

For administration into pathological lesions (depot form): keloid scars, localized hypertrophic, infiltrative and inflammatory lesions in lichen planus, psoriatic plaques, granuloma annulare, neurodermatitis, discoid lupus erythematosus, diabetic necrobiosis lipoidica, alopecia areata; cystic tumors of the aponeurosis or tendon.

Dosage and method of administration of the drug.

Individual, depending on the indications, treatment regimen, dosage form used, patient’s age, clinical situation.

Side effects of Solu-Medrol:

From the endocrine system: menstrual irregularities, suppression of adrenal function, Itsenko-Cushing syndrome, suppression of the pituitary-adrenal system, decreased tolerance to carbohydrates, steroid diabetes or manifestation of latent diabetes mellitus, growth retardation in children, delayed sexual development in children.

From the digestive system: nausea, vomiting, steroid ulcer of the stomach and duodenum, pancreatitis, esophagitis, bleeding and perforation of the gastrointestinal tract, increased or decreased appetite, flatulence, hiccups. In rare cases, increased activity of liver transaminases and alkaline phosphatase.

From the metabolic side: negative nitrogen balance due to protein catabolism, increased excretion of calcium from the body, hypocalcemia, increased body weight, increased sweating.

From the cardiovascular system: potassium loss, hypokalemic alkalosis, arrhythmia, bradycardia (up to cardiac arrest); steroid myopathy, heart failure (development or intensification of symptoms), ECG changes characteristic of hypokalemia, increased blood pressure, hypercoagulation, thrombosis. In patients with acute myocardial infarction - the spread of necrosis, slowing down the formation of scar tissue, which can lead to rupture of the heart muscle.

From the musculoskeletal system: slowing of growth and ossification processes in children (premature closure of epiphyseal growth zones), osteoporosis (very rarely - pathological fractures, aseptic necrosis of the head of the humerus and femur), rupture of muscle tendons, muscle weakness, steroid myopathy, reduction muscle mass (atrophy).

From the central nervous system: headache, increased intracranial pressure, delirium, disorientation, euphoria, hallucinations, manic-depressive psychosis, depression, nervousness or anxiety, insomnia, dizziness, vertigo, pseudotumor of the cerebellum, seizures.

On the part of the organ of vision: posterior subcapsular cataract, increased intraocular pressure (with possible damage to the optic nerve), trophic changes in the cornea, exophthalmos, tendency to develop a secondary infection (bacterial, fungal, viral).

Dermatological reactions: petechiae, ecchymosis, thinning and fragility of the skin, hyper- or hypopigmentation, acne, stretch marks, tendency to develop pyoderma and candidiasis.

Reactions caused by immunosuppressive effects: slowing down regeneration processes, reducing resistance to infections.

With parenteral administration: in isolated cases, anaphylactic and allergic reactions, hyper- or hypopigmentation, atrophy of the skin and subcutaneous tissue, exacerbation after intrasynovial use, Charcot-type arthropathy, sterile abscesses, when administered into lesions on the head - blindness.

Contraindications to the drug:

For short-term use for health reasons - hypersensitivity to methylprednisolone.

For intra-articular injection and injection directly into the lesion: previous arthroplasty, pathological bleeding (endogenous or caused by the use of anticoagulants), intra-articular bone fracture, infectious (septic) inflammatory process in the joint and periarticular infections (including a history), as well as general infectious disease, severe periarticular osteoporosis, absence of signs of inflammation in the joint (“dry” joint, for example, in osteoarthritis without synovitis), severe bone destruction and joint deformation (sharp narrowing of the joint space, ankylosis), joint instability as a result of arthritis, aseptic necrosis of the forming epiphyseal joint of bones.

For external use: bacterial, viral, fungal skin diseases, skin tuberculosis, skin manifestations of syphilis, skin tumors, post-vaccination period, violation of the integrity of the skin (ulcers, wounds), children's age (up to 2 years, with itching in the anus - up to 12 years), rosacea, acne vulgaris, perioral dermatitis.

For use in ophthalmology: bacterial, viral, fungal diseases of the eyes, tuberculosis of the eyes, trachoma, violation of the integrity of the ocular epithelium

Use during pregnancy and lactation.

In the first trimester, it is used in cases where the expected benefit of therapy for the mother exceeds the potential risk for the fetus. Long-term use during pregnancy causes fetal growth disturbances. In the third trimester of pregnancy, there is a risk of atrophy of the adrenal cortex in the fetus, which may require replacement therapy in the newborn.

During lactation it is used in cases where the expected benefit of therapy for the mother outweighs the potential risk for the infant.

Special instructions for the use of Solu-Medrol.

Use with caution within 8 weeks before and 2 weeks after vaccination), with lymphadenitis after BCG vaccination, with immunodeficiency conditions (including AIDS or HIV infection).

Use with caution in diseases of the gastrointestinal tract: gastric and duodenal ulcers, esophagitis, gastritis, acute or latent peptic ulcers, recently created intestinal anastomosis, ulcerative colitis with the threat of perforation or abscess formation, diverticulitis.

Use with caution for diseases of the cardiovascular system, incl. after a recent myocardial infarction (in patients with acute and subacute myocardial infarction, the necrotic focus may spread, slowing down the formation of scar tissue and, as a result, rupture of the heart muscle), with decompensated chronic heart failure, arterial hypertension, hyperlipidemia), with endocrine diseases - diabetes mellitus ( including impaired carbohydrate tolerance), thyrotoxicosis, hypothyroidism, Itsenko-Cushing's disease, severe chronic renal and/or liver failure, nephrourolithiasis, hypoalbuminemia and conditions predisposing to its occurrence, systemic osteoporosis, myasthenia gravis, acute psychosis , obesity (III-IV degree), with poliomyelitis (with the exception of the form of bulbar encephalitis), open- and closed-angle glaucoma.

If intra-articular administration is necessary, use with caution in patients with a general severe condition, ineffectiveness (or short duration) of the action of 2 previous administrations (taking into account the individual properties of the corticosteroids used).

Not effective for septic shock (possible increased mortality).

In case of stress during GCS therapy, an increase in dose is indicated.

For tuberculosis, use is only possible in combination with appropriate anti-tuberculosis therapy.

After taking it for several days, withdrawal should be done gradually.

Intradermal injection should not be deep. Depot forms should not be administered by non-recommended methods (including IV).

During the treatment period, do not carry out any types of vaccination.

In children during the growth period, the use of GCS is possible only according to absolute indications and under especially careful medical supervision.

Interaction of Solu-Medrol with other drugs.

When used simultaneously with barbiturates, the effectiveness of methylprednisolone may be reduced.

When used simultaneously with NSAIDs, the risk of erosive and ulcerative lesions of the gastrointestinal tract may increase.

With simultaneous use of methylprednisolone with oral anticoagulants, heparin, the anticoagulant effect increases or decreases; with salicylates - the effect of salicylates may be reduced; with thiazide diuretics, furosemide - hypokalemia may be potentiated.

When used simultaneously with glibenclamide, metformin, and insulins, the effectiveness of hypoglycemic agents decreases; with ketoconazole, itraconazole - the concentration of methylprednisolone in the blood plasma increases; with methotrexate - synergistic immunosuppressive effect; with neostigmine, pyridostigmine - the development of myasthenic crisis is possible; with pancuronium - reduction of neuromuscular blockade; with salbutamol - increasing the effectiveness and potential toxicity of salbutamol; with rifampicin - increased clearance of methylprednisolone.

When used simultaneously with phenytoin and phenobarbital, the clearance of methylprednisolone increases and its effectiveness decreases.

With simultaneous use, the effect of phenytoin may be reduced; with cyclosporine - inhibition of the metabolism of cyclosporine and methylprednisolone; with erythromycin - there is a possibility of inhibition of the metabolism of methylprednisolone.

INN: Methylprednisolone

Manufacturer: Pfizer Manufacturing Belgium N.V.

Anatomical-therapeutic-chemical classification: Methylprednisolone

Registration number in the Republic of Kazakhstan: No. RK-LS-5No. 014910

Registration period: 12.12.2014 - 12.12.2019

ALO (Included in the List of free outpatient drug provision)

Instructions

Tradename

SOLU-MEDROL ®

International nonproprietary name

Methylprednisolone

Dosage form

Lyophilisate for the preparation of injection solution 250 mg, 500 mg and 1000 mg complete with solvent

Compound

One two-pot vial of ACT-O-VIAL contains

active substance - methylprednisolone hemisuccinate 250 mg, equivalent to methylprednisolone sodium succinate 250 mg

One bottle contains

active substance - methylprednisolone hemisuccinate 500 mg and 1000 mg, equivalent to methylprednisolone sodium succinate 500 mg or 1000 mg,

Excipients: sodium dihydrogen phosphate monohydrate, sodium hydrogen phosphate anhydrous, sodium hydroxide 10% solution to pH,

solvent: benzyl alcohol, water for injection.

Description

White or almost white lyophilized mass.

Solvent: a clear, colorless solution with a slight odor of benzyl alcohol.

Pharmacotherapeutic group

Hormones for systemic use (excluding sex hormones and insulins). Corticosteroids for systemic use. Glucocorticoids. Methylprednisolone.

ATX code H02AB04

Pharmacological properties

Pharmacokinetics

The pharmacokinetics of methylprednisolone is linear and does not depend on the route of administration.

Absorption

After intramuscular (IM) administration of 40 mg methylprednisolone to healthy male volunteers, the maximum plasma concentration (Cmax) of 454 ng/ml was achieved after 1 hour (Tmax). After 12 hours, the concentration of methylprednisolone decreased to 31.9 ng/ml, and after 18 hours, methylprednisolone was not detected in the blood plasma. Based on the results of the AUC (area under the concentration/time curve) study, the total dose of methylprednisolone absorbed into the body after intramuscular administration was equivalent to that administered intravenously (IV). It was found that the level of absorption of free methylprednisolone after parenteral administration (IV and IM administration) was equivalent, but higher than when taking tablets or oral solution of methylprednisolone orally.

The results of the study indicate that, regardless of the method of administration, the methylprednisolone ester is quickly and intensively hydrolyzed by cholinesterases to form free methylprednisolone (the active component). Although the level of methylprednisolone absorbed by IV and IM administration was equivalent, the concentration of hemisuccinate ester in the general circulation was higher by IV administration. The lower level of concentration of hemisuccinate ester in blood plasma with intramuscular administration is explained by the fact that it is converted in tissues and is further absorbed in the form of free methylprednisolone.

Distribution

Methylprednisolone is intensively distributed in tissues, penetrates the blood-brain barrier and is excreted in breast milk. Its apparent volume of distribution is approximately 1.4 l/kg. The binding of methylprednisolone to plasma proteins is approximately 77%.

Metabolism

Methylprednisolone is metabolized in the liver mainly through CYP3A4, with the formation of passive metabolites. The main metabolites are 20α-hydroxymethylprednisolone, 20β-hydroxymethylprednisolone and 20β-hydroxy-6α-methylprednisone.

Methylprednisolone, like many CYP3A4 substrates, can act as a substrate for the ATP-binding cassette (ABC) transporter P-glycoprotein, which explains its high ability to distribute into tissues and significant interactions with many drugs.

Removal

Metabolites are excreted mainly in the urine, both in unbound form and in the form of glucuronides and sulfates, which are formed mainly in the liver and partly in the kidneys. The half-life of methylprednisolone ranges from 1.8 to 5.2 hours. The total clearance is 5-6 ml/min/kg. In case of renal failure, no dose adjustment is required. Methylprednisolone is amenable to hemodialysis.

Pharmacodynamics

SOLU-MEDROL® is an injectable form of methylprednisolone, a synthetic glucocorticosteroid (GCS), for intramuscular and intravenous administration. This dosage form is intended primarily for the treatment of pathological conditions in which a pronounced and rapid effect is required.

Methylprednisolone is a potent anti-inflammatory steroid. Its anti-inflammatory potential is higher than that of prednisolone. It also delays the removal of sodium and water from the body less than prednisolone. Methylprednisolone has the same metabolic and anti-inflammatory effects as methylprednisolone. When administered parenterally and in equal doses, both drugs are equivalent to each other in biological activity. The ratio of the eosinophilic erythrocyte suppressive potential of methylprednisolone to hydrocortisone sodium succinate is at least 4:1. A dose of 4 mg methylprednisolone is equivalent to 20 mg hydrocortisone. The same ratio is observed if methylprednisolone and hydrocortisone are used orally. Methylprednisolone has only minor mineralocorticoid activity (200 mg methylprednisolone is equivalent to 1 mg deoxycorticosterone).

Methylprednisolone penetrates cell membranes and forms complexes with specific cytoplasmic receptors. Then these complexes penetrate the cell nucleus, bind to DNA (chromatin) and stimulate the transcription of mRNA and the subsequent synthesis of various enzymes, which determine the pharmacological effects of SOLU-MEDROL® when administered systemically. SOLU-MEDROL® has anti-inflammatory, immunosuppressive and antiallergic effects due to:

inhibition of phospholipase A2 activity

stabilization of lysosomal membranes

reducing the number of immune active cells

reducing vasodilation

inhibition of phagocytosis

increasing the number and sensitivity of receptors to biologically active substances (catecholamines, thyroid hormone, etc.).

SOLU-MEDROL® affects carbohydrate, protein, and fat metabolism. Reduces the flow of glucose into the cell, stimulates neoglucogenesis and glycogenolysis, increases the catabolism of muscle proteins, mucosal proteins, reduces the formation of calcium-binding protein, somatomedins. Increases the synthesis of liver enzymes, fibrinogen, erythropoietin, lipomodulin, surfactant. Increases lipolysis in the extremities and promotes fat deposition in the upper torso and face.

Indications for use

- Endocrine diseases

primary and secondary adrenal insufficiency (if necessary, together with mineralocorticoids)

acute adrenal insufficiency (if necessary, together with mineralocorticoids)

shock resulting from adrenal insufficiency, or shock that is not amenable to conventional treatment when adrenal insufficiency is possible (when mineralocorticoid activity is not desired)

in the preoperative period, in case of severe injury or serious illness in patients with established or suspected adrenal insufficiency

congenital adrenal hyperplasia

subacute thyroiditis

hypercalcemia due to cancer

- Rheumatic diseases as a short-term adjuvant treatment during exacerbation

post-traumatic osteoarthritis

synovitis in osteoarthritis

rheumatoid arthritis, Still-Shoffard disease

acute and subacute bursitis

epicondylitis

acute nonspecific tenosynovitis

acute gouty arthritis

psoriatic arthritis

ankylosing spondylitis

- Diffuse connective tissue diseases (collagenoses) and immune complex diseases (during exacerbation or as maintenance therapy)

systemic lupus erythematosus and lupus nephritis

acute rheumatic carditis

dermatomyositis (polymyositis)

nodose periarteritis

Goodpasture's syndrome

- Dermatological diseases

pemphigus (pemphigus)

severe erythema multiforme (Stevens-Johnson syndrome)

exfoliative dermatitis

severe psoriasis

bullous dermatitis herpetiformis

severe seborrheic dermatitis

mycosis fungoides

- Allergic diseases (to control severe or disabling allergic conditions, when traditional antiallergic therapy is ineffective)

bronchial asthma

contact dermatitis

atopic dermatitis

serum sickness

seasonal or year-round allergic rhinitis

hypersensitivity to drugs

hives after blood transfusion

acute non-infectious laryngeal edema

- Eye diseases (including severe acute and chronic allergic/inflammatory processes)

ocular form of Herpes zoster (ocular herpes zoster)

iritis, iridocyclitis

chorioretinitis

diffuse posterior uveitis and choroiditis

Optic neuritis

sympathetic ophthalmia

inflammation of the anterior segment

allergic conjunctivitis

allergic marginal corneal ulcer

- Diseases of the gastrointestinal tract (to control critical periods of the disease)

nonspecific ulcerative colitis

regional enteritis

- Respiratory diseases

symptomatic sarcoidosis

berylliosis

fulminant or disseminated tuberculosis (in combination with anti-tuberculosis chemotherapy)

Loeffler's syndrome not responding to other treatments

aspiration pneumonitis

moderate or severe pneumocystis jiroveci pneumonia in HIV-infected patients (as an additional treatment to the main anti-pneumocystis therapy in the first 72 hours)

exacerbation of chronic obstructive pulmonary diseases (COPD)

- Blood diseases

acquired (autoimmune) hemolytic anemia

idiopathic thrombocytopenic purpura in adults (IV administration only; IM administration is contraindicated)

secondary thrombocytopenia in adults

erythroblastopenia (erythrocyte anemia)

hereditary (erythroid) hypoplastic anemia

- Neoplastic diseases (palliative care)

leukemia and lymphoma in adults

acute leukemia in children

improving the quality of life in patients with terminal cancer

- Edema syndrome

stimulation of diuresis or achieving remission of proteinuria in patients with nephrotic syndrome without uremia

- Diseases of the nervous system

swelling of the brain due to a primary or metastatic tumor or associated with surgery or radiation therapy

exacerbation of multiple sclerosis

acute spinal cord injury: treatment should begin within the first 8 hours after injury

tuberculous meningitis with subarachnoid block or threatened block (in combination with appropriate anti-tuberculosis chemotherapy)

- Other indications

trichinosis with damage to the nervous system or myocardium

organ transplantation

prevention of nausea and vomiting associated with chemotherapy for cancer

Directions for use and doses

SOLU-MEDROL® can be administered as an intravenous (IV), intramuscular (IM) injection, or IV infusion. In emergency situations, intravenous administration of the drug is recommended. Data on recommended dosages are shown in Table 1.

Children should be given lower doses - no more than 0.5 mg/kg/day, i.e. every 24 hours, however, 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.

Preparation of solutions

Whenever possible, parenteral preparations should be inspected visually for discoloration or particles.

Instructions for using two types of bottles(the first is a bottle with two separate compartments for storing the drug itself and the diluent separately; the second is where the needle and the diluent are directly inserted):

a) Act-O-Vial® Two-Container Vial

1. Remove the protective cap, rotate the travel stop ninety degrees, and press. Next, the diluent will flow into the lower compartment of the bottle.

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 appropriate antiseptic.

5. Pierce the center of the cork with a needle so that the tip of the needle is visible. Turn the bottle over and remove the required amount of solution with a syringe.

b) Bottle

Using aseptic technique, introduce the solvent into the vial with the lyophilisate. Use only a special solvent.

c) Preparation of solutions for intravenous infusion

Prepare the solution as above. The drug can also be administered in the form of diluted solutions obtained by mixing the original solution of the drug with a 5% aqueous solution of dextrose, with saline, with a 5% solution of dextrose in 0.45% or 0.9% sodium chloride solution. The prepared solutions are physically and chemically stable for 48 hours.

To avoid incompatibility of methylprednisolone with other drugs, as well as to maintain its stability, it is recommended to use the drug separately whenever possible. You will need a separate compartment to accommodate an IV bag, or a “peggy back” type IV bag.

Side effects

The following adverse reactions have been reported using the contraindicated routes of administration listed below: intrathecal or epidural administration: arachnoiditis, gastrointestinal dysfunction/bladder dysfunction, headache, meningitis, paraparesis/paraplegia, seizures and sensory disturbances. The incidence of these adverse reactions is unknown.

Infections, including opportunistic infections

Leukocytosis

Drug hypersensitivity, including anaphylactoid and anaphylactic

Cushingoid, hypopituitarism and complications when stopping the drug - “steroid syndrome”

Decreased glucose tolerance, dyslipidemia, hypokalemic alkalosis, increased need for insulin or oral hypoglycemic drugs in diabetic patients, sodium and fluid retention in the body, negative nitrogen balance (due to protein catabolism), increased blood urea, increased appetite (with subsequent weight gain), lipomatosis

Affective mental disorders (including affective lability, depressive mood, euphoria, drug dependence, suicidal thoughts), psychosis (including mania, delusions, hallucinations, schizophrenia, clouding of consciousness, mental disorders, anxiety, personality changes, emotional lability, abnormal behavior, insomnia, irritability

Increased intracranial pressure (with papilledema, benign intracranial hypertension), seizures, amnesia, cognitive impairment, dizziness, headache, epidural lipomatosis

Exophthalmos, glaucoma, cataracts, increased intraocular pressure, central serous chorioretinopathy

Vertigo (impaired sense of balance)

Congestive heart failure (in patients at risk), arrhythmia

Hypertension, hypotension

Gastric bleeding, intestinal perforation, peptic ulcer (with possible perforation of the peptic ulcer and bleeding), pancreatitis, peritonitis, erosive esophagitis, esophagitis, abdominal pain, abdominal distension, diarrhea, dyspepsia, nausea

Angioedema, peripheral edema, ecchymosis, hemorrhages, skin atrophy, skin striae, skin hypopigmentation, hirsutism, rash, erythema, itching, urticaria, acne, hyperhidrosis

Osteonecrosis, pathological fracture, growth retardation, muscle atrophy, myopathy, osteoporosis, neuropathic arthropathy, arthralgia, myalgia, muscle weakness, tendon rupture, vertebral compression fracture

Menstrual irregularities

Slow wound healing, reactions at the injection site

Fatigue, malaise

Increased alanine aminotransaminase, aspartate aminotransaminase, increased alkaline phosphatase in the blood, increased intraocular pressure, decreased tolerance to carbohydrates, decreased potassium in the blood, increased calcium in the urine, delayed reactions to skin tests

Contraindications

Hypersensitivity to methylprednisolone or any component of the drug

Systemic fungal infections

Acute and subacute myocardial infarction

Children under 3 years of age (this drug contains benzyl alcohol, which can cause “choking syndrome” with a fatal outcome in premature newborns, toxic and allergic reactions in children under 3 years of age)

- intrathecal (intrathecal) application

- epidural route of administration

- concomitant use of live or attenuated vaccines and immunosuppressive doses of corticosteroids

Drug interactions

Methylprednisolone is a substrate of cytochrome CYP P450 enzymes and is primarily metabolized by the CYP3A4 enzyme. The CYP3A4 enzyme dominates in production compared to other enzymes of the CYP subfamily in the liver of adults. It catalyzes the 6β-hydroxylation of steroids, which in turn is an important first phase of the metabolic process for both endogenous and synthetic corticosteroids. Other multicomponent substances are also CYP3A4 substrates. Some of them, as well as other drugs, are capable of modifying the metabolism of glucocorticoids by inducing (increased regulation) or inhibiting the CYP3A4 enzyme.

CYP3A4 INHIBITORS are drugs that inhibit the activity of CYP3A4 by reducing hepatic clearance and increasing plasma concentrations of drugs that are CYP3A4 substrates. An example is methylprednisolone. In the presence of a CYP3A4 inhibitor, the dose of methylprednisolone should be titrated to avoid steroid toxicity.

CYP3A4 INDUCERS are drugs that enhance the activity of CYP3A4 by increasing hepatic clearance and decreasing plasma concentrations of drugs that are CYP3A4 substrates. When used together, an increase in the dose of methylprednisolone may be required to achieve the desired therapeutic result.

CYP3A4 SUBSTRATES - In the presence of other CYP3A4 substrates, the hepatic clearance of methylprednisolone may be impaired, so dose adjustment of methylprednisolone is necessary.

When methylprednisolone is used together with other drugs, the likelihood of side effects increases.

Drug interactions

Drug interactions not related to CYP3A4 but the most common and clinically important ones that occur when methylprednisolone is used with other drugs are listed below in Table 2.

Table 2. Interactions of the most important drugs or active substances with methylprednisolone

Incompatibility

To avoid incompatibility and instability, it is recommended to use methylprednisolone separately from other drugs administered intravenously. Drugs incompatible when mixed with methylprednisolone include, but are not limited to, calcium gluconate, vecuronium bromide, rocuronium bromide, cisatracurium besylate, glycopyrrolate and propofol.

special instructions

Immunosuppression/increased susceptibility to infections

Corticosteroids increase susceptibility to infections, promote latent infection (they can mask some symptoms of an infectious disease) and the emergence of new infections during their use. When using corticosteroids, resistance to infections and the body's ability to localize the infectious process may decrease. The appearance of various foci of infections caused by viruses, bacteria, fungi, protozoa and helminths can be caused by the use of corticosteroids alone or in combination with other immunosuppressive drugs that can inhibit cellular or humoral immunity, or neutrophil function. These infections can occur in moderate to severe forms and can sometimes be fatal. With increasing doses of corticosteroids, the incidence of infectious complications increases accordingly.

People taking immunosuppressive drugs are more susceptible to infections than healthy people. For example, chickenpox and measles in children and adults who are immunocompromised as a result of corticosteroid use are severe and sometimes fatal.

Administration of live or attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids. Such patients are only allowed to use killed or attenuated vaccines, but the level of immune response to vaccination may be reduced. In patients receiving non-immunosuppressive doses of corticosteroids, these types of vaccinations are permitted.

The use of corticosteroids in active tuberculosis is limited to their use in fulminant or disseminated tuberculosis to control the progress of the process as an adjuvant drug to the main anti-tuberculosis treatment.

If corticosteroids are prescribed to patients with latent tuberculosis or tuberculin reactivation, then strict monitoring of such patients is required, since there is a likely risk of disease reactivation. With long-term therapy with corticosteroids, such patients are prescribed chemoprophylaxis.

There have been reports of Kaposi's sarcoma being diagnosed in patients undergoing corticosteroid therapy. Interruption of corticosteroid treatment may induce clinical remission.

The role of corticosteroids in the development of septic shock is controversial, with early studies reporting both beneficial and negative effects. Recent studies suggest that adjunctive corticosteroid therapy is beneficial in patients with established septic shock associated with adrenal insufficiency.

However, their use in the standard treatment regimen for septic shock is not recommended. Systematic reviews of short-course, high-dose corticosteroids do not support their use. However, meta-analyses and one review suggest that longer courses (5–11 days) of low-dose corticosteroids may reduce patient mortality, especially in patients with septic shock who require vasopressors.

Effect on the immune system

There is a possible risk of developing allergic reactions. Although cutaneous and anaphylactic/anaphylactoid reactions have been rare in patients receiving corticosteroids, every precaution should be taken immediately prior to administration of the drug, especially if the patient has a history of allergy to any drug.

Effect on the endocrine system

In patients receiving corticosteroids and exposed to severe stress, increased doses of rapid-acting corticosteroids are indicated before, during, and after the stressful situation.

Long-term use of therapeutic doses of corticosteroids can cause hypothalamic-pituitary-adrenal (HPA) suppression, i.e., secondary adrenocorticoid insufficiency. The severity and duration of adrenocorticoid insufficiency varies and depends on the dose, frequency, time and duration of glucocorticoid therapy. This side effect of therapy can be minimized by prescribing the drug every other day.

In addition, abrupt cessation of glucocorticoids can cause acute adrenal insufficiency with a fatal outcome.

Therefore, in order to minimize the severity of symptoms of drug-induced secondary adrenocorticoid insufficiency, a gradual reduction in the dose of the drug is necessary. This secondary adrenocorticoid insufficiency may persist for several months after cessation of treatment. Therefore, during this period, if stressful situations arise, hormonal therapy may be re-prescribed.

Steroid “withdrawal syndrome,” unrelated to adrenocorticoid insufficiency, can occur when the use of glucocorticosteroids is abruptly stopped. This syndrome includes the following symptoms: anorexia, nausea, vomiting, lethargy, headaches, fever, joint pain, peeling skin, muscle pain, weight loss and/or hypotension. This symptomatology is due to sudden changes in glucocorticoid concentrations rather than a decrease in corticosteroid levels.

Since glucocorticoids can cause or aggravate Cushing's syndrome, their use in patients with this disease is prohibited.

Corticosteroids have an enhanced effect in patients with hypothyroidism.

Metabolism and nutrition

Corticosteroids, including methylprednisolone, can increase blood glucose levels, thereby exacerbating previously diagnosed diabetes. Also, their long-term use can lead to the development of diabetes.

Impact on the mental sphere

When using corticosteroids, mental disorders may occur, including euphoria, insomnia, mood lability, personality changes, severe depression with manifestations in psychosis. In addition, pre-existing emotional instability or tendencies towards mental disorders are aggravated by the use of corticosteroids.

The most severe psychological side effects may be associated with systemic steroid use. Typical symptoms usually appear a few days or weeks after starting treatment. Most reactions go away on their own, either after the dose is reduced or when the drug is stopped. However, in some cases, appropriate treatment is required to eliminate such adverse reactions. There have been reports that some patients had to stop taking corticosteroids due to severe adverse reactions, but the incidence is unknown. If psychiatric symptoms, especially severe depression or suicidal thoughts, occur, patients or their caregivers should seek medical attention. Patients or caregivers should be aware that mental disorders may appear or worsen immediately after the dose of systemic steroids is reduced, shortly after, or after they are completely stopped.

Effect on the nervous system

Corticosteroids should be used with caution in patients with seizure disorders.

Corticosteroids should also be used with caution in patients with myasthenia gravis (See section on effects on the musculoskeletal system).

Although controlled clinical trials have demonstrated the effectiveness of corticosteroids in accelerating the resolution of exacerbations of multiple sclerosis, they have not demonstrated the effect of corticosteroids on the final outcome of the disease or its natural history. The study results suggest that relatively high doses of corticosteroids are required to demonstrate a significant effect.

There have been reports of severe medical events associated with intrathecal or epidural administration of the drug (see section "Side effects").

There are reports of the development of epidural lipomatosis in patients taking corticosteroids, usually long-term and in high doses.

Effect on the visual apparatus

Corticosteroids should be used with caution in patients with herpes eye infections as they may cause corneal perforation.

Long-term use of corticosteroids can lead to the development of posterior subcapsular and nuclear cataracts (especially in children), exophthalmos, and increased intraocular pressure, which can cause glaucoma with possible damage to the optic nerve. When using glucocorticoids, the likelihood of developing secondary fungal and viral eye infections increases.

Corticosteroid therapy has in some cases been associated with the development of central serous chorioretinopathy, which can lead to retinal detachment.

Effect on cardiac activity

Side effects of glucocorticoids on the cardiovascular system can manifest themselves in the form of dyslipidemia and arterial hypertension. With long courses of treatment and the use of high doses in patients with existing cardiovascular risk factors, other cardiovascular complications may appear. Therefore, in such patients, corticosteroids should be prescribed judiciously, taking into account the possible risks and additional monitoring of cardiac parameters as necessary. If complications occur in this group of patients, lower dosages are selected or corticosteroid therapy is prescribed every other day.

Cardiac arrhythmia, vascular collapse, and/or cardiac conduction slowing have been reported with rapid intravenous administration of high doses of methylprednisolone (more than 0.5 g over less than 10 minutes).

There have been reports of bradycardia during or after administration of high doses of methylprednisolone, but the relationship of its occurrence with the rate or duration of drug infusion has not been proven.

In congestive heart failure, systemic corticosteroids should be used with caution and only when absolutely necessary.

Effect on the vascular system

Steroids should be used with caution in patients with hypertension.

Effect on the gastrointestinal tract

Although there is no consensus regarding the ability of corticosteroids to cause the development of peptic ulcers during therapy, glucocorticoid therapy may mask the symptoms of peptic ulcers, and therefore perforation or bleeding from it is not accompanied by significant pain. When using the drug with NSAIDs, the risk of developing gastrointestinal ulcers increases.

Corticosteroids should be used with caution in patients with ulcerative colitis if there is a risk of perforation, abscess or other pyogenic infection, as well as with diverticulitis, recent intestinal anastomoses, active or latent peptic ulcer.

Effect on the hepatobiliary system

High doses of glucocorticosteroids can provoke acute pancreatitis.

Effect on the musculoskeletal system

There have been reports of acute myopathy with the use of high doses of corticosteroids, which most often occurred in patients with neuromuscular conduction disorders (for example, myasthenia gravis), or in patients receiving concomitant therapy with anticholinergics such as neuromuscular blockers (for example, pancuronium ). This acute myopathy may become generalized, affecting the eye and respiratory muscles and may result in tetraparesis. It is also possible that the level of the enzyme creatine kinase in the blood may increase. It may take several weeks to several years for the body to feel better and recover after using corticosteroids.

Osteoporosis is an expected but not common side effect that occurs with long-term use of glucocorticoids in high doses.

Urorenal disorders

Corticosteroids should be used with caution in patients with renal impairment.

Laboratory and instrumental research data

Medium and high doses of hydrocortisone or cortisone can cause increased blood pressure, water and salt retention, and increased potassium excretion from the body. The negative effects of the above synthetic drugs are likely when used in large doses. In such cases, a diet that limits salt intake and supplements with potassium is recommended. All corticosteroids can increase calcium excretion from the body.

Injuries, intoxications and local complications

According to the results of a multicenter study, methylprednisolone should not be used routinely in the treatment of head injuries. The study results showed that mortality from 2 weeks to 6 months after injury was higher with methylprednisolone than with placebo. However, the cause-and-effect relationship of this fact with the use of methylprednisolone has not been established.

Other Cautions

Since complications from glucocorticoid therapy depend on the dose and duration of treatment, it is necessary to individually select the dose and duration of therapy for each patient, as well as the choice of a daily or intermittent (intermittent) regimen of drug use, taking into account the risk/benefit ratio.

It is recommended for maintenance therapy to select the lowest possible dose of corticosteroid, which in turn will be most suitable for a particular patient. If it becomes possible to reduce the dose, this should be done gradually.

Acetylsalicylic acid and non-steroidal anti-inflammatory drugs should be used with caution in combination with corticosteroids. Fatal pheochromocytoma crisis has been reported following the use of systemic corticosteroids. Corticosteroids should be prescribed to patients with suspected or known pheochromocytoma only after an appropriate assessment of risks and benefits.

Use in children

Parenterally administered drugs containing benzyl alcohol are prohibited for use in children under 3 years of age. The drug SOLU-MEDROL® contains benzyl alcohol, which causes toxic irritation of the mucous membranes of the respiratory tract of newborns and can cause Gasping syndrome (“suffocation syndrome”) with a fatal outcome.

Although standard therapeutic doses of the drug contain benzyl alcohol in quantities significantly lower than those at which the development of “choking syndrome” was observed, the minimum amount of benzyl alcohol that can cause a toxic reaction is unknown. The risk of developing toxic reactions when using benzyl alcohol depends on the amount of the substance administered and the detoxification capacity of the liver. Toxic reactions may be more likely to occur in premature and low birth weight infants.

Growth and development parameters of neonates and children undergoing long-term treatment with corticosteroids should be carefully monitored. This is due to the fact that long-term treatment with glucocorticoids and splitting daily doses into several doses (usually the frequency of administration is 2 times a day) can inhibit the growth of children. Therefore, such drug treatment regimens are prescribed only in the most extreme cases. Using the drug every other day usually helps to avoid side effects or reduce them to a minimum.

Newborns and children receiving long-term courses of corticosteroid therapy are at risk for developing intracranial hypertension.

High doses of corticosteroids can cause pancreatitis in children.

Pregnancy

Animal studies have shown that the use of high doses of methylprednisolone in females causes the development of fetal deformities. However, similar results have not been observed with the use of corticosteroids in pregnant women. Taking into account the fact that experiments on humans cannot give an absolute guarantee, pregnant women are recommended to use SOLU-MEDROL® according to absolute indications only in exceptional cases.

Some corticosteroids are able to cross the placenta. One retrospective study found that mothers taking corticosteroids had low birth weight babies. Infants born to mothers who received significant doses of corticosteroids during pregnancy should be closely monitored and assessed for signs of adrenal insufficiency, although adrenal insufficiency is quite common in neonates exposed to large doses of corticosteroids in utero. rarely.

Corticosteroids do not affect the ability of uterine contractility and childbirth.

Cases of lens opacification have been identified in newborns whose mothers were prescribed long courses of corticosteroids during pregnancy.

Lactation period

Corticosteroids are found in mother's breast milk.

Corticosteroids excreted in breast milk can inhibit growth and negatively affect the endogenous production of glucocorticoids in infants.

Since appropriate studies have not been conducted to study the reproductive toxicity of glucocorticoids in nursing mothers, SOLU-MEDROL® is recommended to be prescribed only in cases where the likely benefits of treatment for the mother outweigh the potential risks for the newborn.

Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms

The effect of corticosteroids on the ability to drive vehicles and operate machinery has not been systematically studied. Side effects such as dizziness, balance problems, visual disturbances and fatigue are likely to occur after corticosteroid treatment. If present, patients should refrain from driving a vehicle or operating other potentially dangerous machinery.

Overdose

No clinical syndromes of severe overdose were identified with the use of corticosteroids. Reports of acute corticosteroid intoxication are very rare.

Treatment: There is no specific antidote for overdose. Standard symptomatic therapy is carried out. Methylprednisolone is eliminated by dialysis.

Release form and packaging

For a dosage of 250 mg: the drug and solvent are placed in a two-capacity Act-O-Vial type bottle made of class I hydrolytic glass, sealed with a top and central butyl rubber stopper. 4 ml of solvent is placed above the central stopper (upper part), 250 mg of lyophilisate is placed under the central stopper (lower part). 1 two-capacity bottle along with instructions for medical use in the state and Russian languages ​​is placed in a cardboard box.

For dosages of 500 mg and 1000 mg: 500 mg or 1000 mg of the drug is placed in a class I hydrolytic glass bottle, sealed with a butyl rubber stopper and a tamper evident cap. 7.8 ml (for a dosage of 500 mg) and 15.6 ml (for a dosage of 1000 mg) of the solvent are placed in a class I hydrolytic glass bottle, sealed with a butyl rubber stopper. 1 bottle of the drug and 1 bottle of solvent, together with instructions for medical use in the state and Russian languages, are placed in a cardboard box.

Storage conditions