Instruction for use: Lemod

Active substance Methylprednisolone

ATX Code H02AB04 Methylprednisolone

Pharmacological group

Glucocorticosteroids

Nosological classification (ICD-10)

A16 Tuberculosis of respiratory organs, not confirmed bacteriologically or histologically

A17.0 Tuberculous meningitis (G01 *)

Tuberculosis of serous membranes, Tuberculous meningitis, Meningitis tuberculosis

C85 Other and unspecified types of non-Hodgkin's lymphoma

Lymphoma of mixed type, Lymphomas from cells of the mantle zone, Malignant lymphoma, Lymphoma non-Hodgkin's disease, Lymphocytic lymphoma

C91 Lymphoid leukemia [lymphatic leukemia]

Lymphocytic leukemia, Lymphoproliferative diseases, Neuroleukemia, Refractory acute lymphoblastic leukemia, Refractory lymphoblastic leukemia, Transformation of preleukemias, Chronic lymphatic leukemia, Lymphoproliferative disorders

C95.9 Other specified leukemia

Leukemia, Acute leukemia after chemotherapy and / or radiation, Lymphoproliferative disorders, Pre-malignant state

D59.1 Other autoimmune hemolytic anemia

Autoimmune hemolytic anemia, Immune hemolytic anemia, Autoimmune hemolytic anemia

D69.3 Idiopathic thrombocytopenic purpura

Werlhof's disease, Idiopathic autoimmune thrombocytopenia, Idiopathic thrombocytopenic purpura of adults, Idiopathic thrombocytopenic purpura in adults, Immune idiopathic thrombocytopenic purpura, Immune thrombocytopenia, Bleeding in patients with thrombocytopenic purpura, Evans Syndrome, Thrombocytopenic purpura, Thrombocytopenia of immune origin, Chronic idiopathic thrombocytopenic purpura, Essential thrombocytopenia, Autoimmune thrombocytopenic purpura in pregnancy, Posttransfusion purpura

D86 Sarcoidosis

Beca disease, Beka sarcoid, Bénie-Beca-Schaumann disease, Bénya-Beca-Schaumann syndrome, Granulomatosis benign, Lymphogranulomatosis benign, Reticuloendotheliosis epithelioid cell chronic, Shaumann benign lymphogranulomatosis, Shaumann syndrome, Symptomatic sarcoidosis

E27.1 Primary insufficiency of the adrenal cortex

Addison's Disease, Addisonism, Adrenocortical insufficiency, Hypofunction of the adrenal cortex, Collapse with Addison's Disease, Insufficiency of the adrenal cortex primary, Primary adrenocortical insufficiency, Primary adrenal insufficiency

E27.4 Other and unspecified adrenocortical insufficiency

Hypocorticism, Hypoaldosteronism, Adrenal insufficiency, Insufficiency of the adrenal cortex, Insufficiency of the adrenal cortex, Secondary adrenocortical insufficiency, Secondary adrenal insufficiency, Secondary insufficiency of the adrenal cortex, Temporary decrease in the function of the adrenal cortex, Dysfunction of the adrenal cortex

E27.8 Other specified disorders of the adrenal gland

G35 Multiple sclerosis

Disseminated sclerosis, multiple sclerosis, Relapsing Multiple Sclerosis, Secondary progressive multiple sclerosis, Exacerbation of multiple sclerosis, Mixed forms of multiple sclerosis

H20 Iridocyclitis

recurrent iritis, sympathetic iridocyclitis, Sluggish posterior uveitis, Sluggish posterior uveitis, Posterior uveitis, the posterior segment of the eye Iridocyclitis, Iridocyclitis and other uveitis, Irit, Keratoiridotsiklit, Acute iritis, uveitis, cycle of Acute iridocyclitis, Acute non-infectious uveitis

H44.1 Other endophthalmitis

Ophthalmic sympathetic, Egyptian ophthalmia,Endophthalmitis

H46 Optic neuritis

Leber Retinitis, Inflammatory optic neuritis of the optic nerve, Strona syndrome, Inflammation of the optic nerve, Papillitis

I01 Rheumatic fever with involvement of the heart

Rheumatic carditis acute

J30 Vasomotor and allergic rhinitis

Allergic rinopatiya, Allergic rhinosinusopathy, Allergic respiratory diseases, Allergic rhinitis, nasal allergy, Seasonal Allergic Rhinitis, Vasomotor rhinitis, Long-allergic rhinitis, Perennial allergic rhinitis, Perennial allergic rhinitis, Year-round or seasonal allergic rhinitis, Year-round allergic rhinitis nature, Rhinitis allergic vasomotor, Exacerbation of pollen allergy in the form of Syndrome rinokonyunktivalnogo, Acute allergic rhinitis, Edema of the nasal mucosa, Edema of the nasal mucosa, Swelling of the mucosa of the nasal cavity, Swelling of the nasal mucosa, Swelling of the nasal mucosa, pollen disease, Permanent allergic rhinitis, rhinoconjunctivitis, rhinosinusitis,rhinosinusopathy, Seasonal allergic rhinitis, Seasonal Allergic Rhinitis, Haymarket rhinitis, Chronic allergic rhinitis, Allergic respiratory diseases

J45 Asthma

Asthma physical effort, status asthmaticus, Bronchial asthma, Asthma lung flow, Bronchial asthma with obstruction of sputum discharge, Bronchial asthma heavy currents, Bronchial asthma physical effort, hypersecretory asthma, Hormone-dependent form of bronchial asthma, Relief of asthma attacks in bronchial asthma, Non-allergic asthma, nocturnal asthma, Exacerbation of asthma, Asthma attacks, Endogenous forms of asthma, Night asthma, Cough with bronchial asthma

J63.2 Berylliosis

J69 Pneumonitis caused by solids and liquids

J82 Pulmonary eosinophilia, not elsewhere classified

Pulmonary infiltrate, Eosinophilic pulmonary infiltrate, Leffler's syndrome, Leffler's disease

K50 Crohn's disease [regional enteritis]

Crohn's disease, Crohn's disease with fistula, Granuloma of the intestine, Granulomatous enteritis, Crohn's disease, Regional ileitis, Terminal Ileitis, Enteritis regional

K51 Ulcerative colitis

Colitis acute ulcerative, Colitis ulcerative, Ulcerative-necrotic colitis, Colitis ulcerative-hemorrhagic nonspecific, Colitis ulcerative and trophic, Colitis ulcerative idiopathic, Colitis ulcerative nonspecific, Nonspecific ulcerative colitis, Proctocolitis ulcers, Hemorrhagic purulent rectoxitis, Rectoccolitis ulcerative-hemorrhagic

L10 Pemphigus [pemphigus]

Benign pemphigoid of mucous membranes, Bubble dermatosis, Pemphigus, Dermatitis, vesicular, Benign pemphigus, Ordinary pemphigus, Pemphigus, Bubble dermatitis, Family benign pemphigus Hailey-Hailey

L13.9 Bullous changes, unspecified

Bullous dermatitis

L20 Atopic dermatitis

Itchy atopic eczema, Common neurodermatitis, Allergic skin diseases, Allergic skin diseases of non-infectious etiology, Allergic skin diseases of non-microbial etiology, Allergic skin diseases, Allergic skin lesions, Allergic manifestations on the skin, Allergic dermatitis, Allergic diathesis, Allergic itching dermatosis, Allergic Skin Disease, Allergic skin irritation, Dermatitis allergic, Atopic dermatitis, Dermatosis allergic, Diathesis exudative, Skin Allergic Disease, Skin allergic reaction to medicinal and chemical preparations, Skin reaction to medication, Skin and allergic disease, Acute eczema, Chronic atopic dermatitis, Exudative diathesis, Itching allergic dermatosis

L21 Seborrheic dermatitis

Dermatitis seborrheic, Increased sebum separation, Seborrheic Eczema, Seborrheic dermatitis of the scalp, Seborrheic pyodermatitis, Seborrhea, Eczema seborrheic

L26 Exfoliative dermatitis

Dermatitis exfoliative, Exfoliative dermatitis generalized

L30 Other dermatitis

Non-aboriginal dermatitis

L40 Psoriasis

Chronic psoriasis with diffuse plaques, Generalized psoriasis, Psoriasis of the scalp, Psoriasis of the scalp, Generalized form of psoriasis, Psoriasis dermatitis, Psoriasis complicated by erythroderma, Invalidative psoriasis, Isolated psoriatic plaque, Exfoliative psoriasis, Psoriatic Erythroderma, Psoriasis with eczematosis, Hyperkeratosis in psoriasis,Inverse psoriasis,Psoriasis eczematous, Dermatosis of psoriasis, Psoriasis of the genitals, Psoriasis with lesions of hairy areas of skin, Erythrodermal psoriasis, Chronic psoriasis of the scalp, Chronic psoriasis, Ordinary psoriasis, Refractory psoriasis, Kebner phenomenon, Scaly lichen

L51 Erythema multiforme

Stevens-Johnson syndrome, Malignant exudative erythema, Multiforme exudative erythema, Erythema multiforme, Multiforme exudative erythema, Stevens-Johnson Syndrome, Exudative multiform erythema, Erythema is polymorphic

M06.9 Other specified rheumatoid arthritis

Rheumatoid arthritis,Pain syndrome in rheumatic diseases, Pain in rheumatoid arthritis, Inflammation in rheumatoid arthritis, Degenerative forms of rheumatoid arthritis, Children's rheumatoid arthritis, Exacerbation of rheumatoid arthritis, Acute articular rheumatism, Rheumatic arthritis, Rheumatic polyarthritis, Rheumatoid arthritis, Rheumatic polyarthritis, Rheumatoid arthritis, Rheumatoid arthritis of active course, Rheumatoid arthritis, Rheumatoid polyarthritis, Acute rheumatoid arthritis, Acute rheumatism

M08 Juvenile [juvenile] Arthritis

Juvenile arthritis, Juvenile chronic polyarthritis, Juvenile chronic arthritis, Juvenile rheumatoid arthritis, Arthritis juvenile chronic

M32 Systemic lupus erythematosus

Lupus erythematosus red disseminated, Disseminated lupus erythematosus, Chronic lupus erythematosus

M33 Dermatopolymiositis

Dermatomyositis, Wagner's disease, Wagner-Unferricht-Hepp Syndrome, Systemic dermatomyositis, Sclerodermatomyositis

M35.3 Rheumatic polymyalgia

Pseudoarthritis rhizomelic, Rheumatic polymyalgia, Pain syndrome in rheumatic diseases, Muscle pain with rheumatism, Extra-articular rheumatism, Extra-articular rheumatic syndrome, Extra-articular rheumatic diseases, Extra-articular rheumatic soft tissue injury, Extra-articular forms of rheumatism, Rheumatic soft tissue damage, Rheumatism of soft tissues, Rheumatic diseases of soft tissues, Rheumatic diseases of the periarticular soft tissues, Rheumatic affections of soft tissues, Rheumatic collagen diseases

M45 Ankylosing spondylitis

Ankylosing spondylarthrosis, Marie-Strumpel disease, Ankylosing spondylitis, Pain syndrome in acute inflammatory diseases of the musculoskeletal system, Pain syndrome in chronic inflammatory diseases of the musculoskeletal system, Bechterew's disease, Ankylosing spondylitis, Diseases of the spinal column, Rheumatic spondylitis, Bechterew-Marie-Strumpel disease

T80.6 Other serum reactions

Serum sickness, Allergic reaction of the type of serum sickness, Serous disease accelerated

T88.7 Abnormal reaction to drug and medicines, unspecified

Allergic drug reactions, Allergic reactions to drugs, Allergic reactions to medication, Allergic reactions to taking drugs, Allergic reactions to reception of radiocontrast agents, Allergic reactions due to medication, Anaphylactic reactions to medications, Anaphylactic reactions to taking drugs, Hepatotoxic effect of drugs, Idiosyncrasy to drugs, Drug dependence, Drug-induced leukopenia, Drug-induced liver damage, Medicinal damage of the lungs, Undesirable effects of drugs, Acute allergic reaction to drugs, Idiosyncrasy toxic

Z94 Presence of the transplanted organ and tissue

Allogeneic transplantation, Allotransplantation, Autotransplantation, Gomotransplant, Isotransplantation, Transplantation, Orthotopic transplantation

Composition and form of release

Tablets 1 table.

Methylprednisolone (in the form of a mixture of methylprednisolone-starch 50:50 micronized) 4 mg

Auxiliary substances: lactose monohydrate; corn starch; Sucrose; Liquid paraffin wax; Calcium stearate

In a blister for 10 pcs., In a pack of cardboard 2 blisters.

Lyophilizate for solution for intravenous and intramuscular administration 1 fl.

Methylprednisolone (in the form of methylprednisolone sodium succinate) 125 mg

(Corresponding to methylprednisolone hydrosuccinate-158.5 mg)

Auxiliary substances: sodium hydrophosphate anhydrous; Sodium phosphate monohydrate in the form of monohydrate

Solvent: 2 ml of solvent (0.9% benzyl alcohol) contain - benzyl alcohol 18 mg, water for injection

In vials of 125 mg (with a solvent in ampoules of 2 ml); In a pack of cardboard 1 bottle and 1 ampoule.

Description of dosage form

Tablets: round, biconcave, white tablets with one-sided risk.

Lyophilizate for solution preparation for intravenous and intravenous administration: white or almost white, fine crystalline lyophilizate.

Solvent (0.9% benzyl alcohol): a clear, colorless solution.

Characteristic

Synthetic GCS (glucocorticosteroids).

pharmachologic effect

Pharmacological action - anti-inflammatory, antiallergic, immunosuppressive.

Pharmacodynamics

Has anti-inflammatory, anti-allergic and immunosuppressive effects.

It interacts with specific cytoplasmic receptors (receptors for GCS are present in all tissues, especially in the liver), with the formation of a complex inducing the formation of proteins (including enzymes that regulate vitally important processes in cells).

Protein metabolism: reduces the number of globulins in the plasma, increases the synthesis of albumins in the liver and kidneys (with increasing albumin / globulin ratio), reduces synthesis and enhances protein catabolism in muscle tissue.

Lipid metabolism: increases synthesis of higher fatty acids and triglycerides, redistributes fat (accumulation of fat occurs mainly in the area of the shoulder girdle, face, abdomen), leads to the development of hypercholesterolemia.

Carbohydrate metabolism: increases the absorption of carbohydrates from the digestive tract; Increases the activity of glucose-6-phosphatase (increased intake of glucose from the liver into the blood); Increases the activity of phosphoenolpyruvate carboxylase and the synthesis of aminotransferases (activation of gluconeogenesis); Promotes the development of hyperglycemia.

Water-electrolyte metabolism: retards sodium (Na +) and water in the body, stimulates the excretion of potassium (K +) (mineralocorticoid activity), reduces the absorption of calcium (Ca2 +) from the digestive tract, reduces the mineralization of bone tissue.

The anti-inflammatory effect is associated with the suppression of the release of eosinophils and mast cells by inflammatory mediators; Inducing the formation of lipocortins and reducing the number of mast cells that produce hyaluronic acid; Reduced capillary permeability; Stabilization of cell membranes (especially lysosomal) and membranes of organelles.

It acts on all stages of the inflammatory process: it inhibits the synthesis of PG at the level of arachidonic acid (lipocortin depresses phospholipase A2, inhibits the liberation of arachidonic acid and inhibits the biosynthesis of endoperexides, leukotrienes, promoting inflammation, allergies, etc.), the synthesis of pro-inflammatory cytokines (IL-1, factor Tumor necrosis of alpha, etc.); Increases the resistance of the cell membrane to the action of various damaging factors.

Immunodepressive effect is caused by induced lymphoid tissue involution, suppression of lymphocyte proliferation (especially T-lymphocytes), suppression of B-cell migration and interaction of T and B lymphocytes, inhibition of release of cytokines (IL-1, -2, gamma-interferon) from lymphocytes and Macrophages and a decrease in the formation of antibodies.

The antiallergic effect develops as a result of a decrease in the synthesis and secretion of mediators of allergy, inhibition of release from sensitized mast cells and basophils of histamine and other biologically active substances, a decrease in the number of circulating basophils, suppression of lymphoid and connective tissue development, a decrease in the number of T- and B-lymphocytes, mast cells , Reducing the sensitivity of effector cells to mediators of allergy, inhibition of antibody formation, changes in the body's immune response. In obstructive airway diseases, the effect is mainly due to the inhibition of inflammatory processes, the prevention or reduction of the degree of edema of the mucous membranes, the decrease in the eosinophilic infiltration of the submucosal layer of the bronchial epithelium and the deposition of circulating immune complexes in the bronchial mucosa, as well as the inhibition of erosion and desquamation of the mucosa. Increases the sensitivity of beta-adrenergic receptors of small and medium-sized bronchial tubes to endogenous catecholamines and exogenous sympathomimetics, reduces the viscosity of mucus by reducing its production. Suppresses the synthesis and secretion of ACTH and, secondarily, the synthesis of endogenous GCS.

It inhibits connective tissue reactions during the inflammatory process and reduces the possibility of scar tissue formation.

Pharmacokinetics

When ingested quickly absorbed, the absorption is more than 70%. Has the effect of "first pass" through the liver.

With a / m (intramuscular) injection, the absorption is complete and fast enough. Absorption when injected into the muscles of the thigh is faster than when injected into the gluteal muscles. Bioavailability with a / m (intramuscular) injection - 89%.

Binding to plasma proteins - 62% (binds only to albumin), regardless of the dose administered.

The time to reach Cmax after ingestion is 1.5 h, with IM im injection - 0.5-1 h. Cmax in plasma after intravenous administration at a dose of 30 mg / kg for 20 min or In / in the drip in a dose of 1 g for 30-60 minutes reaches 20 mcg / ml. After an intravenous injection of 40 mg after approximately 2 hours, a C max in plasma of 34 μg / ml was achieved.

T1 / 2 - 3-4 hours With chronic renal failure excretion does not change.

It penetrates the GEB (blood-brain barrier) and the placental barrier. Metabolites are found in breast milk.

Metabolized mainly in the liver, metabolites (11-keto- and 20-hydroxy compounds) do not have hormonal activity and are excreted mainly by the kidneys (about 85% of the administered dose is detected within 24 hours in urine and about 10% in feces).

Indications

Pills:

Endocrine diseases: primary and secondary adrenal insufficiency, congenital adrenal hyperplasia;

Diseases of the musculoskeletal system (including rheumatic diseases): rheumatoid arthritis, juvenile rheumatoid arthritis, ankylosing spondylitis;

Systemic connective tissue diseases: systemic lupus erythematosus, systemic dermatomyositis, acute rheumatic carditis, rheumatic polymyalgia;

Skin diseases: vulgar (ordinary) pemphigus, herpetiform bullous dermatitis, severe erythema multiforme (Stevens-Johnson syndrome), exfoliative dermatitis, fungal mycosis, severe psoriasis, severe seborrheic dermatitis;

Allergic conditions: severe seasonal and all-year-round allergic rhinitis, allergic drug reactions, serum sickness, allergic contact dermatitis, bronchial asthma;

Eye diseases: anterior and posterior uveitis (irites, iridocyclitis), optic neuritis, sympathetic ophthalmia;

Respiratory diseases: symptomatic sarcoidosis, fulminant and disseminated tuberculosis (in combination with appropriate anti-tuberculosis therapy), aspiration pneumonitis, berylliosis, Leffler's syndrome, not amenable to therapy by other means;

Hematological diseases: idiopathic thrombocytopenic purpura, hemolytic anemia (autoimmune);

Oncological diseases: leukemia (acute and lymphocytic leukemia), malignant lymphoma;

Diseases of the digestive tract (gastrointestinal tract): ulcerative colitis, Crohn's disease;

Tuberculous meningitis (in combination with appropriate anti-tuberculosis therapy), multiple sclerosis, transplantation.

Solution for iv and / m administration:

Endocrine diseases:

- Primary and secondary adrenal insufficiency (if necessary in combination with mineralocorticoids, especially in pediatric practice); Acute adrenal insufficiency (it may be necessary to add mineralocorticoids); Shock resulting from adrenal insufficiency, or shock that can not be treated by standard methods, where adrenal insufficiency is possible (if mineralocorticoid action is undesirable); In the preoperative period, in case of severe trauma or severe illness in patients with established or suspected adrenal insufficiency; Congenital adrenal hyperplasia;

- subacute thyroiditis;

- hypercalcemia on the background of cancer;

Allergic diseases and conditions: bronchial asthma, asthmatic state, angioedema, anaphylactic shock, serum sickness, atopic dermatitis;

Rheumatic diseases: posttraumatic osteoarthritis, bursitis, tendovaginitis, epicondylitis, fibrositis, psoriatic arthritis and gout, ankylosing spondylitis;

Systemic connective tissue diseases: systemic lupus erythematosus (and lupus nephritis), acute rheumatic carditis, systemic dermatomyositis, rheumatoid arthritis, juvenile rheumatoid arthritis;

Skin diseases: severe erythema multiforme (Stevens-Johnson syndrome), pemphigus, exfoliative dermatitis, herpetiform bullous dermatitis, mushroom mycosis, severe forms of psoriasis and seborrheic dermatitis;

Diseases of the digestive tract: ulcerative colitis, Crohn's disease;

Respiratory diseases: fulminant and disseminated tuberculosis (in combination with appropriate anti-tuberculosis therapy), symptomatic sarcoidosis, diffuse interstitial fibrosis, aspiration pneumonitis, berylliosis, Leffler's syndrome, not amenable to therapy by other means;

Diseases of the nervous system: multiple sclerosis (during exacerbation);

Eye diseases: eye form Herpes zoster, iritis and iridocyclitis, chorioretinitis, diffuse posterior uveitis and choroiditis, optic neuritis, sympathetic ophthalmia, anterior segment inflammation, allergic conjunctivitis, allergic marginal ulcers of the cornea, keratitis;

Oncological diseases: lymphomas and leukemia (as part of complex therapy);

Hematological diseases: acquired (autoimmune) hemolytic anemia, idiopathic thrombocytopenic purpura in adults (only IV, v / m is contraindicated), secondary thrombocytopenia in adults, erythroblastopenia (erythrocyte anemia), congenital (erythroid) hypoplastic anemia;

Edematous syndrome: to stimulate diuresis and achieve remission of proteinuria in patients with nephrotic syndrome without uremia;

Diseases of the nervous system: cerebral edema caused by a tumor - primary or metastatic, and / or associated with surgical or radiotherapy, multiple sclerosis;

Organ transplantation: graft rejection reactions;

Other: prevention of nausea and vomiting associated with chemotherapy for oncological diseases.

Contraindications

For short-term use according to vital indications, the only contraindication is hypersensitivity.

Absolute contraindications to prolonged use:

Herpes simplex cornea;

Acute peptic ulcer;

Acute psychosis;

Active tuberculosis;

Severe diabetes mellitus;

Systemic fungal infections.

Carefully:

Gastrointestinal diseases: peptic ulcer of stomach and duodenum, esophagitis, gastritis, acute or latent peptic ulcer, newly created intestinal anastomosis, ulcerative colitis with perforation or abscessing threat, diverticulitis;

Parasitic and infectious diseases of a viral, fungal or bacterial nature (current or recent, including recent contact with a patient): herpes simplex, herpes zoster (viremic phase), chicken pox, measles; Amebiasis, strongyloidiasis; Systemic mycosis; Active and latent tuberculosis; Application in severe infectious diseases is permissible only on the background of specific therapy; Pre- and post-vaccination period (8 weeks before and 2 weeks after vaccination), lymphadenitis after BCG vaccination;

Immunodeficiency states (including AIDS or HIV infection);

Diseases of the cardiovascular system, incl. Recently suffered myocardial infarction (in patients with acute and subacute myocardial infarction, the spread of the necrosis foci, slowing the formation of scar tissue and, consequently, rupture of the heart muscle), severe chronic heart failure, hypertension, hyperlipidemia;

Endocrine diseases: diabetes mellitus (including a violation of carbohydrate tolerance), thyrotoxicosis, hypothyroidism, Itenko-Cushing's disease, obesity (III-IV century);

Severe chronic renal and / or hepatic insufficiency, nephrourolythiasis;

Hypoalbuminemia and conditions predisposing to its occurrence;

Systemic osteoporosis, myasthenia gravis;

Acute psychosis, poliomyelitis (with the exception of the form of bulbar encephalitis);

Open and closed angle glaucoma.

In children during the period of growth, the drug should be used only in absolute indications and under the special supervision of the attending physician.

The drug in a dosage form for parenteral administration contains benzyl alcohol.

It has been established that benzyl alcohol can cause choking syndrome with a fatal outcome in premature newborns. The drug is not recommended for use in newborns.

pregnancy and lactation

When pregnancy (especially in the first trimester) is used for life indications.

Since SCS (glucocorticosteroids) pass into breast milk, if it is necessary to use the drug during breastfeeding, it is recommended to stop breastfeeding.

Side effects

The frequency of development and the severity of side effects depend on the duration of the application, the amount of the dose used and the possibility of observing the circadian rhythm of the appointment.

On the part of the endocrine system: a decrease in glucose tolerance, steroid diabetes mellitus or manifestation of latent diabetes mellitus, acne, suppression of adrenal function, Itenko-Cushing syndrome (lunar face, obesity of the pituitary type, hirsutism, increased blood pressure, dysmenorrhea, amenorrhea, Muscular weakness, striae), delay in sexual development in children.

On the part of the digestive system: nausea, vomiting, pancreatitis, steroid ulcer of the stomach and duodenum, erosive esophagitis, bleeding and perforation of the gastrointestinal tract, increased or decreased appetite, digestive disorders, flatulence, hiccough; In rare cases - increased activity of hepatic transaminases and alkaline phosphatase (alkaline phosphatase).

From the cardiovascular system: arrhythmias, bradycardia, cardiac arrest; Aggravation of the phenomena or development of heart failure (in predisposed patients), ECG (electrocardiogram, electrocardiography) changes, characteristic of hypokalemia, increased blood pressure, hypercoagulation, thrombosis; In patients with acute and subacute myocardial infarction - the spread of the focus of necrosis, slowing the formation of scar tissue, which can lead to rupture of the heart muscle.

From the nervous system: delirium, disorientation, euphoria, hallucinations, manic-depressive psychosis, depression, paranoia, increased intracranial pressure, nervousness or anxiety, insomnia, dizziness, vertigo, pseudotumor, cerebral palsy, headache, convulsions.

From the senses: sudden loss of vision (with parenteral administration in the area of the head, neck, nasal concha, scalp may be the deposition of drug crystals in the vessels of the eye), posterior subcapsular cataract, increased intraocular pressure with possible damage to the optic nerve, propensity to develop secondary bacterial , Fungal or viral infections of the eyes, trophic changes in the cornea, exophthalmos.

From the side of metabolism: fluid retention and sodium (edema), hypernatremia, hypokalemic syndrome (hypokalemia, arrhythmia, myalgia or muscle spasm, unusual weakness), increased calcium excretion, hypocalcemia, weight gain, negative nitrogen balance (increased protein breakdown), Increased sweating, promoting the development of pyoderma and candidiasis.

Allergic reactions: generalized (skin rash, itching, anaphylactic shock), local allergic reactions.

Local with parenteral administration: burning, numbness, pain, tingling at the injection site, infection at the injection site; Rarely - necrosis of surrounding tissues, scar formation together with injections; Atrophy of the skin and subcutaneous tissue with the / m introduction (especially dangerous is the introduction to the deltoid muscle).

Other: exacerbation of infections, increased activity of the renin-angiotensin-aldosterone system, leukocyturia, withdrawal syndrome, flushing of blood to the face.

Interaction

Methylprednisolone pharmaceuticals are incompatible with other drugs (can form insoluble compounds).

The simultaneous administration of methylprednisolone:

- with inducers of hepatic microsomal enzymes (phenobarbital, phenytoin, theophylline, rifampicin, ephedrine) - leads to a decrease in its concentration;

- Diuretics (especially thiazide and inhibitors of carbonic anhydrase) and amphotericin B - can lead to increased excretion of K + from the body and an increased risk of developing heart failure;

- amphotericin B and carbonic anhydrase inhibitors - an increased risk of osteoporosis.

- Sodium-containing drugs - leads to the development of edema and increased blood pressure;

- Cardiac glycosides - their tolerance is worsened and the risk of ventricular extrasystole development increases (due to hypokalemia caused);

- indirect anticoagulants - weakens (less intensifies) their effect (dose adjustment is required);

- anticoagulants and thrombolytic - increases the risk of bleeding from ulcers in the gastrointestinal tract;

- ethanol and NSAIDs (non-steroidal anti-inflammatory drugs) - the risk of erosive and ulcerative lesions in the gastrointestinal tract and the development of bleeding increases (in combination with NSAIDs in the treatment of arthritis, there may be a reduction in the dose of GCS due to the summation of the therapeutic effect);

- paracetamol - the risk of hepatotoxicity increases (induction of hepatic enzymes and the formation of a toxic metabolite of paracetamol);

- Acetylsalicylic acid - accelerates its excretion and reduces the concentration in the blood (when methylprednisolone is canceled, the level of salicylates in the blood increases and the risk of side effects increases);

- insulin and oral hypoglycemic drugs, hypotensive drugs - their effectiveness decreases;

- vitamin D - its effect on absorption of Ca2 + in the intestine decreases;

- STH (somatotropic hormone) - reduces the effectiveness of the latter, and with praziquantel - its concentration;

- m-holinoblokatorami (including antihistamines and tricyclic antidepressants) and nitrates - contributes to increased intraocular pressure;

- isoniazid and mexiletine - increases their metabolism (especially in fast acetylators), which leads to a decrease in their plasma concentrations.

Increases (with prolonged therapy) the content of folic acid.

Carboanhydrase inhibitors and loop diuretics can increase the risk of osteoporosis.

Indomethacin, displacing methylprednisolone from bond with albumin, increases the risk of its side effects.

ACTH (adrenocorticotropic hormone) enhances the effect of methylprednisolone.

Ergocalciferol and parathyroid hormone interfere with the development of osteopathy caused by methylprednisolone.

Ketoconazole, by slowing the metabolism of methylprednisolone, may in some cases increase its toxicity.

Joint use with cyclosporine causes mutual inhibition of metabolism - the risk of side effects of both drugs (with joint use, cases of seizures were noted).

Simultaneous appointment of androgens and steroid anabolic drugs with methylprednisolone promotes the development of peripheral edema and hirsutism, the appearance of acne.

Estrogens and oral estrogen-containing contraceptives reduce the clearance of methylprednisolone, which may be accompanied by an increase in the severity of its action. Mitotane and other inhibitors of adrenal cortex function may necessitate an increase in the dose of methylprednisolone.

With simultaneous use with live antiviral vaccines and against other types of immunization, the risk of virus activation and the development of infections increases.

Tricyclic antidepressants can increase the severity of depression caused by taking GCS (not shown for the therapy of these side effects).

Antipsychotic drugs (antipsychotics) and azathioprine increase the risk of cataracts in the prescription of methylprednisolone.

Hypokalemia caused by SCS can increase the severity and duration of muscle blockade against the background of muscle relaxants.

Simultaneous administration of antacids reduces the absorption of methylprednisolone.

Immunosuppressants increase the risk of infection and lymphoma or other lymphoproliferative disorders associated with the Epstein-Barr virus.

With simultaneous use with antithyroid drugs is reduced, and with thyroid hormones - increases the clearance of methylprednisolone.

Dosing and Administration

Pills

Inside, in the morning, after eating, every day or every other day.

The initial dose of the drug can be from 4 mg to 48 mg of methylprednisolone per day, depending on the nature of the disease. In less severe cases, it is usually sufficient to use lower doses, although higher doses may be required for individual patients. High doses may be required for such diseases and conditions as multiple sclerosis (200 mg / day), cerebral edema (200-1000 mg / day) and organ transplantation (up to 7 mg / kg / day). If a satisfactory clinical effect is not obtained after a sufficient period of time, the drug should be withdrawn and another type of therapy prescribed to the patient.

To children, the dose is determined by the doctor taking into account the mass or surface of the body. If adrenal insufficiency is 0.18 mg / kg or 3.33 mg / m2 per day in 3 doses, with other indications - 0.42-1.67 mg / kg or 12.5-50 mg / m2 per day in 3 reception.

Lyophilizate for solution preparation for intravenous and / or intravenous administration

In / in or / m, in the form of injection or in the form of IV infusion, but with urgent conditions, start treatment preferably with IV injection.

Children should be given lower doses (but not less than 0.5 mg / kg / day), but when choosing a dose, first of all, the severity of the condition and the patient's reaction to therapy, rather than age and body weight, are taken into account.

As an additional therapy for life-threatening conditions-30 mg / kg body weight IV for at least 30 minutes. The administration of this dose can be repeated every 4-6 hours for no more than 48 hours.

Pulse therapy in the treatment of diseases in which GCS therapy is effective, with exacerbations of the disease and / or with ineffectiveness of standard therapy.

Oncological diseases in the terminal stage: to improve the quality of life - 125 mg / day IV daily for up to 8 weeks.

Prevention of nausea and vomiting associated with chemotherapy for cancer

In chemotherapy, characterized by a slight or moderate vomiting effect, 250 mg IV is administered for at least 5 minutes 1 hour prior to the administration of the chemotherapeutic drug, at the beginning of chemotherapy, and after its termination. To enhance the effect with the first dose of the drug Lemod ® can be administered drugs chlorophenotiazine. In chemotherapy characterized by severe emetic action, 250 mg IV is administered for at least 5 minutes in combination with appropriate doses of metoclopramide or butirofenone 1 hour prior to the administration of the chemotherapy drug, then 250 mg IV at the beginning of chemotherapy and after it .

The prepared solution should be stored in a dark place and used for 2 days.

Overdose

Symptoms: it is possible to strengthen the side effects described above.

Treatment: symptomatic, it is necessary to reduce the dose of Lemod®.

special instructions

During treatment with Lemod® (especially prolonged), it is necessary to observe the oculist, monitor blood pressure, the state of water-electrolyte balance, as well as patterns of peripheral blood and blood glucose levels.

In order to reduce side effects, it is possible to prescribe antacids, and also to increase the intake of potassium in the body (diet, potassium preparations). Food should be rich in proteins, vitamins, with the restriction of fat, carbohydrates and table salt

The effect of the drug is increased in patients with hypothyroidism and liver cirrhosis.

The drug may exacerbate existing emotional instability or psychotic disorders. When referring to a psychosis in an anamnesis, Lemod® in high doses is prescribed under the strict supervision of a doctor.

With edema of the brain, due to head trauma, the drug can not be used due to an increase in mortality.

With caution should be used in acute and subacute myocardial infarction - possibly spreading the focus of necrosis, slowing the formation of scar tissue and rupture of the heart muscle.

In stressful situations during maintenance treatment (for example, surgical operations, trauma or infectious diseases), a correction of the dose of the drug should be made in connection with an increase in the need for GCS.

With sudden abolition, especially in the case of previous use of high doses, it is possible to develop withdrawal syndrome (anorexia, nausea, blocking, generalized musculoskeletal pain, general weakness), as well as exacerbation of the disease for which Lemod® was prescribed.

During treatment with Lemod®, vaccination should not be given due to a decrease in its effectiveness (immune response).

When appointing Lemod® with intercurrent infections, septic conditions and tuberculosis, it is necessary to simultaneously perform antibiotic treatment with bactericidal action.

At children during long treatment by a preparation careful monitoring over dynamics of growth and development is necessary. Children who during the period of treatment were in contact with sick measles or chickenpox, prophylactically prescribe specific immunoglobulins.

Due to the weak mineralocorticoid effect for replacement therapy for adrenal insufficiency, Lemod® is used in combination with mineralocorticoids. Patients with diabetes should monitor blood glucose and, if necessary, adjust therapy.

An x-ray control of the osteoarticular system (images of the spine, brushes) is shown.

Lemod® in patients with latent infectious diseases of the kidneys and urinary tract can cause leukocyturia, which can be of diagnostic significance. Lemod® increases the metabolites content of 11- and 17-oxyketocorticosteroids.

Lyophilizate for the preparation of solution for iv and / m administration should be used only in inpatient medical institutions.

storage Conditions

In dry, the dark place at a temperature of 15-25 ° C.

Keep out of the reach of children.

Shelf life

Lyophilizate for the preparation of a solution for intravenous and intramuscular injection 125 mg - 5 years.

Tablets 4 mg - 3 years.

Do not use after the expiry date printed on the package.