Years-MEDROL

Active material: Methylprednisolone
When ATH: H02AB04
CCF: GCS for injection
When CSF: 04.02
Manufacturer: PFIZER MFG. BELGIUM N.V. (Belgium)

Pharmaceutical form, composition and packaging

Lyophylisate dlya preparing a solution for intravenous and intramuscular administration in the form of powder or porous mass of white or almost white.

Solvent: benzyl alcohol (9 mg), water d / and (to 1 ml).

Bottles (1) together with the solvent 15.6 ml – packs cardboard.

Valium for drug of a solution for I / O, and the / m in the form of powder or porous mass of white or almost white.

Solvent: benzyl alcohol (9 mg), water d / and (to 1 ml).

Two-capacity bottles (1) Solvent 4 ml – packs cardboard.

Valium for drug of a solution for I / O, and the / m in the form of powder or porous mass of white or almost white.

Solvent: benzyl alcohol (9 mg), water d / and (to 1 ml).

Bottles (1) together with the solvent 7.8 ml – packs cardboard.

Valium for solution for injection in the form of powder or porous mass of white or almost white.

Solvent: benzyl alcohol (9 mg), water d / and (to 1 ml).

Two-capacity bottles (1) Solvent 2 ml – packs cardboard.

Valium for solution for injection in the form of powder or porous mass of white or almost white.

Solvent: benzyl alcohol (9 mg), water d / and (to 1 ml).

Two-capacity bottles (1) Solvent 1 ml – packs cardboard.

Pharmacological action

Synthetic glucocorticoid (synthetic analogue of adrenal hormone, affecting carbohydrate and protein metabolism), anti-inflammatory, antiallergic, immunosuppressive (immunosuppressive) activity. Under the influence of solumedrol, the number of immunoactive cells around the inflammatory focus decreases, decreased vasodilation (expansion of the lumen of blood vessels), stabilization of lysosomal membranes (outer shell of lysosomes – intracellular elements of cells, containing hydrolytic / decomposing biological macromolecules / enzymes), inhibition of phagocytosis (suppression of the process of active capture and destruction of pathogens by phagocytes / blood cells /), decreased production of prostaglandins (biologically active substances) and related substances. Solumedrol dose 4 mg has the same anti-inflammatory effect, as hydrocortisone dose 20 mg. The drug has a low mineralocorticoid (characteristic of hormones of the adrenal cortex, regulating mineral metabolism) activity (200 mg of the drug are equivalent 1 mg deoxycorticosterone).
The clinical effect is usually observed after 4-6 h after application. In the treatment of asthma, the first positive effects can be noted after 1-2 no.

Indications

Endocrine diseases, such as primary or secondary adrenal insufficiency, congenital hyperplasia (proliferation)
adrenal, purulent thyroiditis (non-purulent inflammation of the thyroid gland), Hypercalcemia (elevated blood calcium) due to tumor disease. Rheumatic diseases with a short course as an auxiliary therapy for exacerbation of the process. Inflammatory-degenerative and metabolic diseases of the joints, including psoriatic arthritis (joint inflammation due to psoriasis), rheumatoid arthritis (infectious-allergic disease from the group of collagenoses, characterized by chronic progressive inflammation of the joints), juvenile (in childhood or adolescence) rheumatoid arthritis, ankylosing spondylitis (spinal disease), acute and subacute bursitis (inflammation of the joint capsule), acute and nonspecific tenosynovitis (combined inflammation of the tendon and the inner lining of the joint), acute gouty arthritis (inflammation of the joint as a result of deposition of uric acid in the joint tissues), post-traumatic osteoarthritis (non-inflammatory joint disease), synovitis (inflammation of the inner lining of the joint) in osteoarthritis, epicondylitis (inflammation of a limited area of ​​the humerus, being the site of attachment of muscles and tendons).
Collagen diseases (during an exacerbation or as maintenance therapy if necessary), such as systemic lupus erythematosus, systemic dermatomyositis (systemic disease of muscle tissue and skin, characterized by impaired mobility and redness and swelling of exposed skin), Acute rheumatic heart disease (inflammation of all or individual tissues of the heart in rheumatism), rheumatic polymyalgia (common muscle pain due to rheumatism), periarteritis nodosa (inflammation of the artery walls, which leads to the formation of areas of necrosis in tissues and organs – necrosis), giant cell arthritis (variant of the course of inflammatory joint disease).
Skin diseases, such as pemphigus (disease, characterized by a rash of blisters on apparently unchanged skin and mucous membranes), bullous dermatitis herpetiformis (disease, characterized by the appearance on the skin of the torso and extremities of an itchy rash in the form of blisters and vesicles, arranged in the form of rings and garlands), severe erythema multiforme (various skin diseases, manifested by redness of damaged areas of the skin), exfoliative dermatitis (disease, characterized by redness of all or almost all of the skin, accompanied by large-plate peeling), granulosarcoid (malignant tumor /cancer/ of lymphoid tissue), severe psoriasis, severe seborrheic dermatitis (skin disease, mainly the face and scalp, caused by dysfunction of the sebaceous glands). Allergic conditions (severe or disabling conditions, not amenable to adequate conventional therapy), such as seasonal or chronic allergic rhinitis (inflammation of the nasal mucosa), serum sickness (allergic disease, caused by parenteral (bypassing the digestive tract) introduction of large amounts of protein into the body), bronchial asthma, drug allergy (allergy to any medicine), contact (inflammation of the skin due to direct exposure to a damaging factor/physical, chemical, etc.. p./) or atonic (skin disease, caused by dysfunction of the nervous system, characterized by the formation of a small itchy rash on symmetrically located surfaces of the facial skin, Neck, as well as in the anus and genital area) Dermatitis.
Eye diseases (severe acute and chronic processes), such as allergic marginal corneal ulcers, ocular herpeszoster(eye disease, caused by the herpes virus), inflammation of the anterior segment, diffuse posterior uveitis (inflammation of the uvea), transferred ophtalmia (inflammation of the anterior mucous membrane of the eye due to penetrating injury to the other eye), allergic conjunctivitis (inflammation of the outer membrane of the eye), keratit (inflammation of the cornea), chorioretinitis (inflammation of the retina and blood vessels of the eye), neuritis (inflammation) optic nerve, Irit (iritis) and iridocyclite (inflammation of the iris and ciliary body of the eye). Respiratory diseases, such as symptomatic sarcoidosis (disease, characterized by the appearance of dense nodes and tubercles under the skin and in the internal organs), Loffler's syndrome (allergic lung disease, characterized by the formation in one or both lungs of transient dense formations, consisting of a cluster of eosinophils – special form of leukocytes), berylliosis (occupational lung disease, caused by inhalation of beryllium or its compounds), focal or disseminated pulmonary tuberculosis (during anti-tuberculosis chemotherapy), aspiration pneumonitis (inflammation of the lungs due to foreign bodies or fluid entering them).
Hematologic Disorders (blood disease), such as idiopathic (caused by unclear reasons) trombotsitopenicheskaya purpura (multiple small hemorrhages in the skin and mucous membranes, associated with low levels of platelets in the blood) adult, secondary thrombocytopenia (low platelet levels in the blood) adult, autoimmunnaya gemoliticheskaya anemia (increased breakdown of red blood cells in the blood due to a violation of the body’s immune status), erythroblastopenia (reduction in content, mainly, bone marrow, erythroid cells – precursor cells of blood cells), Congenital (erythroid) gipoplasticheskaya anemia (decrease in hemoglobin level in the blood due to inhibition of the hematopoietic function of the bone marrow). Leukemia (malignancy, arising from hematopoietic cells, and affecting the bone marrow /blood cancer/) and lymphomas (general name for tumors, arising from lymphoid tissue) Adult – in a combination therapy. Children's acute leukemia - as part of combination therapy. Terminal (preceding death) stage of the process in cancer patients – to improve quality of life. Gastrointestinal Disorders, such as ulcerative colitis (inflammation of the colon with the formation of ulcers and regional enteritis (inflammation of a specific area of ​​the small intestine) – as part of systemic therapy during the critical period of the disease.
Nervous System Disorders, such as multiple sclerosis (systemic disease of the nerve sheaths of the brain and spinal cord) during exacerbation, traumatic spinal cord injury (not later 8 h from the moment of injury), swelling of the brain due to a tumor (primary or metastatic) and/or related to trauma, with surgery or radiation therapy. Shock due to adrenocorticoid deficiency (insufficient function of the adrenal cortex) or shock, resistant (stable) to standard therapy – in situations, when adrenal insufficiency cannot be ruled out. Trichinella (human disease, caused by parasitic worms – trichinelloi) with damage to the nervous system or myocardium (heart muscle). Transplant (transplantation) bodies. Prevention of nausea and vomiting, associated with antitumor chemotherapy. The drug is also used to increase diuresis (urination) or achieving remission (temporary weakening or disappearance of disease manifestations) nephrotic syndrome (painful condition, characterized by massive edema and high protein content in the urine; observed in kidney diseases), with tuberculosis meningitis (inflammation of the meninges, caused by Mycobacterium tuberculosis) with subarachnoid block (disruption of the outflow of cerebrospinal fluid into the space between the arachnoid and pia mater of the brain) or if there is a threat of block - with simultaneous anti-tuberculosis therapy.

Mode of application

As an adjuvant therapy for life-threatening conditions, a dose of 30 mg / kg body weight. The drug is administered intravenously for, least, 30 m. Administration can be repeated every 4-6 no.
For rheumatoid arthritis, it is prescribed according to 1 g per day for 1, 2, 3 or 4 days or 1 g per month intravenously. For systemic lupus erythematosus – 1 g per day intravenously for 3 days. At multiple sclerosis – 1 g per day intravenously for 3 or 5 days. For edematous conditions (glomerulonephritis, lupus nephritis) appointed 30 mg / kg intravenously over 4 days every other day or 1 g per day for 3, 5 or 7 days.
To improve the quality of life in the terminal stages of tumor diseases, solumedrol is prescribed in a dose 125 mg per day intravenously up to 8 weeks.
The drug should be administered within, least, 30 minutes. Introductions can be repeated, if there is no improvement within a week after the end of therapy, or depending on the patient's condition.
To prevent nausea and vomiting, caused by antitumor therapy, the dose of the drug is prescribed depending on the emetogenicity (severity of the emetic effect) Chemotherapy. Introduction is usually recommended 250 mg solumedrol intravenously for, least, 5 min an hour before the administration of antitumor drugs, at the beginning and after the end of their administration.
For acute traumatic injuries of the spinal cord, solumedrol is administered intravenously at the rate of 30 mg per kg body weight, no less, than 15 m, then – by continuous infusion at a rate 5,4 mg/kg per hour during the course 23 no. The drug should be administered using an infusion pump into a vein, without mixing with other drugs. Treatment should be started within the first 8 h after injury.
For other indications, the initial dose may range from 100 to 500 mg depending on the clinical situation.
Higher doses may be required for short-term therapy for severe and acute conditions. Initial dose up to 250 mg should be administered, least, 5 m, and if the dose is more 250 mg, then it should be entered at least 30 m. Subsequent administrations may be given intramuscularly or intravenously at intervals, the duration of which is determined by the clinical condition and effect in a given patient.
For children, solumedrol is prescribed in smaller doses., but the dosage is largely determined by the effect and severity of the condition, than age or body weight. The dose should not be less 0,5 mg per kg body weight every 24 hours.
The drug should be used with caution in premature infants, since there are messages, that benzyl alcohol, which is part of the drug, can cause suffocation syndrome with lethal (fatal) exodus. Since complications of solumedrol therapy depend on the dose and duration of treatment, in each specific case it is necessary to evaluate the ratio of possible risks and benefits in relation to the dosage and duration of treatment, and the treatment regimen – daily or intermittent.
In children, long-term therapy with solumedrol is possible only for the most serious indications due to possible growth suppression.
To prepare solutions of the drug solumedrol, a special solvent is used., attached to the package. If necessary, the drug can be used in the form of diluted solutions after mixing the original solution with 5% glucose in water, saline, 5% glucose on 0,45% or 0,9% sodium chloride. The resulting solutions are physically and chemically stable for 48 no.

Side effects

Menstrual irregularities, the development of Cushing's syndrome (Obesity, accompanied by decreased sexual function, increased bone fragility due to increased release of adrenocorticotropic hormone from the pituitary gland), suppression of the pituitary-adrenal axis (suppression of pituitary hormone release, regulating adrenal function), decreased tolerance (Portability) to carbohydrates, manifestation of diabetes mellitus (increased blood sugar levels in patients with latent forms of diabetes mellitus), increased need for insulin or oral (administered orally) hypoglycemic (lowering blood sugar levels) remedies for diabetics, growth suppression in children. Steroid myopathy (muscular weakness, caused by a violation of steroid hormone metabolism), osteoporosis (malnutrition of bone tissue, accompanied by an increase in its fragility), pathological fractures, compression (under compression) vertebral fractures, aseptic necrosis (tissue necrosis) joints. Peptic ulcers (gastric ulcer, intestines or esophagus, developed as a result of the destructive effect of gastric juice on the mucous membrane) with perforation option (occurrence of a through defect in the organ wall) and bleeding, gastrorrhagia, pancreatitis (Pancreatic inflammation), esophagitis (inflammation of the esophagus), intestinal perforation. Wound healing disorders, petechiae (pinpoint hemorrhages under the skin or mucous membranes) and ecchymoses (extensive hemorrhages under the skin or mucous membranes), thinning and fragility of the skin. Increased intracranial pressure, mental disorders, depression (state of depression), sudden mood swings, seizures, zadnyaya subkapsulyarnaya cataracts (eye disease, characterized by partial or complete clouding of the lens of the eye, with localization of the lesion under the lens capsule), increased intraocular pressure, exophthalmos (forward displacement of the eyeball, accompanied by widening of the palpebral fissure , secondary eye infections, caused by viruses and fungi. Erasing the clinical picture of infectious diseases, activation of latent (hidden) Infections, suppression of reactions to allergens in skin tests, increased susceptibility to fungal infections, viral and bacterial infections. Sodium retention, potassium loss, hypokalemic alkalosis (exfoliation of blood, accompanied by a decrease in the content of potassium ions), increased excretion (allocation) Calcium, fluid retention. Negative nitrogen balance due to metabolism (decomposition) proteins. Allergic reactions, cardiac arrest, bronchospasm (sharp narrowing of the lumen of the bronchi), heart rhythm disturbances, arterial hypertension (rise in blood pressure) or hypotension (lowering blood pressure).
There are indications of the onset of cardiac arrhythmias and/or vascular collapse (sudden drop in blood pressure) and/or cardiac arrest after rapid intravenous administration of large doses of solumedrol (more 0,5 in less than 10 m).
If stress occurs during therapy with solumedrol, the use of fast-acting corticosteroids in high doses is indicated..
Solumedrol-induced relative adrenal insufficiency may persist for several months after discontinuation of the drug.. Consequently, in any stressful situation, arising during this period, hormonal therapy is resumed with simultaneous administration of salts and/or mineralocorticoids (adrenal hormones, regulating mineral metabolism).
Solumedrol may exacerbate pre-existing emotional instability or psychotic tendencies.
To reduce the severity of side effects on the water-electrolyte balance, a sodium-restricted diet is prescribed (table salt) and high potassium content.

Contraindications

Systemic fungal infections; hypersensitivity to methylprednisolone.
During treatment with the drug, vaccination against smallpox and other immunization procedures should not be performed due to the possibility of neurological complications and the lack of antibody formation..
Solumedrol is used with caution in nonspecific ulcerative colitis, diverticulum (inflammation of the diverticulum due to stagnation of its contents /diverticulum – protrusion of the wall of a hollow organ, communicating with its cavity/), presence of fresh intestinal anastomoses (created operatively by communications between intestinal loops), latent ulcer of the stomach or duodenum, for abscesses (I suppurated) or other purulent infection, renal failure, hypertension, osteoporosis, myasthenia (muscle weakness).
The use of solumedrol during pregnancy and breastfeeding requires a careful assessment of the balance between the benefits of the drug and the potential risk for the mother and fetus., it is prescribed only when there is an undoubted need. Children, born of women, who received significant doses of solumedrol during pregnancy, should be closely monitored for signs of adrenal insufficiency.

Product form

Sterile powder for intramuscular and intravenous use in bottles according to 0,02 g, 0,04 g, 0,125 g, 0,25 g, 0,5 g, 1,0 or g 2,0 g methylprednisolone sodium succinate complete with solvent.

Storage conditions

List B. In the cool, protected from light.