Solu-Medrol - Instructions For Use, Price, Reviews, 1000 Mg, 250 Mg

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Solu-Medrol

Solu-Medrol: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. In case of impaired renal function
12. 12. Use in the elderly
13. 13. Drug interactions
14. 14. Analogs
15. 15. Terms and conditions of storage
16. 16. Terms of dispensing from pharmacies
17. 17. Reviews
18. 18. Price in pharmacies

Latin name: Solu-Medrol

ATX code: H02AB04

Active ingredient: methylprednisolone (Methylprednisolone)

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

Description and photo update: 2018-27-11

Prices in pharmacies: from 359 rubles.

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Solu-Medrol is a glucocorticosteroid (GCS) for injection.

Release form and composition

Produced in the form of a lyophilisate for the preparation of a solution for intravenous (i / v) and intramuscular (i / m) administration: the drug is a powder or a porous mass from almost white to white; solvent - a colorless, transparent liquid, for 500 and 1000 mg - with a slight smell of benzyl alcohol [40, 125 or 250 mg of active ingredient and 1, 2 or 4 ml of solvent, respectively, in a two-volume Act-O-Vial bottle made of colorless glass, sealed with 2 stoppers (one separates the two containers, the other closes the bottle) with a plastic activator over the top cap, in a cardboard box 1 double-volume bottle; 500 or 1000 mg of active substance in a vial of colorless glass, sealed with a stopper with a plastic protective cap, in a cardboard box 1 vial with lyophilisate complete with 1 vial with solvent (7.8 ml - for 500 mg; 15,6 ml - for 1000 mg); each pack also contains instructions for the use of Solu-Medrol].

Contents of 1 vial with lyophilisate:

• active substance: methylprednisolone (in the form of sodium succinate) - 40, 125, 250, 500 or 1000 mg;
• auxiliary components: secondary acid sodium phosphate, monobasic sodium phosphate monohydrate; additionally for a dosage of 40 mg - lactose monohydrate.

Solvent composition: water for injection, benzyl alcohol.

Pharmacological properties

Pharmacodynamics

Solu-Medrol is an injectable form of methylprednisolone, a synthetic GCS, intended for intramuscular and intravenous administration. The active substance forms complexes with specific receptors in the cytoplasm, the interaction with which occurs after its penetration into the cell through the membrane. These complexes subsequently enter the cell nucleus, form a bond with DNA (chromatin) and activate mRNA transcription with the subsequent production of various enzymes, which ensures the effect of methylprednisolone when used systemically. It has a significant effect on the immune response and the course of the inflammatory process, and also affects the metabolism of proteins, carbohydrates and fats. In addition, it indirectly affects the cardiovascular system, skeletal muscle tissue and the central nervous system.

The overwhelming majority of indications for the use of GCS are due to their immunosuppressive, anti-inflammatory and anti-allergic effects. These properties allow you to achieve the following results:

• the number of immunoactive cells near the focus of inflammation decreases;
• lysosomal membranes are stabilized;
• decreases vasodilation;
• phagocytosis is suppressed;
• the production of prostaglandins and related biologically active compounds decreases.

Methylprednisolone is characterized by a strong anti-inflammatory effect - its effect is superior to that of prednisolone, while the substance causes water and sodium ion retention to a lesser extent than prednisolone.

With parenteral administration of appropriate doses of methylprednisolone sodium succinate and methylprednisolone, the biological activity of these compounds is the same. The mechanism of anti-inflammatory action and metabolism of the active component of Solu-Medrol are similar to those of methylprednisolone. After intravenous administration, the ratio of the activity of methylprednisolone sodium succinate and hydrocortisone sodium succinate, determined by reducing the number of eosinophils, is at least 4 ÷ 1. This is consistent with data on the relative potency of methylprednisolone and hydrocortisone when taken orally. Methylprednisolone at a dose of 4 mg exhibits the same anti-inflammatory (glucocorticosteroid) effect as hydrocortisone at a dose of 20 mg. Methylprednisolone has minimal mineralocorticosteroid activity,while at a dose of 200 mg corresponds to deoxycorticosterone at a dose of 1 mg.

GCS exhibit lipolytic activity, mainly spreading to the adipose tissue of the extremities. Also, this group of drugs has a lipogenic effect, which is mainly observed in the chest, head and neck. This all determines the redistribution of fat deposits in the body.

GCS increase the intensity of protein catabolism. The amino acids released in the process of dissimilation undergo biotransformation in the liver during gluconeogenesis into glycogen and glucose. As a result, glucose consumption in peripheral tissues decreases, which can cause hyperglycemia and glucosuria, mainly in patients with a threat of developing diabetes mellitus.

The maximum pharmacological effect of GCS is observed not when the peak of their content in the blood plasma is reached, but after it, this indicates that the effect of these drugs is primarily associated with their effect on enzyme activity.

Pharmacokinetics

Due to the action of cholinesterases, with any method of administration of methylprednisolone sodium succinate, it is rapidly and largely hydrolyzed, forming an active form - free methylprednisolone. After intravenous infusion at a dose of 30 mg / kg for 20 minutes or at a dose of 1000 mg for 30-60 minutes, the highest plasma methylprednisolone concentration (approximately 20 μg / ml) is observed approximately 15 minutes later.

On average, 25 minutes after an intravenous bolus injection of methylprednisolone at a dose of 40 mg, it is possible to reach a peak of its plasma concentration of 42–47 μg / 100 ml. With the i / m administration of the active substance at a dose of 40 mg, its level in the blood plasma after 120 minutes is 34 μg / 100 ml. After intramuscular administration, a lower peak rate is noted than with intravenous administration. The average maximum concentration (C _max) in blood plasma is observed 1 hour after i / m administration of methylprednisolone sodium succinate at a dose of 40 mg and is 454 ng / ml. After 12 hours, the content of methylprednisolone in plasma decreases to 31.9 ng / ml, and after 18 hours, the substance is not detected in the blood.

When comparing the values of AUC (area under the curve "concentration - time"), the same efficacy of methylprednisolone sodium succinate was found with intravenous and intramuscular administration of equivalent doses. However, in the blood plasma in this case, after i / m injection, the drug is present for a longer time than after i / v infusion. These differences are of minimal clinical significance if we take into account the mechanism of action of GCS.

The clinical effect is usually observed 4–6 hours after the administration of Solu-Medrol. In the treatment of bronchial asthma, the first favorable results are noted within 1–2 hours. The pharmacological activity of methylprednisolone is retained even when the level of its content in blood plasma can no longer be determined. The duration of the anti-inflammatory activity of methylprednisolone approximately corresponds to the duration of inhibition of the hypothalamic-pituitary-adrenal (HPA) system.

The half-life (T _1/2) of a substance from blood plasma can be 2.3-4 hours and is presumably not related to the route of administration, the volume of distribution is approximately 1.4 ml / kg, the total clearance is 5-6 ml / min / kg … Methylprednisolone refers to GCS, which have an intermediate duration of action, T _{1/2 of the} substance from the body is 12–36 hours. As a result of intracellular activity, there is a pronounced difference between T _{1/2 of the} drug from the body as a whole and from blood plasma.

Methylprednisolone can bind to plasma proteins (albumin and corticosteroid-binding globulin) by 40–90%. The metabolic transformation of the substance occurs in the liver, mainly with the participation of the isoenzyme CYP3A4 (the process is similar to the metabolism of cortisol). The main metabolites, 20β-hydroxy-6α-methylprednisone and 20β-hydroxymethylprednisolone, are excreted mainly in the urine in unbound form, and in the form of sulfates and glucuronides, which are formed mainly in the liver and partly in the kidneys. When on / in a carbon-labeled ¹⁴ C methylprednisolone excreted through the kidneys 75% of total radioactivity at 96 hours through the intestine - 9% for 5 days, and 20% is detected in the bile.

Methylprednisolone is well and quickly distributed in body tissues, passes through the blood-brain barrier and is excreted in breast milk.

Indications for use

• rheumatic lesions (briefly as an adjunct therapy for exacerbation or for removal from an acute condition): synovitis with osteoarthritis; post-traumatic osteoarthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (in some cases, low-dose maintenance treatment may be prescribed); epicondylitis; acute and subacute bursitis; acute nonspecific tendosynovitis; psoriatic arthritis; acute gouty arthritis; ankylosing spondylitis;
• endocrine lesions: primary and secondary adrenal insufficiency, acute form of adrenal insufficiency (if necessary in combination with mineralocorticosteroids, especially when treating children); shock caused by adrenal insufficiency, or arising from the ineffectiveness of symptomatic therapy with possible adrenal insufficiency (if the action of mineralocorticosteroids is undesirable); with established / suspected adrenal insufficiency in case of severe trauma (illness), before surgery; subacute thyroiditis; congenital adrenal hyperplasia; hypercalcemia associated with cancer;
• systemic connective tissue diseases (in the exacerbation phase; as maintenance therapy in some cases): acute rheumatic heart disease; SLE (systemic lupus erythematosus) and lupus nephritis; Goodpasture syndrome; systemic dermatomyositis (polymyositis); periarteritis nodosa;
• allergic conditions (severe disabling conditions, in the treatment of which traditional therapy is ineffective): serum sickness; bronchial asthma; atopic dermatitis; contact dermatitis; seasonal / perennial allergic rhinitis; drug hypersensitivity reactions; acute non-infectious laryngeal edema; post-transfusion reactions (such as urticaria);
• dermatological lesions: severe erythema multiforme (Stevens-Johnson syndrome); pemphigus; exfoliative dermatitis; bullous dermatitis herpetiformis; severe psoriasis; fungal mycosis; severe seborrheic dermatitis;
• diseases of the gastrointestinal tract (in order to remove from a critical state): regional enteritis; ulcerative colitis;
• respiratory tract lesions: beryllium; symptomatic sarcoidosis; fulminant and disseminated pulmonary tuberculosis in combination with appropriate anti-tuberculosis chemotherapy; aspiration pneumonitis; Leffler's syndrome, resistant to treatment with other drugs;
• ophthalmic diseases (chronic allergic and inflammatory; severe acute processes affecting the eyes): iritis and iridocyclitis; ophthalmic form of Herpes zoster; diffuse posterior uveitis and choroiditis; chorioretinitis; optic neuritis; inflammation of the anterior segment; sympathetic ophthalmia; allergic edge corneal ulcers; allergic conjunctivitis; keratitis;
• oncological lesions (as palliative treatment): acute leukemia in children; leukemia and lymphoma in adults; at the terminal stage of cancer to improve the quality of life of patients;
• hematological diseases: idiopathic thrombocytopenic purpura in adults (only intravenous injection, intramuscular injections are contraindicated); secondary thrombocytopenia in adults; acquired (autoimmune) hemolytic anemia; congenital (erythroid) hypoplastic anemia; erythroblastopenia (erythrocytic anemia);
• acute traumatic spinal cord injuries (therapy should be started within the first 8 hours after injury);
• exacerbation of multiple sclerosis;
• swelling of the brain caused by a primary or metastatic tumor and / or adjunctive treatment with radiation therapy or surgery;
• edematous syndrome: in order to increase diuresis and achieve remission of proteinuria in the presence of nephrotic syndrome without uremia;
• trichinosis with damage to the heart muscle or nervous system;
• tuberculous meningitis with subarachnoid block or threatened block, combined with appropriate anti-tuberculosis chemotherapy;
• nausea and vomiting due to chemotherapy of a malignant neoplasm (for the purpose of prevention).

Contraindications

Absolute contraindications:

• systemic mycoses;
• idiopathic thrombocytopenic purpura (with intramuscular injection);
• brain damage due to traumatic brain injury;
• simultaneous use of live or attenuated vaccines with immunosuppressive doses of the drug;
• intrathecal / epidural administration (cases of severe complications have been reported with these methods of drug administration);
• lactation period;
• a history of hypersensitivity to any component of the drug.

It is not recommended to use Solu-Medrol in patients with acute and subacute myocardial infarction, since treatment can cause them to spread the focus of necrosis, slow down the formation of scar tissue and, as a result, rupture of the heart muscle.

It is not recommended to use GCS in newborns because of the benzyl alcohol contained in it.

The use of Solu-Medrol in patients with Itsenko-Cushing's disease should be avoided, since methylprednisolone can enhance the clinical manifestations of the syndrome.

Relative contraindications (Solu-Medrol must be used with extreme caution):

• the presence of fresh intestinal anastomoses;
• diverticulitis; peptic ulcer and 12 duodenal ulcer, active / latent peptic ulcer;
• ulcerative colitis in the presence of a threat of perforation or purulent infection (including abscess);
• parasitic and infectious lesions of a fungal, viral or bacterial nature (measles, chickenpox, strongyloidiasis, shingles, etc.);
• active or latent tuberculosis (due to the possible reactivation of the disease);
• secondary failure of the adrenal cortex, renal failure;
• chronic heart failure (CHF) - Solu-Medrol should be used only if absolutely necessary;
• arterial hypertension;
• myasthenia gravis, osteoporosis;
• diabetes mellitus, hypothyroidism;
• a history of allergic reactions (including bronchospasm) to the use of methylprednisolone;
• convulsive syndrome;
• the presence of thromboembolic complications or a predisposition to their development;
• glaucoma;
• eye damage caused by the herpes simplex virus (due to an increased risk of corneal perforation);
• acute psychosis.

Solu-Medrol, instructions for use: method and dosage

Solu-Medrol is administered as an intravenous or intramuscular injection or by intravenous infusion, but when providing emergency care, therapy begins with an intravenous injection. Children are recommended to use lower doses, but not less than 0.5 mg / kg per day. When setting the dose, they are guided to a greater extent by the severity of the patient's condition and the response to the therapy, and not by his weight and age.

If Solu-Medrol is used as an adjunctive therapy for life-threatening conditions, it is administered intravenously for at least 30 minutes at a dose of 30 mg / kg, intravenous infusions at the same dose can be carried out every 4-6 hours for no more than 48 hours.

When conducting pulse therapy for the treatment of lesions in which the use of corticosteroids is effective, against the background of exacerbations of the disease and / or the ineffectiveness of standard therapy, the following drug use regimens are recommended (subject to intravenous administration):

• multiple sclerosis: Solu-Medrol 1000 mg per day for 3 or 5 days;
• rheumatic lesions: 1000 mg per day for 1-4 days or 1000 mg per month for 6 months;
• systemic lupus erythematosus: 1000 mg per day for 3 days;
• edematous conditions, including lupus nephritis, glomerulonephritis: 30 mg / kg every other day for 4 days or 1000 mg per day for 3, 5 or 7 days.

The doses indicated above must be administered for at least 30 minutes. Repeated administrations of Solu-Medrol are allowed in cases where no improvement was noted within 1 week after therapy, or the patient's condition requires it.

Recommended dosing regimen for the following diseases / conditions:

• oncological lesions in the terminal stage (to improve the quality of life): daily i.v., 125 mg per day for no more than 8 weeks;
• prevention of nausea and vomiting caused by chemotherapy for oncological lesions: chemotherapy with drugs with a slight or moderate emetic effect - IV Solu-Medrol 250 mg for at least 5 minutes 1 hour before the procedure, as well as at the beginning and after its completion; in order to enhance the effect, chlorphenothiazine preparations can be combined with the first dose of Solu-Medrol; chemotherapy with drugs with a pronounced emetic effect - intravenous in a dose of 250 mg for at least 5 minutes in combination with the corresponding doses of metoclopramide / butyrophenone 1 hour before the procedure, then intravenous 250 mg at the beginning and after completion of the administration of the chemotherapeutic drug;
• acute traumatic spinal cord injuries: it is necessary to start therapy in the first 8 hours after the injury; for 15 minutes at a dose of 30 mg / kg, intravenous bolus administration is carried out, then after a 45-minute break, for 23 hours (if treatment was started in the first 3 hours after injury) or 47 hours (if treatment was started in the first 3–8 hours) at a dose of 5.4 mg / kg / h infused as a continuous infusion; the agent should be injected into an isolated vein using an infusion pump;
• other indications: administered intravenously at an initial dose of 10-500 mg, depending on the type of disease; against the background of severe acute conditions, higher doses can be prescribed for a short course; an initial dose below 250 mg IV is administered for at least 5 minutes, doses exceeding 250 mg - for at least 30 minutes; subsequent doses are administered intravenously or intramuscularly, the period between injections is determined taking into account the patient's clinical condition and his response to Solu-Medrol.

Before the procedure, the solution should be visually checked for the appearance of foreign particles or discoloration.

Before using the drug, placed in a two-volume Act-0-Vial vial, it is required to press the plastic activator in order for the solvent to enter the lower container with the lyophilizate. Then you should gently shake the bottle to completely dissolve the powder, and after that, removing the plastic disk covering the center of the cork, treat its released surface with an appropriate antiseptic. Having inserted the needle vertically into the center of the plug so that its tip is visible, you need to turn the bottle over and draw the required dose of the prepared solution with a syringe.

When using a lyophilisate in a vial, a solvent should be introduced into the vial with the drug, observing asepsis. For these purposes, it is necessary to use only a special solvent.

Solu-Medrol solution for intravenous infusion is prepared according to the above recommendations. It is also allowed to administer the drug in the form of diluted solutions obtained by mixing the initial solution of methylprednisolone sodium succinate with saline, 5% aqueous dextrose solution, 5% dextrose solution in 0.9% or 0.45% sodium chloride solution. The resulting solutions are physically and chemically stable for 48 hours.

Side effects

• cardiovascular system: heart rhythm disturbances (bradycardia, arrhythmias, tachycardia), increase / decrease in blood pressure, CHF (with an existing predisposition), hypertrophic cardiomyopathy in premature infants; pulmonary edema, thromboembolism (including thromboembolism of the pulmonary artery), thrombosis, thrombophlebitis, vasculitis; some reports - the development of circulatory collapse and / or disturbance of the heart rhythm, and / or cardiac arrest after rapid intravenous administration of large doses of methylprednisolone (over 0.5 g, administered for less than 10 minutes); against the background of intravenous injections of high doses and after them, cases of bradycardia were recorded, however, they did not always depend on the duration / rate of infusion;
• water-electrolyte metabolism: increased excretion of potassium, fluid and salt retention, sodium retention, hypokalemic alkalosis;
• blood and lymphatic system: leukocytosis;
• liver and biliary tract: increased activity in blood plasma of aspartate aminotransferase (ACT), aspartate aminotransferase (ACT) and alkaline phosphatase (ALP), as a rule, such changes are insignificant and reversible after completion of treatment; hepatitis (mainly with intravenous administration of Solu-Medrol in a daily dose of 1000 mg);
• gastrointestinal tract: abdominal pain, nausea, persistent hiccups, vomiting, esophagitis (including ulcerative), flatulence, dyspepsia, diarrhea, abdominal wall tension, pancreatitis, peritonitis, intestinal wall perforation, gastric bleeding, peptic ulcer with the risk of perforation and bleeding;
• nervous system: headache, dizziness, vertigo, paresthesia, convulsions, amnesia, increased intracranial pressure with edema of the optic nerve head (benign intracranial hypertension), epidural lipomatosis;
• mental disorders: insomnia, irritability, thought disorder, rapid mood swings, psychotic disorders (including hallucinations, delusions, mania, schizophrenia or its exacerbation), affective disorders (including depressed mood, drug addiction, mood lability, euphoria, suicidal ideas), confusion, anxiety, personality change, inappropriate behavior;
• endocrine system: Itsenko-Cushing syndrome, menstrual irregularities, development of steroid withdrawal syndrome, hypopituitarism, increased need for insulin or oral antidiabetic drugs in patients with diabetes mellitus, decreased glucose tolerance, latent diabetes mellitus, lipomatosis, growth retardation and ossification in children (premature closure of the epiphyseal growth zones);
• musculoskeletal system: muscle weakness, myopathy, osteonecrosis, osteoporosis, muscle atrophy, pathological fractures, myalgia, arthralgia, neuropathic atrophy, aseptic necrosis of the epiphyses of tubular bones, compression fractures of the vertebrae, tendon ruptures (mainly Achilles tendon); acute myopathy, which most often occurs when high doses of methylprednisolone are used in patients with impaired neuromuscular transmission (including myasthenia gravis), or with concomitant treatment with anticholinergic drugs, including peripheral muscle relaxants (pancuronium bromide); such a complication is generalized, can cause damage to the muscles of the eyes and the respiratory system, lead to the appearance of tetraparesis, and the risk of an increase in the level of creatine kinase;after the cancellation of GCS, several months or even several years may pass before clinical improvement or recovery;
• immune system: development of infections excited by opportunistic microorganisms, infectious lesions (when using high doses, the risk of developing infectious complications increases), hypersensitivity reactions (including anaphylaxis, with or without circulatory collapse, bronchospasm, cardiac arrest), suppression of reactions during the implementation of skin tests;
• sensory organs: increased intraocular pressure, posterior subcapsular cataract, exophthalmos, glaucoma, vertigo, corneal perforation (with manifestations of herpes simplex in the eyes); secondary fungal / viral eye infection;
• metabolism: increased appetite (can cause an increase in body weight), negative nitrogen balance associated with protein catabolism; increased sweating;
• skin: urticaria, pruritus, acne, rash, hyperpigmentation, decreased skin pigmentation, erythema, petechiae and ecchymosis, skin striae, angioedema, slow wound healing, skin atrophy, allergic dermatitis, reactions at the injection site;
• others: weakness, increased fatigue, peripheral edema, tingling and burning (in most cases in the perineum after intravenous injections);
• laboratory parameters: dyslipidemia, an increase in the level of urea in the blood plasma, hypocalcemia, an increase in the concentration of calcium in the urine.

Overdose

There are no descriptions of any clinical syndrome of acute overdose of Solu-Medrol. Cases of acute toxicity have been reported extremely rarely against the background of prolonged use of high doses of methylprednisolone. With a chronic overdose of the drug, the development of symptoms of Itsenko-Cushing syndrome is possible.

There is no specific antidote, treatment for this condition is prescribed symptomatic, the active substance is removed by dialysis.

special instructions

Due to the fact that the occurrence of complications in the treatment of GCS depends on the duration of therapy and the size of the dose, the decision on the need to use Solu-Medrol, as well as the establishment of the duration and frequency of its use, the specialist carries out individually based on the analysis of the risk / benefit ratio.

For better control of the patient's condition, it is recommended to use the lowest effective dose of the drug. When the desired result is achieved, it is necessary to gradually reduce the dose to a maintenance dose or complete the treatment.

Due to the existing threat of arrhythmia development, the administration of high doses of Solu-Medrol should be carried out in a hospital setting.

Against the background of a long course of treatment, it is required to regularly monitor body weight, blood pressure, plasma glucose levels 2 hours after a meal, conduct chest x-ray, general urinalysis, and X-ray / endoscopic examination if there is a history of gastrointestinal ulcers. path.

Methylprednisolone effectively contributes to the recovery process during exacerbation of multiple sclerosis, however, there is no evidence that Solu-Medrol affects the outcome and pathogenesis of this disease.

In the presence of confirmed / suspected parasitic infections (eg, strongyloidosis), immunosuppression with methylprednisolone can cause strongyloid hyperinfection and dissemination of the process with widespread larval migration. This complication is often accompanied by the occurrence of severe forms of enterocolitis and gram-negative septicemia (up to a lethal outcome).

Patients who have used the drug in doses that do not have an immunosuppressive effect can be immunized for appropriate indications.

Cases of Kaposi's sarcoma have been reported in patients receiving Solu-Medrol therapy. Clinical remission can occur when the drug is canceled.

GCS is not recommended for use in septic shock, due to the doubtful effect of the effect.

People who use drugs that suppress the immune system are more susceptible to infections. Diseases such as measles and chickenpox, which arose during drug therapy in unimmunized children or adults, can have an extremely severe course, up to a lethal outcome.

Injections of the solution into the deltoid muscle should be avoided to prevent atrophy of the subcutaneous fat.

When using Solu-Medrol for a long time in therapeutic doses, the threat of the development of secondary adrenal insufficiency (suppression of the HPA system) is aggravated. The duration and degree of adrenocortical insufficiency are individual, depend on the dose, frequency of administrations, time of application and course of therapy. By gradually reducing the dose or using Solu-Medrol every other day, you can reduce the severity of this effect. This type of relative deficiency can be observed after the completion of therapy for several months, therefore, if any stressful situations arise, it is necessary to re-prescribe Solu-Medrol during this period with the concomitant use of electrolytes and / or mineralocorticosteroids. It should also be borne in mind that with a sudden cessation of the use of GCS, the development of acute adrenal insufficiency is possible,leading to death.

Withdrawal syndrome unrelated to adrenal insufficiency can also result from abrupt drug withdrawal after a long course of treatment. Symptoms of this syndrome include: vomiting, nausea, anorexia, headache, fever, myalgia, joint pain, peeling skin, weight loss and / or decreased blood pressure, lethargy. These disorders are presumably due to a sharp fluctuation in the concentration of methylprednisolone in plasma, and not due to a decrease in its level in the blood.

In the presence of hypothyroidism or cirrhosis, the action of Solu-Medrol may be enhanced.

Influence on the ability to drive vehicles and complex mechanisms

Since weakness, visual impairment or dizziness may occur during the period of therapy, patients who drive any complex and potentially dangerous equipment (including driving a vehicle) should be especially careful.

Application during pregnancy and lactation

Animal studies have shown that high doses of methylprednisolone in females can cause fetal malformations. At the same time, in a number of clinical studies it has been demonstrated that the use of the drug during pregnancy, apparently, does not lead to congenital anomalies.

The use of methylprednisolone during pregnancy or in patients of fertile age is possible only if the intended therapeutic effect for the mother significantly outweighs the possible danger of negative effects on the health of the fetus. For pregnant women, Solu-Medrol should be used only for absolute indications.

Methylprednisolone crosses the placenta easily. In one retrospective study, mothers treated with methylprednisolone found an increased incidence of low birth weight babies. The risk of such pathology is dose-dependent and can be minimized by reducing the dose of the drug. If a woman received significant doses of Solu-Medrol during pregnancy, the newborn should be carefully examined to identify possible symptoms of adrenal hypofunction, despite the fact that adrenal insufficiency in such children is quite rare.

Cases of cataracts have been reported in newborns whose mothers used methylprednisolone during pregnancy.

Solu-Medrol is contraindicated to use during breastfeeding, since methylprednisolone is found in breast milk in quantities that can lead to growth retardation of the child and interaction with endogenous GCS. If necessary, use of the drug during lactation should stop breastfeeding.

Pediatric use

It is not recommended to use Solu-Medrol in newborns, since benzyl alcohol is included in its composition, which can provoke a lethal suffocation syndrome in premature newborns.

In children, especially if long-term use of Solu-Medrol is necessary, it should be used with extreme caution due to the increased threat of intracranial hypertension. High doses of methylprednisolone in children can trigger pancreatitis.

With impaired renal function

Patients with renal insufficiency should be used with caution in methylprednisolone therapy.

Use in the elderly

In elderly patients, due to the increased threat of arterial hypertension and osteoporosis, Solu-Medrol must be used with caution.

Drug interactions

When Solu-Medrol is administered intravenously with other agents included in mixtures for intravenous infusions, the stability and compatibility of solutions depend on the concentration, pH, temperature, time of use, as well as on the solubility of methylprednisolone itself. Solu-Medrol is recommended to be administered separately from other drugs, in the form of intravenous bolus injections, intravenous drip infusion or by means of an additional dropper as a second solution.

Methylprednisolone in solution is incompatible with the following drugs: tigecycline, doxapram hydrochloride, sodium allopurinol, vecuronium bromide, calcium gluconate, diltiazem hydrochloride, glycopyrrolate, cisatracurium besylate, propofol, rocuronium bromide.

When combined with inhibitors of the isoenzyme CYP3A4, the metabolism of methylprednisolone may be inhibited, its clearance may decrease, and the plasma level may increase. In order to prevent overdose in this case, titration of the dose of the active substance should be performed.

When combined with inducers of the isoenzyme CYP3A4, the clearance of methylprednisolone may increase and its plasma concentration in the blood may decrease, as a result of which an increase in the dose of Solu-Medrol may be required.

When combined with substrates of the CYP3A4 isoenzyme, the clearance of methylprednisolone may change and its dose must be adjusted accordingly. It is also possible to increase the frequency of side effects when compared with the frequency of their manifestations when using these drugs in the form of monotherapy.

Possible reactions of interaction of methylprednisolone with medicinal substances / agents that may be of clinical significance:

• antibacterial drugs (isoniazid), grapefruit juice, inhibitors of the isoenzyme CYP3A4: an increase in the degree of acetylation and clearance of isoniazid is possible;
• immunosuppressants (tacrolimus, cyclophosphamide), substrates of the CYP3A4 isoenzyme;
• antiemetic drugs (fosaprepitant, aprepitant), antifungal drugs (ketoconazole, itraconazole), calcium channel blockers (diltiazem), oral contraceptives (ethinyl estradiol / norethindrone), macrolide antibiotics (clarithromycin, erythromycin and CYP3 substrates), inhibitors
• immunosuppressants (cyclosporine), inhibitor and substrate of the isoenzyme CYP3A4: there is a mutual inhibition of the metabolism of both drugs and the plasma concentration of one or both drugs increases, which increases the risk of adverse reactions; with this combination, cases of seizures have been reported;
• HIV protease inhibitors (ritonavir, indinavir), inhibitors and substrates of the CYP3A4 isoenzyme: an increase in the level of methylprednisolone in the blood plasma is possible; the metabolism of HIV protease inhibitors may increase and their plasma concentration may decrease;
• antiepileptic drugs (phenytoin, phenobarbital), inducers of the CYP3A4 isoenzyme; carbamazepine, inducer and substrate of the CYP3A4 isoenzyme; oral anticoagulants: it is possible to increase / weaken their action, a constant monitoring of the coagulogram is required;
• anticholinergics, blockers of neuromuscular transmission: against the background of the use of high doses of methylprednisolone, the risk of developing acute myopathy is aggravated; with this combination, there was an antagonism of the result of the blockade of vecuronium and pancuronium; a similar effect can occur when using any n-anticholinergic drugs;
• cholinesterase inhibitors: their effect may be reduced in the presence of myasthenia gravis;
• antidiabetic agents: the concentration of glucose in plasma may increase, because of which the dose of these drugs should be adjusted;
• aromatase inhibitors (aminoglutethimide): endocrine changes caused by prolonged treatment with Solu-Medrol may be weakened, due to aminoglutethimide-induced adrenal suppression;
• drugs that reduce the concentration of potassium in the blood plasma (diuretics, amphotericin B), xanthines or β ₂ -agonists: the risk of hypokalemia increases; careful monitoring is required;
• cardiac glycosides: there is a threat of arrhythmias on the background of hypokalemia;
• non-steroidal anti-inflammatory drugs (NSAIDs): the threat of gastrointestinal bleeding and ulceration increases; an increase in the clearance of acetylsalicylic acid, used for a long time in high doses, is possible, which can cause a decrease in the level of salicylates in plasma or increase the risk of their toxicity against the background of the withdrawal of methylprednisolone; this combination requires caution.

Analogs

Solu-Medrol's analogues are Ivepred, Depo-Medrol, Medrol, Lemod, Metipred, Methylprednisolone-native, Metipred Orion, etc.

Terms and conditions of storage

Store the lyophilisate and the finished solution out of the reach of children, at a temperature of 15-25 ° C.

The shelf life is 5 years. After preparation, the solution can be used within 48 hours.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Solu-Medrol

According to the few reviews about Solu-Medrol, the drug has shown good results in the treatment of exacerbations of multiple sclerosis, use against the background of rheumatic diseases, especially in case of exacerbation, as well as for other diseases. Doctors also respond positively to the drug, noting its effectiveness, provided it is used strictly according to indications, with all recommendations being followed.

The main disadvantage is unanimously called a large number of side effects that occur during drug therapy. Many patients are also unhappy with its high cost.

Price for Solu-Medrol in pharmacies

The price of Solu-Medrol depends on the dose. Average cost:

• Solu-Medrol 250 mg + solvent (4 ml) in a two-volume bottle - 340–390 rubles;
• Solu-Medrol 500 mg in a bottle complete with a bottle of solvent (7.8 ml) - 350-400 rubles;
• Solu-Medrol 1000 mg in a bottle complete with a bottle of solvent (15.6 ml) - 480-560 rubles.

Solu-Medrol: prices in online pharmacies

Drug name Price Pharmacy

Solu-Medrol 250 mg lyophilisate for preparation of a solution for intravenous and intramuscular administration 4 ml 1 pc. 359 r Buy

Solu-Medrol 500 mg lyophilisate for the preparation of a solution for intravenous and intramuscular administration 1 pc. 383 r Buy

Solu-Medrol 1 g lyophilisate for the preparation of a solution for intravenous and intramuscular administration, complete with a solvent 1 pc. RUB 565 Buy

Maria Kulkes Medical journalist About the author

Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!