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Methylprednisolone

Pfizer
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Clinical Pharmacology

Solu-Medrol - GCS penetrate cell membranes and form complexes with specific cytoplasmic receptors. Then these complexes penetrate into the cell nucleus, bind to DNA (chromatin) and stimulate the transcription of mRNA and the subsequent synthesis of various enzymes, which explains the effect of GCS during systemic use. GCS not only have a significant effect on the inflammatory process and immune response, but also affect carbohydrate, protein and fat metabolism. Most of the indications for the use of corticosteroids due to their anti-inflammatory, immunosuppressive and anti-allergic properties. Thanks to these properties, the following therapeutic effects are achieved:

  • Reduction in the number of immunoactive cells near the inflammatory focus.
  • Reduction of vasodilation.
  • Stabilization of lysosomal membranes.
  • Inhibition of phagocytosis.
  • Decreased production of prostaglandins and related compounds. Methylprednisolone has a strong anti-inflammatory effect, and its activity is higher than that of prednisone, and its ability to cause water and sodium ion retention is reduced compared to prednisone.

The metabolism and mechanism of the anti-inflammatory action of methylprednisolone sodium succinate are similar to those of methylprednisolone. When administered parenterally equivalent amounts, the biological activity of both compounds is the same. With the on / in the introduction of the ratio of the activities of methylprednisolone sodium succinate and hydrocortisone sodium succinate, calculated by reducing the number of eosinophils, is not less than 4: 1. This correlates well with data on the relative activity of methylprednisolone and hydrocortisone when administered orally. A dose of 4 mg of methylprednisolone has the same glucocorticosteroid (anti-inflammatory) effect as 20 mg of hydrocortisone. Methylprednisolone has only a slight mineralocorticoid activity (200 mg of methylprednisolone is equivalent to 1 mg of deoxycorticosterone).

The maximum pharmacological activity of corticosteroids is manifested not at the peak concentration in plasma, but after it, therefore, the action of corticosteroids is primarily due to their effect on the activity of enzymes.

Indications

Endocrine diseases

  • primary and secondary adrenal insufficiency (if necessary in combination with mineralocorticosteroids, especially in pediatric practice);
  • acute adrenal insufficiency (it may be necessary to add mineralocorticosteroids);
  • shock resulting from adrenal insufficiency, or shock, with the ineffectiveness of symptomatic therapy, when adrenal insufficiency is possible (if the mineralocorticosteroid effect is undesirable);
  • in the preoperative period, in the case of severe injury or serious illness, in patients with established or suspected adrenal insufficiency;
  • congenital adrenal hyperplasia;
  • subacute thyroiditis;
  • hypercalcemia on the background of cancer.

Rheumatic diseases (as an adjunctive therapy, short-term for removal from an acute condition or during exacerbation)

  • post-traumatic osteoarthritis;
  • synovitis in osteoarthritis;
  • rheumatoid arthritis, including juvenile rheumatoid arthritis (in some cases, low-dose maintenance therapy may be required);
  • acute and subacute bursitis;
  • epicondylitis.
  • acute nonspecific tendosynovit;
  • acute gouty arthritis;
  • psoriatic arthritis;
  • ankylosing spondylitis.

Systemic diseases of the connective tissue (in the period of exacerbation or in some cases as maintenance therapy)

  • systemic lupus erythematosus (and lupus nephritis);
  • acute rheumatic heart disease;
  • systemic dermatomyositis (polymyositis);
  • periarteritis nodosa;
  • Goodpasture syndrome.

Skin diseases

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

Allergic states (in case of severe or disabling conditions in which conventional therapy is ineffective)

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

Eye diseases (severe acute and chronic allergic and inflammatory processes with eye damage)

  • Herpes zoster eye form;
  • iritis and iridocyclitis;
  • chorioretinitis;
  • diffuse posterior uveitis and choroiditis;
  • optic neuritis;
  • sympathetic ophthalmia;
  • inflammation of the anterior segment;
  • allergic conjunctivitis;
  • allergic corneal ulcers;
  • keratitis

Diseases of the gastrointestinal tract (for removing a patient from a critical condition)

  • ulcerative colitis;
  • regional enteritis.

Respiratory diseases

  • symptomatic sarcoidosis;
  • berylliosis;
  • fulminant and disseminated pulmonary tuberculosis in combination with appropriate anti-tuberculosis chemotherapy;
  • Leffler syndrome, which is not amenable to therapy by other means;
  • aspiration pneumonitis.

Hematological diseases

  • acquired (autoimmune) hemolytic anemia;
  • idiopathic thrombocytopenic purpura in adults (only V / V administration; IM administration is contraindicated);
  • secondary thrombocytopenia in adults;
  • erythroblastopenia (erythrocyte anemia);
  • congenital (erythroid) hypoplastic anemia.

Oncological diseases (as palliative therapy)

  • leukemia and lymphomas in adults;
  • acute leukemia in children;
  • to improve the quality of life of patients with cancer in the terminal stage.

Edema syndrome

  • to stimulate diuresis and achieve remission of proteinuria in patients with nephrotic syndrome without uremia.

Nervous system

  • swelling of the brain due to a tumor - primary or metastatic, and / or associated with surgical or radiotherapy;
  • exacerbations of multiple sclerosis;
  • acute traumatic injuries of the spinal cord. Treatment should begin in the first 8 hours after the injury occurred.

Other indications for use

  • tuberculous meningitis with a subarachnoid block or with a threat of block (in combination with appropriate anti-tuberculosis chemotherapy);
  • trichinosis with damage to the nervous system or myocardium;
  • organ transplantation;
  • prevention of nausea and vomiting associated with chemotherapy for cancer.

Use in children

The use of the drug in children during the growth period is possible only by absolute indications and with especially careful observation of the attending physician.

Composition

1 bottle contains:

Active ingredient: methylprednisolone (as sodium succinate) 500 mg;

Excipients: monohydrate monobasic sodium phosphate; secondary sodium phosphate.

Methylprednisolone is marketed under different brands and generic names, and comes in different dosage forms:

Brand nameManufacturerCountryDosage form
Solu-Medrol Pfizer USA lyophilisate
Medrol Pfizer USA pills
Metipred Orion Corporation Finland pills
Metipred Orion Corporation Finland vials

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Methylprednisolone

Dosage and Administration

Solu-medrol can be administered as an intravenous or intramuscular injection or as an intravenous infusion, but for emergency conditions, it is preferable to begin treatment with intravenous injection. Children should be given lower doses (but not less than 0.5 mg / kg / day), but when choosing a dose, first of all, take into account the severity of the condition and the patient's response to therapy, rather than age and body weight.

As additional therapy for life-threatening conditions.

30 mg / kg body weight IV for at least 30 minutes. The introduction of this dose can be repeated every 4-6 hours for a maximum of 48 hours.

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

Recommended regimens:

  • Rheumatic diseases: 1 g / day IV for 1–4 days or 1 g / month IV for 6 months.
  • Systemic lupus erythematosus: 1 g / day IV for 3 days.
  • Multiple sclerosis: 1 g / day in / for 3 or 5 days.
  • Edematous conditions, for example, glomerulonephritis, lupus nephritis: 30 mg / kg every other day for 4 days or 1 g / day i.v. for 3, 5 or 7 days

The above doses should be administered for at least 30 minutes, and the introduction can be repeated if there was no improvement within a week after the treatment, or if the patient's condition requires it.

Cancer in the terminal stage - to improve the quality of life

  • 125 mg / day i.v. daily for up to 8 weeks.

Prevention of nausea and vomiting associated with chemotherapy for cancer

In chemotherapy with drugs with a slight or moderate emetic effect, 250 mg IV are administered for at least 5 minutes one hour before the chemotherapeutic agent is administered, at the beginning of the chemotherapy, as well as after its termination. To enhance the effect with the first dose of the drug Solu-medrol, you can enter drugs chlorphenothiazine.

In chemotherapy with drugs that have a pronounced emetic effect, 250 mg IV is administered for at least 5 minutes in combination with the appropriate doses of metoclopramide or butyrophenone one hour before the chemotherapy drug is given, then 250 mg IV at the beginning of chemotherapy and after endings

Acute Traumatic Spinal Cord Damage

Treatment must begin in the first 8 hours after injury. It is recommended intravenous bolus administration for 15 minutes at 30 mg / kg body weight, then take a break for 45 minutes, and then carry out a continuous infusion at a dose of 5.4 mg / kg / h for 23 hours (if treatment is started in the first 3 h after injury) or 47 h (if treatment is started in the first 3-8 h after injury). The drug should be injected using an infusion pump into an isolated vein.

With other indicationsThe initial dose is 10-500 mg IV according to the nature of the disease. For a short course in severe acute conditions, higher doses may be required. An initial dose not exceeding 250 mg should be administered IV for at least 5 minutes, doses above 250 mg should be administered for at least 30 minutes. Subsequent doses are administered intravenously or intramuscularly, and the duration of the intervals between injections depends on the patient's response to therapy and on his clinical condition.

Preparation of solutions

Preparations for parenteral administration should, if possible, be visually inspected for color change or the appearance of particles.

a) Act-0-Vial Dual Capacity Vial

  1. Press the plastic activator so that the solvent flows into the lower container.
  2. Swing the bottle gently until the lyophilis is dissolved.
  3. Remove the plastic disc covering the center of the cork.
  4. Treat the cork surface with an appropriate antiseptic.
  5. Pierce the center of the needle with a needle so that the tip of the needle is visible. Invert the vial and remove the required amount of solution with a syringe.

b) Bottle

With observance of asepsis, enter the solvent in a vial with a lyophilisate. Use only special solvent.

c) Preparation of solutions for intravenous infusion

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

Adverse reactions

From the water and electrolyte exchange: sodium retention, chronic heart failure in patients with an appropriate predisposition, fluid and salt retention in the body, increased excretion of potassium, hypokalemic alkalosis.

Since the cardiovascular system: increase or decrease in blood pressure; cardiac arrhythmias (arrhythmias, bradycardia, tachycardia); chronic heart failure (in patients with predisposition); in patients with acute and subacute myocardial infarction - the spread of necrosis, slowing the formation of scar tissue, which can lead to rupture of the heart muscle. There are reports of heart rhythm disturbances and / or the development of circulatory collapse and / or cardiac arrest after rapid on / in the introduction of high doses of methylprednisolone (more than 0.5 g, administered in less than 10 minutes). During and after the on / in the high doses of methylprednisolone, there were also cases of bradycardia, but they did not necessarily depend on the rate or duration of the infusion.

From the musculoskeletal system: osteonecrosis, myopathy, muscular weakness, osteoporosis, pathological fractures, muscular atrophy, neuropathic atrophy, arthralgia, myalgia, vertebral compression fractures, aseptic necrosis of the epiphysis of the tubular bones, tendon ruptures, especially the Achilles tendon. Acute myopathy most often develops when high doses of methylprednisolone are used in patients with impaired neuromuscular transmission (for example, with myasthenia gravis), or in patients who are simultaneously treated with anticholinergic drugs, such as peripheral muscle relaxants (for example, pancuronium bromide). Such an acute myopathy is generalized, can affect the muscles of the eye and respiratory system, and lead to the development of tetraparesis. Creatine kinase may increase. In this case, improvement or recovery after the abolition of methylprednisolone can occur only after many weeks or even after several years.

From the digestive system: peptic ulcer with possible perforation and bleeding, gastric bleeding, pancreatitis, peritonitis, esophagitis (including), intestinal wall perforation, abdominal pain, tension of the abdominal wall, diarrhea, dyspepsia, flatulence, nausea, vomiting, persistent hiccups.

After treatment with methylprednisolone, an increase in the activity of alanine aminotransferase (ALT), aspartate aminotransferase (ACT) and alkaline phosphatase in plasma was observed. Usually these changes are minor, not associated with any clinical syndromes and are reversible after cessation of treatment.

On the part of the skin: angioedema, peripheral edema, skin aphrophy, skin striae, petechiae and ecchymosis, reduced skin pigmentation, hirsutism, rash, erythema, pruritus, urticaria, acne, slow wound healing, reactions at the injection site.

Metabolism: negative nitrogen balance (increased protein breakdown) caused by protein catabolism, slower growth and ossification process in children (premature closure of epiphyseal growth zones), increased appetite (can lead to an increase in body weight), increased sweating.

From the nervous system: increased intracranial pressure with edema of the optic nerve face (benign intracranial hypertension), convulsions, amnesia, thinking disorders, dizziness, headache, affective disorders (including mood lability, depressive mood, state of euphoria, psychological dependence, suicidal thinking), psychotic disorders including, mania, dslyuzii, hallucinations, schizophrenia or its exacerbation), confusion, mental disorder, anxiety, personality change, quick mood changes, neo ychnoe behavior, insomnia, irritability.

On the part of the endocrine system: menstrual disorders, Itsenko-Cushing syndrome, hypopituitarism, the development of the syndrome of "cancellation" of steroid drugs, reduced glucose tolerance, increased need for insulin or giogliksmicheskimi drugs for oral administration in patients with diabetes, growth in children, lipomatosis, latent diabetes.

Laboratory indicators: elevated urea concentration in blood plasma, dyslipidemia, increased urinary calcium concentration, hypocalcemia.

From the senses: posterior subcapsular cataract, increased intraocular pressure, glaucoma, exophthalmos, vertigo, secondary fungal or viral eye infection, corneal perforation (with ocular manifestations of herpes simplex).

On the part of the immune system: infectious diseases, the occurrence of infections caused by opportunistic pathogens, hypersensitivity reactions, including anaphylaxis with or without circulatory collapse, cardiac arrest, broncho-slasma, suppression of reactions during skin tests.

Other: fatigue, weakness.

Contraindications

Carefully:

  • In patients with eye damage caused by the herpes simplex virus, as this may lead to corneal perforation.
  • In case of ulcerative colitis, if there is a threat of perforation, abscess or other purulent infection.
  • With diverticulitis.
  • In the presence of fresh intestinal anastomoses.
  • With active or latent peptic ulcer.
  • Renal failure.
  • Hypertension.
  • Osteoporosis.
  • Myasthenia gravis.

This preparation contains gasoline alcohol. It has been established that gasoline alcohol can cause a "choking syndrome" with a fatal outcome in preterm infants. The drug is not recommended for use in newborns.

Drug interactions

Compatibility and stability of solutions of methylprednisolone sodium succinate with a / in the introduction with other drugs that are part of mixtures for a / in the introduction, depend on the p H, concentration, time, temperature, as well as the solubility of methylprednisolone itself.

Whenever possible, SOLU-MEDROL is recommended to be administered separately from other drugs, in the form of IV bolus injections, IV drip infusion, or through an additional IV as a second solution.

The following examples of drug interactions may be of significant clinical importance.

The combined use of methylprednisolone and cyclosporine causes mutual inhibition of metabolism, so it is likely that the side effects associated with the use of each of these drugs as monotherapy, with their joint use may occur more often. When these drugs were used together, there were cases of seizures. Liver enzyme activating drugs, such as phenobarbital, phenytoin, and rifampicin, can increase the clearance of methylprednisolone, which may require an increase in the dose of the drug to achieve the desired effect.

CYP3A4 inhibitors (such as macrolide antibiotics, antifungals from the azole group, some calcium channel blockers) can inhibit methylprednisolone metabolism and reduce its clearance.In this case, to avoid the effects of overdose, reduce the dose of methylprednisolone. Methylprednisolone can increase the clearance of acetylsalicylic acid, taken in high doses for a long period, which may lead to a decrease in the level of salicylates in the serum or increase the risk of toxicity of salicylates with the abolition of methylprednisolone. In patients with hypoprothrombinemia, acetylsalicylic acid should be prescribed in combination with GCS with caution. Methylprednisolone has a diverse effect on oral anticoagulants. It is reported as about strengthening, and about reduction of effect of the anticoagulants taken along with methylprednisolone. To maintain the desired effect of anti-coagulant, a constant determination of coagulation parameters is necessary.

Pregnancy and Lactation

A number of animal studies have shown that the administration of high doses of corticosteroids to females can lead to fetal deformities. However, in a number of clinical studies it has been shown that the use of corticosteroids during pregnancy does not seem to cause congenital anomalies. In one retrospective study, an increase in the incidence of low birth weight infants in mothers receiving GCS was found. Since research on pregnant women does not exclude possible harm to GCS, the use of these drugs during pregnancy, in nursing mothers or women of childbearing age requires an assessment of the likely positive effect of the drug in comparison with the potential risk to the mother, the embryo or the fetus. GCS should be prescribed during pregnancy only in absolute indications.

GCS easily penetrate the placenta. Although infants born to mothers who received significant doses of GCS during pregnancy, adrenal insufficiency is rare, such children should be carefully examined to identify possible symptoms of adrenal hypofunction. The effect of GCS on the course and outcome of labor is unknown.

GCS is excreted into breast milk, so if necessary, the prescription of the drug SOLU-MEDROL during breastfeeding should be stopped.

Special instructions

Since the complications of GCS therapy depend on the size of the dose and the duration of treatment, in each particular case, based on an analysis of the risk / benefit ratio, they decide on the need for such treatment, and also determine the duration of treatment and the frequency of treatment.

The efficacy of the drug SOLU-MEDROL in septic shock has not been confirmed. An increased mortality was noted in patients from the high-risk group (for example, with an increase in the level of creatinine above 2.0 mg / dl, or in secondary infections).

Patients who may be exposed to stress during GCS therapy are shown to increase the dose before, during and after a stressful situation.

Due to the fact that an increase in mortality was detected 2 weeks after a head injury in patients treated with methylprednisolone sodium succinate compared with placebo, SOLU-MEDROL should not be used for brain edema caused by a head injury. The causal relationship of deaths with the use of methylprednisolone sodium succinate has not been established.

During GCS therapy, some infections can occur in a worn form, in addition, new infections can develop. When using GCS, a decrease in resistance to infections is possible, and the body’s ability to localize the infection process is also reduced. The development of infections caused by various pathogenic organisms, such as viruses, bacteria, fungi, protozoa or helminths, which are localized in various systems of the human body, may be associated with the use of GCS, both as monotherapy and in combination with other immunosuppressants that affect cellular immunity, humoral immunity or neutrophil function. These infections can be mild, however, in some cases it may be severe and even fatal. Moreover, the higher doses of GCS are used, the higher the likelihood of developing infectious complications.

Administration of live or live attenuated vaccines is contraindicated in patients receiving GCS in doses that have an immunosuppressive effect, but killed or inactivated vaccines can be administered, but the response to the introduction of such vaccines may be reduced. Patients receiving treatment of corticosteroids in doses that do not have immunosuppressive effects, according to appropriate indications can be immunized.

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

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

Since patients receiving parenteral therapy of GCS may rarely develop anaphylactoid reactions (for example, bronchospasm), appropriate preventive measures should be taken before administering the drug, especially if the patient had a history of allergic reactions to any medications.

  • Active ingredient: Methylprednisolone

Studies and clinical trials of Methylprednisolone (Click to expand)

  1. Oral high-dose methylprednisolone and intravenous immunoglobulin treatments in adult chronic idiopathic thrombocytopenic purpura
  2. Long-term treatment of refractory thrombocytopenia in a patient with wiskott-aldrich syndrome with vincristine, immunoglobulin, and methylprednisolone
  3. Quantity of human cytomegalovirus (CMV) DNAemia as a risk factor for CMV disease in renal allograft recipients: Relationship with donor/recipient CMV serostatus, receipt of augmented methylprednisolone and antithymocyte globulin (ATG)
  4. Decline of muscle fiber conduction velocity during short-term high-dose methylprednisolone therapy
  5. Effects of long-term low-dose methylprednisolone on rat diaphragm function and structure
  6. Chronic interstitial lung disease in children: Response to high-dose intravenous methylprednisolone pulses
  7. Immunodynamics of methylprednisolone induced T-cell trafficking and deactivation using whole blood lymphocyte proliferation techniques in the rat
  8. Successful treatment of refractory anemia by high-dose methylprednisolone associated with an increment in CD68-positive cells in bone marrow
  9. Comparison of 6α-methyl-9α-fluoro-17-acetoxy-21-deoxyprednisolone with fluoxymesterone and methylprednisolone in treatment of metastatic breast cancer
  10. Antiemetic superiority of lorazepam over oxazepam and methylprednisolone as premedicants for patients receiving cisplatin-containing chemotherapy
  11. Clinical and flow cytometry characteristics of malignant pleural effusions in patients after intracavitary administration of methylprednisolone acetate
  12. Oral granisetron with or without methylprednisolone versus metoclopramide plus methylprednisolone in the management of delayed nausea and vomiting induced by cisplatin-based chemotherapy. A prospective randomized trial
  13. Effect of vitamin A and methylprednisolone on canine prostate in organ culture
  14. Myeloprotective effect of short-course high-dose methylprednisolone treatment before consolidation therapy in children with acute myeloblastic leukemia
  15. Bone mineral density and serum bone turnover markers in survivors of childhood acute lymphoblastic leukemia: Comparison of megadose methylprednisolone and conventional-dose prednisolone treatments
  16. Methylprednisolone pulse therapy for severe immune thrombocytopenia associated with infectious mononucleosis
  17. Intra-arterial methylprednisolone for the management of steroid-refractory acute gastrointestinal and hepatic graft versus host disease
  18. Intraarticular methylprednisolone therapy in hemophilic arthropathy
  19. Letter to the editor: Intravenous high dose methylprednisolone for thrombotic thrombocytopenic purpura
  20. High-dose intravenous methylprednisolone for kasabach-merritt syndrome
  21. Successful treatment of refractory anemia with high-dose methylprednisolone
  22. Letter to the editor: High-dose intravenous methylprednisolone for pure red cell aplasia
  23. High-dose methylprednisolone in children with acute nonlymphoblastic leukemia
  24. Treatment of aplastic anaemia with antilymphocyte globulin and high-dose methylprednisolone

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