Solu-medrol 1g lyophilisate for prig. for injection No. 1 bottle + 15.6 ml solvent

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Solu-medrol 1g lyophilisate for prig. solution for injection No. 1 vial + 15.6 ml solvent

pharmachologic effect

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 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:

- Reducing the number of immunoactive cells near the focus of inflammation.
- Reduction of vasodilation.
- Stabilization of lysosomal membranes.
- Inhibition of phagocytosis.

- Reduced 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 with 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 of plasma concentration, 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 mineralocorticoid, especially in pediatric practice).
- Acute adrenal insufficiency (it may be necessary to add mineralocorticoids).
- Shock resulting from adrenal insufficiency, or shock that is not amenable to treatment with conventional methods, when adrenal insufficiency is possible (if mineralocorticoid action 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.

- Post-traumatic osteoarthritis.
- Sinovit with 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 lupus erythematosus (and lupus nephritis).
- Acute rheumatic heart disease.
- Systemic dermatomyositis (polymyositis).
- Nodose periarteritis.
- Goodpasture syndrome.

- Bubbly.
- Severe erythema multiforme (Stevens-Johnson syndrome).
- Exfoliative dermatitis.
- Severe psoriasis.
- Herpetiformis bullous dermatitis.
- Severe seborrheic dermatitis.
- Mushroom mycosis.

- Bronchial asthma.
- Contact dermatitis.
- Atopic dermatitis.
- Serum sickness.
- Seasonal or perennial allergic rhinitis.
- Drug hypersensitivity reactions.
- Post-transfusion reactions such as urticaria.
- Acute non-infectious laryngeal edema.

- Herpes zoster eye form.
- Irit and iridocyclitis.
- Chorioretinitis.
- Diffuse posterior uveitis and choroiditis.
- Optic neuritis.
- Sympathetic ophthalmia.
- Inflammation of the anterior segment.
- Allergic conjunctivitis.
- Allergic corneal ulcers.
- Keratitis.

- Ulcerative colitis.
- Regional enteritis.

- 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.

- Acquired (autoimmune) hemolytic anemia.
- Idiopathic thrombocytopenic purpura in adults (only B / V introduction; i / m administration is contraindicated).
- Secondary thrombocytopenia in adults.
- Erythroblastopenia (erythrocyte anemia).
- Congenital (erythroid) hypoplastic anemia.

- Leukemia and lymphomas in adults.
- Acute leukemia in children.
- To improve the quality of life of patients with cancer in the terminal stage.

- To stimulate diuresis and achieve remission of proteinuria in patients with nephrotic syndrome without uremia.

- Cerebral edema caused by 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.

- 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.

Contraindications

- Systemic fungal infections.
- Hypersensitivity to any component of the drug in history.
- It is not recommended to use the drug in patients with acute and subacute myocardial infarction, since the use of glucocorticosteroids in them can lead to the spread of necrosis, slowing the formation of scar tissue and, consequently, rupture of the heart muscle.

Carefully:

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

This drug 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.

Use during 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, embryo or 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 the 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 may occur in a worn form, in addition, new infections may 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 is 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 has a history of allergic reactions to any medications.

Drug interaction

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.

Where 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. With the joint use of these drugs have been noted 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 can 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 variety of effects 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, it is necessary to constantly determine the coagulation parameters.

Overdose

The clinical syndrome of acute overdose is not described. Cases of acute toxicity in overdose of corticosteroids are extremely rare. There is no specific antidote. Symptomatic treatment. Methylprednisolone is derived from dialysis.



It is a drug. Consultation with a doctor is required.

Composition

Lyophilisate for solution for injection contains: Methylprednisolone in the form of methylprednisolone sodium succinate 1000 mg

Excipients: Lactose (40 mg vials only), monobasic sodium phosphate monohydrate, secondary acid sodium phosphate

Solvent: Benzyl alcohol 9 mg, water for injection qs 1 ml

Mode of application

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, and not age and body weight.

As an additional therapy for life-threatening conditions of 30 mg / kg body weight. In / in for at least 30 minutes The introduction of this dose in the treatment of diseases for which corticosteroid therapy is effective, can be repeated every 4-6 hours for no more than 48 hours.

Pulse therapy: 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 IV for 3 or 5 days. Edematous conditions, for example, glomerulonephritis, lupus nephritis: 30 mg / kg IV / every other day for 4 days or 1 g / day IV 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.

Oncological diseases 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: When chemotherapy is characterized by insignificant or moderate vomiting, 250 mg IV is administered for at least 5 minutes one hour before the chemotherapy drug is administered, at the beginning of chemotherapy, as well as after its ending. To enhance the effect with the first dose of SOLU-MEDROL, chlorphenothiazine preparations can be administered. During chemotherapy, characterized by a pronounced emetic effect, 250 mg IV is administered for at least 5 minutes in combination with 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 it ends. .

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

For other indications: The initial dose is 10 - 500 mg IV, depending on 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 checked for color change or the appearance of particles.
Act-0-Vial ® Dual Capacity Vial:

Bottle:
- With the observance of asepsis, enter the solvent in a vial of lyophilized. Use only special solvent.

- 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 solution of dextrose, with saline, with a 5% solution of dextrose in 0.45% or 0.9% sodium chloride solution. The prepared solutions are physically and chemically stable for 48 hours.