Solu-medrol

Leaflet accompanying the packaging: information for the user

SOLU-MEDROL, 40 mg, powder and solvent for solution for injection

SOLU-MEDROL, 125 mg, powder and solvent for solution for injection

SOLU-MEDROL, 500 mg, powder and solvent for solution for injection

SOLU-MEDROL, 1000 mg, powder and solvent for solution for injection

Methylprednisolone

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is SOLU-MEDROL and what is it used for
• 2. Important information before using SOLU-MEDROL
• 3. How to use SOLU-MEDROL
• 4. Possible side effects
• 5. How to store SOLU-MEDROL
• 6. Contents of the packaging and other information

1. What is SOLU-MEDROL and what is it used for

The active substance of SOLU-MEDROL, methylprednisolone, belongs to a group of medicines called glucocorticosteroids. Glucocorticosteroids penetrate cell membranes and bind to specific receptors located in the cytoplasm. Then, these complexes enter the cell nucleus, stimulating further synthesis of various enzymes, which are probably responsible for the numerous actions of glucocorticosteroids observed after general use. In addition to its significant effect on inflammatory and immune processes, glucocorticosteroids also affect carbohydrate, protein, and fat metabolism. They also act on the cardiovascular system, skeletal muscles, and the central nervous system.

SOLU-MEDROL is used as symptomatic treatment, except in cases of endocrine disorders, when it is used as substitution therapy, in the following diseases:

Endocrine disorders

• primary or secondary adrenal cortex insufficiency (in certain circumstances, in combination with mineralocorticosteroids)
• acute adrenal cortex insufficiency (may require administration in combination with mineralocorticosteroids)
• treatment of shock caused by adrenal cortex insufficiency, or shock that does not respond to conventional treatment, in case of confirmed or suspected adrenal cortex insufficiency (in cases where mineralocorticosteroids are contraindicated)
• before surgical procedures and in cases of severe illness or injury, in patients with diagnosed adrenal cortex insufficiency or decreased adrenal hormone levels
• congenital adrenal hyperplasia
• subacute thyroiditis
• hypercalcemia in cancer

Rheumatic diseases

Supportive treatment for short-term use during episodes of exacerbation or worsening of the condition in:

post-traumatic osteoarthritis

synovial inflammation in osteoarthritis

rheumatoid arthritis, including juvenile rheumatoid arthritis

acute and subacute bursitis

epicondylitis

acute non-specific tenosynovitis

acute gouty arthritis

psoriatic arthritis

ankylosing spondylitis

Systemic connective tissue diseases

During exacerbation or as maintenance treatment in:

systemic lupus erythematosus (and kidney inflammation in lupus)

acute rheumatic myocarditis

systemic polymyositis and dermatomyositis

giant cell arteritis

Goodpasture's syndrome

Dermatological diseases

pemphigus

severe form of erythema multiforme (Stevens-Johnson syndrome)

exfoliative dermatitis

severe form of psoriasis

bullous pemphigoid

severe form of seborrheic dermatitis

granulomatous dermatitis

Allergic diseases

Treatment of severe allergic diseases, when other treatment methods are ineffective:

bronchial asthma

contact dermatitis (contact eczema)

atopic dermatitis

urticaria

drug hypersensitivity reaction

transfusion-related urticaria

acute non-inflammatory laryngeal edema (the first-choice drug is epinephrine)

Ophthalmic diseases

Severe, acute, and chronic allergic and inflammatory processes involving the eye and its appendages, such as:

herpes zoster ophthalmicus

uveitis, iritis, and iridocyclitis

chorioretinitis

diffuse posterior uveitis and chorioretinitis

optic neuritis

sympathetic ophthalmia

inflammatory conditions of the anterior segment of the eye

allergic conjunctivitis

allergic marginal corneal ulcers

keratitis

Gastrointestinal diseases

As systemic treatment during exacerbation of:

ulcerative colitis

Crohn's disease

Respiratory diseases

Symptomatic sarcoidosis

Berylliosis

Fulminant or disseminated pulmonary tuberculosis, simultaneously with appropriate antitubercular chemotherapy

Loeffler's syndrome not responding to other treatments

Aspiration pneumonia

Moderate or severe pneumonia caused by Pneumocystis jiroveci in patients with AIDS (as supportive treatment, when administered within the first 72 hours of initial treatment against Pneumocystis)

Hematological diseases

Acquired (autoimmune) hemolytic anemia

Idiopathic thrombocytopenic purpura in adults (only intravenous administration; intramuscular administration is contraindicated)

Secondary thrombocytopenia in adults

Erythroblastopenia in the bone marrow

Congenital hypoplastic anemia

Oncological diseases

Palliative treatment:

leukemias and lymphomas in adults

acute leukemia in children

improving the quality of life of patients with advanced cancer

Edema

To induce diuresis or remission of proteinuria in nephrotic syndrome, without uremia

Nervous system

Brain edema associated with the presence of a tumor - primary or metastatic - and (or) related to surgical treatment or radiation therapy

Exacerbation in multiple sclerosis

Acute spinal cord injuries. Treatment should be started within 8 hours of injury.

Other indications

Tuberculous meningitis with subarachnoid block or in a situation threatening subarachnoid block, along with appropriate antitubercular therapy

Trichinosis with involvement of the nervous system or heart muscle

Organ transplantation

Prevention of nausea and vomiting associated with cancer chemotherapy

2. Important information before using SOLU-MEDROL

When not to use SOLU-MEDROL

• if the patient is hypersensitive to methylprednisolone or any of the other ingredients of this medicine (listed in section 6)
• if the patient has systemic fungal infections
• for intrathecal administration
• for epidural administration
• in premature infants and newborns.

Administration of live or live attenuated vaccines is contraindicated during treatment with SOLU-MEDROL, in doses that cause immunosuppressive effects.

Warnings and precautions

In patients with the following diseases, treatment with SOLU-MEDROL should be as short as possible and they require special medical care during the use of SOLU-MEDROL.

Before starting to take this medicine, the patient should discuss it with their doctor or pharmacist if they have any of the following conditions:

Infectious diseases,such as tuberculosis and certain viral diseases (herpes and herpes zoster with eye symptoms).

The use of SOLU-MEDROL in active tuberculosis should be limited to cases of fulminant or disseminated pulmonary tuberculosis, in which SOLU-MEDROL is used in the treatment of the disease in combination with antitubercular chemotherapy. During long-term treatment with SOLU-MEDROL, in patients with latent tuberculosis or a positive tuberculin test, careful observation is necessary, as the disease may recur.

In patients with ocular herpes simplex infection, who are given SOLU-MEDROL, there is a risk of corneal perforation.

Diabetes

Treatment with SOLU-MEDROL may cause symptoms of latent diabetes, increased insulin requirements, or oral hypoglycemic agents.

Hypertension

Treatment with SOLU-MEDROL may exacerbate hypertension.

Psychiatric disorderscurrently or in the past

SOLU-MEDROL may exacerbate existing emotional instability or psychotic tendencies. During treatment, psychiatric disorders may occur, ranging from euphoria, insomnia, mood swings, personality changes, and severe depression to severe psychotic disorders.

Severe stress

In patients exposed to severe stress, it may be necessary to increase the dose of rapidly acting glucocorticosteroids before, during, and after the stress situation.

Allergyto any medicines

If an allergic reaction occurred after taking any medicine, the doctor should be informed before starting treatment with SOLU-MEDROL.

Hypothyroidism

The effect of SOLU-MEDROL is stronger in patients with hypothyroidism.

Liver cirrhosis

The effect of SOLU-MEDROL is stronger in patients with liver cirrhosis.

Head injury

Non-specific ulcerative colitis,in case of possible perforation, abscess, or other purulent infection

Diverticulitis

Recent intestinal anastomosis

Active or latent peptic ulcer

Kidney failure

Osteoporosis

Myasthenia gravis(acquired, chronic disease characterized by rapid fatigue and weakness of skeletal muscles).

If the patient experiences blurred vision or other vision disturbances, they should contact their doctor.

Immunosuppressive effect, increased susceptibility to infections

SOLU-MEDROL may increase the susceptibility to infections and may mask some symptoms of infection. During its use, new infections may develop. During the use of SOLU-MEDROL, there may be decreased immunity and inability to limit the development of infection. The risk of infections with pathogens such as viruses, bacteria, fungi, protozoa, or parasites increases with the increase in dose.

Patients using SOLU-MEDROL are more susceptible to infections than healthy individuals, e.g., in children with immunodeficiency or in adults using SOLU-MEDROL, chickenpox and measles can have a more severe course or even be fatal.

During treatment with SOLU-MEDROL, in doses that cause immunosuppressive effects, the administration of certain vaccines is contraindicated. Inactivated vaccines may be administered, but the response to them may be limited or they may be ineffective. Patients receiving SOLU-MEDROL in doses that do not have an immunosuppressive effect may be subjected to all required vaccinations.

In patients treated with SOLU-MEDROL, Kaposi's sarcoma has been observed. Discontinuation of treatment may lead to remission of the disease.

Effect on the immune system

In patients, allergic reactions may occur. In patients taking SOLU-MEDROL, skin reactions and anaphylactic or pseudo-anaphylactic reactions have rarely occurred.

Endocrine disorders

During long-term treatment with SOLU-MEDROL, adrenal insufficiency may occur, which may persist for several months after discontinuation of treatment.

The doctor may also decide to gradually reduce the dose of SOLU-MEDROL. The patient should inform their doctor about any stressful situations that occur during this period. The doctor will consider initiating hormone therapy.

Sudden discontinuation of SOLU-MEDROL may cause acute adrenal cortex insufficiency, leading to death.

After sudden discontinuation of SOLU-MEDROL, a "steroid withdrawal syndrome" may also occur. This syndrome includes symptoms such as loss of appetite, nausea, vomiting, lethargy, headache, fever, joint pain, peeling, muscle pain, weight loss, and (or) hypotension.

SOLU-MEDROL may cause or exacerbate Cushing's syndrome, so patients with Cushing's disease should not use it.

In patients with hypothyroidism, the effect of SOLU-MEDROL is stronger.

Psychiatric disorders

During treatment with SOLU-MEDROL and after its completion, psychiatric disorders may occur. They usually occur within a few days or weeks of starting treatment with SOLU-MEDROL. Most of them disappear after reducing the dose or discontinuing SOLU-MEDROL. Patients and their caregivers should consult a doctor if the patient develops psychological symptoms, especially if they suspect depressive mood or suicidal thoughts. Patients and their caregivers should pay special attention to psychiatric disorders that may occur during treatment, immediately after dose reduction, or after discontinuation of SOLU-MEDROL.

Effect on the nervous system

SOLU-MEDROL should be used with caution in patients with seizure disorders.

In patients using SOLU-MEDROL, usually with long-term use of high doses, cases of supratentorial lipoma have been reported.

Effect on the eye

In patients using SOLU-MEDROL for a long time, posterior subcapsular cataract and nuclear cataract (especially in children) may develop, as well as exophthalmos or increased intraocular pressure, which can cause glaucoma with potential optic nerve damage. In patients using SOLU-MEDROL, secondary fungal or viral eye infections may also occur more frequently.

Due to systemic and local use of the medicine, vision disturbances may occur. If they occur, the patient should contact their doctor to determine possible causes, which may include cataract, glaucoma, or rare diseases such as central serous chorioretinopathy.

Central serous chorioretinopathy may lead to retinal detachment.

The use of SOLU-MEDROL is associated with the occurrence of central serous chorioretinopathy, which may lead to retinal detachment.

Effect on the heart

In the case of using high doses and long-term treatment with SOLU-MEDROL, patients with cardiovascular risk factors should be given the medicine with caution and additional monitoring of the cardiovascular system if necessary. The frequency of complications associated with the use of SOLU-MEDROL can be reduced by using small doses and administering the medicine every other day.

After rapid intravenous administration of high doses of SOLU-MEDROL, cardiac arrhythmias and (or) circulatory collapse, and (or) cardiac arrest may occur.

In patients with congestive heart failure, SOLU-MEDROL should be administered with caution and only if necessary.

Effect on the vascular system

During the use of SOLU-MEDROL, thrombosis, including venous thromboembolism, has been reported. Therefore, caution should be exercised in patients with thromboembolic disorders or those who may be prone to them.

Effect on the stomach and intestines

After the use of high doses of SOLU-MEDROL, acute pancreatitis may occur.

Treatment with SOLU-MEDROL may mask symptoms of peptic ulcers, so perforation or bleeding may occur without significant pain. Glucocorticosteroid treatment may mask peritonitis or other symptoms related to gastrointestinal disorders, such as perforation, obstruction, or pancreatitis.

In combination with the use of non-steroidal anti-inflammatory drugs (NSAIDs), the risk of developing gastric and intestinal ulcer disease increases.

Effect on the liver and bile ducts

Cyclic, pulse intravenous administration of methylprednisolone may cause drug-induced liver damage, such as acute hepatitis. Acute hepatitis may occur within a few weeks or longer. After the end of treatment, this adverse event has been observed to resolve.

Effect on the musculoskeletal system

During the use of high doses of SOLU-MEDROL, acute myopathy may occur, especially in patients with neuromuscular transmission disorders (e.g., myasthenia gravis) or in patients treated with anticholinergic drugs, including neuromuscular blockers (e.g., pancuronium). Myopathy may affect the eye muscles and respiratory muscles, as well as lead to quadriparesis. Increased creatine kinase activity may occur. Improvement in clinical condition or complete recovery after the end of treatment with SOLU-MEDROL may appear after several weeks or even years.

Effect on the kidneys and urinary tract

Caution should be exercised in patients with systemic sclerosis, as an increased frequency of scleroderma renal crisis has been observed with corticosteroids, including methylprednisolone.

SOLU-MEDROL should be used with caution in patients with renal failure.

Diagnostic tests

In patients using medium and high doses of SOLU-MEDROL, blood pressure, sodium and water retention, and potassium excretion may increase. Therefore, it may be necessary to limit salt in the diet and supplement potassium. All glucocorticosteroids, including SOLU-MEDROL, increase calcium excretion.

Injuries, poisonings, and post-procedure complications

SOLU-MEDROL should not be used to treat traumatic brain injury.

Other

Complications of glucocorticosteroid therapy depend on the dose and duration of treatment. The doctor will decide on the dosage and duration of treatment individually for each patient.

Patients should be careful when taking aspirin and non-steroidal anti-inflammatory drugs (NSAIDs) with SOLU-MEDROL.

After the administration of SOLU-MEDROL, a crisis in the course of a pheochromocytoma has been reported, sometimes fatal. In patients suspected of having or diagnosed with pheochromocytoma, the doctor will decide on the use of SOLU-MEDROL only after a thorough assessment of the benefit-risk ratio.

Tumor lysis syndrome may occur during the use of corticosteroids in cancer treatment. Patients should inform their doctor if they have cancer and symptoms of tumor lysis syndrome, such as muscle cramps, muscle weakness, confusion, irregular heartbeat, vision loss or disturbances, and shortness of breath.

Use in children

In children, long-term treatment with SOLU-MEDROL in divided daily doses may lead to growth retardation. The use of this treatment regimen should be limited to the most severe indications, and treatment with SOLU-MEDROL should be as short as possible. Patients should be under close medical supervision.

Infants and children taking SOLU-MEDROL for a long time are particularly at risk of increased intracranial pressure.

After the administration of high doses of SOLU-MEDROL in children, pancreatitis may develop.

After the administration of SOLU-MEDROL in premature infants, hypertrophic cardiomyopathy (thickening of the heart muscle) may develop.

Other warnings

Tell your doctor about all medicines you are taking now or have taken recently, as well as any medicines you plan to take.

Some medicines may enhance the effect of SOLU-MEDROL, and the doctor may want to monitor the patient's condition closely when taking such medicines (including some HIV medicines: ritonavir, cobicistat).

Corticosteroid therapy affects the results of many tests and biological parameters (e.g., skin tests, thyroid hormone level tests).

SOLU-MEDROL should not be administered by intramuscular injection into the deltoid muscle, due to the frequent occurrence of subcutaneous atrophy.

Use of SOLU-MEDROL in patients with liver function disorders

The effect of SOLU-MEDROL is particularly strong in patients with liver cirrhosis.

Caution should be exercised when using SOLU-MEDROL in patients with liver function disorders.

Use of SOLU-MEDROL in patients with hypothyroidism

The effect of SOLU-MEDROL is particularly strong in patients with hypothyroidism.

SOLU-MEDROL and other medicines

The patient should inform their doctor or pharmacist about all medicines they are taking now or have taken recently, as well as any medicines they plan to take. SOLU-MEDROL may affect the action of other medicines, and other medicines may affect the action of SOLU-MEDROL.

It may be necessary to adjust the dose of SOLU-MEDROL when used in combination with the following medicines:

antibacterial drugs: isoniazid

antitubercular antibiotic: rifampicin

• anticoagulant drugs (oral). Concomitant use with SOLU-MEDROL may decrease or increase the effect of anticoagulant drugs. Blood coagulation tests should be monitored to ensure adequate anticoagulant effect. antiepileptic drugs: carbamazepine, phenobarbital, phenytoin anticholinergic drugs: blocking neuromuscular conduction. During concomitant use of high doses of SOLU-MEDROL and anticholinergic drugs, such as neuromuscular blockers, cases of acute myopathy have been reported muscle relaxants, such as pancuronium, vecuronium: SOLU-MEDROL may partially inhibit neuromuscular blockade caused by muscle relaxants anticholinesterases: SOLU-MEDROL may reduce the effect of anticholinesterases in patients with myasthenia gravis
• antidiabetic drugs: in diabetic patients, it may be necessary to adjust the dose of antidiabetic drugs, as SOLU-MEDROL may increase blood glucose levels antiemetic drugs: aprepitant, fosaprepitant antifungal drugs: itraconazole, ketoconazole antiviral drugs - HIV protease inhibitors: indinavir and ritonavir aromatase inhibitor: aminoglutethimide calcium channel blocker: diltiazem oral contraceptives: ethinyl estradiol/norethindrone

grapefruit juice

immunosuppressive drugs: cyclosporine. When cyclosporine and SOLU-MEDROL are used concomitantly, there is mutual inhibition of metabolism, which may increase the concentration of one or both drugs in the blood. Therefore, there is a possibility that the risk of adverse effects associated with the use of one of the drugs may increase during concomitant administration. Cases of seizures have been reported during concomitant use. immunosuppressive drugs: cyclophosphamide, tacrolimus macrolide antibacterial drugs: clarithromycin, erythromycin, troleandomycin

• non-steroidal anti-inflammatory drugs (NSAIDs): high doses of aspirin (acetylsalicylic acid). Concomitant use of anti-inflammatory drugs with SOLU-MEDROL may increase the frequency of bleeding and ulceration of the gastrointestinal tract. Caution should be exercised when using aspirin in combination with SOLU-MEDROL
• potassium-lowering drugs. During concomitant use of SOLU-MEDROL with potassium-lowering drugs (e.g., diuretics), patients should be monitored for the development of hypokalemia (a condition in which the potassium ion concentration in the blood is below the laboratory norm). During concomitant use of SOLU-MEDROL with amphotericin B, xanthines, or beta2 agonists, the risk of hypokalemia increases.

Pregnancy, breastfeeding, and fertility

Fertility

In animal studies, it has been shown that SOLU-MEDROL has a fertility-reducing effect.

Pregnancy

If the patient is pregnant or breastfeeding, suspects that she may be pregnant, or plans to have a child, she should consult her doctor or pharmacist before using this medicine.

In some animal studies, it has been shown that corticosteroids administered to pregnant mothers in high doses may cause fetal developmental abnormalities. However, it does not appear that SOLU-MEDROL administered to pregnant women causes congenital abnormalities in the fetus. Until appropriate studies are conducted on the effect of SOLU-MEDROL on human reproductive processes, this medicine should not be administered to pregnant women unless a thorough assessment of the benefit-risk ratio for the mother and fetus is made.

SOLU-MEDROL crosses the placenta. In one retrospective study, an increased frequency of low birth weight in newborns born to mothers who took corticosteroids was found. In humans, the risk of low birth weight is dose-dependent. This risk may be reduced by administering lower doses of corticosteroids.

Although rare, newborn adrenal insufficiency has been reported in infants who were exposed to SOLU-MEDROL in utero. Children born to mothers who took high doses of SOLU-MEDROL during pregnancy should be carefully monitored and evaluated for adrenal insufficiency.

The effect of SOLU-MEDROL on the course of labor is unknown.

In infants born to mothers who were treated with SOLU-MEDROL for a long time during pregnancy, cataract development has been observed.

SOLU-MEDROL 500 mg and 1000 mg, powder and solvent for solution for injection, contains 9 mg of benzyl alcohol in each 1 ml of solution, which corresponds to 9 mg/1 ml of benzyl alcohol. Benzyl alcohol may cause allergic reactions. Administration of benzyl alcohol to newborns and young children is associated with a risk of serious adverse effects, including respiratory disorders. SOLU-MEDROL containing benzyl alcohol should not be used in newborns (up to 4 weeks of age) and should not be used in young children (under 3 years of age) for more than a week without a doctor's recommendation.

Breastfeeding

SOLU-MEDROL is excreted in human milk.

In children breastfed by mothers taking SOLU-MEDROL, the drug that has passed into the milk may inhibit growth and affect the production of endogenous glucocorticosteroids. This medicine may be used by breastfeeding women only after a thorough assessment of the benefit-risk ratio for the mother and infant.

SOLU-MEDROL 500 mg and 1000 mg, powder and solvent for solution for injection, contains 9 mg of benzyl alcohol in each 1 ml of solution, which corresponds to 9 mg/1 ml of benzyl alcohol.

Driving and operating machinery

The effect of SOLU-MEDROL on the ability to drive and operate machinery has not been studied.

Patients who experience dizziness, vision disturbances, and fatigue during treatment with SOLU-MEDROL should not drive vehicles or operate machinery.

SOLU-MEDROL 500 mg and 1000 mg contains benzyl alcohol

SOLU-MEDROL 500 mg and 1000 mg, powder and solvent for solution for injection, contains 9 mg of benzyl alcohol in each 1 ml of solution, which corresponds to 9 mg/1 ml of benzyl alcohol. Benzyl alcohol may cause allergic reactions. Administration of benzyl alcohol to newborns and young children is associated with a risk of serious adverse effects, including respiratory disorders. Do not use SOLU-MEDROL containing benzyl alcohol in newborns (up to 4 weeks of age) and do not use it in young children (under 3 years of age) for more than a week without a doctor's recommendation.

SOLU-MEDROL contains sodium

SOLU-MEDROL 40 mg and 125 mg, powder and solvent for solution for injection, contains less than 1 mmol (23 mg) of sodium per vial, i.e., the medicine is considered "sodium-free".

SOLU-MEDROL 500 mg, powder and solvent for solution for injection, contains 58.3 mg of sodium (the main component of table salt) in each vial, which corresponds to 2.92% of the maximum recommended daily sodium intake in the diet for adults.

SOLU-MEDROL 1000 mg, powder and solvent for solution for injection, contains 116.8 mg of sodium (the main component of table salt) in each vial, which corresponds to 5.84% of the maximum recommended daily sodium intake in the diet for adults.

3. How to use SOLU-MEDROL

This medicine should be used as directed by the doctor, who will adjust the dose individually for the patient. In case of doubts, consult a doctor.

During treatment with SOLU-MEDROL, as well as in case of discontinuation of long-term treatment, the patient should remain under close medical supervision.

SOLU-MEDROL can be administered by intravenous or intramuscular injection, or by intravenous infusion. The dose may be reduced in infants and children, but should be based on the patient's condition and response to treatment, rather than age or body weight (not less than 0.5 mg/kg body weight/24 hours).

Dosing requirements are variable and should be individualized, depending on the disease being treated, its severity, and the patient's response to treatment throughout the treatment period. The decision based on the benefit-risk ratio in each individual case should be made on an ongoing basis.

It is recommended to use the smallest effective dose of corticosteroid that ensures control of the treated disease for as short a time as possible. The appropriate maintenance dose should be established by gradually reducing the initial dose of the medicine at appropriate intervals until the smallest dose that provides an adequate clinical response is achieved.

If treatment is to be discontinued after a long period of use, the medicine should be discontinued gradually; it should not be stopped abruptly.

After the initial period of use in emergency situations, it is recommended to switch to treatment with a long-acting injection or oral medicine.

If the medicine is used as supportive treatment in life-threatening conditions, it should be administered intravenously in a dose of 30 mg/kg body weight over at least 30 minutes. The dose can be repeated every 4 to 6 hours for a period not exceeding 48 hours.

Administration of methylprednisolone in the form of intravenous pulses in a dose of 250 mg/day or higher for several days (usually ≤ 5 days) may be effective in the treatment of exacerbations of the disease or conditions in which standard therapy does not produce the desired effects. These include rheumatic diseases, systemic lupus erythematosus, and edematous conditions such as nephrotic syndrome or lupus nephritis. In patients with multiple sclerosis, in whom standard therapy has proven ineffective (or in patients with exacerbations of the disease), intravenous pulses of 500 mg/day or 1000 mg/day should be administered for 3 or 5 days.

If the medicine is used as supportive treatment for other conditions, the initial dose administered intravenously will range from 10 to 500 mg, depending on the patient's clinical condition.

In the case of short-term treatment of severe, acute conditions, higher doses may be required. Initial doses not exceeding 250 mg should be administered intravenously over at least 5 minutes, while higher doses should be administered over at least 30 minutes.

Subsequent doses can be administered intravenously or intramuscularly at intervals dictated by the patient's response to treatment and clinical condition.

During prolonged therapy, routine laboratory tests should be performed regularly, such as urinalysis, postprandial glucose level, blood pressure measurement, body weight measurement, and chest X-ray. Radiological images of the upper gastrointestinal tract are required in patients with a history of ulcers or significant dyspepsia.

If the patient feels that the effect of SOLU-MEDROL is too strong or too weak, they should consult their doctor.

Use of a higher than recommended dose of SOLU-MEDROL

In case of taking too much SOLU-MEDROL, the patient should immediately consult a doctor or pharmacist. There are no clinical symptoms of acute overdose of SOLU-MEDROL.

Chronic overdose causes typical symptoms of Cushing's syndrome. Dialysis is an effective method of removing SOLU-MEDROL from the body.

Missing a dose of SOLU-MEDROL

A double dose should not be used to make up for a missed dose.

Discontinuation of SOLU-MEDROL

In case of any further doubts related to the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, SOLU-MEDROL can cause side effects, although not everybody gets them.

The following side effects have been reported in the case of the following routes of administration:

intrathecal/intrathecal: meningitis, gastrointestinal or urinary tract disorders, headache, meningitis, transverse myelitis/paralysis, seizures, sensory disturbances.

In case of occurrence of any of the following symptoms, the patient should immediately inform their doctor or go to the nearest hospital:

Frequency not known (frequency cannot be estimated from the available data)

• opportunistic infections, infections, peritonitis
• leukocytosis (increased white blood cell count in the blood)
• hypersensitivity reactions, anaphylactic reactions, anaphylactoid reactions
• Cushing's syndrome, inhibition of the hypothalamic-pituitary-adrenal axis, steroid withdrawal syndrome
• metabolic acidosis, lipomatosis, sodium retention, fluid retention, hypokalemic alkalosis, dyslipidemia, impaired glucose tolerance, increased insulin requirements (or oral hypoglycemic agents in diabetic patients), fat accumulation in certain parts of the body, increased appetite (which may lead to weight gain)
• affective disorders (including depressive mood, euphoric mood, emotional instability, drug dependence, suicidal thoughts), psychotic disorders (including manic excitement, delusions, hallucinations, and schizophrenia), mental disorders, personality changes, confusion, anxiety, mood swings, abnormal behavior, insomnia, irritability
• increased intracranial pressure (with papilledema [benign intracranial hypertension]), seizures, memory impairment, cognitive function disorders, dizziness, headache
• chorioretinopathy (retina and choroid disorders), cataract, glaucoma, exophthalmos, or increased intraocular pressure, which can cause glaucoma with potential optic nerve damage, rarely - blurred vision
• congestive heart failure (in susceptible patients), arrhythmia
• increased blood coagulability, hypotension, hypertension
• pulmonary embolism, hiccup
• peptic ulcers (with possible subsequent perforation and bleeding), perforation of the intestine, gastrointestinal bleeding, pancreatitis, esophagitis, esophageal ulceration, flatulence, abdominal pain, diarrhea, dyspepsia
• methylprednisolone may cause liver damage. Cases of hepatitis and increased liver enzyme activity (increased alanine aminotransferase and aspartate aminotransferase activity) have been reported
• angioedema, hirsutism, purpura, subcutaneous or skin hemorrhages, skin atrophy, flushing, excessive sweating, striae, rash, pruritus, urticaria, acne, skin discoloration
• muscle weakness, muscle pain, myopathy, muscle atrophy, osteoporosis, bone necrosis, pathological fractures, neuropathic arthropathy, joint pain, growth retardation
• irregular menstruation
• wound healing disorders, peripheral edema, fatigue, malaise, injection site reactions
• increased intraocular pressure, impaired glucose tolerance, decreased potassium levels in the blood, increased calcium levels in the urine, increased alkaline phosphatase activity in the blood, increased urea levels in the blood, inhibition of response to skin tests
• vertebral compression fractures, tendon rupture.

†Hepatitis has been reported with intravenous administration (see section 2).

≠ Peritonitis may be the first objective or subjective symptom of gastrointestinal disorders, such as perforation, obstruction, or pancreatitis (see section 4.4 Special warnings and precautions for use).

5. How to Store SOLU-MEDROL

SOLU-MEDROL, 40 mg, 125 mg, 500 mg, 1000 mg: There are no special recommendations for storing the medicinal product. SOLU-MEDROL, 40 mg: After reconstitution, the medicinal product should be stored at a temperature below 25°C and used immediately or stored at a temperature of 2°C - 8°C and used within 48 hours. After reconstitution and further dilution with other infusion solutions, the medicinal product should be stored at a temperature of 20°C - 25°C and used within 3 hours or stored at a temperature of 2°C - 8°C and used within 24 hours. SOLU-MEDROL, 125 mg, 500 mg, 1000 mg: After reconstitution, the medicinal product should be stored at a temperature below 25°C and used within 12 hours or stored at a temperature of 2°C - 8°C and used within 48 hours. After reconstitution and further dilution with other infusion solutions, the medicinal product should be stored at a temperature of 20°C - 25°C and used within 3 hours or stored at a temperature of 2°C - 8°C and used within 24 hours. From a microbiological point of view, the solution should be used immediately, unless the medicinal product has been opened and diluted under controlled and validated aseptic conditions. If the prepared solution is not used immediately, the user is responsible for the storage conditions and storage time. More information on the storage of reconstituted and diluted solutions can be found in the section "Information intended exclusively for healthcare professionals". The medicinal product should be stored out of the sight and reach of children. Do not use this medicinal product after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the month stated. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package Contents and Other Information

What SOLU-MEDROL Contains

SOLU-MEDROL, 40 mg, powder and solvent for solution for injection

• The active substance is methylprednisolone in the form of sodium succinate.
• The other excipients are: sucrose, sodium dihydrogen phosphate monohydrate, disodium phosphate anhydrous (see section 2 "SOLU-MEDROL contains sodium"). Solvent: water for injections.

SOLU-MEDROL, 125 mg, powder and solvent for solution for injection

• The active substance is methylprednisolone in the form of sodium succinate.
• The other excipients are: sodium dihydrogen phosphate monohydrate, disodium phosphate anhydrous (see section 2 "SOLU-MEDROL contains sodium"). Solvent: water for injections.

SOLU-MEDROL, 500 mg, 1000 mg, powder and solvent for solution for injection

• The active substance is methylprednisolone in the form of sodium succinate.
• The other excipients are: sodium dihydrogen phosphate monohydrate, disodium phosphate anhydrous (see section 2 "SOLU-MEDROL contains sodium"). Solvent: benzyl alcohol (E1519) (see section 2 "SOLU-MEDROL 500 mg and 1000 mg contain benzyl alcohol"), water for injections.

What SOLU-MEDROL Looks Like and What the Package Contains

SOLU-MEDROL is a white, compact powder and a clear, colorless solvent.

Package Contents:

SOLU-MEDROL, 40 mg
A two-chamber vial made of colorless glass with powder and solvent of 1 ml in a cardboard box.
SOLU-MEDROL, 125 mg
A two-chamber vial made of colorless glass with powder and solvent of 2 ml in a cardboard box.
SOLU-MEDROL, 500 mg
A vial made of colorless glass with powder and a vial with solvent of 8 ml in a cardboard box.
SOLU-MEDROL, 1000 mg
A vial made of colorless glass with powder and a vial with solvent of 16 ml in a cardboard box.

Marketing Authorization Holder

Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium

Manufacturer

Pfizer Manufacturing Belgium NV, Rijksweg 12, 2870 Puurs, Belgium

For More Information, Please Contact the Local Representative of the Marketing Authorization Holder:

Pfizer Polska Sp. z o.o., tel. 22 335 61 00

Date of Last Update of the Leaflet: 09/2023

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Information Intended Exclusively for Healthcare Professionals

Incompatibilities
It is recommended to administer methylprednisolone sodium succinate separately, without other intravenously administered compounds, to avoid problems with compatibility or stability. Medicinal products that are not compatible in terms of physical parameters in a solution with methylprednisolone sodium succinate include, but are not limited to: allopurinol sodium, doksapram hydrochloride, tygecycline, diltiazem hydrochloride, calcium gluconate, vecuronium bromide, rocuronium bromide, cisatracurium besylate, glycopyrrolate, propofol.
The compatibility and stability of intravenously administered methylprednisolone sodium succinate solution and in combination with other products depend on the pH of the solution, concentration, time, temperature, and solubility of methylprednisolone in the given solution. Therefore, whenever possible, the methylprednisolone sodium succinate solution should be administered separately, in the form of a bolus or intravenous infusion, or "piggy-back" infusion.
To administer SOLU-MEDROL in the form of a bolus or intravenous infusion, or "piggy-back" infusion, the solution should be prepared according to the recommendations.
PREPARATION OF THE SOLUTION
In aseptic conditions, add the solvent to the vial containing the sterile powder. Use only the specially designed solvent. Treatment can be started by administering the methylprednisolone sodium succinate solution intravenously over at least 5 minutes (doses up to 250 mg) or over at least 30 minutes (doses of 250 mg and above). Subsequent doses can be administered in a similar manner.
SOLU-MEDROL, 40 mg:
The reconstituted solution should be stored at a temperature of 2°C - 8°C and used within 48 hours. If stored at a temperature below 25°C, it should be used immediately.
SOLU-MEDROL, 125 mg, 500 mg, 1000 mg:
The reconstituted solution should be stored at a temperature below 25°C and used within 12 hours or stored at a temperature of 2°C - 8°C and used within 48 hours.
If necessary, the reconstituted solution can be further diluted in solutions of:

• 5% dextrose in water for injections
• physiological saline solution
• 5% dextrose in 0.45% NaCl solution
• 5% dextrose in 0.9% NaCl solution

SOLU-MEDROL, 40 mg:
The reconstituted and further diluted solution stored at a temperature of 2°C - 8°C is chemically and physically stable for 24 hours. If stored at a temperature of 20°C - 25°C, it should be used within 3 hours.
SOLU-MEDROL, 125 mg, 500 mg, 1000 mg:
The reconstituted and further diluted solution stored at a temperature of 20°C - 25°C is chemically and physically stable for 3 hours or 24 hours when stored at a temperature of 2°C - 8°C.
From a microbiological point of view, the solution should be used immediately, unless the medicinal product has been opened and diluted under controlled and validated aseptic conditions. If the prepared solution is not used immediately, the user is responsible for the storage conditions and storage time.
INSTRUCTIONS FOR PREPARING THE SOLUTION IN TWO-CHAMBER VIALS (SOLU-MEDROL, 40 mg and SOLU-MEDROL, 125 mg)

• 1. Press the plastic activator to allow the solvent to flow into the lower chamber.
• 2. Gently shake to obtain the solution.
• 3. Remove the plastic cap covering the center of the stopper.
• 4. Sterilize the upper part of the stopper with a suitable bactericidal agent.

Note: Steps 1 to 4 should be performed before withdrawing the medicinal product.

• 5. Insert the needle perpendicularly through the center of the stopperuntil the tip is visible.
• 6. Turn the vial over and withdraw the required dose.

Medicines administered parenterally should be inspected visually for particulate matter and discoloration prior to administration, whenever the solution and container permit.