Methylprednisolone Sodium Succinate for Injection

This product is methylprednisolone for intravenous and intramuscular injection, which is a synthetic glucocorticoid. This high-concentration aqueous solution is particularly suitable for disease states that require strong and fast-acting hormone treatment. Methylprednisolone has strong anti-inflammatory, immunosuppressive and anti-allergic activities. Glucocorticoids diffuse through the cell membrane and bind to specific receptors in the cytoplasm. This conjugate then enters the cell nucleus and binds to DNA (chromatin), initiating the transcription of messenger ribonucleic acid (mRNA), and then synthesizing various enzyme proteins. It is believed that glucocorticoids ultimately rely on these enzymes to exert their various systemic effects. Glucocorticoids not only play an important role in inflammatory and immune processes, but also affect carbohydrate, protein and fat metabolism, and have effects on the cardiovascular system, skeletal muscle system and central nervous system. Effects on inflammatory and immune processes: Most of the therapeutic effects of glucocorticoids are related to their anti-inflammatory, immunosuppressive and anti-allergic properties, which lead to the following results: Reduction of immune active cells around inflammatory lesions Reduction of vasodilation Stabilization of lysosomal membranes Inhibition of phagocytosis Reduction of the production of prostaglandins and related substances The glucocorticoid effect (anti-inflammatory effect) of 4mg methylprednisolone is the same as that of 20mg hydrocortisone. Methylprednisolone has only a very low mineralocorticoid effect (200mg methylprednisolone is equivalent to 1mg deoxycorticosterone). Effects on carbohydrate and protein metabolism: Glucocorticoids have the effect of decomposing proteins, and the released amino acids are converted into glucose and glycogen in the liver through the process of gluconeogenesis; at the same time, the absorption of glucose by peripheral tissues is reduced, resulting in increased blood sugar and glucosuria. This is particularly evident in patients with a tendency to diabetes. Effects on fat metabolism: Glucocorticoids have the effect of decomposing fat, which mainly affects the limbs; in addition, glucocorticoids have the effect of lipogenesis, which is particularly evident in the chest, neck and head. All of this leads to the redistribution of fat. The maximum pharmacological effect of glucocorticoids occurs after the peak blood concentration, indicating that most of their effects are caused by changes in enzyme activity rather than a direct effect of the drug.

Methylprednisolone sodium succinate.

Unless used as a replacement for certain endocrine diseases, glucocorticoids are only a symptomatic treatment. 1. Anti-inflammatory therapy - Rheumatic diseases As a short-term adjuvant drug (to help patients get through the acute or critical period), used for: (1) post-traumatic osteoarthritis (2) synovitis caused by osteoarthritis (3) rheumatoid arthritis, including juvenile rheumatoid arthritis (individual patients may need low-dose maintenance treatment) (4) acute or subacute bursitis (5) epicondylitis (6) acute nonspecific synovitis (7) acute gouty arthritis (8) psoriatic arthritis (9) ankylosing spondylitis 2. Collagen diseases (immune complex diseases) used for the critical period or maintenance treatment of the following diseases: (1) systemic lupus erythematosus (and lupus nephritis) (2) acute rheumatic myocarditis (3) systemic dermatomyositis (polymyositis) (4) polyarteritis nodosa (5) Goodpath Good Pasture's Syndrome 3. Skin diseases (1) Pemphigus (2) Severe erythema multiforme (Stevens-Johnson syndrome) (3) Exfoliative dermatitis (4) Bullous dermatitis herpeticum (5) Severe seborrheic dermatitis (6) Severe psoriasis (7) Mycosis fungoides (8) Urticaria 4. Allergic conditions Used to control the following severe or functionally impaired allergic diseases that are difficult to treat with conventional therapy: (1) Bronchial asthma (2) Contact dermatitis (3) Atopic dermatitis (4) Serum sickness (5) Seasonal or year-round allergic rhinitis (6) Drug allergic reaction (7) Urticarial transfusion reaction (8) Acute non-infectious laryngeal edema (epinephrine is the preferred drug) 5. Eye Severe acute and chronic allergic and inflammatory conditions of the eye, such as: (1) Herpes zoster ophthalmicus (2) Iritis, iridocyclitis (3) Chorioretinitis (4) Diffuse posterior uveitis and choroiditis (5) Optic neuritis (6) Sympathetic ophthalmia 6. Gastrointestinal diseases Help patients through the critical stages of the following diseases: (1) Ulcerative colitis (systemic treatment) (2) Regional ileitis (systemic treatment) 7. Respiratory diseases (1) Pulmonary sarcoidosis (2) Beryllium poisoning (3) Combined with appropriate antituberculosis chemotherapy for fulminant or disseminated pulmonary tuberculosis (4) Loeffler's Syndrom that cannot be controlled by other methods (5) Aspiration pneumonia 8. Edema states: used for spontaneous or lupus nephritis without uremia Diuresis and relief of proteinuria in the case of leukemia syndrome 9. Immunosuppressive therapy (1) Organ transplantation for the treatment of blood diseases and tumors (2) Blood diseases: acquired (autoimmune) hemolytic anemia, spontaneous thrombocytopenic purpura in adults (only intravenous injection is allowed, intramuscular injection is contraindicated), secondary thrombocytopenia in adults, erythroblastopenia (erythrocyte anemia), congenital (erythrocyte) aplastic anemia (3) Tumors 10. For the palliative treatment of the following diseases: (1) Adult leukemia and lymphoma (2) Acute leukemia in children (3) Treatment of shock secondary to adrenal insufficiency, or shock that is unresponsive to conventional treatment due to possible adrenal insufficiency (the commonly used drug is hydrocortisone; if mineralocorticoid activity is not desired, methylprednisolone can be used). Hemorrhagic, traumatic and surgical shock that is unresponsive to conventional treatment. Although there are no complete (double-blind controlled) clinical studies, data from animal experiments show that this product may be effective for shock that is resistant to conventional treatments (e.g., fluid replacement). Please also refer to the "Infectious Shock" section in [Precautions]. 11. Others (1) Cerebral edema caused by primary or metastatic tumors, or surgery and radiotherapy in the nervous system Acute spinal cord injury in the acute critical stage of multiple sclerosis. Treatment should be started within 8 hours after the injury. - Used in combination with appropriate anti-tuberculosis chemotherapy for tuberculous meningitis with subarachnoid obstruction or tendency to obstruction - Trichinosis involving the nerves or myocardium - Prevention of nausea and vomiting caused by cancer chemotherapy (2) Endocrine disorders - Primary or secondary adrenal insufficiency - Acute adrenal insufficiency For the above diseases, hydrocortisone or cortisone is the first choice; if necessary, synthetic glucocorticoids can be used in combination with mineralocorticoids. Patients with known or suspected adrenal insufficiency. Administration prior to surgery and in the event of severe trauma or illness is not well established. - Congenital adrenal hyperplasia - Nonsuppurative thyroiditis - Hypercalcemia due to cancer

As an adjunctive drug for life-threatening situations, the recommended dose is 30 mg/kg, which should be injected intravenously over at least 30 minutes. This dose can be repeated every 4-6 hours within 48 hours in the hospital according to clinical needs (see [Precautions]). Shock therapy is used for severe disease exacerbation and/or diseases that do not respond to conventional treatments (such as nonsteroidal anti-inflammatory drugs, gold salts and penicillamine). Recommended regimen: - Rheumatoid arthritis: - 1g/day, intravenous injection, for 1, 2, 3 or 4 days; - 1g/month, intravenous injection, for 6 months. Because high-dose corticosteroids can cause arrhythmias, this treatment method is limited to use in the hospital so that electrocardiograms and defibrillation can be performed in time. Each administration should take at least 30 minutes. If the condition does not improve within one week after treatment or if necessary, this treatment regimen can be repeated. Recommended regimen for preventing nausea and vomiting caused by chemotherapy: --For mild to moderate vomiting caused by chemotherapy: 250 mg of this product is injected intravenously over at least 5 minutes 1 hour before chemotherapy, at the beginning of chemotherapy and after the end of chemotherapy. When giving the first dose of this product, chlorinated phenothiazine can be given at the same time to enhance the effect. --For severe vomiting caused by chemotherapy: 250 mg of this product is injected intravenously over at least 5 minutes 1 hour before chemotherapy, and an appropriate amount of metoclopramide or butyrophenone is given at the same time, followed by 250 mg of this product injected intravenously at the beginning and end of chemotherapy. Treatment of acute spinal cord injury should be started within 8 hours after injury. For patients treated within 3 hours of injury: the initial dose is 30 mg of methylprednisolone per kilogram of body weight, injected intravenously over 15 minutes under continuous medical supervision. A large dose should be paused for 45 minutes after injection, followed by continuous intravenous drip at a rate of 5.4 mg/kg/hour for 23 hours. The infusion pump should be placed at a different injection site from the large dose injection. For patients treated within 3-8 hours of injury: Initial dose is 30 mg of methylprednisolone per kg of body weight, given intravenously over 15 minutes under continuous medical supervision. A 45-minute pause after the bolus should be followed by a continuous intravenous infusion of 5.4 mg/kg/hour for 47 hours. This bolus rate is appropriate for this indication only, and it should be given with ECG monitoring and access to a defibrillator. Rapid intravenous administration of large doses of methylprednisolone (>500 mg of methylprednisolone given in less than 10 minutes) may cause arrhythmias, circulatory collapse, and cardiac arrest. For other indications, the initial dose ranges from 10 mg to 500 mg, depending on the clinical condition. Large doses of methylprednisolone can be used to control certain acute, severe conditions in the short term, such as bronchial asthma, serum sickness, urticarial transfusion reactions, and acute exacerbations of multiple sclerosis. Initial doses of ≤250 mg should be given intravenously over at least 5 minutes; initial doses of >250 mg should be given intravenously over at least 30 minutes. Depending on the patient's response and clinical needs, the next dose can be given intravenously or intramuscularly after a certain interval. Corticosteroids can only be used as an adjunct, not as a substitute for conventional therapy. Infants and children can be given a reduced dose, but this should not be based solely on age and size, but more on the severity of the disease and the patient's response. The total amount per 24 hours should not be less than 0.5 mg/kg. After a few days of medication, the dose must be gradually reduced or the drug must be gradually discontinued. If a chronic disease spontaneously resolves, treatment should be stopped. Patients on long-term treatment should undergo regular routine laboratory tests, such as urine routine, blood sugar 2 hours after meals, blood pressure and weight, and chest X-ray examination. Patients with a history of ulcers or significant indigestion should undergo upper gastrointestinal X-ray examinations. Patients who interrupt long-term treatment also need medical monitoring. This product can be administered by intravenous injection, intramuscular injection or intravenous drip. In emergency treatment, intravenous injection should be used. For intravenous (intramuscular) injection, prepare the solution according to the instructions. Instructions for using double-chamber bottles 1. Press the plastic pusher to allow the diluent to flow into the lower bottle chamber. 2. Gently shake the bottle. 3. Remove the plastic loop from the center of the stopper. 4. Disinfect the top rubber tip with an appropriate disinfectant. 5. Insert the needle vertically into the center of the rubber tip until the needle tip is visible, invert the vial and withdraw the medication. Instructions for using the vials Add the diluent to the vial containing the sterile powder under a sterile environment. Only the specific diluent should be used. Preparation of the infusion solution First prepare the solution as directed. Initial treatment may be an intravenous infusion of methylprednisolone over at least 5 minutes (for doses less than or equal to 250 mg) or at least 30 minutes (for doses greater than 250 mg); the next dose may be reduced and administered in the same manner. If necessary, the drug may be diluted and administered by mixing the dissolved drug with 5% dextrose in water, normal saline, or a mixture of 5% dextrose and 0.45% sodium chloride. The reconstituted solution remains physically and chemically stable for 48 hours.

1. Systemic adverse reactions may be observed. Although they rarely occur during short-term treatment, they should still be carefully followed up. This is part of the follow-up of steroid treatment and is not specific to a particular drug. Possible adverse reactions of glucocorticoids (such as methylprednisolone) are: Infection and infestation: masking of infection, onset of latent infection, opportunistic infection Eye abnormalities: posterior subcapsular cataract, proptosis. Long-term use of glucocorticoids can cause glaucoma (possibly involving the optic nerve) and increase the chance of secondary fungal or viral infection of the eye. 2. To prevent corneal perforation, glucocorticoids should be used with caution in patients with ocular herpes simplex. 3. Cardiac abnormalities: congestive heart failure, myocardial rupture after myocardial infarction, and arrhythmias in some sensitive patients. 4. It has been reported that intravenous injection of large doses of methylprednisolone in a short period of time (more than 0.5g given within 10 minutes) can cause arrhythmias and/or circulatory collapse and/or cardiac arrest. There are also reports that large doses of methylprednisolone can cause bradycardia, but it may not be related to the administration rate or infusion time. There are also reports that high-dose glucocorticoids can cause tachycardia. 5. Vascular abnormalities: hypertension, hypotension, petechiae. 6. Respiratory system, chest and mediastinal abnormalities: persistent hiccups associated with administration of higher doses of glucocorticoids. 7. Gastrointestinal abnormalities: peptic ulcers with possible perforation and bleeding, peptic bleeding, pancreatitis, esophagitis, intestinal perforation. 8. Skin and subcutaneous tissue abnormalities: ecchymoses, thin and fragile skin. Repeated local subcutaneous injections may cause local skin atrophy. 9. Musculoskeletal and connective tissue abnormalities: steroid myopathy, myasthenia, osteoporosis, aseptic necrosis. 10. Reproductive system and breast abnormalities: menstrual disorders. 11. Systemic abnormalities and administration site conditions: poor wound healing, inhibition of growth in children. 12. Laboratory tests: potassium loss, elevated alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase, negative nitrogen balance due to protein breakdown. Increased intraocular pressure, inhibition of skin test reactions. 13. Injury, poisoning and operation complications: pathological fractures, vertebral compression fractures, tendon rupture (mainly seen in the Achilles tendon). Fluid and electrolyte disorders.

1. Systemic fungal infection. 2. Allergic to methylprednisolone sodium succinate or excipients. 3. Relative contraindications 4. Special risk groups: 5. Patients belonging to the following special risk groups should be closely monitored and the course of treatment should be shortened as much as possible (also refer to [Precautions] and [Adverse Reactions]): children; patients with diabetes; patients with hypertension; patients with a history of mental illness; certain infectious diseases with obvious symptoms, such as tuberculosis; or certain viral diseases with obvious symptoms, such as herpes and herpes zoster affecting the eyes. 6. To avoid compatibility and stability problems, this product should be administered separately from other drugs as much as possible.

Precautions for children: The dosage can be reduced for infants and children, but it is not just based on age and size, but more importantly, the severity of the disease and the patient's response should be considered. The total amount per 24 hours should not be less than 0.5 mg/kg. Precautions for pregnancy and lactation: 1. Some animal experiments have shown that mothers taking large doses of corticosteroids may cause fetal malformations. 2. Because there have been insufficient human reproductive studies, when corticosteroids are used in pregnant women, lactating women or women preparing to give birth, the relationship between its benefits and its potential risks to the mother and the embryo or fetus should be carefully weighed. Corticosteroids can only be used in pregnant women when they are really needed. If long-term corticosteroids must be discontinued during pregnancy (the same as other long-term therapies), the discontinuation process must be carried out gradually (also refer to [Usage and Dosage]). However, the treatment of certain diseases (such as replacement therapy for adrenal cortex insufficiency) may need to be continued or even increased in dose. Because corticosteroids easily cross the placenta, infants born to mothers who have used large amounts of corticosteroids during pregnancy should be carefully observed and evaluated for signs of adrenal cortex hypofunction. 3. The effect of this product on childbirth is unknown. 4. Corticosteroids are secreted with breast milk. Elderly precautions: There is currently a lack of research data on the safety and effectiveness of this product for elderly patients. Please take the medicine as directed by your doctor.

Beneficial interactions 1. Prevent nausea and vomiting caused by tumor chemotherapy: 2. Chemotherapy regimens for mild to moderate vomiting: Chlorinated phenothiazines can be used in combination with the first dose of methylprednisolone (1 hour before chemotherapy) to enhance the effect. 3. Chemotherapy regimens for severe vomiting: Metoclopramide or butyrophenone drugs can be used in combination with the first dose of methylprednisolone (1 hour before chemotherapy) to enhance the effect. 4. This product can be used in combination with other anti-tuberculosis chemotherapy to treat fulminant or diffuse pulmonary tuberculosis and tuberculous meningitis with subarachnoid obstruction or tendency to obstruction. 5. This product is often used in combination with alkylating agents, anti-metabolites and vinca alkaloids for tumor diseases such as leukemia and lymphoma. Harmful interactions 1. The combination of this product with ulcer-causing drugs (such as salicylates and non-steroidal anti-inflammatory drugs) will increase the risk of gastrointestinal complications. 2. The combination of this product with thiazide diuretics will increase the risk of impaired glucose tolerance. 3. This product will increase the demand for insulin and oral hypoglycemic drugs in diabetic patients. 4. Patients receiving this product should not be vaccinated with cowpox or receive other immunization measures, especially those taking large doses, because there is a risk of neurological complications and/or lack of antibody response. 5. This product should be used with caution in combination with acetylsalicylic acid in patients with hypoprothrombin. 6. There are reports that taking this product and cyclosporine at the same time can cause convulsions. Because the above two drugs inhibit each other's metabolism, convulsions and other side effects caused by taking either drug are more likely to occur when taking both drugs at the same time.

Undissolved medicine should be sealed and stored at 15-25℃. The solution obtained by dissolving with the attached diluent can be stored at room temperature (15-25℃) for 48 hours.

0.125g (based on methylprednisolone C22H30O5)

24 months.

Sinopharm Ronshyn Pharmaceutical Co., Ltd.

• Founded in:

  1999-05-06

• Address:

  No. 686, Yingbin Avenue, Wuzhi County, Jiaozuo City, Henan Province

• Tax NO.:

  914108237156088969

• Registered Funds:

  150 million yuan

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