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Methylprednisolone Sodium Succinate for Injection

Name:

English Name:

Methylprednisolone Sodium Succinate for Injection

Strength:

(1) 40mg (2)500mg (Calculated on C22H30O5)

Package:

Glass vial with rubber stoppers and covered by aluminum caps. 40mg: 1 bottle/box, 10 bottles/box, 20 bottles/box; 500mg: 1 bottle/box, 10 bottles/box.

Approval Number:

H20143136 (40mg); H20153195(500mg)

Detail

Indications: 
Reference Listed Drug during bioequivalence study of this medication is SOLU-MEDROL® by Pharmacia And Upjohn Co.

Unless used as an alternative treatment for certain endocrine diseases, glucocorticoids are only a symptomatic treatment.

This product is indicated for: 

Anti-inflammatory therapy

-- Rheumatic Disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in post-traumatic osteoarthritis, synovitis caused by osteoarthritis, acute or subacute bursitis, epicondylitis, acute non-specific tenosynovitis, acute gouty arthritis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). 

-- Collagen disease (immune complex diseases):

Critical or maintenance treatment in systemic lupus erythematosus (lupus nephritis), acute rheumatic myocarditis, dermatomyositis (polymyositis), polyarteritis nodosa, Good Pasture’s Syndrome.

-- Allergic States: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in bronchial asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, serum sickness, urticaria-like transfusion reactions, acute throat oedema of non-infectious origin (epinephrine is as priority drugs), seasonal or perennial allergic rhinitis.

-- Dermatologic Diseases: Bullous dermatitis herpetiformis, exfoliative dermatitis, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome), severe seborrheic dermatitis, severe psoriasis and urticaria.

-- Gastrointestinal Diseases: To tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis (systemic therapy).

-- Respiratory Diseases: Pulmonary sarcoidosis, berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, Loeffler's syndrome that is not controlled by other treatments, aspiration pneumonia.

-- Ophthalmic Diseases: Severe acute or chronic ocular allergy and inflammation, such as: Herpes zoster ophthalmicus, iritis, iridocyclitis, chorioretinitis, diffuse posterior chamber chromatophotis and choroiditis, sympathetic ophthalmia, optic neuritis.

-- Edematous state: Diuresis and relief of proteinuria in patients with spontaneous or lupus nephrotic syndrome without uremia

Immunosuppressive therapy

-- Organ transplantation:

Treatment of hematologic disorders and tumors.

-- Hematologic Disorders: Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia, idiopathic thrombocytopenic purpura in adults (intravenous administration only; intramuscular administration is contraindicated), erythropoiesis (megaloblastic macrocytic anemia), secondary thrombocytopenia in adults.

-- Neoplastic Diseases: For palliative management of: leukemias and lymphomas in adults and acute childhood leukemia. 

Treatment of shock

Shock which is secondary reaction to adrenocortical insufficiency, or shock with the possibility of adrenocortical insufficiency which making patients unresponsive to conventional treatment (hydrocortisone is the drug of choice; methylprednisolone is used if glucocorticoid activity is not desired).

Hemorrhagic, traumatic and surgical shock in which cases no response to conventional treatment. Although there are no complete (double-blind controlled) clinical studies, data from animal studies suggest that methylprednisolone may be effective against shock that does not respond to conventional therapies such as rehydration. Also see "septic shock" in【Precautions】

Miscellaneous

-- Nervous System: Acute exacerbations of multiple sclerosis, cerebral edema associated with primary or metastatic brain tumor or craniotomy, acute spinal cord injury (Treatment should begin within 8 hours of the injury). 

-- Trichinosis with neurologic or myocardial involvement.

-- Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy.

-- Trichinosis with neurologic or myocardial involvement.

-- To prevent nausea and vomiting caused by tumor chemotherapy.

-- Endocrine Disorders: Primary or secondary adrenocortical insufficiency, acute adrenal insufficiency (For above diseases, hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; for patients with known or probable adrenal insufficiency, administration before surgery and in the event of severe trauma or disease is unclear), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis.

Other information such as dosage, contraindications, and adverse reactions is detailed in the instructions.

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