Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
INJECTION, POWDER, FOR SOLUTION
**4.2 Posology and Method of Administration** Methylprednisolone sodium succinate may be administered by intravenous (IV) injection or infusion, or by intramuscular (IM) injection. The preferred method for initial emergency use is IV injection. Dosage may be reduced for infants and children but should be selected based on the severity of the condition and the response of the patient rather than on the age or weight of the patient. The pediatric dosage should not be less than 0.5 mg/kg every 24 hours. Dosage requirements are variable and must be individualized on the basis of the disease under treatment, its severity and the response of the patient over the entire duration of treatment. A risk/benefit decision must be made in each individual case on an ongoing basis. The lowest possible dose of corticosteroid should be used to control the condition under treatment for the minimum period. The proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage, which will maintain an adequate clinical response, is reached. If after long-term therapy the drug is to be stopped, it needs to be withdrawn gradually rather than abruptly (see section **4.4 Special Warnings and Precautions for Use** – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Following the initial emergency period, consideration should be given to employing a longer acting injectable preparation or an oral preparation. As adjunctive therapy in life-threatening conditions, administer 30 mg/kg IV over a period of at least 30 minutes. The dose may be repeated every 4 to 6 hours for up to 48 hours. Methylprednisolone IV pulses, consisting of administration of 250 – 1000 mg/day for a few days (usually ≤ 5 days) may be suitable during exacerbation episodes or conditions unresponsive to standard therapy, such as: rheumatic disorders, systemic lupus erythematosus, edematous states, such as glomerulonephritis or lupus nephritis. In treatment of acute exacerbations of multiple sclerosis, administer pulses of 500 or 1000 mg/day for 3 or 5 days over 30 minutes. As adjunctive therapy in other conditions, the initial dose will vary from 10 to 500 mg IV, depending on the clinical condition. Larger doses may be required for short-term management of severe, acute conditions. Initial doses up to 250 mg should be administered IV over a period of at least 5 minutes, while larger doses should be administered over at least 30 minutes. Subsequent doses may be administered IV or IM at intervals dictated by the patient's response and clinical condition. To avoid compatibility and stability problems, it is recommended that methylprednisolone sodium succinate be administered separately from other drugs whenever possible, as either IV push, through an IV medication chamber, as an IV "piggy-back" solution, or via an infusion pump (see section **6.6 Instructions for Use / Handling Preparation of Solutions** – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Some of the methylprednisolone sodium succinate formulations come with a diluent that contains benzyl alcohol (see section **4.4 Special Warnings and Precautions for Use, Use in Children** – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
INTRAVENOUS, INTRAMUSCULAR
Medical Information
**4.1 Therapeutic Indications** Methylprednisolone sodium succinate is indicated in the following conditions: **Endocrine Disorders** - primary or secondary adrenocortical insufficiency (in conjunction with mineralocorticoids, where applicable); - acute adrenocortical insufficiency (mineralocorticoid supplementation may be necessary); - shock secondary to adrenocortical insufficiency, or shock unresponsive to conventional therapy when adrenal cortical insufficiency may be present (when mineralocorticoid activity is undesirable); - pre-operatively, or in the event of serious trauma or illness, in patients with known adrenal insufficiency or when adrenocortical reserve is doubtful; - congenital adrenal hyperplasia; - non-suppurative thyroiditis; - hypercalcemia associated with cancer. **Rheumatic Disorders** (as adjunctive therapy for short-term administration in the management of an acute episode or exacerbation) - post-traumatic osteoarthritis; - synovitis of osteoarthritis; - rheumatoid arthritis, including juvenile rheumatoid arthritis; - acute and subacute bursitis; - epicondylitis; - acute non-specific tenosynovitis; - acute gouty arthritis; - psoriatic arthritis; - ankylosing spondylitis. **Collagen Diseases and Immune Complex Diseases** (during an exacerbation or as maintenance therapy in selected cases) - systemic lupus erythematosus (and lupus nephritis); - acute rheumatic carditis; - systemic dermatomyositis (polymyositis); - polyarteritis nodosa; - Goodpasture's syndrome. **Dermatologic Diseases** - pemphigus; - severe erythema multiforme (Stevens-Johnson syndrome); - exfoliative dermatitis; - severe psoriasis; - bullous dermatitis herpetiformis; - severe seborrheic dermatitis; - mycosis fungoides. **Allergic States** (to control severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment) - bronchial asthma; - contact dermatitis; - atopic dermatitis; - serum sickness; - drug hypersensitivity reactions; - urticarial transfusion reactions; - acute non-infectious laryngeal edema. **Ophthalmic Diseases** (severe acute and chronic allergic and inflammatory processes involving the eye) - herpes zoster ophthalmicus; - iritis, iridocyclitis; - chorioretinitis; - diffuse posterior uveitis and choroiditis; - optic neuritis; - sympathetic ophthalmia. **Gastrointestinal Diseases** (to manage critical periods of the disease) - ulcerative colitis; - regional enteritis. **Respiratory Diseases** - symptomatic sarcoidosis; - berylliosis; - fulminating or disseminated tuberculosis (when used concurrently with appropriate antituberculous chemotherapy); - Loeffler's syndrome not manageable by other means; - aspiration pneumonitis. **Hematologic Disorders** - acquired (autoimmune) hemolytic anemia; - idiopathic thrombocytopenic purpura in adults; - secondary thrombocytopenia in adults; - erythroblastopenia (RBC anemia); - congenital (erythroid) hypoplastic anemia. **Neoplastic Diseases** (palliative management) - leukemias and lymphomas in adults; - acute leukemia of childhood. **Edematous States** - To induce diuresis or remission of proteinuria in the nephrotic syndrome without uremia. **Nervous System** - cerebral edema from primary or metastatic tumors, or surgical or radiation therapy; - acute exacerbations of multiple sclerosis; - acute spinal cord injury. The treatment should begin within 8 hours of injury. **Other Indications** - tuberculous meningitis with subarachnoid block or impending block (when used concurrently with appropriate antituberculous chemotherapy); - trichinosis with neurologic or myocardial involvement; - organ transplantation; - prevention of nausea and vomiting associated with cancer chemotherapy.
**4.3 Contraindications** Methylprednisolone sodium succinate is contraindicated: - In patients who have systemic fungal infections. - In patients with known hypersensitivity to methylprednisolone or any component of the formulation. - For use by the intrathecal route of administration. - For use by the epidural route of administration. Administration of live or live, attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids.
H02AB04
methylprednisolone
Manufacturer Information
PFIZER PRIVATE LIMITED
PFIZER MANUFACTURING BELGIUM NV
Active Ingredients
METHYLPREDNISOLONE SODIUM SUCCINATE EQV METHYLPREDNISOLONE
500 mg/8 ml
Documents
Package Inserts
Solu-Medrol For Injection PI and PIL.pdf
Approved: May 10, 2023