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HSA Product

SOLU-MEDROL FOR INJECTION 500 mg/8 ml

Product approved by Health Sciences Authority (SG)

Basic Information

SOLU-MEDROL FOR INJECTION 500 mg/8 ml

INJECTION, POWDER, FOR SOLUTION

Regulatory Information

SIN04683P

June 13, 1990

Prescription Only

Therapeutic

INTRAVENOUS, INTRAMUSCULAR

August 10, 2023

May 30, 2025

XH02AB04

Company Information

PFIZER PRIVATE LIMITED

PFIZER PRIVATE LIMITED

Active Ingredients

Detailed Information

Contraindications

**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.

Indication 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.

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