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methylprednisolone methylprednisolone tablet

INDICATIONS AND USAGE Methylprednisolone Tablets are indicated in the following conditions: 1.Endocrine Disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance). Congenital adrenal hyperplasia Nonsuppurative thyroiditis Hypercalcemia associated with cancer 2.Rheumatic Disorders As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy) Ankylosing spondylitis Acute and subacute bursitis Synovitis of osteoarthritis Acute nonspecific tenosynovitis Post-traumatic osteoarthritis Psoriatic arthritis Epicondylitis Acute gouty arthritis 3.Collagen Diseases During an exacerbation or as maintenance therapy in selected cases of: Systemic lupus erythematosus Systemic dermatomyositis (polymyositis) Acute rheumatic carditis 4.Dermatologic Diseases Bullous dermatitis herpetiformis Severe erythema multiforme (Stevens-Johnson syndrome) Severe seborrheic dermatitis Exfoliative dermatitis Mycosis fungoides Pemphigus Severe psoriasis 5.Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: Seasonal or perennial allergic rhinitis Drug hypersensitivity reactions Serum sickness Contact dermatitis Bronchial asthma Atopic dermatitis 6.Ophthalmic Diseases Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: Allergic corneal marginal ulcers Herpes zoster ophthalmicus Anterior segment inflammation Diffuse posterior uveitis and choroiditis Sympathetic ophthalmia Keratitis Optic neuritis Allergic conjunctivitis Chorioretinitis Iritis and iridocyclitis 7.Respiratory Diseases Symptomatic sarcoidosis Berylliosis Loeffler’s syndrome not manageable by other means Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy Aspiration pneumonitis 8.Hematologic Disorders Idiopathic thrombocytopenic purpura in adults Secondary thrombocytopenia in adults Acquired (autoimmune) hemolytic anemia Erythroblastopenia (RBC anemia) Congenital (erythroid) hypoplastic anemia 9.Neoplastic Diseases For palliative management of: Leukemias and lymphomas in adults Acute leukemia of childhood 10.Edematous States To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. 11.Gastrointestinal Diseases To tide the patient over a critical period of the disease in: Ulcerative colitis Regional enteritis 12.Nervous System Acute exacerbations of multiple sclerosis 13.Miscellaneous Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Trichinosis with neurologic or myocardial involvement.

JUBILANT CADISTA PHARMACEUTICALS, INC.


3 months ago OVAL WHITE TL001 methylprednisolone methylprednisolone tablet

OVAL WHITE TL001

3 months ago OVAL WHITE TL001 methylprednisolone methylprednisolone tablet

TL001 OVAL WHITE

HOW SUPPLIED

METHYLPREDNISOLONE Tablets, USP are available in the following strengths and package sizes: 4mg (white, oval shaped tablets, debossed with "TL 001" on one side and quadrisected on the other side.) Bottles of 100 tablets with Child Resistant Closure, NDC 59746-001-06 Unit of use pack (21 tablets): NDC 59746-001-03 8mg (white, oval shaped tablets, debossed with "TL 002", scored on one side and plain on the other side.) Bottles of 25 tablets with Child Resistant Closure, NDC 59746-002-04 Bottles of 100 tablets with Child Resistant Closure, NDC 59746-002-06 16mg (white, oval shaped tablets, debossed with "TL 003" on one side and quadrisected on the other side.) Bottles of 50 tablets with Child Resistant Closure, NDC 59746-003-14 32 mg (white, oval shaped tablets, debossed with "TL 015" on one side and bisected on the other side.) Bottles of 25 tablets with Child Resistant Closure, NDC 59746-015-04 Store at 20 to 25° C (68 to 77° F) [see USP Controlled Room Temperature]. Manufactured by: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA Revised: 01/2024


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