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.
Zydus Pharmaceuticals (USA) Inc.
HOW SUPPLIED Methylprednisolone tablets USP, are available in the following strengths and package sizes: Methylprednisolone tablets USP, 4 mg are white to off-white, oval-shaped, flat-faced, beveled-edge tablets, debossed with '916' on one side and quadrisect on other side and are supplied as follows: NDC 68382-916-01 in bottle of 100 tablets NDC 68382-916-05 in bottle of 500 tablets NDC 68382-916-34 in unit-of-use cartons of 21 tablets Methylprednisolone tablets USP, 8 mg are white to off-white, oval-shaped, biconvex tablets, debossed with '917' on one side and bisect on other side and are supplied as follows: NDC 68382-917-11 in bottle of 25 tablets NDC 68382-917-01 in bottle of 100 tablets NDC 68382-917-05 in bottle of 500 tablets NDC 68382-917-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets Methylprednisolone tablets USP, 16 mg are white to off-white, oval-shaped, biconvex tablets, debossed with '918' on one side and quadrisect on other side and are supplied as follows: NDC 68382-918-18 in bottle of 50 tablets NDC 68382-918-01 in bottle of 100 tablets NDC 68382-918-05 in bottle of 500 tablets NDC 68382-918-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets Methylprednisolone tablets USP, 32 mg are white to off-white, oval-shaped, biconvex tablets, debossed with '919' on one side and bisect on other side and are supplied as follows: NDC 68382-919-11 in bottle of 25 tablets NDC 68382-919-01 in bottle of 100 tablets NDC 68382-919-05 in bottle of 500 tablets NDC 68382-919-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets Store at 20Â° to 25Â° C (68Â° to 77Â° F) [See USP Controlled Room Temperature].
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