Country: Amerika Syarikat
Bahasa: Inggeris
Sumber: NLM (National Library of Medicine)
Methylprednisolone (UNII: X4W7ZR7023) (Methylprednisolone - UNII:X4W7ZR7023)
JUBILANT CADISTA PHARMACEUTICALS INC.
Methylprednisolone
Methylprednisolone 4 mg
ORAL
PRESCRIPTION DRUG
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
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: 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:NDC 59746-002-04 Bottles of 100: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: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:NDC 59746-015-04 Store at 20 to 25° C (68 to 77° F) [see USP Controlled Room Temperature]. Rx only Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA Revised: 08/2018
Abbreviated New Drug Application
METHYLPREDNISOLONE - METHYLPREDNISOLONE TABLET JUBILANT CADISTA PHARMACEUTICALS INC. ---------- METHYLPREDNISOLONE TABLETS, USP RX ONLY DESCRIPTION Methylprednisolone Tablets, USP contain methylprednisolone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Methylprednisolone occurs as a white to practically white, odorless, crystalline powder. It is sparingly soluble in alcohol, in dioxane, and in methanol, slightly soluble in acetone, and in chloroform, and very slightly soluble in ether. It is practically insoluble in water. The chemical name for methylprednisolone is pregna-1,4-diene-3,20-dione, 11, 17, 21-trihydroxy-6- methyl-,(6α,11β)- and the molecular weight is 374.48. The structural formula is represented below: C H O Methylprednisolone Tablets, USP, for oral administration, are available as scored tablets in the following strengths: 4 mg, 8 mg, 16 mg, and 32 mg. In addition each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose anhydrous (4 mg and 8 mg), lactose monohydrate (16 mg and 32 mg), magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate, and sodium starch glycolate. CLINICAL PHARMACOLOGY Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs are primarily used for their potent anti-inflammatory effects in disorders of many organ systems. Glucocorticoids cause profound and varied metabolic effects. In addition, they modify the body's immune responses to diverse stimuli. 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 Baca dokumen lengkap