Country: United States
Language: English
Source: NLM (National Library of Medicine)
METHYLPREDNISOLONE (UNII: X4W7ZR7023) (METHYLPREDNISOLONE - UNII:X4W7ZR7023)
Physicians Total Care, Inc.
METHYLPREDNISOLONE
METHYLPREDNISOLONE 4 mg
ORAL
PRESCRIPTION DRUG
Methylprednisolone Tablets are indicated in the following conditions: - 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 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 - Rheumatic Disorders As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Rheumatoid arthritis, including juvenile rheum
Methylprednisolone Tablets USP are supplied as follows: 4 mg tablets: White to off-white, oval tablets debossed WATSON and 790 on one side and quadrisected on the other side, available in Unit of use blister packages of 21 NDC 54868-6624-1 Store at controlled room temperature 15° to 30°C (59° to 86°F). [See USP.] Dispense in a tight, light-resistant container as defined in USP/NF. Manufactured for: Watson Laboratories, Inc. Corona, CA 92880 USA Manufactured by: Patheon Pharmaceuticals Inc. Cincinnati, OH 45215 USA 70010609 Rev 12/03
Abbreviated New Drug Application
METHYLPREDNISOLONE - METHYLPREDNISOLONE TABLET PHYSICIANS TOTAL CARE, INC. ---------- 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 11β,17,21-Trihydroxy-6α-methylpregna-1,4-diene-3,20- dione and the molecular weight is 374.48. The molecular formula is C H O . The structural formula is represented below: Each Methylprednisolone tablet, for oral administration, contains 4 mg of methylprednisolone. In addition, each tablet contains the following inactive ingredients: anhydrous lactose, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polacrilin potassium, sodium starch glycolate, and stearic acid. 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 applicable; in infancy 22 30 5 mineralocorticoid supplementation is of particular importance). Congenital adrenal hyperplasia Nonsuppur Read the complete document