Label: PREDNISONE tablet
- NDC Code(s): 0054-9817-25, 0054-9817-29, 0054-9818-25, 0054-9818-29, view more
- Packager: Hikma Pharmaceuticals USA Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated February 10, 2023
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- Official Label (Printer Friendly)
- Rx only
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DESCRIPTIONPrednisone is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Prednisone, USP is ...
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ACTIONS Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic ...
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INDICATIONS Prednisone tablets are indicated in the following conditions: 1. Endocrine Disorders - Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice ...
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CONTRAINDICATIONSSystemic fungal infections and known hypersensitivity to components.
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WARNINGSIn patients on corticosteroid therapy subjected to unusual stress, increased dosage of rapidly acting corticosteroids before, during, and after the stressful situation is ...
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PRECAUTIONSGeneral Precautions - Drug-induced secondary adrenocortical insufficiency may be minimized by gradual reduction of dosage. This type of relative insufficiency may persist for months after ...
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ADVERSE REACTIONSFluid and Electrolyte Disturbances Sodium retention - Fluid retention - Congestive heart failure in susceptible patients - Potassium loss - Hypokalemic ...
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DOSAGE AND ADMINISTRATION The initial dosage of prednisone may vary from 5 mg to 60 mg of prednisone per day depending on the specific disease entity being treated. In situations of less severity lower doses will generally ...
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HOW SUPPLIED PredniSONE Tablets, USP - 5 mg – White to off-white, round, biconvex tablet; scored on one side and product identification “54 [above] 612” debossed on the other side. NDC 0054-9828-25: Bottle ...
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PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 5 mg Tablet NDC 0054-9828-25 100 Tablets - PredniSONE - Tablets, USP - 5 mg
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PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 10 mg Tablet NDC 0054-9817-25 100 Tablets - PredniSONE - Tablets, USP - 10 mg
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PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 20 mg Tablet NDC 0054-9818-25 100 Tablets - PredniSONE - Tablets, USP - 20 mg
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INGREDIENTS AND APPEARANCEProduct Information