Label: PREDNISONE tablet
- NDC Code(s): 64380-783-01, 64380-783-06, 64380-783-08, 64380-835-01, view more
- Packager: Strides Pharma Science Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated January 9, 2025
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- Official Label (Printer Friendly)
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DESCRIPTIONPrednisone Tablets USP are available for oral administration containing either 2.5 mg and 5 mg of prednisone USP. Each tablet contains the following inactive ingredients: lactose monohydrate ...
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CLINICAL PHARMACOLOGYNaturally 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 AND USAGEPrednisone tablets USP are indicated in the following conditions: Endocrine Disorders - Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice ...
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CONTRAINDICATIONSPrednisone tablets are contraindicated in systemic 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 indicated ...
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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 alkalosis - Hypertension ...
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DOSAGE AND ADMINISTRATIONThe initial dosage of prednisone may vary from 5 mg to 60 mg per day, depending on the specific disease entity being treated. In situations of less severity lower doses will generally suffice ...
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HOW SUPPLIEDPredniSONE Tablets USP - 2.5 mg - white to off white color, circular, biconvex tablets debossed with "P2.5" on one side and break line on other side. 5 mg - white to off white color, circular ...
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PACKAGE LABEL.PRINCIPAL DISPLAY PANELNDC 64380-835-06 - PredniSONE Tablets, USP - 2.5 mg - 100 Tablets - Rx only - Strides Pharma Inc.
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PACKAGE LABEL.PRINCIPAL DISPLAY PANELNDC 64380-835-01 - PredniSONE Tablets, USP - 2.5 mg - 10x10 Unit-Dose Tablets - Rx only - Strides Pharma Inc.
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PACKAGE LABEL.PRINCIPAL DISPLAY PANELNDC 64380-783-06 - PredniSONE Tablets, USP - 5 mg - 100 Tablets - Rx only - Strides Pharma Inc.
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PACKAGE LABEL.PRINCIPAL DISPLAY PANELNDC 64380-783-01 - PredniSONE Tablets, USP - 5 mg - 10x10 Unit-Dose Tablets - Rx only - Strides Pharma Inc.
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PACKAGE LABEL.PRINCIPAL DISPLAY PANELNDC 64380-783-08 - PredniSONE Tablets, USP - 5 mg - 1000 Tablets - Rx only - Strides Pharma Inc.
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INGREDIENTS AND APPEARANCEProduct Information