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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  • DESCRIPTION
    Prednisone 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 ...
  • 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 ...
  • INDICATIONS AND USAGE
    Prednisone tablets USP are indicated in the following conditions: Endocrine Disorders - Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice ...
  • CONTRAINDICATIONS
    Prednisone tablets are contraindicated in systemic fungal infections and known hypersensitivity to components.
  • WARNINGS
    In patients on corticosteroid therapy subjected to unusual stress, increased dosage of rapidly acting corticosteroids before, during and after the stressful situation is indicated ...
  • PRECAUTIONS
    General Precautions - Drug-induced secondary adrenocortical insufficiency may be minimized by gradual reduction of dosage. This type of relative insufficiency may persist for months after ...
  • ADVERSE REACTIONS
    Fluid and Electrolyte Disturbances - Sodium retention - Fluid retention - Congestive heart failure in susceptible patients - Potassium loss - Hypokalemic alkalosis - Hypertension ...
  • DOSAGE AND ADMINISTRATION
    The 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 ...
  • HOW SUPPLIED
    PredniSONE 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 ...
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
    NDC 64380-835-06 - PredniSONE Tablets, USP - 2.5 mg - 100 Tablets - Rx only - Strides Pharma Inc.
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
    NDC 64380-835-01 - PredniSONE Tablets, USP - 2.5 mg - 10x10 Unit-Dose Tablets - Rx only - Strides Pharma Inc.
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
    NDC 64380-783-06 - PredniSONE Tablets, USP - 5 mg - 100 Tablets - Rx only - Strides Pharma Inc.
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
    NDC 64380-783-01 - PredniSONE Tablets, USP - 5 mg - 10x10 Unit-Dose Tablets - Rx only - Strides Pharma Inc.
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
    NDC 64380-783-08 - PredniSONE Tablets, USP - 5 mg - 1000 Tablets - Rx only - Strides Pharma Inc.
  • INGREDIENTS AND APPEARANCE
    Product Information