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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  • Rx only
  • DESCRIPTION
    Prednisone is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Prednisone, USP is ...
  • ACTIONS
    Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic ...
  • INDICATIONS
    Prednisone tablets are indicated in the following conditions: 1. Endocrine Disorders - Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice ...
  • CONTRAINDICATIONS
    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 ...
  • 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 ...
  • 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 ...
  • 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 ...
  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 5 mg Tablet
    NDC 0054-9828-25     100 Tablets - PredniSONE - Tablets, USP - 5 mg
  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 10 mg Tablet
    NDC 0054-9817-25     100 Tablets - PredniSONE - Tablets, USP - 10 mg
  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 20 mg Tablet
    NDC 0054-9818-25     100 Tablets - PredniSONE - Tablets, USP - 20 mg
  • INGREDIENTS AND APPEARANCE
    Product Information