Label: PREDNISONE tablet

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated February 17, 2025

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  • DESCRIPTION
    Prednisone tablets, USP are available for oral administration containing either 2.5 mg, 5 mg, 10 mg, 20 mg or 50 mg of prednisone USP. Each tablet contains the following inactive ingredients ...
  • 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 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 subject to any 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 ...
  • DOSAGE AND ADMINISTRATION
    The initial dosage of prednisone may vary from 5 mg to 60 mg 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, 10 mgare white to off-white, round, biconvex tablets, scored on one side and “PI”, “10” on other side. They are supplied as follows: Bottles of 21 Tablets NDC ...
  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL
    Prednisone 5mg #21
  • INGREDIENTS AND APPEARANCE
    Product Information