Label: PREDNISONE tablet

  • NDC Code(s): 0591-5052-01, 0591-5052-10, 0591-5052-21, 0591-5052-43, view more
  • Packager: Actavis Pharma, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated June 18, 2024

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  • DESCRIPTION
    Prednisone tablets, USP contain prednisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the ...
  • 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
    General - Rare instances of anaphylactoid reactions have occurred in patients receiving corticosteroid therapy (see ADVERSE REACTIONS: Allergic Reactions). Increased dosage of rapidly acting ...
  • PRECAUTIONS
    General Precautions - The lowest possible dose of corticosteroids should be used to control the condition under treatment. When reduction in dosage is possible, the reduction should be gradual ...
  • ADVERSE REACTIONS
    (listed alphabetically, under each subsection) The following adverse reactions have been reported with prednisone or other corticosteroids: Allergic Reactions - anaphylactoid or ...
  • DOSAGE AND ADMINISTRATION
    Gastric irritation may be reduced if taken before, during, or immediately after meals or with food or milk. The maximal activity of the adrenal cortex is between 2 am and 8 am, and it is minimal ...
  • HOW SUPPLIED
    Prednisone tablets, USP 5 mg are flat faced, beveled, scored, round, white tablets imprinted “DAN DAN” and “5052” supplied in bottles of 100 (NDC 0591-5052-01) and 1000 (NDC 0591-5052-10) and ...
  • REFERENCES
    1. Fekety R. Infections associated with corticosteroids  and immunosuppressive  therapy. In: Gorbach SL, Bartlett JG, Blacklow NR, eds. Infectious Diseases. Philadelphia: WBSaunders Company ...
  • PRINCIPAL DISPLAY PANEL
    NDC 0591-5052-10 - predniSONE Tablets, USP - 5 mg - Rx only - 1,000 Tablets
  • PRINCIPAL DISPLAY PANEL
    NDC 0591-5052-21          Rx only - predniSONE Tablets, USP - 5 mg - Unit of Use - 21 Tablets
  • PRINCIPAL DISPLAY PANEL
    NDC 0591-5442-10 - predniSONE Tablets, USP - 10 mg - Rx only - 1,000 Tablets
  • PRINCIPAL DISPLAY PANEL
    NDC 0591-5442-21        Rx only - predniSONE Tablets, USP - 10 mg - Unit of Use - 21 Tablets
  • PRINCIPAL DISPLAY PANEL
    NDC 0591-5443-10 - predniSONE Tablets, USP - 20 mg - Rx only - 1,000 Tablets
  • INGREDIENTS AND APPEARANCE
    Product Information