Label: HYDROCORTISONE suspension

  • NDC Code(s): 23155-926-51, 23155-926-81
  • Packager: Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated February 5, 2025

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  • DESCRIPTION
    Hydrocortisone is a white to practically white, odorless, crystalline powder, very slightly soluble in water. It has the chemical name Pregn-4-ene-3,20-dione,11,17,21-tri-hydroxy,(11β)-and the ...
  • CLINICAL PHARMACOLOGY
    Hydrocortisone is a naturally occurring glucocorticoid (adrenal corticosteroid), similar to its acetate and sodium hemisuccinate derivatives, is partially absorbed following rectal administration ...
  • INDICATIONS AND USAGE
    Hydrocortisone Rectal Suspension, USP is indicated as adjunctive therapy in the treatment of ulcerative colitis, especially distal forms, including ulcerative proctitis, ulcerative ...
  • CONTRAINDICATIONS
    Systemic fungal infections; and ileocolostomy during the immediate or early post-operative period.
  • WARNINGS
    In severe ulcerative colitis, it is hazardous to delay needed surgery while awaiting response to medical treatment. Damage to the rectal wall can result from careless or improper insertion of an ...
  • PRECAUTIONS
    General: Hydrocortisone Rectal Suspension, USP should be used with caution where there is a probability of impending perforation, abscess or other pyogenic infection; fresh intestinal ...
  • ADVERSE REACTIONS
    Local pain or burning, and rectal bleeding attributed to Hydrocortisone Rectal Suspension, USP have been reported rarely. Apparent exacerbations or sensitivity reactions also occur rarely. The ...
  • DOSAGE AND ADMINISTRATION
    The use of Hydrocortisone Rectal Suspension, USP Hydrocortisone retention enema is predicated upon the concomitant use of modern supportive measures such as rational dietary control, sedatives ...
  • HOW SUPPLIED
    Hydrocortisone Rectal Suspension, USP (Retention) 100 mg/60 mL, is supplied as disposable single-dose bottles with lubricated rectal applicator tips, in boxes of seven x 60 mL (NDC 23155-926-81) ...
  • PATIENT INSTRUCTIONS
    How to use the retention enema: Best results are achieved if the bowel is emptied immediately before the - enema is given. 1 Preparing the Medication for Administration - a Shake the bottle ...
  • PACKAGE LABEL PRINCIPAL DISPLAY PANEL
    Hydrocortisone Rectal Suspension, USP (Retention) 100 mg/60 mL - NDC 23155-926-51-label
  • PACKAGE LABEL PRINCIPAL DISPLAY PANEL
    Hydrocortisone Rectal Suspension, USP (Retention) 100 mg/60 mL - NDC 23155-926-51-carton
  • PACKAGE LABEL PRINCIPAL DISPLAY PANEL
    Hydrocortisone Rectal Suspension, USP (Retention) 100 mg/60 mL - NDC 23155-926-81-carton
  • INGREDIENTS AND APPEARANCE
    Product Information