Label: CORTROSYN injection, powder, lyophilized, for solution

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

Drug Label Information

Updated January 19, 2024

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  • Description
    FOR DIAGNOSTIC USE ONLY - CORTROSYN™ (cosyntropin) for Injection is a sterile lyophilized powder in vials containing 0.25 mg of CORTROSYN™ and 10 mg of mannitol to be reconstituted with 1 mL ...
  • Clinical Pharmacology
    CORTROSYN™ (cosyntropin) for Injection exhibits the full corticosteroidogenic activity of natural ACTH. Various studies have shown that the biologic activity of ACTH resides in the N-terminal ...
  • Indication and Usage
    CORTROSYN™ (cosyntropin) for Injection is intended for use as a diagnostic agent in the screening of patients presumed to have adrenocortical insufficiency. Because of its rapid effect on the ...
  • Contraindication
    The only contraindication to CORTROSYN™ (cosyntropin) for Injection is a history of a previous adverse reaction to it.
  • Precautions
    General - CORTROSYN™ (cosyntropin) for Injection exhibits slight immunologic activity, does not contain animal protein and is therefore less risky to use than natural ACTH. Patients known to be ...
  • Adverse Reactions
    Since CORTROSYN™ (cosyntropin) for Injection is intended for diagnostic and not therapeutic use, adverse reactions other than a rare hypersensitivity reaction are not anticipated. A rare ...
  • Dosage and Administration
    CORTROSYN™ (cosyntropin) for Injection may be administered intramuscularly or as a direct intravenous injection when used as a rapid screening test of adrenal function. It may also be given as an ...
  • How Supplied
    Box of 10 vials of CORTROSYN (cosyntropin) for Injection 0.25 mg - NDC # 0548-5900-00 - Storage - Store at 1530°C (5986°F). CORTROSYN is intended as a single dose injection and contains no ...
  • References
    1. Wood, J.B. et al. LANCET 1.243, 1965. 2. Greig, W.R. et al. J. ENDOCR 34.411, 1966. 3. McGill, P.E. et al. ANN RHEUM DIS 26.123, 1967. Amphastar Pharmaceuticals, Inc. Rancho Cucamonga, CA ...
  • Sample Package Label
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  • INGREDIENTS AND APPEARANCE
    Product Information