Label: CORTROSYN injection, powder, lyophilized, for solution
- NDC Code(s): 0404-9839-99
- Packager: Henry Schein, Inc.
- This is a repackaged label.
- Source NDC Code(s): 0548-5900
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated January 19, 2024
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DescriptionFOR 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 ...
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Clinical PharmacologyCORTROSYN™ (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 ...
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Indication and UsageCORTROSYN™ (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 ...
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ContraindicationThe only contraindication to CORTROSYN™ (cosyntropin) for Injection is a history of a previous adverse reaction to it.
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PrecautionsGeneral - 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 ...
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Adverse ReactionsSince 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 ...
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Dosage and AdministrationCORTROSYN™ (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 ...
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How SuppliedBox 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 ...
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References1. 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 ...
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Sample Package Label
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