CORTROSYN Powder for solution for injection (2020)
Βιβλιογραφική αναφορά
Συγγραφείς
General Injectables & Vaccines, Inc
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1. Description
<b>FOR DIAGNOSTIC USE ONLY</b> 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 of 0.9% ...
2. 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 portion of ...
3. Indications 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 adrenal cortex ...
4. Contraindications
The only contraindication to CORTROSYN (cosyntropin) for Injection is a history of a previous adverse reaction to it.
6.1. 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 sensitized to natural ...
6.4. Drug Interactions
Corticotropin may accentuate the electrolyte loss associated with diuretic therapy.
6.6. Carcinogenesis, Mutagenesis, Impairment of Fertility
Long term studies in animals have not been performed to evaluate carcinogenic or mutagenic potential or impairment of fertility. A study in rats noted inhibition of reproductive function like natural ACTH. ...
6.7. Pregnancy
Pregnancy Category C. Animal reproduction studies have not been conducted with CORTROSYN (cosyntropin) for Injection. It is also not known whether CORTROSYN can cause fetal harm when administered to a ...
6.9. Nursing Mothers
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when CORTROSYN (cosyntropin) for Injection is administered to a nursing ...
6.10. Pediatric Use
(See DOSAGE AND ADMINISTRATION section.)
7. 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 hypersensitivity ...
10. 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 intravenous ...
11. How Supplied
Box of 10 vials of CORTROSYN (cosyntropin) for Injection 0.25 mg NDC # 0548-5900-00 Amphastar Pharmaceuticals, Inc., Rancho Cucamonga, CA 91730 U.S.A., REV. 9-10
12. Storage and Handling
Store at 15–30°C (59–86°F). CORTROSYN is intended as a single dose injection and contains no antimicrobial preservative. Any unused portion should be discarded.
14. 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.