Cortrosyn

Generic Name: cortrosyn

Adrenocorticotropic Hormone [EPC]Over-the-Counter (OTC)

Brand Names:

Cortrosyn

11 Description Cosyntropin is an adrenocorticotropic hormone (ACTH). Cosyntropin is synthetic beta 1 - 24 corticotropin, a synthetic subunit of ACTH. It is an open chain polypeptide containing, the first 24 of the 39 amino acids of natural ACTH in sequence from N terminal. The sequence of amino acids in the 1 - 24 compound is as follows: The empirical formula is C 136 H 210 N 40 O 31 S with a molecular weight of 2934 g/mol.

Overview

11 Description Cosyntropin is an adrenocorticotropic hormone (ACTH). Cosyntropin is synthetic beta 1 - 24 corticotropin, a synthetic subunit of ACTH. It is an open chain polypeptide containing, the first 24 of the 39 amino acids of natural ACTH in sequence from N terminal. The sequence of amino acids in the 1 - 24 compound is as follows: The empirical formula is C 136 H 210 N 40 O 31 S with a molecular weight of 2934 g/mol.

Uses

1 Indications and Usage CORTROSYN is indicated, in combination with other diagnostic tests, for use as a diagnostic agent in the screening of adrenocortical insufficiency in adults and pediatric patients. CORTROSYN is an adrenocorticotropin hormone indicated, in combination with other diagnostic tests, for use as a diagnostic agent in the screening of adrenocortical insufficiency in adults and pediatric patients. (1)

Dosage

2 Dosage and Administration 2.1 Important Information Before Conducting CORTROSYN TESTING In general, stop glucocorticoids and spironolactone on the day of CORTROSYN testing. However, long-acting glucocorticoids may need to be stopped for a longer period before CORTROSYN testing [see Warnings and Precautions (5.2), Drug Interactions (7)]. Stop estrogen-containing drugs four to six weeks before CORTROSYN testing [see Warnings and Precautions (5.2), Drug Interactions (7)]. 2.2 Recommended Dose for Adults The recommended dose of CORTROSYN in adults is 0.25 mg to be administered by intravenous or intramuscular injection.

Side Effects

6 Adverse Reactions Because adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following adverse reactions have been identified during post approval use of CORTROSYN: anaphylactic reaction bradycardia tachycardia hypertension peripheral edema rash Most common adverse reactions are: anaphylactic reaction, bradycardia, tachycardia, hypertension, peripheral edema, and rash (6) To report SUSPECTED ADVERSE REACTIONS, contact Amphastar Pharmaceuticals, Inc. at 1-800-423-4136 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Interactions

7 Drug Interactions 7.1 Drug Effects on Plasma Cortisol Levels Accuracy of the test results can be affected by concomitant medications. Plasma cortisol levels and subsequent diagnosis of adrenocortical insufficiency following CORTROSYN administration may be inaccurate if patients are on certain medications because of their effect on cortisol or cortisol binding globulin levels [see Dosage and Administration (2.1) and Warnings and Precautions (5.2)]. Glucocorticoids and spironolactone: May falsely elevate plasma cortisol levels. Stop these drugs on the day of CORTROSYN testing. Long-acting glucocorticoids may need to be stopped for a longer period before CORTROSYN testing. Estrogen: May elevate plasma total cortisol levels.

Warnings

5 Warnings and Precautions 5.1 Hypersensitivity to CORTROSYN Injection CORTROSYN injection hypersensitivity reactions including anaphylaxis have been reported. Monitor patients for hypersensitivity reactions and treat as needed. 5.2 Diagnostic Inaccuracies Cortisol levels and subsequent diagnosis of adrenocortical insufficiency following CORTROSYN administration may be inaccurate if patients are on certain medications because of their effect on cortisol or cortisol binding globulin levels. Glucocorticoids and spironolactone may result in falsely elevated cortisol levels. Stop these drugs on the day of CORTROSYN testing. Long-acting glucocorticoids may need to be stopped for a longer period before CORTROSYN testing [see Dosage and Administration (2.1) and Drug Interactions (7)]. 4 Contraindications CORTROSYN is contraindicated in patients with a history of hypersensitivity to cosyntropin or to any excipients of CORTROSYN. Reactions have included anaphylaxis [see Warnings and Precautions (5.1)]. CORTROSYN is contraindicated in patients with a history of hypersensitivity to cosyntropin or to any excipients of CORTROSYN. Reactions have included anaphylaxis. (4, 5.1)

Storage

16 How Supplied/Storage and Handling How Supplied CORTROSYN (cosyntropin) for injection 0.25 mg, in a single-dose vial for reconstitution. Box contains 10 single-dose vials NDC 0548-5900-00 Storage and Handling Store at 20º to 25ºC (68º to 77ºF); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Frequently Asked Questions

What is Cortrosyn used for?

1 Indications and Usage CORTROSYN is indicated, in combination with other diagnostic tests, for use as a diagnostic agent in the screening of adrenocortical insufficiency in adults and pediatric patients. CORTROSYN is an adrenocorticotropin hormone indicated, in combination with other diagnostic tests, for use as a diagnostic agent in the screening of adrenocortical insufficiency in adults and pediatric patients. (1)

What are the side effects of Cortrosyn?

6 Adverse Reactions Because adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following adverse reactions have been identified during post approval use of CORTROSYN: anaphylactic reaction bradycardia tachycardia hypertension peripheral edema rash Most common adverse reactions are: anaphylactic reaction, bradycardia, tachycardia, hypertension, peripheral edema, and rash (6) To report SUSPECTED ADVERSE REACTIONS, contact Amphastar Pharmaceuticals, Inc. at 1-800-423-4136 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

What are the important warnings for Cortrosyn?

5 Warnings and Precautions 5.1 Hypersensitivity to CORTROSYN Injection CORTROSYN injection hypersensitivity reactions including anaphylaxis have been reported. Monitor patients for hypersensitivity reactions and treat as needed. 5.2 Diagnostic Inaccuracies Cortisol levels and subsequent diagnosis of adrenocortical insufficiency following CORTROSYN administration may be inaccurate if patients are on certain medications because of their effect on cortisol or cortisol binding globulin levels. Glucocorticoids and spironolactone may result in falsely elevated cortisol levels. Stop these drugs on the day of CORTROSYN testing. Long-acting glucocorticoids may need to be stopped for a longer period before CORTROSYN testing [see Dosage and Administration (2.1) and Drug Interactions (7)]. 4 Contraindications CORTROSYN is contraindicated in patients with a history of hypersensitivity to cosyntropin or to any excipients of CORTROSYN. Reactions have included anaphylaxis [see Warnings and Precautions (5.1)]. CORTROSYN is contraindicated in patients with a history of hypersensitivity to cosyntropin or to any excipients of CORTROSYN. Reactions have included anaphylaxis. (4, 5.1)

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Medical Disclaimer

This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.