Cortrosyn
FDA Drug Information • Also known as: Cortrosyn
- Brand Names
- Cortrosyn
- Drug Class
- Adrenocorticotropic Hormone [EPC]
- Route
- INTRAMUSCULAR, INTRAVENOUS, PARENTERAL
- Dosage Form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Product Type
- HUMAN PRESCRIPTION DRUG
Description
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. CORTROSYN (cosyntropin) for Injection is a sterile lyophilized powder in single-dose vials containing 0.25 mg of cosyntropin and 10 mg of mannitol. Sodium Hydroxide and Glacial acetic acid may be used to adjust pH. Image2.jpg
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)
Dosage and Administration
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. 2.3 Recommended Dose for Pediatric Patients The recommended dose of CORTROSYN in pediatric patients, aged birth to 17 years, to be administered by intravenous or intramuscular injection is presented in Table 1. 2.4 Reconstitution Instructions Aseptically reconstitute the lyophilized powder in the vial using 1 mL of 0.9% Sodium Chloride Injection, USP and gently swirl. After reconstitution, the final concentration of CORTROSYN reconstituted solution is 0.25 mg/mL. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The reconstituted CORTROSYN solution should be clear and colorless, and free of particulates. If CORTROSYN solution is cloudy or contains particulates, do not administer. If the CORTROSYN reconstituted solution is not used immediately, discard the unused CORTROSYN reconstituted solution. 2.5 Administration Information CORTROSYN may be administered by intramuscular or intravenous injection. Obtain blood sample for baseline serum cortisol. Obtain blood samples again for assessment of cortisol levels exactly 30 minutes and 60 minutes after administration of CORTROSYN. 2.6 Interpretation of Plasma Cortisol Levels after CORTROSYN Injection Stimulated plasma cortisol levels of less than 18 mcg/dL at 30- or 60-minutes post CORTROSYN injection are suggestive of adrenocortical insufficiency. Cutoff values for exclusion of adrenocortical insufficiency may vary according to the assay used. Test results can be affected by concomitant medications and certain medical conditions [see Warnings and Precautions (5.2)]. In general, stop glucocorticoids and spironolactone on the day of CORTROSYN testing. For long-acting glucocorticoids, stop for a longer period before CORTROSYN testing. (2.1) For adults, the recommended dose is 0.25 mg to be administered by intravenous or intramuscular injection. (2.2) For pediatric patients, the recommended dose to be administered by intravenous or intramuscular injection is (2.3): ◦ 0.125 mg for patients birth to less than 2 years of age ◦ 0.25 mg for patients 2 to 17 years of age Obtain blood samples for serum cortisol level at baseline and exactly 30 and 60 minutes after CORTROSYN administration. (2.5) See Full Prescribing Information for reconstitution and interpretation of cortisol levels...
Side Effects (Adverse Reactions)
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.
Drug 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. Stop estrogen containing drugs 4 to 6 weeks before CORTROSYN testing to allow cortisol binding globulin levels to return to levels within the reference range. Alternatively, concomitant measurement of cortisol binding globulin at the time of testing can be done; if cortisol binding globulin levels are elevated, plasma total cortisol levels are considered inaccurate. Drug effects on plasma cortisol levels: ◦ Accuracy of the test results can be affected by concomitant medications.◦ Glucocorticoids and spironolactone: May falsely elevate plasma cortisol levels. Stop these drugs on day of CORTROSYN testing. Long-acting glucocorticoids may need to be stopped for a longer period before CORTROSYN testing. (7)◦ Estrogen: May elevate plasma total cortisol levels. Stop estrogen containing drugs 4 to 6 weeks before CORTROSYN testing. (7) See 17 for PATIENT COUNSELING INFORMATION Revised 12/2023
Contraindications
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)
How Supplied
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]. CORTROSYN injection is intended as a single-dose injection and contains no antimicrobial preservative. Any unused portion should be discarded. Product repackaged by: Henry Schein, Inc., Bastian, VA 24314 From Original Manufacturer/Distributor's NDC and Unit of Sale To Henry Schein Repackaged Product NDC and Unit of Sale Total Strength/Total Volume (Concentration) per unit NDC 0548-5900-00 Box of 10 vials NDC 0404-9839-99 1 Vial in a bag (Vial bears NDC 0548-5900-00) 0.25 mg
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.