Cortrosyn

1 Important Information Before Conducting CORTROSYN TESTING In general, stop glucocorticoids and spironolactone on the day of CORTROSYN testing. 2), Drug Interactions (7)]. 2), Drug Interactions (7)]. 25 mg to be administered by intravenous or intramuscular injection.

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. 9% Sodium Chloride Injection, USP and gently swirl.

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. 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. 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. 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.

25 mg to be administered by intravenous or intramuscular injection. 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. 5) See Full Prescribing Information for reconstitution and interpretation of cortisol levels information.

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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.

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1 Hypersensitivity to CORTROSYN Injection CORTROSYN injection hypersensitivity reactions including anaphylaxis have been reported. Monitor patients for hypersensitivity reactions and treat as needed. 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. 1) and Drug Interactions (7)]. Estrogen-containing drugs increase cortisol binding globulin levels which can increase plasma total cortisol levels.

1) and Drug Interactions (7)]. 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.

Any condition that elevates or lowers cortisol binding globulin levels may increase or decrease plasma total cortisol levels, respectively. Cortisol binding globulin levels can be low in cirrhosis or nephrotic syndrome. Measure cortisol binding globulin levels as necessary to ensure accuracy of interpretation of plasma total cortisol levels.

Hypersensitivity: reactions including anaphylaxis have been reported. Monitor patients for hypersensitivity reactions and treat as needed. 1) 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.

Any condition that elevates or lowers cortisol binding globulin levels may increase or decrease plasma total cortisol levels, respectively. 2, 7)

4 Contraindications CORTROSYN is contraindicated in patients with a history of hypersensitivity to cosyntropin or to any excipients of CORTROSYN. 1)]. CORTROSYN is contraindicated in patients with a history of hypersensitivity to cosyntropin or to any excipients of CORTROSYN.

Reactions have included anaphylaxis. 1)