COSYNTROPIN Drug Interactions: What You Need to Know

INTERACTIONS

• Drug effects on plasma cortisol levels: o Accuracy of the test results can be affected by concomitant medications. o Glucocorticoids and spironolactone: May falsely elevate plasma cortisol levels. Stop these drugs on day of cosyntropin for injection testing. Long-acting glucocorticoids may need to be stopped for a longer period before cosyntropin for injection testing. ( 7 ) o Estrogen: May elevate plasma total cortisol levels. Stop estrogen containing drugs 4 to 6 weeks before cosyntropin for injection testing. ( 7 )

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 cosyntropin for injection 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 cosyntropin for injection testing. Long-acting glucocorticoids may need to be stopped for a longer period before cosyntropin for injection testing.
• Estrogen: May elevate plasma total cortisol levels. Stop estrogen containing drugs 4 to 6 weeks before cosyntropin for injection 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.

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 cosyntropin for injection 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 cosyntropin for injection testing. Long-acting glucocorticoids may need to be stopped for a longer period before cosyntropin for injection testing.
• Estrogen: May elevate plasma total cortisol levels. Stop estrogen containing drugs 4 to 6 weeks before cosyntropin for injection 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.

Cosyntropin for injection is contraindicated in patients with a history of hypersensitivity to cosyntropin or to any excipients of cosyntropin for injection. Reactions have included anaphylaxis [see Warnings and Precautions ( 5.1 )] .

• Cosyntropin for injection is contraindicated in patients with a history of hypersensitivity to cosyntropin or to any excipients of cosyntropin for injection. Reactions have included anaphylaxis. ( 4 , 5.1 )

AND PRECAUTIONS

• Hypersensitivity : reactions including anaphylaxis have been reported. Monitor patients for hypersensitivity reactions and treat as needed. ( 5.1 )
• Diagnostic Inaccuracies : Cortisol levels and subsequent diagnosis of adrenocortical insufficiency following cosyntropin for injection 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. ( 2.1 , 5.2 , 7 )

5.1 Hypersensitivity to Cosyntropin for Injection Cosyntropin for 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 cosyntropin for injection 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 cosyntropin for injection testing. Long-acting glucocorticoids may need to be stopped for a longer period before cosyntropin for injection testing <span class="opacity-50 text-xs">[see Dosage and Administration ( 2.1 ) and Drug Interactions ( 7 )]</span> . Estrogen-containing drugs increase cortisol binding globulin levels which can increase plasma total cortisol levels. To obtain accurate plasma total cortisol levels, stop estrogen containing drugs four to six weeks before cosyntropin for injection testing to allow cortisol binding globulin levels to return to levels within the reference range <span class="opacity-50 text-xs">[see Dosage and Administration ( 2.1 ) and Drug Interactions ( 7 )]</span> . 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.

5.1 Hypersensitivity to Cosyntropin for Injection Cosyntropin for 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 cosyntropin for injection 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 cosyntropin for injection testing. Long-acting glucocorticoids may need to be stopped for a longer period before cosyntropin for injection testing <span class="opacity-50 text-xs">[see Dosage and Administration ( 2.1 ) and Drug Interactions ( 7 )]</span> . Estrogen-containing drugs increase cortisol binding globulin levels which can increase plasma total cortisol levels. To obtain accurate plasma total cortisol levels, stop estrogen containing drugs four to six weeks before cosyntropin for injection testing to allow cortisol binding globulin levels to return to levels within the reference range <span class="opacity-50 text-xs">[see Dosage and Administration ( 2.1 ) and Drug Interactions ( 7 )]</span> . 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.