Usual Adult Dose for Adrenocortical Insufficiency

Rapid Screening Test for Adrenal Function: 0.25 mg IV or IM once

• Dose range of 0.25 to 0.75 mg has been used in clinical studies; maximal response occurred with 0.25 mg dose
• At 30 minutes post-dose, a rise of at least 7 mcg/100 mL is expected; stimulated plasma cortisol levels less than 18 to 20 mcg/dL at 30 to 60 minutes post dose are suggestive of adrenocortical insufficiency.

Comments:

• Patients should omit pre-test doses of cortisone, hydrocortisone, or spironolactone to avoid diagnostic inaccuracies.
• An IV infusion has also been used to provide a greater stimulus to the adrenal glands; same dose infused over 4 to 8 hours with adrenal response measured by urinary steroid excretion before and after treatment or measuring plasma cortisol levels before and at the end of the infusion (preferred).
• Test results can be affected by concomitant medications and certain medical conditions.

Use: As a diagnostic drug in screening patients presumed to have adrenocortical insufficiency.

Usual Pediatric Dose for Adrenocortical Insufficiency

Rapid Screening Test for Adrenal Function:

0 to 2 years: 0.125 mg IV or IM once

3 years or older: 0.25 mg IV or IM once

• Dose range of 0.25 to 0.75 mg has been used in clinical studies; maximal response occurred with 0.25 mg dose

At 30 minutes post-dose, a rise of at least 7 mcg/100 mL is expected; stimulated plasma cortisol levels less than 18 to 20 mcg/dL at 30 to 60 minutes post dose are suggestive of adrenocortical insufficiency.

Comments:

• Patients should omit pre-test doses of cortisone, hydrocortisone, or spironolactone to avoid diagnostic inaccuracies.
• An IV infusion has also been used to provide a greater stimulus to the adrenal glands; same dose infused over 4 to 8 hours with adrenal response measured by urinary steroid excretion before and after treatment or measuring plasma cortisol levels before and at the end of the infusion (preferred).
• Test results can be affected by concomitant medications and certain medical conditions.

Use: As a diagnostic drug in screening patients presumed to have adrenocortical insufficiency.

Renal Dose Adjustments

Use caution in patients with nephrotic syndrome

• Cortisol binding globulin levels can be low in patients with nephrotic syndrome; for these patients, cortisol binding globulin levels should be measured

Liver Dose Adjustments

Use caution in patients with cirrhosis

• Cortisol binding globulin levels can be low in patients with cirrhosis; for these patients, cortisol binding globulin levels should be measured

Precautions

CONTRAINDICATIONS:

• Hypersensitivity to active substance, synthetic ACTH, or any product excipients

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:
May be administered IM or IV; however, some products for IV administration only

IV administration:

• IV injection: Add dose to 2 to 5 mL of 0.9% sodium chloride injection; administer over 2-minutes
• IV infusion: Add dose to glucose or saline solution and give at approximately 40 mcg/hour for 6 hours

IM administration:

• Reconstitute 0.25 mg with 1 mL of 0.9% sodium chloride injection; inject IM

ACTH Stimulation Test:

• Collect blood sample (6 to 7 mL) prior to injection
• Administer dose
• Collect second blood sample 30 and/or 60 minutes postdose

Storage requirements:

• Protect from light
• Store refrigerated 36F to 46F (2C to 8C); protect from freezing

General:

• Plasma cortisol levels less than 18 to 20 mcg/dL at 30 or 60 minutes post injection are suggestive of adrenocortical insufficiency.
• Test results may be affected by concomitant medications (e.g. cortisone, hydrocortisone, synthetic glucocorticoids [oral, inhaled, or injectable], spironolactone, and estrogens) or certain medical conditions (e.g., cirrhosis, nephrotic syndrome).
• Concurrent measurement of cortisol binding globulin levels is recommended; if cortisol binding globulin levels are elevated, plasma total cortisol levels should be considered inaccurate.

Monitoring:

• Monitor for hypersensitivity reactions

Patient advice:

• Read the US FDA-approved patient labeling
• Patients should understand that hypersensitivity reactions may occur.